Chronic Low Back PainPACTNCT02409420
A Trial of Brief Physiotherapy Informed by Acceptance and Commitment Therapy for Chronic Low Back Pain: the PACT Study
A study testing Physiotherapy informed by Acceptance and Commitment Therapy in people with Chronic Low Back Pain, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Physiotherapy informed by Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Medically diagnosed lumbar spine pathology (e.g. inflammatory arthritis, fracture, cancer).
- Deteriorating neurological signs (stable neurological signs and pain of apparently neuropathic origin are not exclusion criteria).
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Psychiatry, Psychology and Neuroscience, KCL
London, SE1 9RT
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Physiotherapy informed by Acceptance and Commitment Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy informed by Acceptance and Commitment TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physiotherapy informed by Acceptance and Commitment Therapy |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma Godfrey, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409420
- Sponsor's protocol ID
- 16805
- Acronym
- PACT
- Status last verified
- Aug 2016
- First submitted
- 1 Apr 2015
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Brief Physiotherapy Informed by Acceptance and Commitment Therapy for Chronic Low Back Pain: the PACT Study
- ClinicalTrials.gov ID
- NCT02409420
- Acronym / sponsor ID
- PACT / 16805
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACT | Experimental | Behavioral: Physiotherapy informed by Acceptance and Commitment TherapyPACT: 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. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Medically diagnosed lumbar spine pathology (e.g. inflammatory arthritis, fracture, cancer).
- Deteriorating neurological signs (stable neurological signs and pain of apparently neuropathic origin are not exclusion criteria).
- Previous or awaiting spinal surgery.
- Psychiatric illness (e.g. extremely distressed/severe depression, personality disorders, posttraumatic stress disorders).
- Drug or alcohol misuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy informed by Acceptance and Commitment TherapyPACT 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. | Behavioural | PACT |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Godfrey, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy informed by Acceptance and Commitment Therapy in people with Chronic Low Back Pain, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.