Condition category
Musculoskeletal Diseases
Date applied
22/10/2014
Date assigned
22/10/2014
Last edited
13/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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. We have developed a short ACT-based treatment (PACT) for physiotherapists to deliver and aim to compare it with usual physiotherapy care.

Who can participate?
We will recruit 240 people aged over 18 with CLBP from three hospitals in South East London.

What does the study involve?
Participants are randomly divided 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. We will compare PACT 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, we believe 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vari Wileman

ORCID ID

Contact details

Health Psychology Section
Guy's Campus
5th Floor
Guy House
St. Thomas Street
London
SE1 9RT
United Kingdom
-
vari.wileman@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16805

Study information

Scientific title

A randomised controlled trial of brief physiotherapy informed by Acceptance and Commitment Therapy for chronic low back pain: the PACT study

Acronym

RCT of physiotherapy informed by ACT for CLBP: the PACT study

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

14/SC/0277; First MREC approval date 26/06/2014

Study design

Randomised; Interventional and Observational; Design type: Process of Care, Treatment, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

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. ACT aims to promote the acceptance of pain, the belief that it is not always necessary to change pain to move forward and the understanding that focusing on pain avoida

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Roland-Morris Disability Questionnaire (RMDQ; Roland and Morris, 1983) comprising 24 questions assessing self-report of disability due to low back pain.

Secondary outcome measures

1. Quality of Life (Work and Social Adjustment Scale and EQ-5D-5L)
2. Pain (Pain visual analogue scale)
3. Function (Patient Specific Functional Scale)
4. Mood (Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9)
5. Acceptance (Chronic Pain Acceptance Questionnaire-8)
6. Committed Action (Committed Action Questionnaire-8)
7. Pain Self Efficacy (Pain self-efficacy Questionnaire)
8. Satisfaction (Satisfaction with Life, Global Improvement and Treatment Credibility scales)
9. Health Economics (Health economics: EQ-5D-5L and SF-6D)

Overall trial start date

01/10/2014

Overall trial end date

01/07/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 240; UK Sample Size: 240

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

Trial participating centre

Guy’s and St Thomas’ NHS Foundation Trust
Physiotherapy Service
-
United Kingdom

Trial participating centre

Kings’ College Hospital NHS Foundation Trust
Physiotherapy Service
-
United Kingdom

Trial participating centre

Ashford & St Peter’s Hospitals NHS Foundation Trust
London
-
United Kingdom

Sponsor information

Organisation

Guy's & St Thomas' NHS Foundation Trust (UK)

Sponsor details

16th Floor
Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-1112-29055

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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)

Intention to publish date

30/04/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27267109

Publication citations

Additional files

Editorial Notes

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