Chronic PainNCT03497585
Developing an Activity Pacing Framework: Feasibility and Acceptability
An observational study of Chronic Pain and Fibromyalgia, run by Pennine Acute Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study explores whether it is feasible to use a newly developed activity pacing framework to standardise how activity pacing is instructed by healthcare professionals in rehabilitation programmes for patients with chronic pain/fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Fibromyalgia, Chronic Fatigue Syndrome
- What is being tested?
- Activity pacing framework
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 May 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The study population involves patients with conditions of chronic pain/fatigue, for example, chronic low back pain, chronic widespread pain, fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The study population includes those patients who are referred to the physiotherapy departments of The Pennine Acute Hospitals National Health Service (NHS) Trust and who attend a rehabilitation programme. The activity pacing framework will be used to structure and standardise the pacing component of the programme.
Who may be able to join
None listed.
Who cannot join
- Patients with evidence of a serious underlying pathology, such as a current diagnosis of cancer
- Patients with severe mental health/cognitive functioning issues
- Acceptability Study (qualitative interviews) Inclusion Criteria:
- Patients with an initial GP/hospital consultant referral to The Pennine Acute Hospitals National Health Service (NHS) Trust with diagnoses of chronic low back pain, chronic widespread pain, fibromyalgia or CFS/ME, with a minimum symptom duration of 3 months (as per the feasibility study).
- Patients who attended a minimum of one session of the rehabilitation programme, who consented to the study and completed the first questionnaire booklet. Patients do not need to have completed the programme, since the interviews will include patients who both completed and did not complete the programme.
- Qualified healthcare professionals delivering the rehabilitation programmes who received training in using the activity pacing framework: physiotherapists and psychological wellbeing practitioners employed by The Pennine Acute Hospitals NHS Trust and Pennine Care NHS Foundation Trust.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Pennine Acute Hospitals NHS Trust
Bury, Lancashire, BL9 7TD
About this study
Official title: Developing an Activity Pacing Framework for the Management of Chronic Pain/Fatigue. Stage III: Feasibility and Acceptability Studies
This study explores whether it is feasible to use a newly developed activity pacing framework to standardise how activity pacing is instructed by healthcare professionals in rehabilitation programmes for patients with chronic pain/fatigue.
Read the detailed description
Activity pacing is frequently advised in the management of chronic pain/fatigue, including chronic low back pain, chronic widespread pain/fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis. However, there is no agreed definition of 'activity pacing' and it is instructed in various ways. For some, pacing involves adapting/limiting activities (for example, breaking down tasks/having rests); while for others, pacing involves having consistent activities/gradually increasing activities. Furthermore, pacing has been associated with both improved symptoms (decreased fatigue/anxiety/depression) and worsened symptoms (increased pain/disability).
Due to the high prevalence and cost (personal and financial) of chronic pain/fatigue, it is imperative that coping strategies such as pacing are clearly defined and evidence-based. This study involves Stage III in the development of an activity pacing framework to standardise how pacing is instructed by healthcare professionals. Stage I: Online Survey of pacing involved 92 healthcare professionals (doctors/nurses/physiotherapists/occupational therapists/clinical psychologists). The survey findings, together with existing research were used to develop the pacing framework. The framework was further developed in Stage II: Nominal Group Technique (consensus meeting), involving four patients and six healthcare professionals.
Stage III will test the feasibility of implementing the pacing framework clinically, by using it to underpin existing rehabilitation programmes for chronic pain/fatigue. Patients will attend rehabilitation programmes at the study sites as per usual practice. Patients' participation in this study involves their completion of a booklet of questionnaires. The aim of this feasibility study is to explore whether the activity pacing framework is usable in the clinical setting, to explore recruitment/retention rates, together with changes in symptoms between the start and end of treatment, and at 3-months follow-up. Stage III will also explore the acceptability of the framework by undertaking interviews with the patients and healthcare professionals involved in the rehabilitation programmes. Stage III is expected to last 22 months.
Future study will test the framework in a clinical trial to assess the effects of pacing on patients' symptoms. The pacing framework has the potential to improve treatments by providing guidance on the components of pacing found to have benefits for patients.
This study is funded by a Health Education England/National Institute for Health Research (HEE/NIHR) Integrated Clinical Academic (ICA) Clinical Lectureship.
- Being tested
- Activity pacing framework
- Keywords
- Rehabilitation, Pain Management
- Medical subject headings
- Chronic Pain, Fibromyalgia, Fatigue Syndrome, Chronic, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity pacing frameworkBehavioural
The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
| Study group | Role | What they receive |
|---|---|---|
| Activity Pacing Framework | Adult patients attending rehabilitation programmes underpinned by the activity pacing framework. Receives: Behavioral: Activity pacing framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression.
