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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058522
• Other study ID #: 10.05.7
• Status: Completed
• Phase: N/A
• Start date: September 19, 2008
• Est. completion date: February 10, 2013

Study information

• Verified date: August 2019
• Source: South Eastern Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: February 10, 2013
• Est. primary completion date: February 10, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Impingement
• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

Other:
• Rotator cuff rehabilitation classes

• Individual Physiotherapy

Drug:
• Triamcinolone Injection
Subacromial Injection 40mg/1ml

Locations

Country	Name	City	State
United Kingdom	Ian Ryans	Dundonald	Co Down

Sponsors (4)

Lead Sponsor	Collaborator
South Eastern Health and Social Care Trust	Northern Ireland Clinical Trials Unit, Queen's University, Belfast, University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain And Disability Index (SPADI)	The shoulder pain and disability index	26 Weeks
Secondary	Active range of external rotation	Range of active external rotation of the shoulder measured by goniometer.	26 weeks
Secondary	Internal rotation	Measures as distance in centimetres between thumb tip and C7 spinous process)	26 weeks
Secondary	Global patient self-assessment	Self assessment of global wellbeing measured by a 100mm visual analogue scale. Score minimum 0 and maximum 100 higher score indicates higher wellbeing.	26 weeks
Secondary	Short Form 36 version 2 (SF36v2)	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are, vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.; Each scale is transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	26 weeks
Secondary	EuroQuol 5 - Dimensions - 3 Levels (EQ-5D-3L)	EuroQol's EQ-5D is a generic instrument to measure and evaluate health status. The EQ-5D 3L version, describes general health based on five distinct dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 Levels (indicating no problem, some or moderate problem and extreme problem). EQ-5D comprises of five domains, each with three possible levels, a combination of the characteristic levels produces 243 possible health states (ranging from 11111 to 33333). The EQ-5D index scores are utilities derived from the respondents profile and ranges from 0 to 1; 0 meaning death and 1 complete health.	26 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	The HAD questionnaire comprises seven questions for anxiety and seven questions for depression. The anxiety and depression questions are interspersed within the questionnaire but are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety has a specificity of 0.78 and a sensitivity of 0.9, and for depression a specificity of 0.79 and a sensitivity of 0.83. Each scale has a range of 0-21. Scores of 15-21 indicate severe, 11-14, moderate and 8-10 mild, 7 or less indicates no case	26 weeks