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Ottawa Panel Evidence-Based Clinical Practice Guidelines for Electrotherapy and Thermotherapy Interventions in the Management of Rheumatoid Arthritis in Adults

Ottawa Methods Members

Lucie Brosseau

Physiotherapy Program, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario, Canada

George A Wells

Department of Epidemiology and Community Medicine, University of Ottawa

Peter Tugwell

Centre for Global Health, Institute of Population Health, Ottawa, Ontario, Canada

Mary Egan

Occupational Therapy Program, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa

Claire-Jehanne Dubouloz

Occupational Therapy Program, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa

Lynn Casimiro

Physiotherapy Program, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa

Vivian A Robinson

Centre for Global Health, Institute of Population Health

Lucie Pelland

Physiotherapy Program, School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa

Jessie McGowan, Director

Medical Library, Centre for Global Health, Institute of Population Health

External Experts

Mary Bell

Sunnybrook and Women's College Health Sciences Centre, Toronto, Ontario, Canada

Hillel M Finestone

Sisters of Charity of Ottawa Health Service, Ottawa, Ontario, Canada

France Légaré

University of Laval, Québec City, Québec, Canada

Catherine Caron

Sisters of Charity of Ottawa Health Service

Sydney Lineker

The Arthritis Society, Ontario Division, Research Co-ordinator, Toronto, Ontario, Canada

Angela Haines-Wangda

Ottawa Hospital, General Campus, Ottawa, Ontario, Canada

Marion Russell-Doreleyers

who practices acupuncture, MSc, Canadian Physiotherapy Association and Ottawa Arthritis Rehabilitation and Education Program, Ottawa, Ontario, Canada

Martha Hall

Canadian Association of Occupational Therapists and Ottawa Arthritis Rehabilitation and Education Program

Paddy Cedar

patient with rheumatoid arthritis (named with her written permission)

Assistant Manuscript Writer

Marnie Lamb

School of Rehabilitation Sciences, Faculty of Health Sciences, University of Ottawa

Address all correspondence and requests for reprints to: Lucie Brosseau, PhD, Physiotherapy Program, School of Rehabilitation Sciences, Faculty of Health Sciences, 451 Smyth Rd, University of Ottawa, Ottawa, Ontario, Canada K1H 8M5 (lbrossea{at}uottawa.ca)

	Abstract

 
Background and Purpose. The purpose of this project was to create guidelines for electrotherapy and thermotherapy interventions in the management of adult patients (>18 years of age) with a diagnosis of rheumatoid arthritis according to the criteria of the American Rheumatism Association (1987). Methods. Using Cochrane Collaboration methods, the Ottawa Methods Group identified and synthesized evidence from comparative controlled trials. The group then formed an expert panel, which developed a set of criteria for grading the strength of the evidence and the recommendation. Patient-important outcomes were determined through consensus, provided that these outcomes were assessed with a validated and reliable scale. Results. The Ottawa Panel developed 8 positive recommendations of clinical benefit. Lack of evidence meant that the panel could not gauge the efficacy of electrical stimulation. Discussion and Conclusion. The Ottawa Panel recommends the use of low-level laser therapy, therapeutic ultrasound, thermotherapy, electrical stimulation, and transcutaneous electrical nerve stimulation for the management of rheumatoid arthritis.

Key Words: Clinical practice guidelines • Electrotherapy • Epidemiology • Evidence-based practice • Physical rehabilitation • Rheumatology • Rheumatoid arthritis • Thermotherapy

	Introduction

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

 
Rheumatoid arthritis (RA) affects a large proportion of the population. The Arthritis Foundation reported that more than 2.1 million Americans have the disease.¹ The prevalence of RA is increasing with the aging population in industrial countries.² Rheumatoid arthritis is recognized as an important source of disability and handicap, which leads to considerable socioeconomic costs resulting from medical and surgical interventions and from frequent absences from work.^2,3

A patient is said to have RA if he or she satisfies at least 4 of the following 7 American Rheumatism Association (ARA) criteria: (1) morning stiffness, (2) arthritis of 3 or more joints, (3) arthritis of the hand joints, (4) symmetric arthritis, (5) rheumatoid nodules, (6) serum rheumatoid factor, or (7) radiologic changes.⁴ A classification of functional capacity frequently used in patients with RA is described as: (I) complete functional capacity with ability to carry out all usual duties without handicaps, (II) functional capacity adequate to conduct normal activities despite handicap of discomfort or limited mobility of one or more joints, (III) functional capacity adequate to perform only a few or none of the duties of usual occupation or of self-care, or (IV) largely or wholly incapacitated with patient bedridden or wheelchair-bound, permitting little or no self-care.²

The rehabilitation approach to the management of RA⁵ has 9 goals: (1) to decrease pain, (2) to decrease effusion (joint swelling), (3) to decrease stiffness, (4) to correct or prevent joint deformity, (5) to increase range of motion (ROM), (6) to increase muscle force, or decrease weakness, (7) to improve mobility and walking, (8) to increase physical fitness or reduce fatigue, and (9) to increase functional status.

