Shoulder PainNCT03055117
Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders: a Randomised Controlled Trial
A study testing Group-based exercise rehabilitation, Individual exercise rehabilitation and Home exercise in people with Shoulder Pain, run by Regional Hospital West Jutland at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Group-based exercise rehabilitation, Individual exercise rehabilitation and Home exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Feb 2017to 27 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Influence of co-morbidity, psychiatric illness, pregnancy, fullthickness rotator cuff tear, rotator cuff repair surgery, traumatic lesion, rheumatoid arthritis, frozen shoulder, glenohumeral osteoarthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders
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.
.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- Group-based exercise rehabilitation, Individual exercise rehabilitation, Home exercise
- Keywords
- Shoulder pain, Physiotherapy, Rehabilitation, Exercise
- Medical subject headings
- Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based exercise rehabilitationBehavioural
Group- based physiotherapy-led exercise rehabilitation
Individual exercise rehabilitationBehavioural
Individual physiotherapy-led exercise rehabilitation
Home exerciseBehavioural
Supervised home exercise
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Group-based exercise rehabilitation; Behavioral: 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). Receives: Behavioral: Individual exercise rehabilitation; Behavioral: 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. Receives: Behavioral: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH)
Sum score 0-100
Measured: 6 monhts
Secondary outcomes (11)
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
Measured: 6 months
Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments
Register
Measured: 6 months
Pain intensity
Numeric scale (0-10)
Measured: 6 months
Patients impression of change of overall shoulder condition
Single item question
Measured: 6 months
Patient Acceptable Symptom State (PASS)
Single item question. The highest level of symptom at which patients find their condition acceptable
Measured: 6 months
Well-being wil be assessed by the WHO-5 Well-being Index questionnaire
Sum score of 5 items 0-100
Measured: 6 months
Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation
Register number of contacts
Measured: 6 months
Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire
Sumscore 0-20
Measured: 6 months
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Single item question.
Measured: 3 months
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Single item question.
Measured: 3 months
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Single item question.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start16 Feb 2017
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital West Jutland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Central Denmark Region
- Responsible party
- Principal investigator, David H Christiansen, Regional Hospital West Jutland
- Investigators
- David H Christiansen, PhD, Principal investigator, Occupational Medicine Regional Hospital West Jutland University Research Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055117
- Sponsor's protocol ID
- 1-10-72-178-16
- Status last verified
- Mar 2019
- First submitted
- 3 Feb 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33744191
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders
- ClinicalTrials.gov ID
- NCT03055117
- Acronym / sponsor ID
- 1-10-72-178-16
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, Physiotherapy, Rehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Regional Hospital West JutlandUniversity, hospital or other
- Collaborators
- University of Aarhus, Central Denmark Region
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-based exercise rehabilitation | Experimental | Behavioral: Group-based exercise rehabilitation, Behavioral: Home exerciseGroup-based rehabilitation: Group-based sessions (4-8 patients per group) with physiotherapist and home training for 8 weeks (maximum of 12 training sessions). |
| Individual exercise rehabilitation | Active comparator | Behavioral: Individual exercise rehabilitation, Behavioral: Home exerciseIndividual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions). |
| Home exercise | Active comparator | Behavioral: Home exerciseHome exercise: Instruction in home exercise by physiotherapist, with maximum of 4 follow-up consultations over a period of 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Influence of co-morbidity, psychiatric illness, pregnancy, fullthickness rotator cuff tear, rotator cuff repair surgery, traumatic lesion, rheumatoid arthritis, frozen shoulder, glenohumeral osteoarthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based exercise rehabilitationGroup- based physiotherapy-led exercise rehabilitation | Behavioural | Group-based exercise rehabilitation |
| Individual exercise rehabilitationIndividual physiotherapy-led exercise rehabilitation | Behavioural | Individual exercise rehabilitation |
| Home exerciseSupervised home exercise | Behavioural | Group-based exercise rehabilitation, Home exercise, Individual exercise rehabilitation |
Primary outcome
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
11 secondary outcomes
Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire
Time frame: 6 months
Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments
Time frame: 6 months
Pain intensity
Time frame: 6 months
Patients impression of change of overall shoulder condition
Time frame: 6 months
Patient Acceptable Symptom State (PASS)
Time frame: 6 months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Derived from this study: PubMed 33744191Christiansen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H Christiansen, PhD principal investigator
Occupational Medicine Regional Hospital West Jutland University Research Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based exercise rehabilitation, Individual exercise rehabilitation and Home exercise in people with Shoulder Pain, run by Regional Hospital West Jutland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH) (time frame: 6 monhts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03055117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.