Self-Management for Persistent Subacromial Pain
Primary Purpose
Shoulder Pain Chronic
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Self-Managed Exercise Strategy
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain Chronic focused on measuring Shoulder pain, Persistent pain, Self-management, Exercise
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
Sites / Locations
- Diakonhjemmet Hospital
- Oslo Metropolitan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Self-Managed Exercise Strategy
Arm Description
Outcomes
Primary Outcome Measures
Recruitment rate
How many people that were eligible and how many people that were recruited per week
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
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
Adherence
Determine whether the patients adhere with the self-managed exercises - measured by self-reported exercise log book
Fidelity
Determine whether the therapists delivered the intervention as planned - measured by assessing the therapists' log book
Adverse events
Determine number and nature of adverse events via self-report questionnaire
Secondary Outcome Measures
Shoulder pain and disability index (SPADI)
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)
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)
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)
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
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
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
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)
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
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
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)
Physical activity will be assessed by the 3 questions from the Nord-Trondelag Health Study (HUNT) regarding frequency, intensity and duration.
Physical activity (accelerometer)
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.
Full Information
NCT ID
NCT04190836
First Posted
November 18, 2019
Last Updated
December 6, 2019
Sponsor
Oslo Metropolitan University
Collaborators
Oslo University Hospital, Keele University, National Institute of Occupational Health, Diakonhjemmet Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04190836
Brief Title
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
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
September 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo Metropolitan University
Collaborators
Oslo University Hospital, Keele University, National Institute of Occupational Health, Diakonhjemmet Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain Chronic
Keywords
Shoulder pain, Persistent pain, Self-management, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Managed Exercise Strategy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Self-Managed Exercise Strategy
Intervention Description
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 Measure Information:
Title
Recruitment rate
Description
How many people that were eligible and how many people that were recruited per week
Time Frame
3 months
Title
Follow-up rate
Description
Determine the follow-up rate - measured by the percentage of participants who were followed up successfully until the three months follow-up
Time Frame
3 months
Title
Actigraph assessment of physical activity
Description
Feasibility of Actigraph assessment of physical activity - measured by percentage of participants with valid data at Week 0, Week 6 and 3 months
Time Frame
3 months
Title
Adherence
Description
Determine whether the patients adhere with the self-managed exercises - measured by self-reported exercise log book
Time Frame
3 months
Title
Fidelity
Description
Determine whether the therapists delivered the intervention as planned - measured by assessing the therapists' log book
Time Frame
3 months
Title
Adverse events
Description
Determine number and nature of adverse events via self-report questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Shoulder pain and disability index (SPADI)
Description
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
Time Frame
3 months
Title
Patient Specific Function Scale (PSFS)
Description
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".
Time Frame
3 months
Title
Numeric Pain Rating Scale (NPRS)
Description
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
Time Frame
3 months
Title
Pain self-efficacy 2-item short form (PSEQ-2 item)
Description
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
Time Frame
3 months
Title
Self-efficacy
Description
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
Time Frame
3 months
Title
Working Ability Index
Description
Work ability will be measured on a 11-point scale (0 = Can not work at all, 10 = working ability is best right now)
Time Frame
3 months
Title
EQ-5D-5L
Description
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).
Time Frame
3 months
Title
Global Perceived Effect scale (GPE)
Description
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".
Time Frame
3 months
Title
Bergen Insomnia Scale
Description
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.
Time Frame
3 months
Title
Kinesiophobia
Description
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).
Time Frame
3 months
Title
Physical activity (self-reported)
Description
Physical activity will be assessed by the 3 questions from the Nord-Trondelag Health Study (HUNT) regarding frequency, intensity and duration.
Time Frame
3 months
Title
Physical activity (accelerometer)
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Major, MSc
Organizational Affiliation
Oslo Metropolitan University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yngve Røe, PhD
Organizational Affiliation
Oslo Metropolitan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margreth Grotle, PhD
Organizational Affiliation
Oslo Metropolitan University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chris Littlewood, PhD
Organizational Affiliation
Keele University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dagfinn Matre, PhD
Organizational Affiliation
National Institute of Occupational Health, Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heidi V Gallet, MSc
Organizational Affiliation
Diakonhjemmet Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hege Bentzen, PhD
Organizational Affiliation
Oslo Metropolitan University
Official's Role
Study Director
Facility Information:
Facility Name
Diakonhjemmet Hospital
City
Oslo
Country
Norway
Facility Name
Oslo Metropolitan University
City
Oslo
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
33494821
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.
Results Reference
derived
Learn more about this trial
Self-Management for Persistent Subacromial Pain
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