Clinical trial NCT03497585: Developing an Activity Pacing Framework: Feasibility and Acceptability
Official title: Developing an Activity Pacing Framework for the Management of Chronic Pain/Fatigue. Stage III: Feasibility and Acceptability Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Fibromyalgia
Chronic Fatigue Syndrome
Chronic Low Back Pain
Keywords: Rehabilitation
Pain Management
Lead sponsor: Pennine Acute Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Leeds
name: National Institute for Health Research, United Kingdom
First posted: 2018-04-13
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Feasibility Study Inclusion Criteria:

* Patients with an initial General Practitioner (GP)/hospital consultant referral to The Pennine Acute Hospitals NHS Trust with diagnoses of chronic low back pain, chronic widespread pain, fibromyalgia or CFS/ME, with a minimum symptom duration of 3 months.
* Patients referred to a rehabilitation programme for chronic pain/fatigue
* Patients aged ≥18 years
* Patients able to read/write in English

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme
timeFrame: 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:
measure: Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28)
timeFrame: Baseline (pre-treatment: up to one week before the programme)
measure: Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28)
timeFrame: 6-weeks (end of the programme)
measure: Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28)
timeFrame: 3-months follow-up (after the end of the 6-week's programme)
measure: Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain
timeFrame: Baseline (pre-treatment: up to one week before the programme)
measure: Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain
timeFrame: 6-weeks (end of the programme)
measure: Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain
timeFrame: 3-months follow-up (after the end of the 6-week's programme)
measure: Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline (pre-treatment: up to one week before the programme)
measure: Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6-weeks (end of the programme)
measure: Depression at 3-months Follow-up: Patient Health Questionnaire-9
timeFrame: 3-months follow-up (after the end of the 6-week's programme)
measure: Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: Baseline (pre-treatment: up to one week before the programme)
measure: Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: 6-weeks (end of the programme)
measure: Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7)
timeFrame: 3-months follow-up (after the end of the 6-week's programme)
measure: Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: Baseline (pre-treatment: up to one week before the programme)
measure: Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: 6-weeks (end of the programme)
measure: Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ)
timeFrame: 3-months follow-up (after the end of the 6-week's programme)
measure: Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ)
timeFrame: Baseline (pre-treatment: up to one week before the programme)
measure: Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ)
timeFrame: 6-weeks (end of the programme)
measure: Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ)
timeFrame: 3-months follow-up (after the end of the 6-week's programme)
measure: Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20)
timeFrame: Baseline (pre-treatment: up to one week before the programme)
measure: Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20)
timeFrame: 6-weeks (end of the programme)
measure: Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20)
timeFrame: 3-months follow-up (after the end of the 6-week's programme)
measure: Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12)
timeFrame: Baseline (pre-treatment: up to one week before the programme)
measure: Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12)
timeFrame: 6-weeks (end of the programme)
measure: Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12)
timeFrame: 3-months follow-up (after the end of the 6-week's programme)
measure: General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L)
timeFrame: Baseline (pre-treatment: up to one week before the programme)
measure: General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L)
timeFrame: 6-weeks (end of the programme)
measure: General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L)
timeFrame: 3-months follow-up (after the end of the 6-week's programme)
Other outcomes:
Locations:
city: Bury
country: United Kingdom
facility: The Pennine Acute Hospitals NHS Trust
state: Lancashire
Study officials:
affiliation: Pennine Acute Hospitals NHS Trust
name: Deborah Antcliff, PhD, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Antcliff 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.