Self-Management for Persistent Subacromial Pain

NCT04190836 | Completed Phase 1

• 1 other identifier: 2017/355
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  How many people that were eligible and how many people that were recruited per week

  3 months

• Follow-up rate

  Determine the follow-up rate - measured by the percentage of participants who were followed up successfully until the three months follow-up

  3 months

• Actigraph assessment of physical activity

  Feasibility of Actigraph assessment of physical activity - measured by percentage of participants with valid data at Week 0, Week 6 and 3 months

  3 months

• Adherence

  Determine whether the patients adhere with the self-managed exercises - measured by self-reported exercise log book

  3 months

• Fidelity

  Determine whether the therapists delivered the intervention as planned - measured by assessing the therapists' log book

  3 months

• Adverse events

  Determine number and nature of adverse events via self-report questionnaire

  3 months

Secondary Outcomes (12)

• Shoulder pain and disability index (SPADI)

  3 months

• Patient Specific Function Scale (PSFS)

  3 months

• Numeric Pain Rating Scale (NPRS)

  3 months

• Pain self-efficacy 2-item short form (PSEQ-2 item)

  3 months

• Self-efficacy

  3 months

Study Arms (1)

Self-Managed Exercise Strategy

EXPERIMENTAL

Behavioral: Self-Managed Exercise Strategy

Interventions

Self-Managed Exercise Strategy 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.

Self-Managed Exercise Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Oslo University Hospital: collaborator
• Keele University: collaborator
• National Institute of Occupational Health: collaborator
• Diakonhjemmet Hospital: collaborator

Study Sites (2)

Diakonhjemmet Hospital

Oslo, Norway

Location

Oslo Metropolitan University

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 33494821 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Motor Activity

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Daniel Major, MSc

  Oslo Metropolitan University

  STUDY CHAIR

• Yngve Røe, PhD

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

• Margreth Grotle, PhD

  Oslo Metropolitan University

  STUDY CHAIR

• Chris Littlewood, PhD

  Keele University

  STUDY CHAIR

• Dagfinn Matre, PhD

  National Institute of Occupational Health, Norway

  STUDY CHAIR

• Heidi V Gallet, MSc

  Diakonhjemmet Hospital

  STUDY CHAIR

• Hege Bentzen, PhD

  Oslo Metropolitan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: December 9, 2019
• Study Start: November 1, 2017
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

NO (2)