Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
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Varghese D et al 2017 India | Patients with lateral epicondylitis from PubMed, Ovid and ProQuest databases | Randomized and Non randomized controlled trials Use of Counterforce bracing | No statistical significant difference in pain with different orthotic devices Brace and Physiotherapy group had better outcome in pain in some studies Injection with bandage results are inconsistent for pain relief Non-significant results with different types of orthotic devices | Studies included single orthotic device support the use of it as a non-surgical modality. Studies involved different orthotic device- failed to conclude which one works better. Rising evidence of comprehensive approach- physio and orthosis | Long term benefits of brace are not identified; inconsistent results between various studies of using different orthosis, further high quality clinical trials were recommended. |
Saremi H et al 2016 Iran | 12 Patients with 31-55 years of age, lateral epicondylitis for 6 weeks, 4 +be diagnostic tests for TE with no previous Rx | Non randomized double blind clinical trial | Wedge brace (newly designed orthosis) had a better effect on pain in comparison with traditional TE strap. Result of Comparison of 2 straps was more significant between 1st and 2nd session but not in 1st and 3rd session | Traditional as well as newly designed wedge brace has +ve effect on pain and strength but wedged brace was significantly more effective for pain relief | Pilot study of wedged brace, limited number of participants, no long term effect was identified |
Najafi M et al 2016 Iran | 15 patients with tennis elbow (mean age 43 years) aged 30-55, TOP at CE, pain on resisted extension and at least 3 weeks h/o symptoms. | Quasi-experimental design | Spiral splint restricted supination and pronation positively and therefore reduced pain and improved function and grip force after 4 weeks of application. Restriction of rotational movement may have played main role. | Significant improvement in pain, function, grip force and DASH score. | Long term effect not identified, Lack of control group, Assessor was not blinded. Study did not compare Spiral splint with any other orthosis |
Bisset L et al 2014 Australia | 34 Participants aged 18-67 with clinical diagnosis of TE- TOP at CE, +ve Cozen’s, Maudsley’s and painful grip | Repeated measure, cross over, double blinded randomized controlled trial, Level 2b | Immediate improvement seen in PFG/PPT pre and post application of forearm, forearm-elbow brace and no brace. | No improvement between the group with forearm brace, forearm and elbow brace and no brace. | Only immediate effect was noted, Longer term effect was not identified Improvement may be due to measurement error. The trial was done only with bracing without comparing with other intervention which is rare in clinical setting. Level of tension with each brace might be different. |
Demneh E & Jafarian F 2013 Iran | 52 Participants with 3 weeks h/o lateral elbow pain and diagnosis made by orthopaedics sample size 52 | Randomized controlled crossover trial, Participants acted as their own control and randomisation of orthosis | Counterforce elbow band and Counterforce elbow sleeve were more effective than Extension wrist elbow splint | Orthotic device was considered as a therapeutic method for initial therapy | No functional or outcome measure used. Therefore, clinical acceptability is limited. Prolonged use of orthosis was not mentioned. |
Forogh B et al 2012 Iran | 24 participants, Age 30-50, lateral epicondylitis | Assessor blinded clinical trial, 2 treatment groups with 1 using counterforce and other using newly designed orthosis | Both orthosis relieves pain after 4 weeks and no significant difference in efficacy regarding function. | Newly designed orthosis more effective compared to counterforce orthosis due to limiting supination. | No long term effect with brace identified. Lack of control group. Intervention was not compared without any Rx intervention. |
Altan L & Kamat E 2008 Turkey | 50 patients ranges from 34-60, symptoms of TE | Comparing effectiveness of 2 Groups- 1 with lateral epicondyle bandage and other with wrist resting splint with continuous use. | No significant improvement at 2 weeks for bandage group but significant improvement at 6 weeks. Splint group shown significant improvement at 2 weeks except algometry sensitivity and 6 weeks at all parameter. | No significant difference for parameters between the two groups at their evaluation stage. | Lack of control group, patients were with acute pain, reluctant for wait and see approach, lack of assessment between each splints. |
Hijmans J et al 2004 Netherland | 57 Searches with 18 relevant literatures and 5 RCTs from medline, embase, Cochrane and recal using keywords- elbow and orthosis | Literature review- 5 RCTs from 1989 to June 2003 and 2 Non RCTs | 1st RCT (n=16)- Physio + splint 2nd RCT (n=56)- support compared with massage and stretching 3rd RCT (n= 36)- Comparison of NSAId, Bandage, steroid, steroid+ bandage 4th RCT (n= 61)- comparison of clasp, wrist splint with DF and 2 steroid injection 5th RCT (n= 36)- Comparison of US, US guided injection, clasp and US guided injection + clasp 1st Non RCTs (n=14)- testing Wrist ext and grip strength with splint compared to non affected arm 2nd Non RCT (n= 50)- Comparison of 2 different braces on pain and strength | 1st RCT- Improved strength and pain with splint 2nd RCT- short term relief with support 3rd RCT- no relief with support 4th RCT- No benefit of clasp 5th RCT- No benefit of clasp 1st Non RCT- Counterforce splint increase wrist ext and grip strength 2nd Non RCT- No difference | Conflicting outcome between RCTs and Non RCTs, differebt outcome measures used for both, no definitive conclusion |
Struijs P et al 2001 Australia | 5 RCTs (n= 7-49), Patients with lateral epicondylitis, lateral elbow pain, increased pressure on lateral epicondyle, pain on resisted wrist extension | Systematic review | Orthotic device vs other orthotic device- no significant difference in pain Orthotic device vs additional Rx- no significant difference in pain Orthotic device vs conservative Rx- NSAIDs cream and strap provides short term pain relief. | No definitive conclusions. More well designed and well conducted RCTs warranted. | Heterogenecity of trials, limited RCTs, only 1 study presented intermediate and long term results, no functional outcome measure were used. Relevant trials were may have been missed. |
Wuori J et al 1998 Canada | 50 Patients with unilateral epicondylitis for at least 3 weeks | Repeated measures design included control and randomization. Compared the counter force brace, placebo brace, elbow support and no brace for measuring pain scores | No statistic difference among different brace. | No benefit associated with brace vs no brace. | Pressure application of each brace and consistency of brace were not included. Small sample size, unspecified criteria for selection, lack of reliability and validity of outcome measures. |
Ilfeld F and Filed S 1966 San deigo | 174 patients with tennis elbow aged from under 20 years to over 40 years. | 36 Patients were provided with Brace was provided after failed conservative intervention and patients who did not wish to have a drug injection. | 24 patients achieved good result with brace, fair in 4 and poor in 8. | Brace that limited extension, forearm rotation and supported elbow, provided 80% relief. | Poor methodology, lack of inclusion and exclusion criteria, continuity of brace was not provided. No outcome measures used. |