Understanding barriers to increasing physical activity in chronic pain

ISRCTN ISRCTN95480359
DOI https://doi.org/10.1186/ISRCTN95480359
IRAS number 271891
Secondary identifying numbers IRAS 271891
Submission date
02/10/2020
Registration date
05/10/2020
Last edited
27/11/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic or persistent pain is pain that carries on for longer than 12 weeks despite medication or treatment. Most people get back to normal after pain following an injury or operation. But sometimes the pain carries on for longer or comes on without any history of an injury or operation.
Evidence shows that increasing physical activity can be one of the best things to help manage chronic pain. However, people who suffer from chronic pain are often very inactive. The reasons for this may be quite different from one person to the next. We would like to find out what stops people in pain from being active and what we could do to support them to do more. Eventually, we would like to develop a plan that can be tailored to individual people who are suffering from pain, to help them stay active

Who can participate?
Adults over the age of 18 years referred by the NHS Tayside pain service. Must have experienced pain for at least 6 months

What does the study involve?
Participants are asked to join this study after being referred to the pain service and consenting to take part in the research. Participants must be assessed by the pain service as having moderate to severe pain. Participants will be asked to attend two appointments about a week apart, due to social distancing rules this is most likely to take place remotely, for example, via video call. The first appointment will include fitting an activity monitor, filling in a questionnaire and a semi-structured interview. At the 2nd appointment, participants will fill in a second questionnaire and remove the activity monitor. In between the two appointments the activity monitor will track participants' activity.

What are the possible benefits and risks of participating?
Taking part in the study may not immediately benefit those taking part. However, we hope that the results of the trial will help us manage activity in people who suffer from pain in the future. We anticipate no major disadvantages of taking part. There is a very low risk that participants may develop a skin reaction to the waterproof dressing used to attach the activity monitor to their thigh. If this should happen we would ask participants to remove the tracker and contact the research team.

Where is the study run from?
The University of Dundee (UK)

When is the study starting and how long is it expected to run for?
January 2020 to November 2021

Who is funding the study?
Chief Scientist Office (part of the Scottish Government Health Directorate) (UK)

Who is the main contact?
1. Prof Lesley Colvin
l.a.colvin@dundee.ac.uk
2. Dr Ian-Ju Liang
iliang001@dundee.ac.uk

Contact information

Prof Lesley Colvin
Scientific

Mackenzie Building
University of Dundee
Dundee
DD2 4RB
United Kingdom

ORCiD logoORCID ID 0000-0002-1563-8600
Phone 01382381880
Email l.a.colvin@dundee.ac.uk
Dr Ian-Ju Liang
Public

School of Medicine
University of Dundee
Ninewells Medical School
Level 7 (204) corridor E
Ninewells Hospital
Dundee
DD2 9SY
United Kingdom

ORCiD logoORCID ID 0000-0003-0085-2038
Email iliang001@dundee.ac.uk

Study information

Study designMixed methods observational study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Home
Study typeQuality of life
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleUnderstanding barriers to increasing physical activity in chronic pain: an exploratory study to develop the SUstainable Self Effective Exercise Development (SUSSED) intervention
Study acronymSUSSED
Study objectivesUsing a systematic approach, to understand barriers and facilitators to physical activity in patients with moderate-severe chronic pain
Ethics approval(s)Approved 28/01/2020, London-Chelsea Research Ethics Committee (Research Ethics Committee London Centre, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)207 104 8356; chelsea.rec@hra.nhs.uk), ref: 19/LO/2012
Health condition(s) or problem(s) studiedIncreasing physical activity and exercise in chronic pain patients
InterventionUp to 45 people referred to the Tayside pain service will be invited to take part in the study, aiming for a total of 40 completing the first study visit. They will take part in a semi-structured interview designed to assess their perceptions of the barriers and facilitators to their participation in PA. In addition, participants will be asked to complete 7 validated self-report questionnaires to collect information about their pain severity, and its impact, as well as attitudes to physical activity. Demographic and basic clinical information including age, gender, height and weight will be collected together with underlying diagnosis, other co-morbidities, and postcode to enable Scottish index of multiple deprivation to be recorded. Participants will then be provided with an activPAL4TM activity monitor (http://www.palt.com/pals/) and asked to wear this for 1 week. 20 participants who consent to wearing a Fitbit monitor will be asked to wear a Fitbit Charge 3 (https://www.fitbit.com/uk/charge3) monitor in addition to the activPAL monitor. Both the activPAL and FitBit trackers are CE marked. Participants will be contacted after 1 week and will then be asked to complete the 7 questionnaires as before as well as acceptability and feasibility questions on the activity monitors