Electrotherapeutic modalities and thermotherapy physical agents are used as part of a rehabilitation program offered mainly for pain and inflammation relief in the management of various musculoskeletal conditions.^2,6,7 The electrotherapeutic modalities and thermal agents have been used primarily to reduce pain, effusion, and stiffness in RA. These therapeutic interventions also indirectly contribute to increased ROM, muscle force, mobility, walking ability, functional status, and physical fitness. Thus, electrotherapy and thermotherapy are promising interventions, especially for inflammatory polyarthritis such as RA, which could present subacute and chronic inflammatory symptoms depending on the stage of the disease (eg, chronic stage >1 year).

Electrotherapy and thermotherapy offer several advantages. They are noninvasive interventions that present very few adverse side effects and contraindications compared with a large number of pharmacologic interventions. Electrotherapy and thermotherapy are rapid to administer and are convenient for community-based settings; the modalities and agents either can be found at home (eg, ice packs) or are portable (for instance, the electrotherapy devices for transcutaneous electrical nerve stimulation [TENS] or low-level laser therapy [LLLT]). The effectiveness of electrotherapy and thermotherapy in the management of RA has been reported in systematic or literature reviews.^8–18

Trials on the efficacy of LLLT have been systematically reviewed for RA.^12,13 The experimental and placebo groups in the reviewed studies showed a significant difference (P<.05), suggesting that LLLT is effective for reducing pain and morning stiffness and increasing ROM.^12,13 However, other reviews^8,9 that were not conducted systematically did not yield reports of any effect of LLLT for musculoskeletal pain relief.

To our knowledge, only one systematic review¹⁷ exists on the efficacy of therapeutic ultrasound in the management of RA. The review, involving RA of the hand, found a significant difference (P<.05) between experimental and control groups on reduced number of painful and swollen joints. However, ultrasound combined with an exercise program was not effective for these outcome measures. Four other meta-analyses on the effects of therapeutic ultrasound^19–22 showed no evidence of clinically important or statistically significant results to support the effectiveness of therapeutic ultrasound in reducing musculoskeletal pain. However, these meta-analyses related to musculoskeletal or heel pain and not specifically to RA. They also have not been updated.

For thermotherapy for RA, the results of a systematic review¹⁵ showed that the application of hot packs or ice packs had no effect on measures of disease activity, including joint swelling, pain, medication intake, ROM, grip force, and hand function compared with a control (no intervention). However, paraffin baths combined with therapeutic exercises for arthritic hands showed positive results on measures of pain on nonresisted motion, ROM, and stiffness, but not on grip force and pinch function, compared with a control after 4 consecutive weeks of intervention. No beneficial effects were observed for an application of paraffin alone compared with a control for any of these measures.

In a recent systematic review on the efficacy of TENS in the management of RA,¹⁶ statistically significant results were observed for pain relief at rest for acupuncture-like (low frequency combined with high intensity) TENS compared with placebo. Conventional (high frequency combined with low intensity) TENS showed statistically significant benefit over a placebo for tenderness intensity. Similar results were obtained in previous review articles on pain management in musculoskeletal conditions^23,24 and in rheumatology conditions.^16,25 A systematic review conducted by Pelland et al¹⁸ showed that electrical stimulation had effects on muscle force and endurance of the first dorsal interosseous muscle when compared with a control group that received no intervention.

To our knowledge, only 4 evidence-based clinical practice guidelines (EBCPGs) have been published specifically on electrotherapy and thermotherapy interventions for RA: The RA Management Protocol,⁵ the American College of Rheumatology's guidelines,²⁶ the American Pain Society's guidelines,²⁷ and guidelines for occupational therapists²⁸ (Appendix 1). Because it offers no specific recommendations for practitioners, the RA Management Protocol⁵ can be categorized as somewhere between an exhaustive literature review and a guideline for each specific physical agent mentioned in this article. Regardless, the 4 sets of guidelines have several drawbacks: (1) they were developed for limited clinical practice areas; (2) although the EBCPGs were based on the current scientific literature, a nonstandardized approach was used to synthesize the scientific results, meaning that the evidence of intervention efficacy was not clear or precise, especially when conflicting results were present; (3) the raw data of each article were not analyzed and synthesized using Cochrane Collaboration systematic methods; (4) the studies reviewed were not based on a systematic literature search; (5) the scientific results of each study were reviewed, but no synthesis was carried out; (6) no rigorous grading system was used to assess the evidence; and (7) no recent updating has been completed for most of the guidelines.

