A randomised controlled trial of brief physiotherapy informed by Acceptance and Commitment Therapy for chronic low back pain: the PACT study
| ISRCTN | ISRCTN95392287 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95392287 |
| ClinicalTrials.gov number | NCT02409420 |
| Secondary identifying numbers | 16805 |
- Submission date
- 22/10/2014
- Registration date
- 22/10/2014
- Last edited
- 30/07/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Chronic low back pain (CLBP) is very common and causes much pain and disability. It costs the NHS billions of pounds in treatment every year and is the second leading cause of time off work. There are various treatments for CLBP, but the most effective are still only moderately helpful. Most people with CLBP receive physiotherapy, with varying results. Cognitive behaviour therapy (CBT) may offer more long-term help than current treatments because it enables people to self-manage their condition. A new type of CBT, called Acceptance and Commitment Therapy (ACT), has produced particularly good results for chronic pain. However, a shortage of clinical psychologists means that most patients never receive CBT. Physiotherapists can successfully use CBT techniques with extra training, but this is not standard practice and ACT-based physiotherapy treatment has never been tested. A short ACT-based treatment (PACT) has been developed for physiotherapists to deliver and the aim of this study is to compare it with usual physiotherapy care.
Who can participate?
People aged over 18 with CLBP from three hospitals in South East London
What does the study involve?
Participants are randomly allocated into two groups, with one group receiving PACT and the other group ordinary physiotherapy. PACT consists of two hour long sessions and one follow-up phone call, meaning fewer hospital visits for patients and more time during sessions for individualised treatment. It aims to encourage people to focus less on getting rid of their pain and more on moving forward with what is most important in their lives. PACT is compared with usual physiotherapy to see which is most successful at improving people's ability to function and their quality of life and which approach helps them to manage their back pain best in the long term.
What are the possible benefits and risks of participating?
If PACT is effective, it could reduce the considerable burden of CLBP to patients, the NHS and society
Where is the study run from?
Guy’s and St Thomas’ NHS Foundation Trust Physiotherapy Service and Kings’ College Hospital NHS Foundation Trust Physiotherapy Service (UK)
When is the study starting and how long is it expected to run for?
October 2014 to October 2016
Who is funding the study?
NIHR Research for Patient Benefit (UK)
Who is the main contact?
Dr Vari Wileman
vari.wileman@kcl.ac.uk
Contact information
Scientific
Health Psychology Section
Guy's Campus
5th Floor, Guy House, St Thomas Street
London
SE1 9RT
United Kingdom
| vari.wileman@kcl.ac.uk |
Study information
| Study design | Randomised; Interventional and Observational; Design type: Process of Care, Treatment, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised controlled trial of brief physiotherapy informed by Acceptance and Commitment Therapy for chronic low back pain: the PACT study |
| Study acronym | PACT |
| Study hypothesis | It is hypothesised that the group receiving PACT will have improved self-reported functioning at the primary end point of 3 months follow-up compared to the treatment as usual group. |
| Ethics approval(s) | 14/SC/0277; First MREC approval date 26/06/2014 |
| Condition | Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal |
| Intervention | PACT: a brief physiotherapy intervention based on ACT principles optimised to promote self-management, consisting of two 60 minute face-to-face sessions one week apart, of assessment, individualised treatment and exercise prescription, plus one follow-up phone call (lasting 20 minutes), one month after the last treatment session. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-report of disability due to low back pain, assessed using the Roland-Morris Disability Questionnaire (RMDQ; Roland and Morris, 1983) at baseline, 3 months and 12 months |
| Secondary outcome measures | Measured at baseline, 3 months and 12 months: 1. Quality of life, measured using the Work and Social Adjustment Scale and EQ-5D-5L 2. Pain, measured using the visual analogue scale 3. Function, measured using Patient Specific Functional Scale 4. Mood, measures using Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9 5. Acceptance, measures using Chronic Pain Acceptance Questionnaire-8 6. Committed action, measured using Committed Action Questionnaire-8 7. Pain self efficacy, measured using pain self-efficacy questionnaire 8. Satisfaction, measured using Satisfaction with Life, Global Improvement and Treatment Credibility scales 9. Health economics, measured using EQ-5D-5L and SF-6D |
| Overall study start date | 01/10/2014 |
| Overall study end date | 01/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 240; UK Sample Size: 240 |
| Total final enrolment | 248 |
| Participant inclusion criteria | 1. Aged over 18 years 2. Back pain including associated leg pain of greater than 12 weeks duration 3. Scoring 3 points or more on the Roland-Morris Disability Questionnaire (RMDQ) 4. Able and willing to give informed consent and attend treatment 5. Adequate understanding of spoken and written English to complete trial data collection and participate in programme |
| Participant exclusion criteria | 1. Medically diagnosed lumbar spine pathology (e.g. inflammatory arthritis, fracture, cancer). 2. Deteriorating neurological signs (stable neurological signs and pain of apparently neuropathic origin are not exclusion criteria). 3. Previous or awaiting spinal surgery. 4. Psychiatric illness (e.g. extremely distressed/severe depression, personality disorders, posttraumatic stress disorders). 5. Drug or alcohol misuse. 6. Prior multidisciplinary or CBT pain management at any time. 7. Other physiotherapy in previous 6 months. |
| Recruitment start date | 01/11/2014 |
| Recruitment end date | 01/10/2016 |
Locations
Countries of recruitment
- United Kingdom
Study participating centres
-
United Kingdom
-
United Kingdom
-
United Kingdom
Sponsor information
University/education
16th Floor, Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will be communicated to participants at the end of the study and disseminated via peer reviewed publications, patient interest groups and conference presentations. Key publications are planned as follows: 1. Study protocol (Spring 2016) 2. Efficacy trial and primary outcomes (2018) 3. Intermediary and process evaluations (2018) 4. Clinician experiences of PACT training and delivery (2017) 5. Cost-consequences analysis (2018) |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Emma Godfrey (emma.l.godfrey@kcl.ac.uk). The data will become available on publication of the results of the primary efficacy analyses. Individual level data will be made available upon request for use in academic research e.g. individual patient data meta analyses. Summary level data will be made available with the primary efficacy analyses and made available open access via the institutional website. Consent from participants was obtained. Data is pseudo anonymised. Detailed information that risks breaking anonymity will not be shared outside the research group. No ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/06/2016 | Yes | No | |
| Results article | results | 01/01/2019 | 30/07/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/07/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
23/07/2019: ClinicalTrials.gov number added. No publications found in PubMed, verifying study status with principal investigator.
31/07/2017: IPD sharing statement added.
13/06/2016: Publication reference added.
08/03/2016: Added study hypothesis, secondary outcome measures, data sharing and publication plans
24/02/2016: Changed recruitment start date from 1/10/2014 to 1/11/2014 and overall end date from 1/10/2016 to 1/07/2017. Added "Ashford & St Peter’s Hospitals NHS Foundation Trust" to trial participating centres
