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

Not Applicable

Completed

• Conditions: Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal; Musculoskeletal Diseases

• Registration Number: ISRCTN95392287
• Lead Sponsor: Guy's & St Thomas' NHS Foundation Trust (UK)

Brief Summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27267109 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31173921 (added 30/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-22
• Study Completion: 2017-07-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 248

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> Measured at baseline, 3 months and 12 months:<br> 1. Quality of life, measured using the Work and Social Adjustment Scale and EQ-5D-5L<br> 2. Pain, measured using the visual analogue scale<br> 3. Function, measured using Patient Specific Functional Scale<br> 4. Mood, measures using Generalised Anxiety Disorder-7 and Patient Health Questionnaire-9<br> 5. Acceptance, measures using Chronic Pain Acceptance Questionnaire-8<br> 6. Committed action, measured using Committed Action Questionnaire-8<br> 7. Pain self efficacy, measured using pain self-efficacy questionnaire<br> 8. Satisfaction, measured using Satisfaction with Life, Global Improvement and Treatment Credibility scales<br> 9. Health economics, measured using EQ-5D-5L and SF-6D<br>