The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework.
The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme).
Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Measured: Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme
Secondary outcomes (27)
Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression.
The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework.
The APQ-28 will be used to measure activity pacing at baseline (pre-treatment: up to one week before the programme).
Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Measured: Baseline (pre-treatment: up to one week before the programme)
Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression.
The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework.
The APQ-28 will be used to measure activity pacing at the end of the 6-week's programme.
Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Measured: 6-weeks (end of the programme)
Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression.
The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework.
The APQ-28 will be used to measure activity pacing at 3-months follow up after the end of the 6-week's programme.
Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
Measured: 3-months follow-up (after the end of the 6-week's programme)
Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at baseline (pre-treatment: up to one week before the programme)
Measured: Baseline (pre-treatment: up to one week before the programme)
Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at the end of the 6-week's programme.
Measured: 6-weeks (end of the programme)
Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain
Two 11-point Numerical Rating Scales (NRS) will assess current pain and usual pain, where 0='no pain' and 10='worst possible pain' at 3-months follow up after the end of the 6-week's programme
Measured: 3-months follow-up (after the end of the 6-week's programme)
Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Measured: Baseline (pre-treatment: up to one week before the programme)
Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Measured: 6-weeks (end of the programme)
Depression at 3-months Follow-up: Patient Health Questionnaire-9
The Patient Health Questionnaire (PHQ-9) contains nine items that screen for and measure the severity of depression in the clinical setting. Items are developed based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-27, where 1-4=minimal depression, 5-9=mild depression, 10-14=moderate depression and ≥15=severe depression.
Measured: 3-months follow-up (after the end of the 6-week's programme)
Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7)
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Measured: Baseline (pre-treatment: up to one week before the programme)
Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7)
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Measured: 6-weeks (end of the programme)
Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7)
The Generalised Anxiety Disorder Assessment (GAD-7) contains seven items that screen for and measure the severity of anxiety in the clinical setting. The items are based on the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range of scores is 0-21, where 5-9=mild anxiety, 10-14=moderate anxiety and ≥15=severe anxiety.
Measured: 3-months follow-up (after the end of the 6-week's programme)
Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at baseline (pre-treatment: up to one week before the programme). The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Measured: Baseline (pre-treatment: up to one week before the programme)
Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Measured: 6-weeks (end of the programme)
Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 items that assess a persons' confidence in their ability to do things despite their pain. This will be measured at 3-months follow up after the end of the 6-week's programme. The range of total scores is 0-60 where PSEQ≥40 indicate those patients who are more likely to continue implementing coping strategies and PSEQ≤16 are considered low.
Measured: 3-months follow-up (after the end of the 6-week's programme)
Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ)
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at baseline (pre-treatment: up to one week before the programme). The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Measured: Baseline (pre-treatment: up to one week before the programme)
Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ)
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Measured: 6-weeks (end of the programme)
Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ)
The Chalder Fatigue Questionnaire (CFQ) contains two subscales: physical fatigue (seven items) and mental fatigue (four items). This will be measured at 3-months follow up after the end of the 6-week's programme. The total range for physical fatigue is 7-28 and the range for mental fatigue is 4-16, where higher scores indicated less fatigue.
Measured: 3-months follow-up (after the end of the 6-week's programme)
Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20)
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at baseline (pre-treatment: up to one week before the programme). Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Measured: Baseline (pre-treatment: up to one week before the programme)
Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20)
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Measured: 6-weeks (end of the programme)
Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20)
The Pain Anxiety Symptoms Scale-short version (PASS-20) measures pain-related fear, anxiety and avoidance and it contains four subscales: cognitive anxiety, escape/avoidance, fearful thoughts and physiological anxiety. This will be measured at 3-months follow up after the end of the 6-week's programme. Only the Escape/avoidance subscale data were analysed to provide an measure of avoidance. The total score of this 5 item subscale ranges from 0-25 where higher scores indicated greater avoidance.
Measured: 3-months follow-up (after the end of the 6-week's programme)
Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12)
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at baseline (pre-treatment: up to one week before the programme). The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Measured: Baseline (pre-treatment: up to one week before the programme)
Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12)
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Measured: 6-weeks (end of the programme)
Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12)
The 12-Item Short-Form Health Survey (SF-12) is a generic health survey that assesses physical and mental function. This will be measured at 3-months follow up after the end of the 6-week's programme. The two subscale scores have a maximum score of 100, where higher scores indicated better function.