The generally positive results from the recent meta-analyses and the lack of up-to-date and rigorously developed EBCPGs on electrotherapy and thermotherapy suggest a need for the development of better-quality EBCPGs for these interventions. Evidence suggests that quality of care can be improved through the use of EBCPGs.^29–32 The aim of developing these guidelines was to promote appropriate use of electrotherapy and thermotherapy in the management of RA. These guidelines are aimed at various users, including physical therapists, physicians, and patients. This article discusses only LLLT, therapeutic ultrasound, TENS, electrical stimulation, and thermotherapy (including, for the purposes of this article, both cryotherapy and heat therapy).

	Methods

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

 
For this project, we used the same methods that were used in a previous study conducted by the Ottawa Panel on therapeutic exercises.³³ The methods have been explained in full in a previous article,³³ which discusses all relevant areas: population, trial designs, outcomes, theoretical framework, literature search, selection criteria, statistical analysis, and guideline review. Briefly, an a priori protocol was defined, and it guided separate systematic reviews for each intervention. Positive recommendations were sent to 5 practitioners—a physical therapist, an occupational therapist, a physiatrist, a family physician, and a rheumatologist—for comments.

	Results of Literature Search

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

 
The literature search identified 14,111 potential RA-related articles for electrotherapy and thermotherapy. Of these, several publications were considered potentially relevant based on the selection criteria checklist: (1) for LLLT, 11 articles^34–44 (Tabs. 1 and 2) were initially considered relevant and 5 randomized controlled trials (RCTs) involving 204 patients with RA^34–38 were ultimately included; (2) for therapeutic ultrasound, 8 studies^45–52 (Tabs. 3 and 4) were initially included and 1 RCT involving 50 patients⁴⁵ was ultimately included; (3) for thermotherapy, 23 trials were initially included^{47,49,53–74} (Tabs. 5 and 6) and 2 RCTs involving 76 patients^53,54 were ultimately included; and (4) for TENS, 9 articles were initially included^50,75–82 (Tabs. 7 and 8) and 3 RCTs involving 78 patients^75–77 were ultimately included (Appendix 2–5).

Summary of trials.
Five placebo-controlled RCTs were included (Tab. 1).^34–38 In these RCTs, the LLLT treatment schedule ranged from 2 to 3 sessions a week and from 4 to 10 consecutive weeks. The dosage ranged between 2.7 and 8.1 J/cm². All RCTs used a gallium-aluminum-arsenide laser medium,^34–37 except for that of Walker et al,³⁸ who used a helium-neon type of laser. Walker et al³⁸ also used LLLT to irradiate both painful RA joints and the appropriate superficial nerve, whereas other investigators^34–37 treated only the RA joints (Appendix 2). Four trials^39–42 were excluded because of the lack of an appropriate control group, one trial⁴³ was excluded because the abstract did not provide enough statistical data to be analyzed, and one trial⁴⁴ was excluded because it was a duplicate of an included study (Tab. 2).

Efficacy.
A clinically important benefit was demonstrated for pain relief. Four RCTs^34–36,38 (n=169) demonstrated a significant difference (weighted mean difference [WMD]=–1.05 cm on a 10-cm visual analog scale [VAS], 95% confidence interval [CI]=–1.58 to –0.53 cm) and percentage reductions in pain relative to a control group. Relative reductions in pain were –28% in patients with RA affecting 2 or more groups of joints,³⁴ –25% in patients at a chronic stage,³⁵ –19% in patients with RA according to ARA criteria,³⁸ and –22% in patients with active RA³⁶ (Tab. 9, Fig. 1). For consistency in Figures 1 through 4 the results obtained for the intervention groups are presented on the left of the central vertical line representing no difference (value 0) between groups compared and the results obtained for the control or placebo groups are presented on the right of the central vertical line representing no difference (value=0) between groups compared. Two RCTs^36,37 (n=57) demonstrated a difference in favor of LLLT compared with a placebo (WMD=–1.26 cm, 95% CI=–1.72 to –0.85 cm) in increasing ROM in the hand (–76% to –142% relative difference). The trial by Palmgren et al³⁷ involved only patients with RA. However, the tip-to-palm distance measurement was not considered a valid outcome according to the American Society of Hand Therapists⁸³ (Tab. 10, Fig. 1). No clinically important benefit was shown for tender joints (Ritchie Articular Index) or function (Fig. 1), and the results for grip force conflicted (Tab. 11, Fig. 1).

