Clinical trial NCT04190836: Self-Management for Persistent Subacromial Pain
Official title: Adherence to Self-managed Exercises for Patients With Persistent Subacromial Pain: A Feasibility Study for the Ad-Shoulder Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Shoulder Pain Chronic
Keywords: Shoulder pain
Persistent pain
Self-management
Exercise
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Keele University
name: National Institute of Occupational Health
name: Diakonhjemmet Hospital
First posted: 2019-12-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Physiotherapy-led exercises is the first line treatment for patients with subacromial pain. However, current evidence report that most treatment programmes only show a short-term benefit. There seem to be a potential for enhancing the effectiveness of exercise interventions by improving adherence to self-managed exercises, but there is lack of knowledge about adherence to exercise programmes in shoulder pain. Before conducting a planned randomised controlled trial on the clinical effectiveness of an intervention focusing on adherence to a self-managed exercise strategy (the Ad-Shoulder intervention), it is necessary to run a feasibility study in order to establish whether such a resource-demanding trial is worthwhile. Feasibility studies are designed to answer the key question "Can it work?" The main objectives of the present study was to assess the feasibility in terms of recruitment capability, data collection procedures and acceptability of the Ad-Shoulder intervention in patients with subacromial pain receiving treatment in primary or secondary health care.


Eligibility criteria: Inclusion Criteria:

* Pain located to the upper arm
* Had previously received conservative treatment due to subacromial pain
* Still seek primary or secondary care during the past 6 months

Exclusion Criteria:

* Frozen shoulder diagnosis (\<50% external rotation compared to contralateral side)
* Patients who have received surgical treatment due to shoulder problems
* Pregnant patients
* Patients with insufficient Norwegian language skills
* Serious psychiatric disorder

Primary outcomes:
measure: Recruitment rate
timeFrame: 3 months
measure: Follow-up rate
timeFrame: 3 months
measure: Actigraph assessment of physical activity
timeFrame: 3 months
measure: Adherence
timeFrame: 3 months
measure: Fidelity
timeFrame: 3 months
measure: Adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Shoulder pain and disability index (SPADI)
timeFrame: 3 months
measure: Patient Specific Function Scale (PSFS)
timeFrame: 3 months
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 3 months
measure: Pain self-efficacy 2-item short form (PSEQ-2 item)
timeFrame: 3 months
measure: Self-efficacy
timeFrame: 3 months
measure: Working Ability Index
timeFrame: 3 months
measure: EQ-5D-5L
timeFrame: 3 months
measure: Global Perceived Effect scale (GPE)
timeFrame: 3 months
measure: Bergen Insomnia Scale
timeFrame: 3 months
measure: Kinesiophobia
timeFrame: 3 months
measure: Physical activity (self-reported)
timeFrame: 3 months
measure: Physical activity (accelerometer)
timeFrame: 3 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Oslo
country: Norway
facility: Oslo Metropolitan University
Study officials:
affiliation: Oslo Metropolitan University
name: Daniel Major, MSc
role: STUDY_CHAIR
affiliation: Oslo Metropolitan University
name: Yngve Røe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo Metropolitan University
name: Margreth Grotle, PhD
role: STUDY_CHAIR
affiliation: Keele University
name: Chris Littlewood, PhD
role: STUDY_CHAIR
affiliation: National Institute of Occupational Health, Norway
name: Dagfinn Matre, PhD
role: STUDY_CHAIR
affiliation: Diakonhjemmet Hospital
name: Heidi V Gallet, MSc
role: STUDY_CHAIR
affiliation: Oslo Metropolitan University
name: Hege Bentzen, PhD
role: STUDY_DIRECTOR
References:
citation: Major DH, Grotle M, Littlewood C, Brox JI, Matre D, Gallet HV, Roe Y. Adherence to self-managed exercises for patients with persistent subacromial pain: the Ad-Shoulder feasibility study. Pilot Feasibility Stud. 2021 Jan 25;7(1):31. doi: 10.1186/s40814-021-00767-6.