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Shoulder Pain ChronicPhase 1NCT04190836

Self-Management for Persistent Subacromial Pain

A Phase 1 study testing Self-Managed Exercise Strategy in people with Shoulder Pain Chronic, run by Oslo Metropolitan University at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shoulder Pain Chronic
What is being tested?
Self-Managed Exercise Strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesNorway
Study dates
1 Nov 2017to 12 Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

  • Diakonhjemmet Hospital

    Oslo

  • Oslo Metropolitan University

    Oslo

Other trials in Norway

About this study

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

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.

Being tested
Self-Managed Exercise Strategy
Keywords
Shoulder pain, Persistent pain, Self-management, Exercise
Medical subject headings
Shoulder Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Managed Exercise StrategyBehavioural

    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.

Study groups in NCT04190836
Study groupRoleWhat they receive
Self-Managed Exercise StrategyExperimentalNot described
Receives: Behavioral: Self-Managed Exercise Strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

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

    Measured: 3 months

  2. 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

    Measured: 3 months

  3. 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

    Measured: 3 months

  4. Adherence

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

    Measured: 3 months

  5. Fidelity

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

    Measured: 3 months

  6. Adverse events

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

    Measured: 3 months

Secondary outcomes (12)

  1. 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

    Measured: 3 months

  2. 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".

    Measured: 3 months

  3. 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

    Measured: 3 months

  4. 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

    Measured: 3 months

  5. 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

    Measured: 3 months

  6. 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)

    Measured: 3 months

  7. 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).

    Measured: 3 months

  8. 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".

    Measured: 3 months

  9. 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.

    Measured: 3 months

  10. 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).

    Measured: 3 months

  11. 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.

    Measured: 3 months

  12. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start1 Nov 2017
  3. Primary completion12 Sep 2018
  4. Study completion12 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190836
Sponsor's protocol ID
2017/355
Status last verified
Dec 2019
First submitted
18 Nov 2019
Last updated
9 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33494821

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Self-Managed Exercise Strategy in people with Shoulder Pain Chronic, run by Oslo Metropolitan University at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04190836, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.

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