Low Back PainNCT07766616
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
A study testing Acceptance and Commitment Therapy (ACT) and Standard Physiotherapy Program in people with Low Back Pain, run by Al-Azhar University.
Trial summary
This study is a randomized controlled trial (RCT) investigating whether adding Acceptance and Commitment Therapy (ACT) to standard physiotherapy provides greater benefits for adults with chronic low back pain than physiotherapy alone. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Acceptance and Commitment Therapy (ACT) and Standard Physiotherapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- AAged between 18-55 years. BClinically diagnosed with non-specific chronic low back pain (CLBP). CLow back pain persisting for more than 3 months.
Who cannot join
- History of previous spinal surgeries or invasive interventions in the lumbar region.
- Presence of "Red Flags" or serious underlying pathologies, such as spinal tumors, infections, or vertebral fractures.
- Current or recent (within the last 6 months) participation in structured psychological rehabilitation or behavioral therapy programs.
- Clinical evidence of neurological deficits, radiculopathy, or cauda equina syndrome.
- Pregnancy, due to the physiological changes affecting musculoskeletal mechanics.
- Severe behavioral or communication impairments preclude the ability to follow the intervention protocol or complete the self-report assessments.
- Patients who take any sleep medication or for mental health medication. H. Patients who have done physiotherapy program last 3 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Adding Acceptance and Commitment Therapy to Physiotherapy Program on Pain Catastrophizing, Stress, Disability, and Sleep Quality in Individuals With Chronic Low Back Pain
This study is a randomized controlled trial (RCT) investigating whether adding Acceptance and Commitment Therapy (ACT) to standard physiotherapy provides greater benefits for adults with chronic low back pain than physiotherapy alone.
A total of 60 participants will be randomly allocated into two groups: ACT plus physiotherapy and physiotherapy alone. Both groups will receive a 8-weeks program with two sessions per week. The ACT component focuses on acceptance, psychological flexibility, mindfulness, cognitive defusion, values, and committed action.
The main outcomes are pain catastrophizing, functional disability, perceived stress, and sleep quality, assessed using the PCS, ODI, PSS, and PSQI. The study aims to determine whether combining psychological and physical rehabilitation produces better outcomes than physiotherapy alone.
- Conditions
- Low Back Pain
- Being tested
- Acceptance and Commitment Therapy (ACT), Standard Physiotherapy Program
- Keywords
- low back pain, sleep, Acceptance and Commitment Therapy, Exercises, Randomization
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT)Behavioural
Participants in the experimental group will receive Acceptance and Commitment Therapy (ACT) as part of the integrated rehabilitation program. ACT will be delivered for 15 minutes per session, twice weekly for 8 weeks . The intervention will focus on functional acceptance, psychological flexibility, cognitive defusion, mindfulness and present-moment awareness, values clarification, and committed action. The program aims to reduce pain catastrophizing and avoidance behaviors and promote engagement in meaningful activities despite chronic low back pain. ACT will be followed by 30 minutes of physiotherapy during each session.
Standard Physiotherapy ProgramOther
Participants will receive a standard physiotherapy program twice weekly for 8 weeks . The program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue release, and TENS. The physiotherapy component aims to improve physical function, mobility, and functional ability in individuals with chronic low back pain. The same physiotherapy program will be provided to participants in both study arms.
| Study group | Role | What they receive |
|---|---|---|
| ACT + Physiotherapy | Experimental | Participants will receive an integrated Acceptance and Commitment Therapy (ACT) and physiotherapy program for 8 weeks, with two sessions per week . Each session will last approximately 45 minutes, including 15 minutes of ACT and 30 minutes of physiotherapy. ACT will include acceptance, cognitive defusion, mindfulness, values clarification, and committed action. Physiotherapy will include lumbar stabilization, core strengthening, aerobic conditioning, soft tissue techniques, and TENS. Receives: Behavioral: Acceptance and Commitment Therapy (ACT); Other: Standard Physiotherapy Program |
| Standard Physiotherapy | Active comparator | Participants will receive standard physiotherapy for 8 weeks, with two sessions per week . The physiotherapy program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue techniques, and TENS. Participants in this group will not receive Acceptance and Commitment Therapy or other ACT-based psychological interventions. Receives: Other: Standard Physiotherapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates several aspects of sleep during the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Pre and 8 weeks post intervention
Pain intensity
VAS_Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Pre and 8 weeks post intervention
Disability
Functional disability related to chronic low back pain will be assessed using the Oswestry Disability Index (ODI). The questionnaire evaluates limitations in daily activities, with the total score expressed as a percentage. Higher scores indicate greater disability.
Measured: Pre and 8 weeks post intervention
Stress
Perceived stress will be assessed using the Perceived Stress Scale (PSS), which measures the extent to which situations in an individual's life are perceived as unpredictable, uncontrollable, and overwhelming. Higher scores indicate greater perceived stress.
Measured: pre and 8 weeks post intervention
Pain Catastrophizing
Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale (PCS), which evaluates rumination, magnification, and helplessness related to pain. Higher scores indicate greater pain catastrophizing.
Measured: Pre and 8 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mosab ALdabbas, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766616
- Sponsor's protocol ID
- Al azhar AUG
- Other IDs
- 000
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Godfrey E, Wileman V, Galea Holmes M, McCracken LM, Norton S, Moss-Morris R, Noonan S, Barcellona M, Critchley D. Physical Therapy Informed by Acceptance and Commitment Therapy (PACT) Versus Usual Care Physical Therapy for Adults With Chronic Low Back Pain: A Randomized Controlled Trial. J Pain. 2020 Jan-Feb;21(1-2):71-81. doi: 10.1016/j.jpain.2019.05.012. Epub 2019 Jun 5.
