NCT03055117

Brief Summary

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 16, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

February 3, 2017

Last Update Submit

March 25, 2019

Conditions

Shoulder Pain

Keywords

Shoulder painPhysiotherapyRehabilitationExercise

Outcome Measures

Primary Outcomes (1)

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

    Sum score 0-100

    6 monhts

Secondary Outcomes (11)

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

    6 months

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

    6 months

  • Pain intensity

    6 months

  • Patients impression of change of overall shoulder condition

    6 months

  • Patient Acceptable Symptom State (PASS)

    6 months

  • +6 more secondary outcomes

Study Arms (3)

Group-based exercise rehabilitation

EXPERIMENTAL

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 rehabilitationBehavioral: Home exercise

Individual exercise rehabilitation

ACTIVE COMPARATOR

Individual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).

Behavioral: Individual exercise rehabilitationBehavioral: Home exercise

Home exercise

ACTIVE COMPARATOR

Home exercise: Instruction in home exercise by physiotherapist, with maximum of 4 follow-up consultations over a period of 8 weeks.

Behavioral: Home exercise

Interventions

Group-based exercise rehabilitationBEHAVIORAL

Group- based physiotherapy-led exercise rehabilitation

Group-based exercise rehabilitation
Individual exercise rehabilitationBEHAVIORAL

Individual physiotherapy-led exercise rehabilitation

Individual exercise rehabilitation
Home exerciseBEHAVIORAL

Supervised home exercise

Group-based exercise rehabilitationHome exerciseIndividual exercise rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David H Christiansen

Herning, Central Jutland, 7400, Denmark

Location

Related Publications (1)

  • Christiansen DH, Hjort J. Group-based exercise, individually supervised exercise and home-based exercise have similar clinical effects and cost-effectiveness in people with subacromial pain: a randomised trial. J Physiother. 2021 Apr;67(2):124-131. doi: 10.1016/j.jphys.2021.02.015. Epub 2021 Mar 17.

    PMID: 33744191DERIVED

MeSH Terms

Conditions

Shoulder PainMotor Activity

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • David H Christiansen, PhD

    Occupational Medicine Regional Hospital West Jutland University Research Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 16, 2017

Study Start

February 16, 2017

Primary Completion

August 27, 2018

Study Completion

August 27, 2018

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)