| Abstract | Purpose: Achilles tendinopathy (AT) affects over 150,000 people per year in the UK and is signified by pain on weight bearing activity resulting in disability and limited function. It may affect 9% of recreational runners. Clinical guidelines currently recommend a loaded exercise programme to reduce pain and disability. Although commonly used in clinical practice, there are no clinical trials investigating the effectiveness of performing Transverse Friction Massage (FTM) in addition to exercise, resulting in a quicker return to normal function.
This study aimed to evaluate the procedures and feasibility of a full-scale randomised clinical trial (RCT) establishing the effectiveness of TFM as an adjunct to exercise for AT in an NHS outpatients community care setting.
Methods: An external pilot and feasibility randomised two-arm clinical trial was conducted in two NHS adult musculoskeletal outpatient’s clinics. Target sample size was 24 participants in total. Participants were randomised using block randomisation into two groups, TFM + Exercise (Intervention) or Exercise alone (Control). Both groups were given an individualised progressive, concentric-eccentric loading exercise programme over the course of 12 weeks. The intervention group had up to 6 sessions of weekly TFM in the first 6 weeks. Pain, function and activity were measured using the VISA-A questionnaire at baseline, 6th and 12th weeks. Data was analysed descriptively.
Results: Eight participants (median age 44.5, IQR:9 (4 Control; 4 Intervention) were recruited. Participant recruitment rate was good (3 participants every 4 weeks) and there were no dropouts. No adverse reactions to TFM were reported.
VISA-A scores improved in both groups. Comparison of the mean difference (pre-post) at 6 weeks identified a greater improvement for TFM + Exercise [ 25.75% std error=8.479, 95% CI (-52.734, 1.234)] compared to Exercise alone [Mean=11.00% improvement, std error=9.566, 95% CI (-41.442, 19.442)]. Only participants allocated to TFM + Exercise achieved mean clinically important difference (>12%).
Conclusion(s): A clinically important improvement in VISA-A was identified for participants receiving a combination of TFM + exercises, but not for exercise alone. These findings suggest the addition of TFM to an exercise programme maybe an effective combination of treatment to reduce short term AT pain and disability. Further clinical implications regarding the effectiveness need to be informed by an adequately powered, low risk of bias RCT.
This is the first study to recruit AT patients in an NHS outpatient community care setting within the UK. Despite not reaching the target sample size owing to time limitations the recruitment rate was encouraging. No adverse events were reported supporting the safety and acceptability of TFM for Achilles tendinopathy.
The suggestions for the larger trial would be to use patients with either the insertional or midsection AT, monitor exercise compliance more effectively or utilise exercise classes, use laboratory measurements and to employ a research assistant to do the randomisation and to collect the outcome data.
Impact: The results support the feasibility of a Phase III RCT investigating the effectiveness of TFM + exercise within an NHS outpatient’s community care setting, informing clinical practice and guidelines.
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Funding acknowledgements: *
The trial was funded by Birmingham Community Healthcare NHS Foundation Trust and was completed as part of the lead authors MSc Dissertation.
Ethics details:*
This study gained ethical approval from Middlesex University London Sport Institute Ethics Subcommittee on 19.04.2018 (Application Number 564), South Birmingham Research Ethics Committee- gained favourable opinion on 12.10.2018, with HRA ethical approval given on the same day - 12.10.2018, Research Ethics Committee (REC) reference: 18/WM/0244. |
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