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
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
Scientific
Mackenzie Building
University of Dundee
Dundee
DD2 4RB
United Kingdom
 ORCID ID |
0000-0002-1563-8600 |
|---|---|
| Phone | 01382381880 |
| l.a.colvin@dundee.ac.uk |
Public
School of Medicine
University of Dundee
Ninewells Medical School
Level 7 (204) corridor E
Ninewells Hospital
Dundee
DD2 9SY
United Kingdom
| ORCID ID |
0000-0003-0085-2038 |
|---|---|
| iliang001@dundee.ac.uk |
Study information
| Study design | Mixed methods observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Understanding barriers to increasing physical activity in chronic pain: an exploratory study to develop the SUstainable Self Effective Exercise Development (SUSSED) intervention |
| Study acronym | SUSSED |
| Study objectives | Using 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) studied | Increasing physical activity and exercise in chronic pain patients |
| Intervention | Up 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 type | Behavioural |
| Primary outcome measure | 1. 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 measures | 1. Steps measured using ActivPal over 1 week 2. Steps measured using Fitbit (if applicable) over 1 week |
| Overall study start date | 01/01/2020 |
| Completion date | 30/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 - 45 patients and up to 16 stakeholders |
| Total final enrolment | 57 |
| Key inclusion criteria | Current 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 criteria | 1. Receiving active treatment for cancer 2. Unable to provide informed consent |
| Date of first enrolment | 09/10/2020 |
| Date of final enrolment | 05/10/2021 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
South Block Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Sponsor information
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 |
|---|---|
| tascgovernance@dundee.ac.uk | |
| Website | http://www.dundee.ac.uk/ |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Government
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 date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The 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
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.
