Condition category
Musculoskeletal Diseases
Date applied
02/10/2020
Date assigned
05/10/2020
Last edited
05/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 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, 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. Ms Rebecca Skinner
rskinner001@dundee.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lesley Colvin

ORCID ID

http://orcid.org/0000-0002-1563-8600

Contact details

Mackenzie Building
University of Dundee
Dundee
DD2 4RB
United Kingdom
01382381880
l.a.colvin@dundee.ac.uk

Type

Public

Additional contact

Ms Rebecca Skinner

ORCID ID

http://orcid.org/0000-0002-8399-4527

Contact details

Mackenzie Building
University of Dundee
Dundee
DD2 4RB
United Kingdom
07856408095
rskinner001@dundee.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil Known

Protocol/serial number

IRAS 271891

Study information

Scientific title

Understanding barriers to increasing physical activity in chronic pain: an exploratory study to develop the SUstainable Self Effective Exercise Development (SUSSED) intervention

Acronym

SUSSED

Study hypothesis

Using a systematic approach, to understand barriers and facilitators to physical activity in patients with moderate-severe chronic pain

Ethics approval

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

Study design

Mixed methods observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

01/01/2020

Overall trial end date

30/11/2021

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 - 45

Participant exclusion criteria

1. Receiving active treatment for cancer
2. Unable to provide informed consent

Recruitment start date

09/10/2020

Recruitment end date

05/10/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Dundee

Sponsor details

TASC
Ninewells Hospital and Medical School
Residency Block
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383877
tascgovernance@dundee.ac.uk

Sponsor type

University/education

Website

http://www.dundee.ac.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office, Scottish Government Health and Social Care Directorate

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality.

Intention to publish date

30/11/2022

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/10/2020: Trial’s existence confirmed by London-Chelsea Research Ethics Committee.