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

Shoulder Pain Clinical Trial

— SWESS  

Official title:

SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885377
• Other study ID #: 8820 PV-JN-1
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: March 2021

Study information

• Verified date: August 2022
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Primary Care unit "Rörelse & Hälsa"	Linköping

Sponsors (3)

Lead Sponsor	Collaborator
Linkoeping University	Ostergotland County Council, Sweden, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

PMID: 22349588

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital Anxiety and Depression Scale (HAD)	To screen mental health (depression and/or anxiety) in all included patients. Maximum score is 21 points for the depression and anxiety part respectively. The higher score, the higher risk of a depression and/or anxiety.	Baseline
Other	Sick-leave and return to work or working status	Patient reported can be double checked by the Swedish Social Insurance Agency.	Baseline, 3-, 6- and 12 months
Primary	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	Euro Qol 5D index (EQ 5D)	Health Related Quality of Life by EuroQol 5 dimensions and index. Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal.	Baseline and change 3-, 6- and 12 months
Secondary	Disabilities of the arm, shoulder and hand	Self-assessment of the ability to performed exemplified activities. 0 indicates a non-affected upper extremity.	Baseline and change 3-, 6- and 12 months
Secondary	VAS for pain	Self-assessed for pain at rest, in activity and at night if it disturbs sleeping	Baseline and change 3-, 6- and 12 months
Secondary	Patients Global Impression of Change (PGIC)	The patients are asked to assess change. A scale ranging from getting worse by the intervention to be recovered.	At follow-up: 3-, 6- and 12 months
Secondary	The Patient Specific functional Scale	Self-selected functional activities to relate efficacy to during follow-ups.	Baseline and change 3-, 6- and 12 months
Secondary	Euro Qol VAS (EQ VAS)	In EQ VAS the patients assess their health state on a vertical line valued from 0-100.	Baseline and change 3-, 6- and 12 months