Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial
Objectives To evaluate the feasibility of recruitment, appointment adherence, intervention compliance, acceptance and comprehensibility, in addition to retention rate and data completeness. An ancillary aim was to describe within-group changes in the secondary outcome measures (patient-reported and...
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| Format: | Article |
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BMJ Publishing Group
2024-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/12/e085916.full |
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| author | Jens Ivar Brox Marianne Bakke Johnsen Cecilie Roe Aasne Fenne Hoksrud Håkon Sveinall Kaia B Engebretsen |
| author_facet | Jens Ivar Brox Marianne Bakke Johnsen Cecilie Roe Aasne Fenne Hoksrud Håkon Sveinall Kaia B Engebretsen |
| author_sort | Jens Ivar Brox |
| collection | DOAJ |
| description | Objectives To evaluate the feasibility of recruitment, appointment adherence, intervention compliance, acceptance and comprehensibility, in addition to retention rate and data completeness. An ancillary aim was to describe within-group changes in the secondary outcome measures (patient-reported and performance-based).Design A single-centre, three-armed, randomised controlled feasibility trial with a parallel design, with follow-up after 3 and 6 months.Setting Participants were recruited from the outpatient clinic at Oslo University Hospital.Participants Patients with lateral epicondylalgia, commonly known as tennis elbow.Interventions Participants were randomised in a 1:1:1 ratio to heavy slow resistance training, radial extracorporeal shock wave therapy or information and advice.Main outcome measures Feasibility was assessed according to a priori criteria for success.Results In total, 89 patients were screened for eligibility, and 69 (78%) patients were eligible for randomisation. 60 (92%) participants were randomised which gave a recruitment rate of 3.4 per month (against an a priori success cut-off of 3.75). The participants rated all the interventions as acceptable and comprehensive. Only 6 of 19 (32%) did comply with heavy slow resistance training. Retention rate and completeness of data were successful at 3 months. At 6 months, the retention rate was below the criteria for success. Patient-reported and performance-based outcomes improved in all groups.Conclusion The current study shows that the process of recruitment and the retention rate at follow-up can be feasible with minor amendments. Participants had low compliance with heavy slow resistance training mainly due to pain aggravation, which suggests that this intervention was not suitable for patients with tennis elbow. Shock wave therapy and information and advice should be investigated further in a full-scale randomised controlled trial including sham shock wave therapy.Trial registration number NCT04803825. |
| format | Article |
| id | doaj-art-f96e6a97ec0b4022b995d2fa0ff9aa91 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-f96e6a97ec0b4022b995d2fa0ff9aa912025-01-14T07:50:10ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-085916Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trialJens Ivar Brox0Marianne Bakke Johnsen1Cecilie Roe2Aasne Fenne Hoksrud3Håkon Sveinall4Kaia B Engebretsen51 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway1 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway1 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway3 Norwegian Olympic and Paralympic Committee and Confederation of Sports, Oslo, Norway1 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, Norway1 Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Oslo, NorwayObjectives To evaluate the feasibility of recruitment, appointment adherence, intervention compliance, acceptance and comprehensibility, in addition to retention rate and data completeness. An ancillary aim was to describe within-group changes in the secondary outcome measures (patient-reported and performance-based).Design A single-centre, three-armed, randomised controlled feasibility trial with a parallel design, with follow-up after 3 and 6 months.Setting Participants were recruited from the outpatient clinic at Oslo University Hospital.Participants Patients with lateral epicondylalgia, commonly known as tennis elbow.Interventions Participants were randomised in a 1:1:1 ratio to heavy slow resistance training, radial extracorporeal shock wave therapy or information and advice.Main outcome measures Feasibility was assessed according to a priori criteria for success.Results In total, 89 patients were screened for eligibility, and 69 (78%) patients were eligible for randomisation. 60 (92%) participants were randomised which gave a recruitment rate of 3.4 per month (against an a priori success cut-off of 3.75). The participants rated all the interventions as acceptable and comprehensive. Only 6 of 19 (32%) did comply with heavy slow resistance training. Retention rate and completeness of data were successful at 3 months. At 6 months, the retention rate was below the criteria for success. Patient-reported and performance-based outcomes improved in all groups.Conclusion The current study shows that the process of recruitment and the retention rate at follow-up can be feasible with minor amendments. Participants had low compliance with heavy slow resistance training mainly due to pain aggravation, which suggests that this intervention was not suitable for patients with tennis elbow. Shock wave therapy and information and advice should be investigated further in a full-scale randomised controlled trial including sham shock wave therapy.Trial registration number NCT04803825.https://bmjopen.bmj.com/content/14/12/e085916.full |
| spellingShingle | Jens Ivar Brox Marianne Bakke Johnsen Cecilie Roe Aasne Fenne Hoksrud Håkon Sveinall Kaia B Engebretsen Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial BMJ Open |
| title | Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial |
| title_full | Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial |
| title_fullStr | Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial |
| title_full_unstemmed | Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial |
| title_short | Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial |
| title_sort | heavy slow resistance training radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the norwegian secondary care a randomised controlled feasibility trial |
| url | https://bmjopen.bmj.com/content/14/12/e085916.full |
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