View larger version (26K): [in this window] [in a new window]   Figure 1. Low-level laser therapy (LLLT) versus placebo. ROM=range of motion, VAS=visual analog scale, HAQ=Health Assessment Questionnaire, MCP=metacarpophalangeal joint.

View larger version (28K): [in this window] [in a new window]   Figure 2. Ultrasound versus placebo.

View larger version (16K): [in this window] [in a new window]   Figure 3a. Cryotherapy versus control.

View larger version (29K): [in this window] [in a new window]   Figure 3b. Wax and exercise versus control. ROM=range of motion, VAS=visual analog scale.

View larger version (15K): [in this window] [in a new window]   Figure 4a. High-frequency transcutaneous electrical nerve stimulation (TENS) versus placebo (no TENS). VAS=visual analog scale.

View larger version (17K): [in this window] [in a new window]   Figure 4b. High-frequency transcutaneous electrical nerve stimulation (TENS) versus placebo (no TENS), after intervention, same day. VAS=visual analog scale.

Clinical recommendations compared with other guidelines.
The Ottawa Panel believes that the evidence supports the inclusion of LLLT applied to the foot, knee, or hand as an intervention for the reduction of pain associated with RA (grade A for pain). Low-level laser therapy has not been assessed by other RA guidelines (Appendix 1).

Practitioners' response to Ottawa Panel guidelines.
All surveyed practitioners found the Ottawa Panel's recommendation for LLLT clear. Two practitioners agreed with the recommendation, and 1 practitioner disagreed with the recommendation (although the Ottawa Methods Group sent the recommendations to 5 practitioners, only 3 practitioners responded in this case).

Therapeutic Ultrasound

Therapeutic ultrasound performed on the hand in water versus a placebo, level I (RCT): grade A for tender joints at 10 weeks (clinically important benefit); grade C for swollen joints and morning stiffness at 10 weeks (no benefit). Patients with RA involving the hand (functional class I or II, chronic stage).

Summary of trials.
One placebo-controlled RCT of therapeutic ultrasound⁴⁵ (n=50) was included (Tab. 3, Appendix 3). One trial⁴⁷ was excluded because the sample contained both subjects with RA and subjects without known pathology or impairments, one trial⁴⁶ was excluded because it contained subjects without known pathology or impairments, and the other trials^48–52 were excluded for various reasons (Tab. 4).

Continuous-wave ultrasound was applied in water to the dorsal and palmar aspects of the hand at 0.5 W/cm². The therapeutic session lasted 10 minutes on alternate days for 3 weeks for a total of 10 sessions (Appendix 3).

Efficacy.
Pain relief demonstrated a clinically important difference (–19% relative difference [Tab. 12]) and statistically significant benefits (WMD=1.20 for change in number of tender joints, 95% CI=0.45–1.95).⁴⁵ No clinically important difference was shown for swollen joints (–3% [Tab. 12]). A clinically important difference could not be calculated for grip force or ROM in patients with RA of the hand (functional class I or II, chronic stage). No clinically important difference was found for reduction of morning stiffness (–41% [Tab. 12], Fig. 2) because morning stiffness was not measured using a validated scale.^84,85

Clinical recommendations compared with other guidelines.
The Ottawa Panel believes there is good evidence that therapeutic ultrasound alone performed on the hand in water should be included as an intervention for RA (grade A for tender joints, grade C for swollen joints and morning stiffness). To our knowledge, no EBCPGs in the scientific literature have dealt with therapeutic ultrasound (Appendix 1).

Practitioners' response to Ottawa Panel guidelines.
All surveyed practitioners agreed with the Ottawa Panel's recommendation for therapeutic ultrasound and found it clear.

Thermotherapy

Cryotherapy applied to the knee joint versus a control, level I (RCT): grade C for thermographic index (measurement [in degrees Celsius] obtained using infrared thermography of the joint) at 5 days (no benefit). Patients with chronic RA, and with obvious effusion of joints.

Wax applied to the hand and wrist versus a control, level I (RCT): grade C for pain, ROM, muscle force, and function at 1 month (no benefit). Patients with functional class I or II with hands affected.

