Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection

NCT ID: NCT04058522

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-19
• Study Completion Date: 2013-02-10

Brief Summary

The aim of this study is therefore to examine the clinical effectiveness and provide an economic analysis of individual versus group physiotherapy, following corticosteroid injection, for management of Subacromial Impingement (SAI) of the shoulder.

Detailed Description

This trial was a single blind, randomised, equivalence trial comparing rotator cuff rehabilitation classes with traditional individual physiotherapy in subacromial impingement of the shoulder. A total of 200 patients were planned to be recruited from patients with painful shoulder referred to the Ulster Community and Hospitals Trust and community physiotherapy at the Ulster, Ards and Bangor sites or injection clinics at the Ulster Hospital. Local General Practitioners were also informed of the study and invited to refer appropriate patients.

Intervention - Triamcinolone 40 mg (1 ml) and 6 weekly rotator cuff rehabilitation classes Control - Triamcinolone 40 mg (1 ml) and routine physiotherapy 6 sessions weekly for 6 weeks

The injection technique involving a lateral approach to the subacromial space was used. An interval of between 1 and 3 weeks was allowed between injection and commencement of classes or physiotherapy.

Classes were planned to be run by a rotating group of physiotherapists with at least 1 year of musculoskeletal outpatient's experience. They were to receive instruction on the protocol to use in the classes. Classes were to consist of six 30 min sessions on a weekly basis. A minimum of 5 and maximum of 10 participants were to attend. Advice was to be given on the nature of the condition. Subjects were to be instructed and supervised in exercises for scapulo-humeral mobility, scapulo-humeral stability and specific rotator cuff rehabilitation exercises. Subjects were to be introduced to ongoing classes as they are recruited to the trial.

Six sessions of routine physiotherapy at weekly intervals were to be undertaken. Treatment was to be based on evidence-based guidelines for the treatment of shoulder impingement (Evidence-based clinical guidelines for the diagnosis, assessment and physiotherapy management of shoulder impingement syndrome Chartered Society of Physiotherapists 2005) and consist of mobilisation techniques and supervised exercises and stretches. A therapist with at least 1 year of musculoskeletal outpatients experience was to provide treatments.

Conditions

Shoulder Pain; Rotator Cuff Impingement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group Physiotherapy

1 class per week for 6 weeks (30 min length) aiming for 5-10 participants per class. Classes included advice on the nature of the condition and exercises for scapulo-humeral mobility, scapulo-humeral stability and specific rotator cuff rehabilitation exercises

Group Type: EXPERIMENTAL

Rotator cuff rehabilitation classes

Intervention Type: OTHER

Triamcinolone Injection

Intervention Type: DRUG

Subacromial Injection 40mg/1ml

Routine Physiotherapy

Individual physiotherapy sessions: 6 sessions weekly (30 min) for 6 weeks. Treatment was based on evidence-based guidelines for the treatment of shoulder impingement (CSP 2005) and consisted of mobilisation techniques, supervised exercises and stretches.

Group Type: ACTIVE_COMPARATOR

Individual Physiotherapy

Intervention Type: OTHER

Triamcinolone Injection

Intervention Type: DRUG

Subacromial Injection 40mg/1ml

Interventions

Rotator cuff rehabilitation classes

Intervention Type: OTHER

Individual Physiotherapy

Intervention Type: OTHER

Triamcinolone Injection

Subacromial Injection 40mg/1ml

Intervention Type: DRUG

Other Intervention Names

Kenalog Injection

Eligibility Criteria

Inclusion Criteria

• unilateral shoulder pain of more than 4 weeks duration and a Shoulder Pain and Disability Index (SPADI) score of >= 30 as this represents significant disability. Shoulder pain is defined as pain in the shoulder region, including the upper arm, elicited by active or passive shoulder movement. The diagnosis of "subacromial pain" is defined by range as no limitation in passive range of movement or restriction of passive range of movement mainly in abduction rather than external rotation.

Exclusion Criteria

• inability to give informed consent
• physiotherapy or injection treatment for current shoulder pain in previous 3 months
• blood coagulation disorders
• bilateral shoulder pain
• evidence of systemic infection
• abnormal shoulder X-ray defined as significant glenohumeral or subacromial joint space narrowing suggesting osteoarthritis of glenohumeral joint or complete rotator cuff rupture,
• evidence of rotator cuff tear, tested by external rotation lag sign, drop sign, internal rotation lag sign and static muscle resistance in external rotation, internal rotation and abduction,
• history of significant trauma to the shoulder,
• inflammatory joint disease,
• history of cerebrovascular accident,
• allergy or contraindication to Triamcinolone/contraindication to injection.
• evidence of referred pain from cervical spine disease.
• pregnancy or breast feeding
• patients whose first language is not English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northern Ireland Clinical Trials Unit

OTHER

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: collaborator

South Eastern Health and Social Care Trust

OTHER

Sponsor Role: lead

Responsible Party

Ian Ryans

General Practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian Ryans, MD

Role: PRINCIPAL_INVESTIGATOR

Dundonald Medical Centre

Locations

Ian Ryans

Dundonald, Co Down, United Kingdom

Countries

United Kingdom

References

Ryans I, Galway R, Harte A, Verghis R, Agus A, Heron N, McKane R. The Effectiveness of Individual or Group Physiotherapy in the Management of Sub-Acromial Impingement: A Randomised Controlled Trial and Health Economic Analysis. Int J Environ Res Public Health. 2020 Aug 1;17(15):5565. doi: 10.3390/ijerph17155565.

Reference Type: DERIVED

PMID: 32752234 (View on PubMed)

Other Identifiers

10.05.7

Identifier Type: -

Identifier Source: org_study_id