Monitoring, Implementation and Reporting of Interventions in a Selection of Trials Assessing Exercise Therapy for the Management of Shoulder Subacromial Pain: a Cross-sectional Investigation

Overview

Journal BMJ Open

Specialty General Medicine

Date 2021 Feb 17

PMID 33593786

Citations 1

Authors

Daniel C Ribeiro

Kate Spiers

Laura Thomas

Kiriffi Leilua

Matthew Wilkes

Shontal Norton

Sarah E Lamb

Affiliations

Soon will be listed here.

Abstract

Objectives: To review the reporting of monitoring and implementation of interventions in a selection of trials that assessed the effectiveness of manual therapy and exercise in the management of shoulder subacromial pain.

Design: A review of trials assessing the effectiveness of manual therapy and exercise in the management of patients with shoulder subacromial pain.

Methods: We included in our review a selection of 10 trials that were included in a Cochrane review and compared manual therapy and exercise intervention with another intervention. Trials were assessed independently by two reviewers using two checklists: the Template for Intervention Description and Replication (TIDieR) and the Health Behavior Change Consortium treatment fidelity (National Institutes of Health Behaviour Change Consortium/NIHBCC).

Results: TIDieR overall scores for individual trials ranged from 11.1% to 45% and fidelity scores ranged from 7% to 50%. On average, trials scored the following within each domain of NIHBCC: study design 51%; training of providers 8%; treatment delivery 15%; treatment receipt 14% and treatment enactment 2.5%.

Conclusions: Little information about the monitoring, implementation and reporting of interventions was provided by trials and that is a barrier for implementing or replicating these interventions. The lack of information regarding the implementation of interventions needs to be taken into account when assessing whether effectiveness of interventions was impacted by their design or due to deviations from the protocol within trials.

Citing Articles

Comparing the Efficacy of Manual Therapy and Exercise to Synchronized Telerehabilitation with Self-Manual Therapy and Exercise in Treating Subacromial Pain Syndrome: A Randomized Controlled Trial.

Celik E, Tuncer A Healthcare (Basel). 2024; 12(11).

PMID: 38891149 PMC: 11171729. DOI: 10.3390/healthcare12111074.

References

Beintner I, Vollert B, Zarski A, Bolinski F, Musiat P, Gorlich D . Adherence Reporting in Randomized Controlled Trials Examining Manualized Multisession Online Interventions: Systematic Review of Practices and Proposal for Reporting Standards. J Med Internet Res. 2019; 21(8):e14181. PMC: 6713038. DOI: 10.2196/14181. View

Rhon D, Boyles R, Cleland J . One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management of the unilateral shoulder impingement syndrome: a pragmatic randomized trial. Ann Intern Med. 2014; 161(3):161-9. DOI: 10.7326/M13-2199. View

Cloke D, Watson H, Purdy S, Steen I, Williams J . A pilot randomized, controlled trial of treatment for painful arc of the shoulder. J Shoulder Elbow Surg. 2007; 17(1 Suppl):17S-21S. DOI: 10.1016/j.jse.2007.07.005. View

Dong W, Goost H, Lin X, Burger C, Paul C, Wang Z . Treatments for shoulder impingement syndrome: a PRISMA systematic review and network meta-analysis. Medicine (Baltimore). 2015; 94(10):e510. PMC: 4602475. DOI: 10.1097/MD.0000000000000510. View

Hay E, Thomas E, Paterson S, Dziedzic K, Croft P . A pragmatic randomised controlled trial of local corticosteroid injection and physiotherapy for the treatment of new episodes of unilateral shoulder pain in primary care. Ann Rheum Dis. 2003; 62(5):394-9. PMC: 1754522. DOI: 10.1136/ard.62.5.394. View

Page M, Green S, McBain B, Surace S, Deitch J, Lyttle N . Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016; (6):CD012224. PMC: 8570640. DOI: 10.1002/14651858.CD012224. View

Bennell K, Wee E, Coburn S, Green S, Harris A, Staples M . Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial. BMJ. 2010; 340:c2756. PMC: 2882554. DOI: 10.1136/bmj.c2756. View

Patti F . Optimizing the benefit of multiple sclerosis therapy: the importance of treatment adherence. Patient Prefer Adherence. 2010; 4:1-9. PMC: 2819898. DOI: 10.2147/ppa.s8230. View

Toomey E, Hardeman W . Addressing Intervention Fidelity Within Physical Therapy Research and Clinical Practice. J Orthop Sports Phys Ther. 2017; 47(12):895-898. DOI: 10.2519/jospt.2017.0609. View

10.

Campbell M, Fitzpatrick R, Haines A, Kinmonth A, Sandercock P, Spiegelhalter D . Framework for design and evaluation of complex interventions to improve health. BMJ. 2000; 321(7262):694-6. PMC: 1118564. DOI: 10.1136/bmj.321.7262.694. View

11.

Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L . An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2019; 50(3):131-141. DOI: 10.2519/jospt.2020.8498. View

12.

Szczurko O, Cooley K, Mills E, Zhou Q, Perri D, Seely D . Naturopathic treatment of rotator cuff tendinitis among Canadian postal workers: a randomized controlled trial. Arthritis Rheum. 2009; 61(8):1037-45. DOI: 10.1002/art.24675. View

13.

Yamato T, Maher C, Saragiotto B, Moseley A, Hoffmann T, Elkins M . The TIDieR Checklist Will Benefit the Physiotherapy Profession. Physiother Can. 2016; 68(4):311-314. PMC: 5125504. DOI: 10.3138/ptc.68.4.GEE. View

14.

Underwood M, Harding G, Moffett J . Patient perceptions of physical therapy within a trial for back pain treatments (UK BEAM) [ISRCTN32683578]. Rheumatology (Oxford). 2006; 45(6):751-6. DOI: 10.1093/rheumatology/kei254. View

15.

Kachingwe A, Phillips B, Sletten E, Plunkett S . Comparison of manual therapy techniques with therapeutic exercise in the treatment of shoulder impingement: a randomized controlled pilot clinical trial. J Man Manip Ther. 2009; 16(4):238-47. PMC: 2716147. DOI: 10.1179/106698108790818314. View

16.

Struyf F, Geraets J, Noten S, Meeus M, Nijs J . A Multivariable Prediction Model for the Chronification of Non-traumatic Shoulder Pain: A Systematic Review. Pain Physician. 2016; 19(2):1-10. View

17.

Winters J, Sobel J, Groenier K, Arendzen H, Jong B . Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice: randomised, single blind study. BMJ. 1997; 314(7090):1320-5. PMC: 2126546. DOI: 10.1136/bmj.314.7090.1320. View

18.

Moore G, Audrey S, Barker M, Bond L, Bonell C, Hardeman W . Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015; 350:h1258. PMC: 4366184. DOI: 10.1136/bmj.h1258. View

19.

Kelley J, Kraft-Todd G, Schapira L, Kossowsky J, Riess H . The influence of the patient-clinician relationship on healthcare outcomes: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014; 9(4):e94207. PMC: 3981763. DOI: 10.1371/journal.pone.0094207. View

20.

Yamato T, Maher C, Saragiotto B, Catley M, Moseley A . Rasch analysis suggested that items from the template for intervention description and replication (TIDieR) checklist can be summed to create a score. J Clin Epidemiol. 2018; 101:28-34. DOI: 10.1016/j.jclinepi.2018.05.014. View