Half the participants will receive an Activpal only and the other arm will receive an Activpal and Fitbit, all participants will wear the activity monitors for one week between appointment 1 and 2. After appointment 2 when the activity monitors are removed there is no follow up. Allocation to receive a Fitbit is based on willingness to wear one and availability (i.e. not random).
Intervention typeBehavioural
Primary outcome measure1. Framework analyses of semi-structured interviews with patients with moderate-severe chronic pain
2. Questionnaires at baseline and 1 week:
2.1. Fear of movement measured using the Tampa Scale for Kinesiphobia
2.2. Anxiety and stress measured using the Anxiety and Stress Scale 21
2.3. Pain measured using the Brief pain inventory
2.4. Pain catastrophising measured using the Pain Catastrophising Scale
2.5. Self-efficacy measured using the Pain Self-efficacy Questionnaire
2.6. Physical activity measured using the Physical Activity Stages of Change International Physical Activity Questionnaire (short)
3. Acceptability of activity monitors measured with questionnaire items at 1 week
4. Feasibility outcomes for activity monitors (self report at 1 week):
4.1. Number of days worn
4.2. Reported problems with wearing the monitor
4.3. Reported pain or discomfort while wearing the monitor
4.4. Reported duration and reasons for removing the monitor early (activPAL) or not wearing the monitor (FitBit)
Secondary outcome measures1. Steps measured using ActivPal over 1 week
2. Steps measured using Fitbit (if applicable) over 1 week
Overall study start date01/01/2020
Completion date30/11/2021

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40 - 45 patients and up to 16 stakeholders
Total final enrolment57
Key inclusion criteriaCurrent participant inclusion criteria as of 02/11/2021:
Patients:
1. Referred to Tayside pain service
2. In pain for at least 6 months
3. Pain severity: moderate to severe as assessed by pain clinic questionnaires (NRS>3)
4. No clinical contraindications to wearing Fitbit
5. Consented to being contacted for research
6. Over 18

Stakeholders:
1. Member of stakeholder population, including healthcare professionals (e.g. General practitioners (GPs)/ Allied Health Professionals (AHP)s, Nurses, pharmacists); carers, 3rd sector organisations, leisure centre staff, and others identified through the Green Health Partnership
2. Over 18

Previous participant inclusion criteria:
1. Referred to Tayside pain service
2. In pain for at least 6 months
3. Pain severity: moderate to severe as assessed by pain clinic questionnaires (NRS>3)
4. No clinical contraindications to wearing Fitbit
5. Consented to being contacted for research
6. Over 18
Key exclusion criteria1. Receiving active treatment for cancer
2. Unable to provide informed consent
Date of first enrolment09/10/2020
Date of final enrolment05/10/2021

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

NHS Tayside Pain Service
Pain Service Level 6
South Block Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee
University/education

TASC, Ninewells Hospital and Medical School
Residency Block, Level 3
George Pirie Way
Dundee
DD1 9SY
Scotland
United Kingdom

Phone +44 (0)1382 383877
Email tascgovernance@dundee.ac.uk
Website http://www.dundee.ac.uk/
ROR logo "ROR" https://ror.org/03h2bxq36

Funders

Funder type

Government

Chief Scientist Office, Scottish Government Health and Social Care Directorate
Government organisation / Local government
Alternative name(s)
Chief Scientist Office, Scottish Government Health Directorate CSO, Chief Scientist Office, Scottish Government Health Directorates, Chief Scientist Office of the Scottish Government Health Directorates, Scottish Government Health and Social Care Directorate of the Chief Scientist Office, Scottish Government Health Directorate Chief Scientist Office, The Chief Scientist Office, CSO
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2024
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version 3 31/08/2020 19/08/2022 No No
HRA research summary 28/06/2023 No No

Additional files

38851 Sussed protocol V3 31Aug2020.pdf

Editorial Notes

27/11/2024: The intention to publish date was changed from 30/09/2024 to 31/12/2024.
25/10/2024: Contact details updated.
04/06/2024: The intention to publish date was changed from 30/12/2023 to 30/09/2024.
26/01/2023: The intention to publish date was changed from 30/11/2022 to 30/12/2023.
19/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
02/11/2021: The following changes have been made:
1. The participant inclusion criteria have been updated.
2. The target number of participants has been changed from "40 - 45" to "40 - 45 patients and up to 16 stakeholders".
3. The total target enrolment has been changed from 40 to 56.
4. The total final enrolment number has been changed from 42 to 57.
06/10/2021: The total final enrolment number has been added.
05/10/2020: Trial’s existence confirmed by London-Chelsea Research Ethics Committee.