Measured: 3-months follow-up (after the end of the 6-week's programme)
General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L)
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at baseline (pre-treatment: up to one week before the programme). The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Measured: Baseline (pre-treatment: up to one week before the programme)
General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L)
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Measured: 6-weeks (end of the programme)
General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L)
The EuroQol (EQ-5D-5L) is a generic measure of health status that is widely used to assess both clinical and economic efficacy; and to compare health status across diseases. This will be measured at 3-months follow up after the end of the 6-week's programme. The EQ-5D-5L was calculated as an index score (0-1) where higher scores indicate better health-related quality of life.
Measured: 3-months follow-up (after the end of the 6-week's programme)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start21 May 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennine Acute Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Deborah Antcliff, Pennine Acute Hospitals NHS Trust
- Investigators
- Deborah Antcliff, PhD, BSc, Principal investigator, Pennine Acute Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497585
- Sponsor's protocol ID
- IRAS:242203, V2.1, 27.04.18
- Status last verified
- Nov 2020
- First submitted
- 23 Mar 2018
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antcliff D, Campbell M, Woby S, Keeley P. Activity Pacing is Associated With Better and Worse Symptoms for Patients With Long-term Conditions. Clin J Pain. 2017 Mar;33(3):205-214. doi: 10.1097/AJP.0000000000000401.
PubMed 27322396Antcliff D, Keenan AM, Keeley P, Woby S, McGowan L. Testing a newly developed activity pacing framework for chronic pain/fatigue: a feasibility study. BMJ Open. 2021 Dec 8;11(12):e045398. doi: 10.1136/bmjopen-2020-045398.
PubMed 34880007
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Activity Pacing Framework for the Management of Chronic Pain/Fatigue. Stage III: Feasibility and Acceptability Studies
- ClinicalTrials.gov ID
- NCT03497585
- Acronym / sponsor ID
- IRAS:242203, V2.1, 27.04.18
- Keywords
- Rehabilitation, Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Pennine Acute Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Leeds, National Institute for Health Research, United Kingdom
- Study start
- 21 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Posted 17 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study explores whether it is feasible to use a newly developed activity pacing framework to standardise how activity pacing is instructed by healthcare professionals in rehabilitation programmes for patients with chronic pain/fatigue.
Detailed description
Activity pacing is frequently advised in the management of chronic pain/fatigue, including chronic low back pain, chronic widespread pain/fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis. However, there is no agreed definition of 'activity pacing' and it is instructed in various ways. For some, pacing involves adapting/limiting activities (for example, breaking down tasks/having rests); while for others, pacing involves having consistent activities/gradually increasing activities. Furthermore, pacing has been associated with both improved symptoms (decreased fatigue/anxiety/depression) and worsened symptoms (increased pain/disability).
Due to the high prevalence and cost (personal and financial) of chronic pain/fatigue, it is imperative that coping strategies such as pacing are clearly defined and evidence-based. This study involves Stage III in the development of an activity pacing framework to standardise how pacing is instructed by healthcare professionals. Stage I: Online Survey of pacing involved 92 healthcare professionals (doctors/nurses/physiotherapists/occupational therapists/clinical psychologists). The survey findings, together with existing research were used to develop the pacing framework. The framework was further developed in Stage II: Nominal Group Technique (consensus meeting), involving four patients and six healthcare professionals.
Stage III will test the feasibility of implementing the pacing framework clinically, by using it to underpin existing rehabilitation programmes for chronic pain/fatigue. Patients will attend rehabilitation programmes at the study sites as per usual practice. Patients' participation in this study involves their completion of a booklet of questionnaires. The aim of this feasibility study is to explore whether the activity pacing framework is usable in the clinical setting, to explore recruitment/retention rates, together with changes in symptoms between the start and end of treatment, and at 3-months follow-up. Stage III will also explore the acceptability of the framework by undertaking interviews with the patients and healthcare professionals involved in the rehabilitation programmes. Stage III is expected to last 22 months.
Future study will test the framework in a clinical trial to assess the effects of pacing on patients' symptoms. The pacing framework has the potential to improve treatments by providing guidance on the components of pacing found to have benefits for patients.