PubMed 31173921
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Acceptance and Commitment Therapy to Physiotherapy Program on Pain Catastrophizing, Stress, Disability, and Sleep Quality in Individuals With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07766616
- Acronym / sponsor ID
- Al azhar AUG
- Conditions
- Low Back Pain
- Keywords
- low back pain, sleep, Acceptance and Commitment Therapy, Exercises, Randomization
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- 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.
This study is a randomized controlled trial (RCT) investigating whether adding Acceptance and Commitment Therapy (ACT) to standard physiotherapy provides greater benefits for adults with chronic low back pain than physiotherapy alone.
A total of 60 participants will be randomly allocated into two groups: ACT plus physiotherapy and physiotherapy alone. Both groups will receive a 8-weeks program with two sessions per week. The ACT component focuses on acceptance, psychological flexibility, mindfulness, cognitive defusion, values, and committed action.
The main outcomes are pain catastrophizing, functional disability, perceived stress, and sleep quality, assessed using the PCS, ODI, PSS, and PSQI. The study aims to determine whether combining psychological and physical rehabilitation produces better outcomes than physiotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT + Physiotherapy | Experimental | Behavioral: Acceptance and Commitment Therapy (ACT), Other: Standard Physiotherapy ProgramParticipants will receive an integrated Acceptance and Commitment Therapy (ACT) and physiotherapy program for 8 weeks, with two sessions per week . Each session will last approximately 45 minutes, including 15 minutes of ACT and 30 minutes of physiotherapy. ACT will include acceptance, cognitive defusion, mindfulness, values clarification, and committed action. Physiotherapy will include lumbar stabilization, core strengthening, aerobic conditioning, soft tissue techniques, and TENS. |
| Standard Physiotherapy | Active comparator | Other: Standard Physiotherapy ProgramParticipants will receive standard physiotherapy for 8 weeks, with two sessions per week . The physiotherapy program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue techniques, and TENS. Participants in this group will not receive Acceptance and Commitment Therapy or other ACT-based psychological interventions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- AAged between 18-55 years. BClinically diagnosed with non-specific chronic low back pain (CLBP). CLow back pain persisting for more than 3 months.
Key exclusion criteria (7 listed)
- History of previous spinal surgeries or invasive interventions in the lumbar region.
- Presence of "Red Flags" or serious underlying pathologies, such as spinal tumors, infections, or vertebral fractures.
- Current or recent (within the last 6 months) participation in structured psychological rehabilitation or behavioral therapy programs.
- Clinical evidence of neurological deficits, radiculopathy, or cauda equina syndrome.
- Pregnancy, due to the physiological changes affecting musculoskeletal mechanics.
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 |
|---|---|---|
| Acceptance and Commitment Therapy (ACT)Participants in the experimental group will receive Acceptance and Commitment Therapy (ACT) as part of the integrated rehabilitation program. ACT will be delivered for 15 minutes per session, twice weekly for 8 weeks . The intervention will focus on functional acceptance, psychological flexibility, cognitive defusion, mindfulness and present-moment awareness, values clarification, and committed action. The program aims to reduce pain catastrophizing and avoidance behaviors and promote engagement in meaningful activities despite chronic low back pain. ACT will be followed by 30 minutes of physiotherapy during each session. | Behavioural | ACT + Physiotherapy |
| Standard Physiotherapy ProgramParticipants will receive a standard physiotherapy program twice weekly for 8 weeks . The program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue release, and TENS. The physiotherapy component aims to improve physical function, mobility, and functional ability in individuals with chronic low back pain. The same physiotherapy program will be provided to participants in both study arms. | Other | ACT + Physiotherapy, Standard Physiotherapy |
Primary outcome
Sleep Quality
Time frame: Pre and 8 weeks post intervention
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates several aspects of sleep during the previous month. The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Pain intensity
Time frame: Pre and 8 weeks post intervention
VAS_Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Disability
Time frame: Pre and 8 weeks post intervention
Functional disability related to chronic low back pain will be assessed using the Oswestry Disability Index (ODI). The questionnaire evaluates limitations in daily activities, with the total score expressed as a percentage. Higher scores indicate greater disability.
Stress
Time frame: pre and 8 weeks post intervention
Perceived stress will be assessed using the Perceived Stress Scale (PSS), which measures the extent to which situations in an individual's life are perceived as unpredictable, uncontrollable, and overwhelming. Higher scores indicate greater perceived stress.
Pain Catastrophizing
Time frame: Pre and 8 weeks post intervention
Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale (PCS), which evaluates rumination, magnification, and helplessness related to pain. Higher scores indicate greater pain catastrophizing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Results publication: PubMed 31173921Godfrey E, Wileman V, Galea Holmes M, McCracken LM, Norton S, Moss-Morris R, Noonan S, Barcellona M, Critchley D. Physical Therapy Informed by Acceptance and Commitment Therapy (PACT) Versus Usual Care Physical Therapy for Adults With Chronic Low Back Pain: A Randomized Controlled Trial. J Pain. 2020 Jan-Feb;21(1-2):71-81. doi: 10.1016/j.jpain.2019.05.012. Epub 2019 Jun 5.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) and Standard Physiotherapy Program in people with Low Back Pain, run by Al-Azhar University.
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 1 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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mosab M Aldabbas, PhD (00972597451222, mosab.m.aldabbas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Pre and 8 weeks post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07766616, which also lists 1 linked publication.
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 14 Aug 2026.