Osteoarthritis year 2010 in review: non-pharmacologic therapy.

Authors: Hawker G (1) , Mian S (2) , Bednis K (2) , Stanaitis I (2)
Affiliations:
(1) Canadian Osteoarthritis Research Program, Women's College Research Institute, Women's College Hospital, University of Toronto (2) Department of Medicine, University of Toronto
Source: Osteoarthritis Cartilage. 2011 Apr;19(4):366-74
DOI: 10.1016/j.joca.2011.01.021 Publication date: 2011 E-Publication date: Feb. 13, 2011 Availability: full text Copyright: © 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
Language: English Countries: Not specified Location: Not specified Correspondence address: Hawker GA : Canadian Osteoarthritis Research Program, Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto, ON M5S 1B2, Canada. g.hawker@utoronto.ca

Keywords

Article abstract

OBJECTIVE:

To highlight seminal publications in the past year on the topic of non-pharmacologic management of osteoarthritis (OA).

DESIGN:

A systematic search of the PUBMED and Cochrane databases from September 2009 to September 2010 was conducted to identify articles reporting on studies examining the safety or efficacy of non-pharmacologic therapies in the management of OA. Non-pharmacologic therapies were those considered in the 2008 OARSI OA guidelines. Identified articles were reviewed for quality; those of highest quality and deemed to have greatest potential impact on the management of OA were summarized.

RESULTS:

The search identified 117 unique articles. Of these, four studies were chosen to highlight. A nested two-stage trial found that traditional Chinese acupuncture (TCA) was not superior to sham acupuncture, but that the providers' style affected both pain reduction and satisfaction with treatment, suggesting that the analgesic benefits of acupuncture may be partially mediated by the acupuncturists' behavior. A systematic review found little evidence of a significant effect for electrostimulation vs sham or no intervention on pain in knee OA. A single-blinded trial of Tai Chi vs attention controls found that 12 weeks of Tai Chi was associated with improvements in symptoms and disability in patients with knee OA. A randomized trial of early ACL reconstructive surgery and rehabilitation vs structured rehabilitation alone in subjects with acute anterior cruciate ligament tears found that, at 24 months following randomization, all study participants had improved, suggesting that a strategy of structured rehabilitation followed acute ACL injury may preclude the need for surgical reconstruction.

CONCLUSIONS:

High quality studies of the safety and efficacy of non-pharmacologic agents in the management of OA remain challenging due to difficulties with adequate blinding and appropriate selection of attention controls. High quality studies suggest modest, if any, benefit of many non-pharmacologic therapies over attention control or placebo, but a significant impact of both over no intervention at all.

Article content

Introduction

Non-pharmacologic management of osteoarthritis (OA) is fundamental to effective symptom relief and management of functional limitations. This review sought to highlight studies published over the prior year, since the 2009 meeting of the Osteoarthritis Research Society International, OARSI, pertaining to advances in the non-pharmacologic management of OA.

 

Methods

A systematic search of PUBMED and the Cochrane databases was conducted to identify English language publications evaluating the efficacy and/or safety of non-pharmacologic therapies in the management of OA. Each non-pharmacologic treatment modality was searched separately using medical subject heading (MESH) terms and key words. Non-pharmacologic therapies were those included in the 2008 OARSI guidelines for the management of hip and knee OA120: acupuncture; manual therapy; physical therapy; devices (including orthoses, orthotics, footwear, walking aids); education and self-management; weight loss; transcutaneous electrostimulation or Transcutaneous electrical nerve stimulation (TENS); thermal modalities; nutraceuticals; and surgery and rehabilitation. In addition, the Cochrane database was searched for all reviews on OA over the same time period. Articles were included for consideration if they addressed management of OA using any of the non-pharmacologic therapies. Eligible papers were reviewed for quality (e.g., randomization, blinding and treatment concealment, intent-to-treat analysis approach). Studies selected for inclusion in the review presentation were those deemed by the author to be of high quality with potential to affect the management of OA in clinical practice.

