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

September 11, 2020 updated by: King's College London

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Back pain causes considerable suffering and is a major financial burden, costing the NHS an estimated £1.1 billion annually (Maniadakis and Gray 2000) and representing the second largest cause of absence from work (Young and Bhaumik, 2011). Chronic low back pain (CLBP), defined as pain lasting more than 12 weeks, is responsible for 80% of this cost (Department of Health, 2009). Physiotherapy is a common treatment for CLBP, with 1.26 million patients referred to NHS physiotherapists at a cost of £150 million per annum (Maniadakis and Gray, 2000). Several forms of physiotherapy are recommended for CLBP, including exercises, manual therapy and back classes (NICE, 2009). The type of physiotherapy varies considerably in duration and content, despite evidence that different treatments have similar effects (Critchley et al, 2007). Most trials show no clear superiority for any treatment, with the majority leading to only moderate improvement (Artus et al 2010).

A key focus of treatment is helping people with persistent CLBP to self-manage their condition and thus improve pain, disability and distress to ensure that an episode of low back pain does not result in long-term withdrawal from normal activities, including sickness absence from paid employment. Cognitive behavioural therapy (CBT) has a good evidence base for the treatment of chronic pain (Eccleston et al, 2009; Hoffman et al, 2007; Scascighini et al, 2008) and the Chartered Society of Physiotherapy recognises that CBT can fall within a physiotherapist's scope of practice (Donaghy et al 2008). However, CBT-based treatments delivered by physiotherapist have only produced modest improvements in CLBP (Lamb et al., 2010) and it remains unclear how to best implement cognitive and behavioural approaches during physiotherapy interventions.

One promising theory-based approach to chronic pain is a form of CBT called Acceptance and Commitment Therapy (ACT) (Hayes et al., 1999). The primary focus of ACT is on enhancing psychological flexibility and reducing struggle with pain. This involves helping people to accept their pain and related feelings, become more aware and less dominated by thoughts and beliefs about pain, and identify and follow directions in life that reflect their values (Vowles et al, 2011). A meta-analysis of ACT for chronic pain showed improvements in depression, anxiety, pain intensity, physical functioning and quality of life (Veehof et al, 2011). It has good maintenance of treatment effects up to three years post treatment (Vowles et al 2011), important in a chronic relapsing and remitting condition like CLBP. This suggests that ACT-based interventions could be well suited to patients with CLBP. In all published studies to date, ACT has been delivered by psychologists or within multidisciplinary teams but there is very limited availability of clinical psychologists for CLBP and most patients referred to secondary care are seen by physiotherapists not psychologists (Maniadakis and Gray, 2000).

This study aims to evaluate the efficacy of a novel physiotherapy intervention incorporating the newest and most promising form of CBT, Acceptance and Commitment Therapy (ACT) against usual physiotherapy care. The investigators believe this will optimise outcome for patients, the NHS and society at large. The investigators have conducted a proof of concept feasibility study to develop a brief physiotherapist-delivered ACT-based intervention, 'PACT', consisting of two one hour sessions plus a follow-up phone call. The aim is to test PACT against usual physiotherapy care in a phase 2 trial. The main research question is whether PACT (physiotherapist delivered ACT-based treatment) is effective. The investigators hypothesise that the group receiving PACT will have improved function at 3 months compared to the treatment as usual group, and that this will be maintained at 12 months. The primary objective of this study is to evaluate the efficacy of PACT, a novel brief ACT-based physiotherapy intervention for chronic low back pain, at the primary end point of function at 3 months follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Institute of Psychiatry, Psychology and Neuroscience, KCL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Usual care
Experimental: PACT
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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).
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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).
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emma Godfrey, PhD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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