Wax applied to the hand or wrist and hand exercises versus a control, level I (RCT): grade A for ROM at 1 month (clinically important benefit), grade C+ for pain and stiffness at 1 month (clinical benefit), grade C for muscle force and function at 1 month (no benefit). Patients with functional class I or II with hands affected.

Summary of trials.
Two RCTs^53,54 (n=76) evaluated controls versus 3 different types of thermotherapy for RA-affected upper- and lower-extremity joints: (1) cryotherapy (n=24), (2) wax (n=52), and (3) wax combined with exercise (n=52) (Tab. 5, Appendix 4). The treatment duration ranged from 5 consecutive days to 3 times a week for 4 weeks. The treatment session ranged from 10 to 20 minutes (Appendix 4).

Eight RCTs were excluded for the following reasons: the absence of a control group,^58,62 the inclusion of patients postsurgery,⁷⁰ the use of patients as their own controls,⁶⁷ or the use of individuals without known pathology or impairments as controls.^47,68,69,73 Two other studies^57,63 were excluded because they had no numerical data to be analyzed. Four head-to-head studies (involving comparison of 2 groups of subjects receiving active treatments; no placebo or control group)^49,65,66,74 were not accepted, and other studies^{55,56,59–61,64,67,71,72} were excluded for various reasons (Tab. 6).

Efficacy.
For cryotherapy versus a control (n=24),⁵³ no statistically significant difference or clinically important benefits were observed for thermographic index for patients with chronic RA and obvious effusion of joints (Tab. 13, Fig. 3a). No other outcomes were reported.

Clinical recommendations compared with other guidelines.
The Ottawa Panel found good evidence (grade A for ROM; grade C+ for pain and stiffness) that thermotherapy, especially wax combined with exercise for the hand and wrist, should be included as an intervention for patients with RA. This recommendation concurs with all existing guidelines (Appendix 1).^5,25,27

Practitioners' response to Ottawa Panel guidelines.
All practitioners surveyed agreed with the recommendations for thermotherapy and found them clear.

Transcutaneous Electrical Nerve Stimulation (TENS)

Low-frequency TENS applied to the hand and wrist versus no stimulation, level I (RCT): grade A for pain at 3 weeks (clinically important benefit), grade C+ for power at 3 weeks (clinical benefit), grade C for work at 3 weeks (no benefit). Patients with chronic RA.

High-frequency TENS applied to the hand and wrist versus placebo, level I (RCT): grade C for pain and joint tenderness, same day (no benefit). Patients with chronic RA.

High- versus low-frequency TENS applied to the hand and wrist, level I (RCT): grade C+ for global patient (patient's assessment of overall disease activity or improvement)³³ at 2 weeks (clinical benefit). Patients with chronic RA.

Summary of trials.
Three placebo-controlled RCTs involving TENS (n=78)^75–77 were included (Tab. 7, Appendix 5). Three types of TENS were prescribed: (1) low–frequency (0-70 Hz), acupuncture-like TENS versus no stimulation (n=26),⁷⁵ (2) high-frequency (70–100 Hz), conventional TENS versus a placebo (n=33),⁷⁶ and (3) high- versus low-frequency TENS (n=19).⁷⁷ Thus, both high-frequency TENS^76,77 and low-frequency TENS^75,77 were provided to patients with RA. The therapeutic application of TENS ranged from 5 to 20 minutes a session and from 1 to 15 consecutive sessions for up to 3 consecutive weeks (Appendix 5).

One trial⁷⁹ with a sample size of fewer than 5 patients per group was excluded. One trial⁸⁰ was excluded because the enrolled patients were the control, one trial⁷⁸ was excluded because it involved a sample of patients with total knee replacement who had preoperative osteoarthritis or RA of the knee, another trial⁸² was excluded because it offered no numerical data to be analyzed, and other trials^50,81 were excluded for different reasons (Tab. 8).

Efficacy.
For low-frequency TENS versus no stimulation,⁷⁵ a clinically important benefit was demonstrated for pain relief (–67% relative difference [Tab. 16]), and this outcome was statistically significant (WMD=–59.50 mm on a 100-mm VAS, 95% CI=–76.58 to –42.42 mm; Fig. 4a) for patients with chronic RA. Power (in watts) was improved by 55% compared with baseline. This outcome, however, was not statistically significant in TENS compared with a placebo at 3 weeks. Work (in joules) scores showed little difference between TENS and a control (Tab. 17, Fig. 4a).

