Clinical trial NCT04058522: Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
Official title: Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Rotator Cuff Impingement
Keywords: Physiotherapy
Group Treatment
Lead sponsor: South Eastern Health and Social Care Trust
Sponsor class: OTHER
Collaborators: name: Northern Ireland Clinical Trials Unit
name: University of Ulster
name: Queen's University, Belfast
First posted: 2019-08-15
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomised trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Shoulder Pain And Disability Index (SPADI)
timeFrame: 26 Weeks
Secondary outcomes:
measure: Active range of external rotation
timeFrame: 26 weeks
measure: Internal rotation
timeFrame: 26 weeks
measure: Global patient self-assessment
timeFrame: 26 weeks
measure: Short Form 36 version 2 (SF36v2)
timeFrame: 26 weeks
measure: EuroQuol 5 - Dimensions - 3 Levels (EQ-5D-3L)
timeFrame: 26 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Dundonald
country: United Kingdom
facility: Ian Ryans
state: Co Down
Study officials:
affiliation: Dundonald Medical Centre
name: Ian Ryans, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.