Self-Management for Persistent Subacromial Pain

Shoulder Pain Chronic Clinical Trial

Official title:

Adherence to Self-managed Exercises for Patients With Persistent Subacromial Pain: A Feasibility Study for the Ad-Shoulder Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190836
• Other study ID #: 2017/355
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2017
• Est. completion date: September 12, 2018

Study information

• Verified date: December 2019
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 12, 2018
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain
• Shoulder Pain Chronic

Intervention

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.

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo
Norway	Oslo Metropolitan University	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Oslo Metropolitan University	Diakonhjemmet Hospital, Keele University, National Institute of Occupational Health, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	How many people that were eligible and how many people that were recruited per week	3 months
Primary	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
Primary	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
Primary	Adherence	Determine whether the patients adhere with the self-managed exercises - measured by self-reported exercise log book	3 months
Primary	Fidelity	Determine whether the therapists delivered the intervention as planned - measured by assessing the therapists' log book	3 months
Primary	Adverse events	Determine number and nature of adverse events via self-report questionnaire	3 months
Secondary	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	3 months
Secondary	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".	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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)	3 months
Secondary	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).	3 months
Secondary	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".	3 months
Secondary	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.	3 months
Secondary	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).	3 months
Secondary	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.	3 months
Secondary	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.	3 months