 

Results

Our search identified 117 unique publications on the non-pharmacologic management of OA over the study time period: eight general reviews of the non-pharmacologic management of OA 1, 2, 3, 4, 5, 6, 7, 8; 14 studies of acupuncture 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22; 10 studies of devices 23, 24, 25, 26, 27, 28, 29, 30, 31, 32 (including seven of orthoses 23, 24, 25, 26, 28, 29, 32, two of splints or braces30, 31, and one of temporomandibular joint therapy27); three studies evaluating education or self-management33, 34, 35; 25 studies of exercise36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60; 12 studies of nutraceuticals61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, including five of glucosamine62, 63, 64, 65, 69; 12 of physical therapy73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84; one of manual therapy85; 11 studies evaluating rehabilitation in the context of surgery86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96; five of electrostimulation97, 98, 99, 100, 101, including two evaluating TENS 99, 101; two of weight loss102, 103; one of thermal modalities 104; two of ultrasound 105, 106and 11 of other forms of non-pharmacologic management, including three of spa therapy107, 108, 109, two of mud-bath therapy110, 111, and one each of: Castor oil/diclofenac sodium112; magnetic and copper bracelets113; stimulating massage114; hydrotherapy115; hyperthermia116; guided imagery with relaxation117. The results of our search are summarized in Table I, by modality and study design. Of these, four papers were selected by the authors for detailed review.

Table IResults of systematic search for studies of non-pharmacologic therapies in OA (Sept 2009–Sept 2010)
Modality N Citations
Exercise 25  
 Exercise (general) 13 RCTs (n=9)

(1=Double-blind46; 1=Intervention trial37; 1=Pre-post intervention study40; 1=Feasibility trial48; 1=Non-equivalent, Pretest-Posttest54; 3=RCT49, 53, 55; 1=Quasi-randomized control trial52)

Reviews (n=4)

(2=Systematic reviews50, 51; 2=Reviews41, 47)
 
 Aquatics 3 RCTs (n=3)

(1=Double-blind39; 2=RCTs36, 38)
 
 Continuous passive motion 5 RCTs (n=4)

(1=Double-blind crossover study56; 3=RCT42, 44, 45)

Reviews (n=1)

(1=Systemic review of RCTs43)
 
 Tai Chi 4 RCTs (n=4)

(1=Prospective, single-blind57; 1=Attention controlled clinical trial58; 1=Experimental design59; 1=RCT60)
 
Physical therapy 12 RCTs (n=9)

(1=Double-blind, clinical75;1=Prospective, placebo controlled clinical trial76; 1=Single-blind, cluster77; 1=Single-blind74; 1=Non-randomized controlled design80; 1=Cohort trial, quasi-experimental sequential79; 3=RCT81, 82, 84)

Observational study (n=1)

(1=Prospective cohort study73)

Reviews (n=2)

(1=Literature review83; 1=Case report78)
 
Rehabilitation in surgery 11 RCTs (n=4)

(1=Mulitcentre90 ; 3=RCT 88, 94, 95)

Intervention (n=4)

(1=Multicentre RCT91; 1=Retrospective analysis93; 1=Prospective, non-blinded96; 1=RCT89)

Reviews (n=3)

(1=Descriptive study – prospective, retrospective87; 2=Reviews86, 92)
 
Devices 11  
 Orthosis 7 Trials (n=4)

(1=Controlled trial24; 1=Trial26; 2=RCT25, 32)

Reviews (n=3)

(1=Systematic review23; 1=Clinical intervention strategies - literature review29; 1=Review28)
 
 Splints & Braces 2 RCTs (n=2)

(1=Single-blind31; 1=RCT30)
 
 Other: TMJ 1 RCTs (n=1)

(1=RCT27)
 
Acupuncture 14  
 Acupuncture 7 RCTs (n=5)

(2=Double-blind9, 21; 2=Single-blind12, 22; 1=RCT13)

Reviews (n=2)

(1=Systematic review10; 1=Critical review11)
 
 Electropuncture 2 RCTs (n=2)

(1=Single-blind, sham controlled15; 1=RCT14)
 
 Moxibustion 5 RCTs (n=5)

(3=Single-blind17, 18, 19; 1=Sham controlled clinical trial20; 1=RCT16)
 
Nutraceuticals 12  
 Nutraceuticals 7 RCTs (n=4)

(1=Double-blind67; 1=Single-blind61; 2=RCT66, 71)

Reviews (n=3)

(1=Systematic review72; 1=Review of efficacy studies70; 1=Review68)
 