View larger version (19K): [in this window] [in a new window]   Figure 4c. High- versus low-frequency transcutaneous electrical nerve stimulation (TENS), 2 weeks.

Clinical recommendations compared with other guidelines.
According to the Ottawa Panel, there is good evidence (grade A for pain, grade C+ for global patient and power) suggesting that TENS alone should be included as an intervention for management of RA in the hand and wrist. The Ottawa Panel partially agrees with The Arthritis Society,⁵ which recommends the use of TENS for pain and joint swelling in patients with RA. The American Pain Society²⁶ gives TENS a fair recommendation for pain relief (Appendix 1).

Practitioners' response to Ottawa Panel guidelines.
All practitioners surveyed agreed with the Ottawa Panel's TENS recommendations and found them clear.

Electrical Stimulation of Muscle

Evidence with acceptable research design, interventions, group comparisons, or outcomes could not be identified to guide the development of recommendations for electrical stimulation of muscle. To our knowledge, no EBCPGs exist on electrical stimulation for RA conditions.

	Discussion

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

 
In the area of rehabilitation for RA, evidence-based practice is gaining popularity.^{5,7,25–27,86,87} The Ottawa Panel's systematic review revealed that one or more controlled clinical trials (CCTs) demonstrated some clinically important benefits of electrotherapy and thermotherapy interventions for patients with RA. The Ottawa Panel developed several EBCPGs (n=8 with grade A, B, or C+ recommendations) for these interventions. However, other current clinical interventions for RA still need this evidence to prove their effectiveness (n=16 with grade C recommendations and n=4 with insufficient data).

Credibility of Guidelines

The Ottawa Panel's EBCPGs on electrotherapy and thermotherapy (grouped together in Appendix 6) for the management of RA are generally in accordance with other EBCPGs (Appendix 1). An earlier expert panel (the Philadelphia Panel) agreed on a systematic grading of the evidence for EBCPGs, and the Ottawa Panel's EBCPGs were based on this grading system. The evidence for the Ottawa Panel's EBCPGs came from systematic reviews and meta-analyses that used Cochrane Collaboration methods or similar methods. To ensure that the guidelines were applicable and easy for clinicians to use, several practitioners sat on the Ottawa Panel. Their involvement supports the credibility of the guidelines.

The development of the draft EBCPGs was done in accordance with Appraisal of Guidelines Research and Evaluation (AGREE) criteria.⁸⁸ On dimensions 1 (purpose), 2 (stakeholder involvement), 4 (clarity), and 6 (editorial independence), the guidelines received excellent scores. Dimensions 3 (rigor of development) and 5 (applicability) received lower scores. Inadequate reporting of side effects and risks, which were not reported in the primary trials and therefore not included in the guidelines, lowered the rigor of development score. In identifying cost implications, potential organizational barriers, and methods of applying and monitoring the guidelines, the EBCPGs' applicability was low. Exact scores and a decision aid tool are available on the University of Ottawa School of Rehabilitation Sciences' Web page (http://www.health.uottawa.ca/EBCpg/english/main.htm).

LLLT

According to the Ottawa Panel, there is good evidence suggesting that LLLT should be included as an intervention for reducing RA-related pain. The use of this modality fulfills one intervention goal of the RA Management Protocol.⁵ The Ottawa Panel's position agrees with those of previous systematic reviews.^12,13

Several physiological studies confirm the pain relief observed among patients with RA managed with LLLT. Low-level laser therapy irradiation positively modifies the peripheral nerve activity and provides a reduction in the sensation of the pain,⁷ particularly in long-standing pain such as that associated with RA.⁸⁹ One proposed animal model theory is that LLLT enhances the action of superoxide dismutase, which prevents the proliferation of prostaglandin E.⁹⁰ Other physiological studies in rats⁹¹ and in humans^92–94 suggest a plausible mechanism of action for LLLT stimulation-produced analgesia. This beneficial physiological effect was observed in humans both at the end of intervention and at 1- and 3-month follow-up examinations.⁹⁴ Physiological studies concerned with the inflammatory process suggest that exposure to LLLT results in anti-inflammatory and analgesic effects,⁹⁵ normalization of the permeability of the synovial membrane,⁹⁵ enhancement of regional microcirculation, reduction of exudative and infiltrative fluids, increased synovial membrane fibrosis,⁹⁶ and increased protein synthesis of synovial cells, a synthesis that indicates a regenerative process in the damaged synovial membrane.^97,98

