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Self-Management for Persistent Subacromial Pain

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ClinicalTrials.gov Identifier: NCT04190836
Recruitment Status : Completed
First Posted : December 9, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborators:
Oslo University Hospital
Keele University
National Institute of Occupational Health
Diakonhjemmet Hospital
Information provided by (Responsible Party):
Oslo Metropolitan University

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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Chronic Behavioral: Self-Managed Exercise Strategy Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adherence to Self-managed Exercises for Patients With Persistent Subacromial Pain: A Feasibility Study for the Ad-Shoulder Trial
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : September 12, 2018
Actual Study Completion Date : September 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-Managed Exercise Strategy Behavioral: 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.




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 3 months ]
    How many people that were eligible and how many people that were recruited per week

  2. Follow-up rate [ Time Frame: 3 months ]
    Determine the follow-up rate - measured by the percentage of participants who were followed up successfully until the three months follow-up

  3. Actigraph assessment of physical activity [ Time Frame: 3 months ]
    Feasibility of Actigraph assessment of physical activity - measured by percentage of participants with valid data at Week 0, Week 6 and 3 months

  4. Adherence [ Time Frame: 3 months ]
    Determine whether the patients adhere with the self-managed exercises - measured by self-reported exercise log book

  5. Fidelity [ Time Frame: 3 months ]
    Determine whether the therapists delivered the intervention as planned - measured by assessing the therapists' log book

  6. Adverse events [ Time Frame: 3 months ]
    Determine number and nature of adverse events via self-report questionnaire


Secondary Outcome Measures :
  1. Shoulder pain and disability index (SPADI) [ Time Frame: 3 months ]
    SPADI is a self-reported questionnaire for patients with shoulder pain. The questionnaire consists of 13 questions divided into two domains: pain (five items) and function (eight items) and scored on a numerical scale 0 (best) to 10 (worst) with a score range from 0 to 100 points

  2. Patient Specific Function Scale (PSFS) [ Time Frame: 3 months ]
    PSFS is a patient specific outcome measure where the patient is asked to name three activities which the patient find challenging or are not able to do because of their shoulder pain. Patients rate their ability to complete the activities on a 11-point scale at a level experienced prior to injury or change in functional status. "0" represents "unable to perform" and "10" represents "able to perform at prior level".

  3. Numeric Pain Rating Scale (NPRS) [ Time Frame: 3 months ]
    Pain intensity during the last week was measured using the NPRS (ranging from 0 = no pain, 10 = the most intense pain imaginable). Repeated measures: During a one week pre-treatment phase (A), 3 times. During the 12 week treatment phase (B): collected twice every week. During a one week post-treatment phase (A): 3 times

  4. Pain self-efficacy 2-item short form (PSEQ-2 item) [ Time Frame: 3 months ]
    Measured using a 2-item questionnaire by asking the patients' how confident they are doing some form of work and to live a normal lifestyle at present, despite the pain (ranging from 0 = not at all confident, 6 = completely confident). Repeated measures: During a one week pre-treatment phase (A), 3 times. During the 12 week treatment phase (B): collected twice every week. During a one week post-treatment phase (A): 3 times

  5. Self-efficacy [ Time Frame: 3 months ]
    Measured using one modified question from the Musculoskeletal Health Questionnaire: "How confident have you felt about managing your shoulder pain by yourself (responses were not at all confident, slightly, moderately, very and extremely)? Repeated measures: During a one week pre-treatment phase (A), 3 times. During the 12 week treatment phase (B): collected twice every week. During a one week post-treatment phase (A): 3 times

  6. Working Ability Index [ Time Frame: 3 months ]
    Work ability will be measured on a 11-point scale (0 = Can not work at all, 10 = working ability is best right now)

  7. EQ-5D-5L [ Time Frame: 3 months ]
    Generic health-related quality of life will be assessed by the EQ-5D. It evaluates 5 dimensions: mobility, self-care, activities of daily living, pain, and anxiety and/or depression. For each dimension the patient describes three possible levels of problems (none, mild-to-moderate, and severe).

  8. Global Perceived Effect scale (GPE) [ Time Frame: 3 months ]
    The patient rated perception of change at the follow-ups will be assessed on a Global Perceived Effect scale (GPE) at follow-up (52). The response alternatives were: 1 = "completely recovered", 2 = "much improved", 3 = "slightly improved", 4 = "no change", 5 = "slightly worse", 6 = "much worse", and 7 = "worse than ever".

  9. Bergen Insomnia Scale [ Time Frame: 3 months ]
    Pain-interference with sleep will be assessed by the Bergen Insomnia Scale, which consists of six items. Scoring 3 or above on at least one of the first four items and scoring 3 or above on at least one of the last two items indicate the presence of insomnia.

  10. Kinesiophobia [ Time Frame: 3 months ]
    Kinesiophobia will be assessed using one question: "How much 'fear' do you have that these complaints would be increased by physical activity? (scores range from 0 = no fear, to 10 = very much fear).

  11. Physical activity (self-reported) [ Time Frame: 3 months ]
    Physical activity will be assessed by the 3 questions from the Nord-Trondelag Health Study (HUNT) regarding frequency, intensity and duration.

  12. Physical activity (accelerometer) [ Time Frame: 3 months ]
    To objectively measure physical activity an accelerometer (AX3, 3-axis Logging Accelerometer) was used. This accelerometer provides information about movement and will enable us to objectively measure the amount of general physical activity (minutes of moderate activity). The patients will be measured for three consecutive days at baseline, at 6 weeks and at 3 months to assess changes between the three time points (Week 0, Week 6 and 3 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190836


Locations
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Norway
Diakonhjemmet Hospital
Oslo, Norway
Oslo Metropolitan University
Oslo, Norway
Sponsors and Collaborators
Oslo Metropolitan University
Oslo University Hospital
Keele University
National Institute of Occupational Health
Diakonhjemmet Hospital
Investigators
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Study Chair: Daniel Major, MSc Oslo Metropolitan University
Principal Investigator: Yngve Røe, PhD Oslo Metropolitan University
Study Chair: 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 Director: Hege Bentzen, PhD Oslo Metropolitan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oslo Metropolitan University
ClinicalTrials.gov Identifier: NCT04190836    
Other Study ID Numbers: 2017/355
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oslo Metropolitan University:
Shoulder pain
Persistent pain
Self-management
Exercise
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations