A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial

Enrique Lluch-Girbés, Lirios Dueñas, Silvia Mena-Del Horno, Alejandro Luque-Suarez, Santiago Navarro-Ledesma, Adriaan Louw, Enrique Lluch-Girbés, Lirios Dueñas, Silvia Mena-Del Horno, Alejandro Luque-Suarez, Santiago Navarro-Ledesma, Adriaan Louw

Abstract

Background: Frozen shoulder (FS) is a musculoskeletal condition of poorly understood etiology that results in shoulder pain and large mobility deficits. Despite some physical therapy interventions, such as joint mobilization and exercise, having shown therapeutic benefit, a definitive treatment does not currently exist. The aim of this study will be to compare the effectiveness of a central nervous system (CNS)-directed treatment program versus a standard medical and physical therapy care program on outcomes in participants with FS.

Methods/design: The study is a two-group, randomized clinical trial with blinding of participants and assessors. Participants will be recruited via referrals from orthopedic surgeons and physical therapists, community-based advertisements, private care practices and hospitals. Participants will be randomized to receive either a CNS-focused treatment program or standard medical and physical therapy care. The Shoulder Pain And Disability Index (SPADI) will be the primary outcome, while the Numeric Pain Rating Scale (NPRS), shoulder range of movement (ROM), The Patient Specific Functional Scale, two-point discrimination threshold and laterality judgement accuracy will be the secondary outcomes. Assessment will occur at baseline, at the end of the treatment program (week 10), and at 3 and 6 months' follow-up.

Discussion: Preliminary data suggest that treatments that target CNS function are a promising approach to the treatment of people with shoulder pain including patients with FS. In the context of modest effects from most available physical therapy treatments for FS, this CNS-focused approach may lead to improved clinical outcomes. The trial should determine if the CNS-directed program is more effective than traditional interventions at reducing pain intensity and improving function in a FS cohort and will follow up participants for 6 months, providing important information on the persistence of any treatment effects.

Trial registration: NCT03320200 . Registered on October 25, 2017.

Keywords: Central nervous system; Physiotherapy; Shoulder adhesive capsulitis; Shoulder pain.

Conflict of interest statement

AL receives royalties for books about pain and rehabilitation. AL receives speaker’s fees for lectures on pain and rehabilitation. To minimize the risk of conflict, AL will have no role in data collection or analysis in the current trial. The other authors declare that they have no conflicts of interest.

Figures

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Fig. 1
Schedule of enrollment, interventions and assessments

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