SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain (SWESS)
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|ClinicalTrials.gov Identifier: NCT01885377|
Recruitment Status : Recruiting
First Posted : June 25, 2013
Last Update Posted : November 5, 2018
Objective: A randomized clinical trial in order to evaluate the efficacy of a specific exercise strategy for patients with subacromial pain.
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.
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain Shoulder Impingement Syndrome Disorder of Rotator Cuff Subacromial Bursitis||Other: Specific exercise group Other: Control exercise group||Not Applicable|
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 continues during 2019 and data Collection for all follow ups is anticipated to be completed during the year of 2020.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||167 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain - a Randomized Clinical Trial|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: 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
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.
Active Comparator: Control exercise group
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
A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.
- The Constant-Murley shoulder assessment [ Time Frame: Baseline and change 3-, 6- and 12 months ]
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.
- Euro Qol 5D index (EQ 5D) [ Time Frame: Baseline and change 3-, 6- and 12 months ]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.
- Disabilities of the arm, shoulder and hand [ Time Frame: Baseline and change 3-, 6- and 12 months ]Self-assessment of the ability to performed exemplified activities. 0 indicates a non-affected upper extremity.
- VAS for pain [ Time Frame: Baseline and change 3-, 6- and 12 months ]Self-assessed for pain at rest, in activity and at night if it disturbs sleeping
- Patients Global Impression of Change (PGIC) [ Time Frame: At follow-up: 3-, 6- and 12 months ]The patients are asked to assess change. A scale ranging from getting worse by the intervention to be recovered.
- The Patient Specific functional Scale [ Time Frame: Baseline and change 3-, 6- and 12 months ]Self-selected functional activities to relate efficacy to during follow-ups.
- Euro Qol VAS (EQ VAS) [ Time Frame: Baseline and change 3-, 6- and 12 months ]In EQ VAS the patients assess their health state on a vertical line valued from 0-100.
- Hospital Anxiety and Depression Scale (HAD) [ Time Frame: Baseline ]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.
- Sick-leave and return to work or working status [ Time Frame: Baseline, 3-, 6- and 12 months ]Patient reported can be double checked by the Swedish Social Insurance Agency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885377
|Contact: Jenny Nordqvist, MSc, RPT||+46 10 103 78 firstname.lastname@example.org|
|Contact: Kajsa Johansson, PhD, RPT||+46 10 103 74 email@example.com|
|Primary Care unit "Rörelse & Hälsa"||Recruiting|
|Linköping, Sweden, 581 85|
|Principal Investigator: Jenny Norqvist, MSc, RPT|
|Study Chair:||Birgitta Öberg, Professor||Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University|
|Study Director:||Lars Adolfsson, Professor||Dept. of Orthopaedics, University Hospital Linköping & Linköping University|
|Principal Investigator:||Kajsa Johansson, PhD||Div. of Physical Therapy, Dept. of Medical and Health Sciences, Linköping University|