This study is funded by a Health Education England/National Institute for Health Research (HEE/NIHR) Integrated Clinical Academic (ICA) Clinical Lectureship.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activity Pacing Framework | – | Behavioral: Activity pacing frameworkAdult patients attending rehabilitation programmes underpinned by the activity pacing framework. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population involves patients with conditions of chronic pain/fatigue, for example, chronic low back pain, chronic widespread pain, fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). The study population includes those patients who are referred to the physiotherapy departments of The Pennine Acute Hospitals National Health Service (NHS) Trust and who attend a rehabilitation programme. The activity pacing framework will be used to structure and standardise the pacing component of the programme.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Patients with evidence of a serious underlying pathology, such as a current diagnosis of cancer
- Patients with severe mental health/cognitive functioning issues
- Patients with an initial GP/hospital consultant referral to The Pennine Acute Hospitals National Health Service (NHS) Trust with diagnoses of chronic low back pain, chronic widespread pain, fibromyalgia or CFS/ME, with a minimum symptom duration of 3 months (as per the feasibility study).
- Patients who attended a minimum of one session of the rehabilitation programme, who consented to the study and completed the first questionnaire booklet. Patients do not need to have completed the programme, since the interviews will include patients who both completed and did not complete the programme.
- Qualified healthcare professionals delivering the rehabilitation programmes who received training in using the activity pacing framework: physiotherapists and psychological wellbeing practitioners employed by The Pennine Acute Hospitals NHS Trust and Pennine Care NHS Foundation Trust.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity pacing frameworkThe activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies. | Behavioural | Activity Pacing Framework |
Primary outcome
Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
Time frame: Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme
The Activity Pacing Questionnaire (APQ) was developed to measure different themes of activity pacing. The APQ was initially validated among a sample of patients with chronic pain/fatigue and contained 26 items. Factor analysis identified five themes of pacing contained within the APQ-26: Activity adjustment, Activity consistency, Activity planning, Activity acceptance and Activity progression. The APQ-26 has been modified for the purpose of this study with the addition of two items to correspond to important aspects of pacing that were not included in the APQ-26. The APQ-28 reflects the content of the activity pacing framework. The APQ-28 will be used to assess the changes in activity pacing from baseline (pre-treatment: up to one week before the programme) to end of the programme (6-week's programme). Each of the five themes of pacing is calculated as a mean score (0-4), where higher scores indicated more implementation of pacing strategies.
27 secondary outcomes
Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
Time frame: Baseline (pre-treatment: up to one week before the programme)
Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
Time frame: 6-weeks (end of the programme)
Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain
Time frame: Baseline (pre-treatment: up to one week before the programme)
Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain
Time frame: 6-weeks (end of the programme)
Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (pre-treatment: up to one week before the programme)
Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9)
Time frame: 6-weeks (end of the programme)
Depression at 3-months Follow-up: Patient Health Questionnaire-9
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: Baseline (pre-treatment: up to one week before the programme)
Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: 6-weeks (end of the programme)
Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7)
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ)
Time frame: Baseline (pre-treatment: up to one week before the programme)
Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ)
Time frame: 6-weeks (end of the programme)
Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ)
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ)
Time frame: Baseline (pre-treatment: up to one week before the programme)
Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ)
Time frame: 6-weeks (end of the programme)
Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ)
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20)
Time frame: Baseline (pre-treatment: up to one week before the programme)
Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20)
Time frame: 6-weeks (end of the programme)
Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20)
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12)
Time frame: Baseline (pre-treatment: up to one week before the programme)
Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12)
Time frame: 6-weeks (end of the programme)
Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12)
Time frame: 3-months follow-up (after the end of the 6-week's programme)
General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L)
Time frame: Baseline (pre-treatment: up to one week before the programme)
General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L)
Time frame: 6-weeks (end of the programme)
General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L)
Time frame: 3-months follow-up (after the end of the 6-week's programme)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27322396Antcliff D, Campbell M, Woby S, Keeley P. Activity Pacing is Associated With Better and Worse Symptoms for Patients With Long-term Conditions. Clin J Pain. 2017 Mar;33(3):205-214. doi: 10.1097/AJP.0000000000000401.
- Derived from this study: PubMed 34880007Antcliff D, Keenan AM, Keeley P, Woby S, McGowan L. Testing a newly developed activity pacing framework for chronic pain/fatigue: a feasibility study. BMJ Open. 2021 Dec 8;11(12):e045398. doi: 10.1136/bmjopen-2020-045398.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Antcliff, PhD, BSc principal investigator
Pennine Acute Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Fibromyalgia, run by Pennine Acute Hospitals NHS Trust at 1 site in United Kingdom.
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 0 inclusion and 6 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme (time frame: Change in activity pacing from baseline (pre-treatment: up to one week before the programme) to the end of the 6-week's programme). 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 NCT03497585, which also lists 2 linked publications.
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 17 Dec 2020.