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

NCT04058522 | Completed DMC

• 1 other identifier: 10.05.7
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Rotator Cuff Impingement

Keywords

Physiotherapy; Group Treatment

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain And Disability Index (SPADI)

  The shoulder pain and disability index

  26 Weeks

Secondary Outcomes (6)

• Active range of external rotation

  26 weeks

• Internal rotation

  26 weeks

• Global patient self-assessment

  26 weeks

• Short Form 36 version 2 (SF36v2)

  26 weeks

• EuroQuol 5 - Dimensions - 3 Levels (EQ-5D-3L)

  26 weeks

Study Arms (2)

Group Physiotherapy

EXPERIMENTAL

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

Other: Rotator cuff rehabilitation classes; Drug: Triamcinolone Injection

Routine Physiotherapy

ACTIVE COMPARATOR

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.

Other: Individual Physiotherapy; Drug: Triamcinolone Injection

Interventions

Rotator cuff rehabilitation classes OTHER

Group Physiotherapy

Individual Physiotherapy OTHER

Routine Physiotherapy

Triamcinolone Injection DRUG

Subacromial Injection 40mg/1ml

Also known as: Kenalog Injection

Group Physiotherapy; Routine Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• South Eastern Health and Social Care Trust: lead
• Northern Ireland Clinical Trials Unit: collaborator
• University of Ulster: collaborator
• Queen's University, Belfast: collaborator

Study Sites (1)

Ian Ryans

Dundonald, Co Down, BT16 2LN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32752234 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome

Interventions

Triamcinolone; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ian Ryans, MD

  Dundonald Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Off site randomisation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Practitioner

Model Details: Single blind randomised trial

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: September 19, 2008
• Primary Completion: February 10, 2013
• Study Completion: February 10, 2013
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)