N/A
N=112
Developing an Activity Pacing Framework: Feasibility and Acceptability
Chronic Pain · Fibromyalgia · Chronic Fatigue Syndrome · Chronic Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03497585 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme — 0.70; 0.99; 0.84; 0.67 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Activity pacing framework (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennine Acute Hospitals NHS Trust
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Activity Pacing Questionnaire (APQ-28) From Baseline to the End of the 6-week's Programme |
0.70; 0.99; 0.84; 0.67; 0.94 | — |
| SECONDARY Activity Pacing at Baseline: Activity Pacing Questionnaire (APQ-28) |
1.83; 1.49; 1.85; 1.91; 1.51 | — |
| SECONDARY Activity Pacing at the End of Treatment: Activity Pacing Questionnaire (APQ-28) |
2.43; 2.42; 2.65; 2.55; 2.39 | — |
| SECONDARY Activity Pacing at 3-months Follow up: Activity Pacing Questionnaire (APQ-28) |
2.33; 2.06; 2.37; 2.42; 2.00 | — |
| SECONDARY Pain at Baseline: 11-point Numerical Rating Scale (NRS) of Pain |
6.71; 7.47 | — |
| SECONDARY Pain at the End of Treatment (6-weeks): 11-point Numerical Rating Scale (NRS) of Pain |
5.31; 6.62 | — |
| SECONDARY Pain at 3-months Follow up: 11-point Numerical Rating Scale (NRS) of Pain |
5.65; 6.54 | — |
| SECONDARY Depression at Baseline: Patient Health Questionnaire-9 (PHQ-9) |
13.26 | — |
| SECONDARY Depression at the End of Treatment (6-weeks): Patient Health Questionnaire-9 (PHQ-9) |
7.14 | — |
| SECONDARY Depression at 3-months Follow-up: Patient Health Questionnaire-9 |
9.09 | — |
| SECONDARY Anxiety at Baseline: Generalised Anxiety Disorder Assessment (GAD-7) |
9.89 | — |
| SECONDARY Anxiety at the End of Treatment (6-weeks): Generalised Anxiety Disorder Assessment (GAD-7) |
5.40 | — |
| SECONDARY Anxiety at 3-months Follow up: Generalised Anxiety Disorder Assessment (GAD-7) |
6.10 | — |
| SECONDARY Self-efficacy at Baseline: Pain Self Efficacy Questionnaire (PSEQ) |
25.67 | — |
| SECONDARY Self-efficacy at the End of Treatment: Pain Self Efficacy Questionnaire (PSEQ) |
36.29 | — |
| SECONDARY Self-efficacy at 3-months Follow up: Pain Self Efficacy Questionnaire (PSEQ) |
34.68 | — |
| SECONDARY Fatigue at Baseline: Chalder Fatigue Questionnaire (CFQ) |
14.81; 8.83 | — |
| SECONDARY Fatigue at the End of Treatment: Chalder Fatigue Questionnaire (CFQ) |
20.31; 11.28 | — |
| SECONDARY Fatigue at 3-months Follow up: Chalder Fatigue Questionnaire (CFQ) |
18.18; 10.92 | — |
| SECONDARY Pain-related Anxiety, Fear and Avoidance at Baseline: Pain Anxiety Symptoms Scale-short Version (PASS-20) |
13.14 | — |
| SECONDARY Pain-related Anxiety, Fear and Avoidance at the End of Treatment: Pain Anxiety Symptoms Scale-short Version (PASS-20) |
10.28 | — |
| SECONDARY Pain-related Anxiety, Fear and Avoidance at 3-months Follow up: Pain Anxiety Symptoms Scale-short Version (PASS-20) |
12.12 | — |
| SECONDARY Physical and Mental Function at Baseline: 12-Item Short-Form Health Survey (SF-12) |
33.96; 40.00 | — |
| SECONDARY Physical and Mental Function at the End of Treatment: 12-Item Short-Form Health Survey (SF-12) |
38.82; 45.83 | — |
| SECONDARY Physical and Mental Function at 3-months Follow up: 12-Item Short-Form Health Survey (SF-12) |
36.55; 44.56 | — |
| SECONDARY General Health Status and Quality of Life at Baseline: EuroQol (EQ-5D-5L) |
0.42 | — |
| SECONDARY General Health Status and Quality of Life at the End of Treatment: EuroQol (EQ-5D-5L) |
0.56 | — |
| SECONDARY General Health Status and Quality of Life at 3-months Follow up: EuroQol (EQ-5D-5L) |
0.52 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03497585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.