Self-Management for Persistent Subacromial Pain

NCT ID: NCT04190836

Last Updated: 2019-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-09-12

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.

Conditions

Shoulder Pain Chronic

Keywords

Shoulder pain; Persistent pain; Self-management; Exercise

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-Managed Exercise Strategy

Group Type: EXPERIMENTAL

Self-Managed Exercise Strategy

Intervention Type: BEHAVIORAL

The intervention is a personalised supported self-management intervention which emphasises dynamic, progressively loaded exercises for the shoulder. The intervention consisted of 1-5 individual sessions provided over 3 months, with a duration of 1 hour for the first session and 45 minutes for the following. The participants will have the opportunity to contact the physiotherapist by phone, text message or e-mail for advice during the treatment period (12 weeks). The personalised supported self-management intervention will be based on the components of the self-management framework, provided by Lorig and Holman (2003). The five self-management skills and the operationalization of these will be described when publishing the study. For specific content reporting of the self managed exercises we will follow the Consensus on Exercise Reporting Template.

Interventions

Self-Managed Exercise Strategy

The intervention is a personalised supported self-management intervention which emphasises dynamic, progressively loaded exercises for the shoulder. The intervention consisted of 1-5 individual sessions provided over 3 months, with a duration of 1 hour for the first session and 45 minutes for the following. The participants will have the opportunity to contact the physiotherapist by phone, text message or e-mail for advice during the treatment period (12 weeks). The personalised supported self-management intervention will be based on the components of the self-management framework, provided by Lorig and Holman (2003). The five self-management skills and the operationalization of these will be described when publishing the study. For specific content reporting of the self managed exercises we will follow the Consensus on Exercise Reporting Template.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Keele University

OTHER

Sponsor Role: collaborator

National Institute of Occupational Health

UNKNOWN

Sponsor Role: collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role: collaborator

Oslo Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Major, MSc

Role: STUDY_CHAIR

Oslo Metropolitan University

Yngve Røe, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo Metropolitan University

Margreth Grotle, PhD

Role: STUDY_CHAIR

Oslo Metropolitan University

Chris Littlewood, PhD

Role: STUDY_CHAIR

Keele University

Dagfinn Matre, PhD

Role: STUDY_CHAIR

National Institute of Occupational Health, Norway

Heidi V Gallet, MSc

Role: STUDY_CHAIR

Diakonhjemmet Hospital

Hege Bentzen, PhD

Role: STUDY_DIRECTOR

Oslo Metropolitan University

Locations

Diakonhjemmet Hospital

Oslo, , Norway

Oslo Metropolitan University

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 33494821 (View on PubMed)

Other Identifiers

2017/355

Identifier Type: -

Identifier Source: org_study_id