The evidence suggests that LLLT could be applied without the addition of other physical therapy interventions to solve a specific RA pain-related problem. Because LLLT is rapid to administer and portable devices are available, it offers advantages for community-based services such as the Arthritis Rehabilitation and Education Program of The Arthritis Society (Canada). Further studies are needed to determine the optimal LLLT wavelength, dosage, application techniques, and duration of intervention and to determine long-term effects in patients with RA.⁹⁹

Therapeutic Ultrasound

According to the Ottawa Panel, therapeutic ultrasound without the addition of other physical therapy interventions is effective for reducing joint tenderness caused by RA. Our results do not seem to concur fully with those of previous systematic reviews^19–22 conducted for all musculoskeletal conditions. Perhaps continuous ultrasound¹⁰⁰ is more effective for patients with RA whose condition is chronic and marked by a medium level of disease activity⁴⁵ than for individuals with acute musculoskeletal conditions.

The use of continuous ultrasound is supported by its documented physiological effects.^7,100,101 The mechanical effect of both pulsed and continuous ultrasound increases skin permeability, thus decreasing inflammatory response, reducing pain, and facilitating the soft tissue healing process. Furthermore, both pulsed and continuous ultrasound reduce nerve conduction velocity of pain nerve fibers. Continuous ultrasound, however, has thermal effects that reduce muscle spasms and pain. The thermal effects also cause vasodilation, which enhances the excretion of chronic inflammatory cells.^7,100

Thermotherapy

The Ottawa Panel found good evidence that thermotherapy, especially paraffin baths combined with exercise, should be included as an intervention for patients with RA to improve ROM and decrease pain and hand stiffness. This recommendation agrees with all existing guidelines^5,25–27 on improving pain and is partially supported by Nicholas,¹⁰² who concluded that the current literature in rheumatology does not provide clinicians with precise information on dosage or duration, or specific indications for heat or cold therapy in therapeutic application.

The Ottawa Panel found insufficient evidence on the efficacy of cryotherapy, although physiological studies have shown effects on circulatory and temperature responses, muscle spasms, and inflamed tissue.^9,103 Cryotherapy's mechanism of action has not yet been fully elucidated.¹⁰³ Whether these physiological effects translate to important clinical outcomes (such as pain and functional status) is unknown.

The beneficial effects observed for paraffin baths combined with therapeutic exercises for arthritic hands—effects on measures of ROM, stiffness, and pain on nonresisted motion—concur with the physiological and therapeutic effects such as facilitation of soft tissue healing, decrease of pain by reducing muscle spasms, and reduction of joint stiffness.⁷ Thermotherapy using paraffin baths combined with exercise for RA is more effective as an adjunct therapy than it is alone. The combination of several concurrent therapies within the same treatment session reflects current physical therapist practice⁶ where heat therapy is used for its reflex vasodilative effect, which increases cell metabolism and blood flow⁷ for an optimal muscle preparation before hand exercises. The combination of wax and exercises can introduce confounders. Indeed, endorphin and enkephalin production is stimulated by exercise.¹⁰⁴ The reduction of arthritic pain also could be observed when exercise is combined with a thermotherapy modality.¹⁵

TENS

According to the Ottawa Panel, there is good evidence showing that acupuncture-like TENS alone should be included as an intervention for RA to decrease pain and improve power. However, patients with RA seem to prefer conventional TENS application compared with acupuncture-like TENS.⁷⁷ The Ottawa Panel partly agrees with The Arthritis Society,⁵ which views TENS as beneficial for pain and joint swelling in patients with RA. Our results concur with the conclusions of several descriptive literature reviews.^16,23,24,102

The neuroregulatory peripheral and central effects^89,105–107 of TENS have been proposed to be more effective with higher-intensity applications.⁷⁵ This effect was observed in the study involving acupuncture-like (higher-intensity) application compared with a placebo.⁷⁵ However, both conventional and acupuncture-like TENS excite afferent fibers in the A-alpha-beta range.¹⁰⁸ The plausible effect is explained by the activation of intrinsic pain-suppressive systems^109,110 and the concomitant release of opiate observed in both animals¹¹¹ and humans.¹⁰⁵ The importance of the stimulation parameters in TENS analgesia is shown in animal and human research. Changes in frequency recruit different opioid receptors, for example, and therefore an awareness of the parameters used during TENS treatments is essential.^112,113 Several investigators^114–116 have recommended that vibrator stimulation be part of TENS application, especially when TENS is being applied for relief of chronic pain.

