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

NCT01885377 | Completed

• 1 other identifier: 8820 PV-JN-1
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Subacromial pain; Impingement; Exercises; Physical therapy; Primary care

Outcome Measures

Primary Outcomes (1)

• The Constant-Murley shoulder assessment

  Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength. The score is summarized to a maximum of 100 for best available shoulder function.

  Baseline and change 3-, 6- and 12 months

Secondary Outcomes (6)

• Euro Qol 5D index (EQ 5D)

  Baseline and change 3-, 6- and 12 months

• Disabilities of the arm, shoulder and hand

  Baseline and change 3-, 6- and 12 months

• VAS for pain

  Baseline and change 3-, 6- and 12 months

• Patients Global Impression of Change (PGIC)

  At follow-up: 3-, 6- and 12 months

• The Patient Specific functional Scale

  Baseline and change 3-, 6- and 12 months

Other Outcomes (2)

• Hospital Anxiety and Depression Scale (HAD)

  Baseline

• Sick-leave and return to work or working status

  Baseline, 3-, 6- and 12 months

Study Arms (2)

Specific exercise group

EXPERIMENTAL

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

Other: Specific exercise group

Control exercise group

ACTIVE COMPARATOR

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

Other: Control exercise group

Interventions

Specific exercise group 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.

Also known as: •Strength-endurance exercises, •Rotator cuff, •Scapular stabilization, •Eccentric, •Posture

Specific exercise group

Control exercise group OTHER

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

Also known as: •Movement exercises, •Stretching, •Posture

Control exercise group

Eligibility Criteria

• Age: 30 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead
• University Hospital, Linkoeping: collaborator
• Ostergotland County Council, Sweden: collaborator

Study Sites (1)

Primary Care unit "Rörelse & Hälsa"

Linköping, 581 85, Sweden

Location

Related Publications (1)

• PMID: 22349588

  BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Motor Activity

Interventions

Posture; Exercise Movement Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Therapy Modalities; Therapeutics

Study Officials

• Birgitta Öberg, Professor

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

  STUDY CHAIR

• Lars Adolfsson, Professor

  Dept. of Orthopaedics, University Hospital Linköping & Linköping University

  STUDY DIRECTOR

• Kajsa Johansson, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 25, 2013
• Study Start: September 1, 2011
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

SE (1)