A Trial of Brief Physiotherapy Informed by Acceptance and Commitment Therapy for Chronic Low Back Pain: the PACT Study

NCT02409420 | Completed DMC

• 1 other identifier: 16805
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

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. The investigators have developed a short ACT-based treatment (PACT) for physiotherapists to deliver and aim to compare it with usual physiotherapy care. The investigators will recruit 240 people with CLBP from three hospitals in South East London. They will be randomly divided into two groups, with half receiving PACT and the other half 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. The investigators 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. If PACT is effective, the investigators believe it could reduce the considerable burden of CLBP to patients, the NHS and society.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Roland-Morris Disability Questionnaire (RMDQ; Roland and Morris, 1983) comprising 24 questions assessing self-report of disability due to LBP, ranging from 0 (no disability) to 24 (maximum disability).

  3 months

Secondary Outcomes (1)

• Roland-Morris Disability Questionnaire (RMDQ; Roland and Morris, 1983) comprising 24 questions assessing self-report of disability due to LBP, ranging from 0 (no disability) to 24 (maximum disability).

  12 months

Study Arms (2)

PACT

EXPERIMENTAL

PACT: a brief physiotherapy intervention based on ACT principles optimised to promote self-management. 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 avoidance.

Behavioral: Physiotherapy informed by Acceptance and Commitment Therapy

Control

NO INTERVENTION

Usual care

Interventions

Physiotherapy informed by Acceptance and Commitment Therapy BEHAVIORAL

PACT Treatment consists 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.

PACT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 18 years
• Back pain including associated leg pain of greater than 12 weeks duration.
• Scoring 3 points or more on the Roland-Morris Disability Questionnaire (RMDQ).
• Able and willing to give informed consent and attend treatment.
• Adequate understanding of spoken and written English to complete trial data collection and participate in programme.

You may not qualify if:

• Medically diagnosed lumbar spine pathology (e.g. inflammatory arthritis, fracture, cancer).
• Previous or awaiting spinal surgery.
• Psychiatric illness (e.g. extremely distressed/severe depression, personality disorders, posttraumatic stress disorders).
• Drug or alcohol misuse.
• Prior multidisciplinary or CBT pain management at any time.
• Other physiotherapy in previous 6 months.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Institute of Psychiatry, Psychology and Neuroscience, KCL

London, SE1 9RT, United Kingdom

Location

Study Officials

• Emma Godfrey, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 6, 2015
• Study Start: November 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 16, 2020

Record last verified: 2016-08

Locations

GB (1)