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Completed

NCT Number: NCT01885377

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

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.

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Key information

Conditions

Shoulder Pain Arthralgia Behavior Disorder of Rotator Cuff Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Impingement Syndrome Shoulder Injuries Signs and Symptoms Subacromial Bursitis Wounds and Injuries

Age range

30 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care unit "Rörelse & Hälsa"

Linköping, 581 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: •Strength-endurance exercises, •Rotator cuff, •Scapular stabilization, •Eccentric, •Posture

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.

Other names: •Movement exercises, •Stretching, •Posture

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Ostergotland County Council, Sweden
  • University Hospital, Linkoeping

Registry information

Official study title

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

Acronym: SWESS

Important dates

Study start
2011
Primary completion
2020
Study completion
2021
First posted
Jun 25, 2013
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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