 Glucosamine 5 RCTs (n=4)

(3=Double-blind placebo controlled62, 65, 69; 1=Double-blind, multicentre, comparison63)

Reviews (n=1)

(1=Systematic review of RCTs64)
 
Education & self-management 3 RCTs (n=2)

(1=Single-blind, parallel randomized33; 1=RCT34)

Reviews (n=1)

(1=Systematic literature review35)
Electrostimulation 5  
 TENS 2 Reviews (n=2)

(1=Review of RCTs99; 1=Review of randomized and quasi-randomized trials101)
 Pulsed electromagnetic field 3 RCTs (n=2)

(1=Double-blind100; 1=RCT97)

Reviews (n=1)

(1=Review98)
 
Weight loss 2 RCTs (n=2)

(1=Prospective, pragmatic with blinded-assessors’103; 1=Prospective102)
 
Manual therapy 1 Review (n=1)

(1=Systematic review of RCTs85)
 
Thermal modalities 1 RCTs (n=1)

(1=Randomized order design study104)
 
Ultrasound 2 Reviews (n=2)

(1=Systematic review – Cochrane database106; 1=Systematic review with meta-analysis105)
Other 11  
 Spa Therapy 3 RCTs (n=2)

(1=Single-blinded, prospective109; 1=Multicentre, prospective108)

Reviews (n=1)

(1=Review of RCTs107)
 
 Mud-bath Therapy 2 RCTs (n=2)

(1=Double-blinded, placebo controlled111; 1=RCT110)
 
Others

(1) Castor oil/diclofenac sodium; (2) Magnetic & copper bracelets; (3) Stimulating Massage; (4) Hydrotherapy; (5) Hyperthermia; (6) Guided imagery with relaxation
6 RCTs (n=4)

(1) 1=Double-blind, comparative study112; (2) 1=Placebo-controlled, crossover trial113; (3) 1=Crossover trial114; (4) 1=Cohort, prospective115

Reviews (n=2)

(5) 1=Systematic Review116; (6) 1=Group longitudinal randomized assignment117
All Non-pharmacologic modalities 8 Reviews (n=8)

(4=Systematic reviews3, 4, 6, 7; 1=Literature review2; 1=Evidence-based approach summary review5; 1=Literature review of clinical & experimental treatments8; 1=Review1)
 

Acupuncture

 

Background

There has been conflicting evidence regarding the efficacy of traditional Chinese acupuncture (TCA) in the management of painful knee OA. Variability in results has been attributed in particular to inadequate blinding to treatment, largely due to the use of non-penetrating needling procedures vs superficial but penetrating needling at non-acupuncture (non-meridian) sites22. Further, there have been concerns raised that the effects of placebo may be enhanced by patients’ expectations of treatment benefits, which may be influenced by the treatment provider.

 

Methods

Suarez-Almazor and colleagues conducted a nested, two-stage randomized controlled trial comparing the efficacy of TCA to that of a sham procedure for knee OA; nested within this trial, they evaluated for a moderating effect of acupuncturists’ style of communication (high or neutral expectations). Study subjects were randomized to one of three groups: (1) waiting list controls; (2) high expectations; and (3) neutral expectations. Individuals randomized to groups (2) or (3) were then re-randomized to receive either TCA or a sham procedure (sham). The sham acupuncture was comprised of shallow needling with minimal stimulation at non-meridian points; both sham and TCA were delivered using TENS equipment. Each of six participating acupuncturists was trained to deliver either a ‘high expectations’ or ‘neutral expectations’ style of communication; for the former, acupuncturists were trained to use language such as “I think this will work for you”, while the latter used language such as “It really depends on the patient”. Half way through the trial, the acupuncturists were re-trained to deliver the other style of communication. Acupuncturists received rigorous training both in their communication style as well as their performance of the intervention treatment. Multiple strategies were used to ensure blinding to allocation. Adequacy of blinding was assessed prior to recruitment in volunteers and then at study end. Using an intent-to-treat analysis, the investigators evaluated the treatment arms difference in change OA pain from baseline to 12 weeks based on the following measures: the joint-specific multidimensional assessment of pain (J-MAP), which evaluates pain intensity, frequency and quality, and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. Patient satisfaction with their treatment outcome was also assessed, using a five point Likert scale.

