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

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.

Conditions

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

Interventions

OTHER

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.

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.

Sponsors & Collaborators

• University Hospital, Linkoeping

  collaborator OTHER

• Ostergotland County Council, Sweden

  collaborator OTHER

• Linkoeping University

  lead OTHER_GOV

Principal Investigators

• Birgitta Öberg, Professor · Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University

• Lars Adolfsson, Professor · Dept. of Orthopaedics, University Hospital Linköping & Linköping University

• Kajsa Johansson, PhD · Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

67 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2020-03-31

Completion

2021-03-31

Countries

• Sweden

Study Locations