Low Back Pain
Conditions
Keywords
low back pain, sleep, Acceptance and Commitment Therapy, Exercises, Randomization
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.
Interventions
BEHAVIORALAcceptance 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.
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.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | 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 | 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 | 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 | 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 | 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. |
Contacts
CONTACTMosab M Aldabbas, PhD
Outcome results
None listed