SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain

NCT ID: NCT01885377

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2021-03-31

Brief Summary

Objective: A randomized clinical trial in order to evaluate the efficacy of a specific exercise strategy for patients with subacromial pain.

Hypothesis:

H1 - The three month specific exercise strategy has a satisfactory effect improving shoulder function and/or shoulder pain.

H0 - No difference between the two exercise strategies (specific exercise strategy and active control exercises).

Method: Patients attending primary care with subacromial pain are offered participation. If accepted, they will participate in a three month rehabilitation program. The duration of symptoms can vary from 2 weeks and longer. The patients will be randomized to either rehabilitation; the specific exercise strategy or active control exercises. All patients has an equal number of sessions with the physical therapist (PT) to offer similar attention and support with exercise performance. A blinded physical therapist evaluates the following outcomes at baseline and after three-, six and twelve months:

Primary outcomes: Constant-Murley shoulder assessment (CM-score). Secondary outcomes; Disabilities of the Arm Shoulder and Hand questionnaire (DASH), different aspects of pain by Visual Analogue Scale (VAS), EuroQol-5D index (EQ-5D) and EuroQol-VAS (EQ-VAS), The Patient Specific functional Scale, and Patients' global impression of change (PGIC). Also sick-leave and return to work will be recorded. All patients are evaluated with a diagnostic ultrasound to reveal the status of the rotator cuff.

Additional to the analysis of treatment effect on shoulder function and pain, factors influencing and explaining the CM-score at follow-ups will be analyzed.

This study is warranted in order to evaluate if an earlier reported positive effect on shoulder function and pain with the specific exercise strategy, in patients on waiting list for subacromial decompression, can be repeated in the primary care population of patients with subacromial pain. There is no consensus about first-line exercises for patients with subacromial pain, and these positive results on pain and shoulder function need to be reproduced in primary care before they can be recommended and implemented. Further, knowledge about which factors that can be used in prediction rules for patients that will respond to the exercises or needs surgery is lacking.

Detailed Description

This study will be reopened and will continue the inclusion due to underpowered results.

A new application to the Ethical committee was submitted. Approval to reopen this RCT-study was received at 27th of September 2018 (dnr 218/445-32).

Additional inclusion of 40 additional patients will start at 1th of November 2018. Data from baseline to 12 months follow-up (as described in protocol) will be collected. Inclusion continued and the last inklusion was completed in February 2020. Data Collection for all follow ups is anticipated to be completed at latest during March the year of 2021.

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Disorder of Rotator Cuff; Subacromial Bursitis

Study Design

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

Study Groups

Specific exercise group

A progressive program of strength-endurance exercises for the rotator cuff and scapula stabilizing muscles combined with mobilization of the joint capsule when needed

Group Type: EXPERIMENTAL

Specific exercise group

Intervention Type: OTHER

A program where exercise load is individually adjusted and the exercises progressed during a 3 month period. The 'pain monitoring model' were used to find the individual resistance. Several exercises are performed eccentrically in order to load more. Initially the exercises were PT-tutored every week and then every other week.

Control exercise group

General movements for the neck and shoulder and self-stretching. No progression some addition of exercises during the three month period.

Group Type: ACTIVE_COMPARATOR

Control exercise group

Intervention Type: OTHER

A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.

Interventions

Specific exercise group

A program where exercise load is individually adjusted and the exercises progressed during a 3 month period. The 'pain monitoring model' were used to find the individual resistance. Several exercises are performed eccentrically in order to load more. Initially the exercises were PT-tutored every week and then every other week.

Intervention Type: OTHER

Control exercise group

A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.

Intervention Type: OTHER

Other Intervention Names

•Strength-endurance exercises; •Rotator cuff; •Scapular stabilization; •Eccentric; •Posture; •Movement exercises; •Stretching; •Posture

Eligibility Criteria

Inclusion Criteria

• At least 2 weeks of symptom duration
• Typical history and pain location (C5 dermatome)

Three of these four must be positive:

• Neer impingement sign
• Hawkins-Kennedy impingement sign
• Jobe supraspinatus test
• Patte maneuver

Exclusion Criteria

• Polyarthritis or fibromyalgia
• Pathological hyper-laxity or dislocation of the any of the shoulder joints
• Cervical spine pathology
• Lack of communication skills that prevent the use of outcome measures
• Signs in ultrasound of bone spurs i.e. Acromio-Clavicular joint, that will affect the subacromial space

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: collaborator

Ostergotland County Council, Sweden

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kajsa Johansson

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birgitta Öberg, Professor

Role: STUDY_CHAIR

Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University

Lars Adolfsson, Professor

Role: STUDY_DIRECTOR

Dept. of Orthopaedics, University Hospital Linköping & Linköping University

Kajsa Johansson, PhD

Role: PRINCIPAL_INVESTIGATOR

Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University

Locations

Primary Care unit "Rörelse & Hälsa"

Linköping, , Sweden

Countries

Sweden

References

PMID: 22349588

Reference Type: BACKGROUND

Other Identifiers

8820 PV-JN-1

Identifier Type: -

Identifier Source: org_study_id