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
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain Chronic||Behavioral: Self-Managed Exercise Strategy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- Recruitment rate [ Time Frame: 3 months ]How many people that were eligible and how many people that were recruited per week
- 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
- 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
- Adherence [ Time Frame: 3 months ]Determine whether the patients adhere with the self-managed exercises - measured by self-reported exercise log book
- Fidelity [ Time Frame: 3 months ]Determine whether the therapists delivered the intervention as planned - measured by assessing the therapists' log book
- Adverse events [ Time Frame: 3 months ]Determine number and nature of adverse events via self-report questionnaire
- 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
- 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".
- 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
- 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
- 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
- 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)
- 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).
- 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".
- 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.
- 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).
- 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.
- 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.
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
|Oslo Metropolitan University|
|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|