 

Results

Of 560 subject initially randomized, 527 received a sufficient number of treatments and were included in the analyses (455 received acupuncture – TCA or sham; 72 wait list controls). The groups were comparable with respect to baseline characteristics and dropout rates. At 12 weeks post intervention, no differences were found between those who received TCA vs sham. However, compared with the wait list controls, both treatment groups experienced a significant improvement in pain scores (J-MAP −1.1/7, 95% confidence interval −1.0 to −0.1, P<0.0001; WOMAC pain −13.7/100, 95% confidence interval −14 to −1.7, P<0.001). Compared with the neutral expectations group, the high expectations group had significantly greater improvements in pain and greater treatment satisfaction, but the effect sizes were small (0.25 and 0.22, respectively, at 12 weeks).

 

Summary

This very high quality trial found that TCA was not superior to sham acupuncture, but the providers’ style affected both pain reduction and satisfaction with treatment, suggesting that the analgesic benefits of acupuncture may be partially mediated by the acupuncturists’ behavior. This is in keeping with previous studies that have shown that the neurophysiological changes that can modulate pain relief centrally through placebo effects may be enhanced by expectations118, 119.

 

Transcutaneous electrostimulation

 

Background

Transcutaneous electrical nerve stimulation (TENS), interferential current stimulation, and pulsed electrostimulation are widely used to control both acute and chronic pain arising from many conditions, including OA. However, there remains conflicting results regarding the effectiveness of these treatments.

 

Methods

Rutjes and colleagues101 conducted a systematic Cochrane review of transcutaneous electrostimulation vs sham or no specific intervention on pain, and withdrawal due to adverse events, in individuals with knee OA.

 

Results

The review identified 18 small trials including a total of 813 subjects with painful knee OA (11 TENS, four interferential current stimulation, one TENS and interferential current stimulation, and two pulsed electrostimulation). Overall, the quality of these trials was poor; there was a high degree of heterogeneity across the studies, limiting comparison across trials. The calculated predicted standardized mean difference for pain intensity was −0.07 (95% confidence interval −0.46 to 0.32), which corresponds to a difference in pain scores between electrostimulation and control of 0.2 cm on a 10 cm visual analog scale for pain.

 

Summary

This systematic review found little evidence of a significant effect for electrostimulation vs sham or no intervention on pain in knee OA. Further, no evidence was found to support a differential effect based on the type of electrostimulation. Higher quality trials are required before this treatment can be recommended in the management of knee OA.

 

Tai Chi

 

Background

Tai Chi is a traditional mind–body exercise that enhances balance, strength, flexibility, and self-efficacy, while reducing pain, depression and anxiety in diverse groups with chronic conditions. Tai Chi may be useful in the management of painful OA; the physical component provides exercise consistent with recommendations for OA, while the mental component may address chronic OA pain through its effects of psychological well-being.

 

Methods

Wang and colleagues13 conducted a single-blinded randomized, controlled trial of Tai Chi in subjects with symptomatic tibiofemoral knee OA (confirmed radiographically). Subjects were randomized to receive 60 min of Tai Chi vs nutrition education and stretching exercises (the attention control group) twice per week for 12 weeks. Usual OA medications were unchanged. The primary outcome of interest was the difference in change in pain (WOMAC pain score) from baseline to 12 weeks, using an intent-to-treat approach. Secondary outcomes included physical functioning (WOMAC function score; timed chair stand), patient global assessment, depression, self-efficacy and quality of life, using valid and reliable measures for each. WOMAC subscales were scored such that each item within the scale had a maximum score of 100; thus the pain subscale scores ranged from 0 to 500, and the function subscale score from 0 to 1700. To reduce the potential for bias due to lack of blinding to treatment allocation, participants were told that the study objective was to compare two types of exercise, one of which was combined with education.

 

Results

Forty patients were randomized; their mean age was 65 years, with a mean BMI of 30. Compared with the attention control group, those who received Tai Chi experienced greater improvements in WOMAC pain scores (between group mean difference −118.80, 95% confidence interval −183.66 to −53.94, P=0.0005)(Fig. 1) and all secondary outcome measures. No serious adverse events were reported and there were no study withdrawals. Correction for baseline differences in severity of OA disability (which was higher in the controls), did not change the results.

 

             Thumbnail image of Fig. 1. Opens large image

Fig. 1

WOMAC pain subscale over a 12-week intervention period by treatment group. Reprinted with permission of authors and Arthritis Care and Research.

 

 

Summary

This single-blinded trial found 12 weeks of Tai Chi to be associated with improvements in symptoms and disability in patients with knee OA. Future research is required to confirm these results in larger, higher quality studies.

 

Surgical treatment for acute Anterior Cruciate Ligament (ACL) tears

 

Background

ACL tears represent a serious knee injury that results in joint instability which leads in turn to reduced physical activity and lower knee-related quality of life. ACL tear is often a precursor for knee OA. Surgical ACL reconstruction is commonly performed, with or without rehabilitation by a physical therapist, to manage this injury. However, high quality evidence from randomized, controlled trials supporting this approach is lacking.

 

Methods

Frobell and colleagues94 conducted a randomized, controlled clinical trial in young (18–35 years old), active adults with acute ACL tear (within 4 weeks of injury, confirmed using magnetic resonance imaging). Subjects were randomized to receive structured rehabilitation plus early ACL reconstruction (within 10 weeks) vs structured rehabilitation with optional delayed reconstruction in the presence of symptomatic knee instability (defined as self-reported symptoms of instability with a positive pivot shift test). The primary outcome of interest was the absolute change in the Knee Injury and Osteoarthritis Outcome Score4, KOOS4, at 24 months. The KOOS4 incorporates the average scores for each of four KOOS subscales: pain, symptoms, function in sports and recreation, and knee-related quality of life. Supervised rehabilitations, delivered by nine therapists at nine out-patient clinics, targeted goals for range of motion, muscle function, and functional performance. ACL reconstruction was performed by four senior, high volume knee surgeons who used one of two procedures previously shown to have similar results. Additional meniscal surgery was performed at the surgeons’ discretion as needed.

 

Results

Of 121 subjects randomized, 62 received rehabilitation plus early ACL reconstruction and 59 received rehabilitation with optional delayed ACL reconstruction. Among those who received optional delayed ACL reconstruction, 23 underwent subsequent ACL reconstruction and 36 did not. Subjects in the early surgery group received a greater number of rehabilitation visits (63 vs 53, P=0.05); no other group differences were found. One subject in the early reconstruction group was excluded from the primary analysis due to missing data at interim visits. At 24 months follow-up, both groups had improved significantly; the absolute between group difference in KOOS4 scores was 0.18 (95% confidence interval −6.5 to 6.8, P=0.96). In a post-hoc as-treated analysis that compared 24-month outcomes in those assigned to early reconstruction, those who received later reconstruction (5.5–19 months post-randomization) and those who received only structured rehabilitation, no significant by-group differences were observed (Fig. 2)

            .Thumbnail image of Fig. 2. Opens large image

Fig. 2

Mean KOOS4 scores during the 2-year study period, according to treatment group. Reprinted with permission of authors and New England Journal of Medicine.

 

 

Summary

At 24 months following randomization, all study participants had improved, suggesting that a strategy of structured rehabilitation followed acute ACL injury may preclude the need for surgical reconstruction. Ongoing follow-up of the treatment groups to evaluate for development of knee OA in the injured knee will be critical to understanding whether early ACL reconstruction reduces or accelerates the risk for knee OA.

 

Summary and conclusions

There is an ongoing need for large, high quality randomized, controlled trials of non-pharmacologic therapies in OA. Studies to date have been limited by small sample sizes, lack of appropriate attention controls, and insufficient attention to blinding concealment in particular. Further, heterogeneity across studies of similar treatments precludes pooling of results in meta-analyses. Two high quality trials have been reported here; one suggests no benefit of TCA vs sham acupuncture but, that enhanced patient expectations can influence treatment response to non-pharmacologic therapies in OA. Future studies should consider this finding in their design. The second compared early ACL reconstruction and rehabilitation to rehabilitation and found that both groups had similar knee-related symptoms and disability at 24 months follow-up. This study raises serious questions about the role of surgical reconstruction in acute ACL injury. Follow-up to examine for subsequent rates of knee OA incidence in the two treatment groups will be critical.

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