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NCT Number: NCT03055117

Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders: a Randomised Controlled Trial

Degenerative shoulder disorders are frequent in the Danish population and often cause disability and sick leave. After hospital discharge patients are often referred to physiotherapy rehabilitation as part of the treatment, and it is often assumed that one-on-one sessions will yield better results than group-based sessions, because individual needs can be better meet and targeted

The project aims to evaluate the effect and cost-effectiveness of group- based exercise rehabilitation as compared to individual exercise rehabilitation in patients with degenerative shoulder disorders.

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Key information

Conditions

Shoulder Pain Arthralgia Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

David H Christiansen

Herning, Central Jutland, 7400, Denmark

About this study

The study is a three-armed controlled randomized trial in which a total of 180 patients referred to the municipal rehabilitation after hospital treatment due to shoulder disorders in 6 municipalities in Region Midtjylland expected to participate. Patients will be allocated to either 1) Group-based rehabilitation 2) Individual rehabilitation or 3) Home exercise.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years and above, ability to speak and understand Danish and referred to physiotherapy rehabilitation after hospital conservative or surgical treatment under diagnose of rotator cuff/shoulder impingement or acromioclavicular osteoarthritis (International Classification of Diseases 10th revision [ICD-10] group M75.1-M75.8, M19.8).

Exclusion criteria

  • Influence of co-morbidity, psychiatric illness, pregnancy, fullthickness rotator cuff tear, rotator cuff repair surgery, traumatic lesion, rheumatoid arthritis, frozen shoulder, glenohumeral osteoarthritis.

Treatment and study plan

Group-based exercise rehabilitation

Behavioral

Group- based physiotherapy-led exercise rehabilitation

Individual exercise rehabilitation

Behavioral

Individual physiotherapy-led exercise rehabilitation

Home exercise

Behavioral

Supervised home exercise

Primary outcomes

  1. Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH)

    Time frame: 6 monhts

    Sum score 0-100

Secondary outcomes

  1. Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire

    Time frame: 6 months

    Quality of life scale EQ-5D-5L will be used to calculate quality adjusted life years (QALYs) used in the health economic evaluation

  2. Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments

    Time frame: 6 months

    Register

  3. Pain intensity

    Time frame: 6 months

    Numeric scale (0-10)

  4. Patients impression of change of overall shoulder condition

    Time frame: 6 months

    Single item question

  5. Patient Acceptable Symptom State (PASS)

    Time frame: 6 months

    Single item question. The highest level of symptom at which patients find their condition acceptable

  6. Well-being wil be assessed by the WHO-5 Well-being Index questionnaire

    Time frame: 6 months

    Sum score of 5 items 0-100

  7. Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation

    Time frame: 6 months

    Register number of contacts

  8. Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire

    Time frame: 6 months

    Sumscore 0-20

  9. Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire

    Time frame: 3 months

    Single item question.

  10. Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire

    Time frame: 3 months

    Single item question.

  11. Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire

    Time frame: 3 months

    Single item question.

Sponsors and collaborators

Lead sponsor

Regional Hospital West Jutland

Other

Collaborators

  • Central Denmark Region
  • University of Aarhus

Registry information

Official study title

Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 16, 2017
Registry last updated
Mar 26, 2019

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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