Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain

NCT07766616 | Not Yet Recruiting DMC

• 2 other identifiers: Al azhar AUG000
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

low back pain; sleep; Acceptance and Commitment Therapy; Exercises; Randomization

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Pre and 8 weeks post intervention

Study Arms (2)

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.

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.

Other: Standard Physiotherapy Program

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

ACT + Physiotherapy

Standard Physiotherapy Program OTHER

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.

ACT + Physiotherapy; Standard Physiotherapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A\_Aged between 18-55 years. B\_Clinically diagnosed with non-specific chronic low back pain (CLBP). C\_Low back pain persisting for more than 3 months.

You may not qualify if:

• A. History of previous spinal surgeries or invasive interventions in the lumbar region.
• B. Presence of "Red Flags" or serious underlying pathologies, such as spinal tumors, infections, or vertebral fractures.
• C. Current or recent (within the last 6 months) participation in structured psychological rehabilitation or behavioral therapy programs.
• D. Clinical evidence of neurological deficits, radiculopathy, or cauda equina syndrome.
• E. Pregnancy, due to the physiological changes affecting musculoskeletal mechanics.
• F. Severe behavioral or communication impairments preclude the ability to follow the intervention protocol or complete the self-report assessments.
• G. Patients who take any sleep medication or for mental health medication. H. Patients who have done physiotherapy program last 3 months.

Sponsors & Collaborators

• Al-Azhar University: lead

Related Publications (1)

• 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.

  PMID: 31173921 RESULT

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mosab M Aldabbas, PhD

CONTACT

00972597451222; mosab.m.aldabbas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08