Electrical Stimulation of Muscle

Electrical stimulation of muscle is one of the therapeutic interventions available to minimize the loss of joint mobility and function by enhancing muscle performance in patients with RA.^18,117 However, despite the potential benefits of electrical stimulation in RA management, only one CCT¹¹⁷ was identified for this intervention, and the study was ultimately rejected because the control group included fewer than 5 patients, indicating a very low statistical power. This CCT¹¹⁷ is also considered a head-to-head study because 2 methods of stimulation were compared.

Clinically, electrical stimulation is used to facilitate effective muscle force and endurance in situations involving a decrease in the voluntary recruitment of the muscle. Electrical stimulation helps to increase this recruitment in subjects without known pathology or impairments. However, patients with RA are not able to voluntarily recruit motor units to the level required for the performance of high-intensity exercises needed to enhance muscle function,¹⁸ and electrical stimulation does not help these patients, who have chronic muscle weakness. Furthermore, the Ottawa Panel does not recommend high-intensity exercises for patients with RA.³³ Musculoskeletal dysfunction, including pain and muscle disuse atrophy that are observed in patients with RA, may cause decreased voluntary recruitment.

Although the biophysical actions of many physical therapy interventions are partially understood, further investigation needs to be undertaken in several areas of physical therapy research, particularly that involving rheumatology: the mechanism of action; the differential effects of dose, of wavelength, and of treatment duration⁹⁹; disease staging and treatment combinations; and the relationship of pain, impairment, and disability. To reproduce the results of published RCTs, it is crucial that details on various kinds of characteristics be systematically reported. Characteristics include those of the device (eg, size of the ultrasound head or temperature of the paraffin); those of the therapeutic application (eg, specific area of application or mode of application); duration of the intervention; and schedule of intervention. Characteristics of the population such as age, sex, concurrent interventions, and disease status (eg, acuity and joint involvement) also must be reported.

	Conclusion

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

 
Despite the fact that the scientific literature is limited in quantity, good-quality evidence exists to recommend and support the use of LLLT, ultrasound, thermotherapy, and TENS for the management of RA. Conversely, evidence is lacking as to whether the use of electrical stimulation should be included or excluded in physical rehabilitation for RA management.

The main difficulty in determining the effectiveness of rehabilitation interventions is the lack of well-designed prospective RCTs. Future research in physical therapy should adopt rigorous methods such as the use of an appropriate placebo (and double-blind procedure), adequate randomization, a homogeneous sample of patients based on rigorous selection and diagnostic criteria, and an adequate sample size to detect clinically important differences with confidence.

Unfortunately, at present, there is insufficient evidence to recommend or not recommend the use of several modalities and physical agents in certain clinical circumstances. The main difficulty is the lack of studies available and the methodological weaknesses in those studies: the variation in the quality of the included trials (sometimes because the randomization procedure is not described properly), the difficulty of masking patients to a physical agent or modality,¹¹⁸ and the lack of standardized outcomes.^2,99

	Appendix 1

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

 

View larger version (28K): [in this window] [in a new window]   Appendix 1. Previous Clinical Practice Guidelines for Rheumatoid Arthritisa

	Appendix 2

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

View larger version (124K): [in this window] [in a new window]   Appendix 2. Included Trials for LLLTa

	Appendix 3

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

View larger version (34K): [in this window] [in a new window]   Appendix 3. Included Trials for Therapeutic Ultrasounda

	Appendix 4

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

View larger version (54K): [in this window] [in a new window]   Appendix 4. Included Trials for Thermotherapya

	Appendix 5

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

View larger version (73K): [in this window] [in a new window]   Appendix 5. Included Trials for TENSa

	Appendix 6

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

View larger version (69K): [in this window] [in a new window]   Appendix 6. Clinical Practice Guidelines

	Footnotes

 
This study was financially supported by The Arthritis Society (Canada); the Ontario Ministry of Health and Long-Term Care (Canada); the Career Scientist Salary Support Program, University of Ottawa for Dr Brosseau; the University Research Chair Program for Dr Brosseau; and the Ministry of Human Resources, Summer Students Program (Canada).

Acknowledgments: The Ottawa Panel is indebted to Ms Catherine Lamothe, Ms Shannon Rees, Mr Shaun Cleaver, Ms Lucie Lavigne, Mr Guillaume Léonard, Ms Marie-Andrée Ouimet, Mr Martin Campbell, Ms Isabelle Blais, Ms Simon Barsoum, Ms Judith Robitaille, and Ms Karin Phillips for their technical support and help in data extraction.

	References

Top Abstract Introduction Methods Results of Literature Search Discussion Conclusion Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 References

 

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