An interventional study of Group-based exercise rehabilitation and Individual exercise rehabilitation in Shoulder Pain, sponsored by Regional Hospital West Jutland. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Regional Hospital West Jutland · Not applicable, Interventional, and Treatment
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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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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 180 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Regional Hospital West Jutland is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Behavioral: Home exercise
Individual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).
Behavioral: Individual exercise rehabilitation · Behavioral: 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
Group- based physiotherapy-led exercise rehabilitation
Individual physiotherapy-led exercise rehabilitation
Supervised home exercise
Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH)
Sum score 0-100
Time frame: 6 monhts
Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire
Quality of life scale EQ-5D-5L will be used to calculate quality adjusted life years (QALYs) used in the health economic evaluation
Time frame: 6 months
Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments
Register
Time frame: 6 months
Pain intensity
Numeric scale (0-10)
Time frame: 6 months
Patients impression of change of overall shoulder condition
Single item question
Time frame: 6 months
Patient Acceptable Symptom State (PASS)
Single item question. The highest level of symptom at which patients find their condition acceptable
Time frame: 6 months
Well-being wil be assessed by the WHO-5 Well-being Index questionnaire
Sum score of 5 items 0-100
Time frame: 6 months
Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation
Register number of contacts
Time frame: 6 months
Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire
Sumscore 0-20
Time frame: 6 months
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Single item question.
Time frame: 3 months
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Single item question.
Time frame: 3 months
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Single item question.
Time frame: 3 months
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Regional Hospital West Jutland