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

This study is currently recruiting participants.
Verified February 2017 by David H Christiansen, Regional Hospital West Jutland
Sponsor:
ClinicalTrials.gov Identifier:
NCT03055117
First Posted: February 16, 2017
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Aarhus
Central Denmark Region
Information provided by (Responsible Party):
David H Christiansen, Regional Hospital West Jutland
  Purpose

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.


Condition Intervention
Shoulder Pain Behavioral: Group-based exercise rehabilitation Behavioral: Individual exercise rehabilitation Behavioral: Home exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders

Resource links provided by NLM:


Further study details as provided by David H Christiansen, Regional Hospital West Jutland:

Primary Outcome Measures:
  • Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH) [ Time Frame: 6 monhts ]

Secondary Outcome Measures:
  • 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

  • Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments [ Time Frame: 6 months ]
  • Pain intensity numeric scale (0-10) [ Time Frame: 6 months ]
  • Patients impression of change of overall shoulder condition [ Time Frame: 6 months ]
    Single item question

  • Patient Acceptable Symptom State (PASS) [ Time Frame: 6 months ]
    Single item question. The highest level of symptom at which patients find their condition acceptable

  • Well-being wil be assessed by the WHO-5 Well-being Index questionnaire [ Time Frame: 6 months ]
  • Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation [ Time Frame: 6 months ]
    Register

  • Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire [ Time Frame: 6 months ]
  • Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [ Time Frame: 3 months ]
  • Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [ Time Frame: 3 months ]
  • Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [ Time Frame: 3 months ]

Estimated Enrollment: 180
Actual Study Start Date: February 16, 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group-based exercise rehabilitation
Group-based rehabilitation: Group-based sessions (4-8 patients per group) with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).
Behavioral: Group-based exercise rehabilitation
Group- based physiotherapy-led exercise rehabilitation
Behavioral: Home exercise
Supervised home exercise
Active Comparator: Individual exercise rehabilitation
Individual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).
Behavioral: Individual exercise rehabilitation
Individual physiotherapy-led exercise rehabilitation
Behavioral: Home exercise
Supervised home exercise
Active Comparator: Home exercise
Home exercise: Instruction in home exercise by physiotherapist, with maximum of 4 follow-up consultations over a period of 8 weeks.
Behavioral: Home exercise
Supervised home exercise

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT03055117


Contacts
Contact: David H Christiansen, PhD +45 21688431 david.christiansen@vest.rm.dk

Locations
Denmark
David H Christiansen Recruiting
Herning, Central Denmark Region, Denmark, 7400
Contact: David H Christiansen, PhD    +4521688431    david.Christiansen@vest.rm.dk   
Sponsors and Collaborators
Regional Hospital West Jutland
University of Aarhus
Central Denmark Region
Investigators
Principal Investigator: David H Christiansen, PhD Department of Occupational Medicine Regional Hospital West Jutland University Research Clinic
  More Information

Responsible Party: David H Christiansen, Researcher, Regional Hospital West Jutland
ClinicalTrials.gov Identifier: NCT03055117     History of Changes
Other Study ID Numbers: 1-10-72-178-16
First Submitted: February 3, 2017
First Posted: February 16, 2017
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David H Christiansen, Regional Hospital West Jutland:
Shoulder pain
Physiotherapy
Rehabilitation
Exercise

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms