Clinical trial NCT03863808: Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization
Official title: Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Central Sensitisation
Keywords: Cognitive Behavioural Therapy
Flexion Relaxation Phenomenon
Electromyography
Biofeedback
Functional Training
Lead sponsor: MTI University
Sponsor class: OTHER
Collaborators: name: MTI University
First posted: 2019-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PURPOSE:

The main objectives of the study are:

1. To find the efficacy of using cognitive behavioural therapy on chronic low back pain with central sensitization.
2. To assist in planning an ideal physical therapy rehabilitation program for these patients.

BACKGROUND:

Recent research has shown that CLBP is a multifactorial disorder comprising psychosocial factors like pain catastrophization, fear avoidance and central sensitization. Central sensitization has been defined as "An amplification of neural signaling within the central nervous system that elicits pain hypersensitivity", and "increased responsiveness of nociceptive neurons in the central nervous system to their normal or subthreshold afferent input".

Maladaptive behavior, false beliefs and misinformation regarding the cause of the pain are all contributing factors to the chronicity of LBP.

Central sensitization has been attributed to cortical reorganization and amplification of the somatosensory representation of the back causing increased pain and further contributing to the maladaptive behavior and beliefs.

Cognitive behavioral treatment has been an important intervention for psychological disorders for decades and recently has gained a lot of interest as an intervention for chronic pain in general and CLBP in specific.

HYPOTHESES:

It will be hypothesized that: Cognitive behavioural therapy will have a significant effect on centrally sensitized pain intensity and disability.

RESEARCH QUESTION:" Does cognitive behavioral therapy have a significant effect on chronic low back pain with central sensitization"


Eligibility criteria: Inclusion Criteria:

1. Age between 18- 50.
2. Patient must have experienced low back pain for at least 3 months.
3. Patient must have a score above or equal 40 in the Central Sensitization Inventory (CSI) (Neblett R. C., 2013) (Neblett R, 2015) (Neblett H. M., 2016) (R. De Pauw, 2015) (Mayer TG N. R., 2012) .
4. Patient must have a score of 3 and above on the Numerical Pain Rating Scale.

Exclusion Criteria:

* Patients were excluded if they had taken pain medications on the day of the assessment.
* Patient who had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, narrowing of spinal canal and other conditions or severe cardiorespiratory diseases.
* Uncontrolled mental health condition that prevents successful compliance.

Primary outcomes:
measure: The Oswestry disability index
timeFrame: Upto 24 weeks of treatment
Secondary outcomes:
measure: The fear avoidance beliefs questionnaire
timeFrame: Upto 24 weeks of treatment
Other outcomes:
measure: The numerical rating scale (NRS)
timeFrame: Upto 24 weeks of treatment
Locations:
city: Cairo
country: Egypt
facility: MTI University
state: Mokattam
Study officials:
References:
citation: . Airaksinen O, B. J.-M. (2006). European guidlines for the management of chronic nonspecific low back pain. Eur spine, 192-300. .: The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. . (2011). Arch Phys Med Rehabil, 2041-56. Ahern DK, F. M. (1988). Comparison of lumbar paravertebral EMG patterns in chronic low back pain patients and non-patient controls. Pain, 153-160. Airaksinen O, B. J.-M. (2006). European guidlines for the management of chronic nonspecific low back pain. Eur spine, 192-300. Angela Searle, M. S. (2015). Exercise interventions for the treatment of chronic low back pain: A systematic review and meta-analysis of randomised controlled trials. Clinical Rehabilitation, 1-13. Balagué F, M. A. (2012). Non specific low back pain. lance, 482-491. Clarke CL, R. C. (2011). Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis. Manual Therapy, 544-549. Cohen JE, G. V. (1994). Group education interventions for people with low back pain. An overview of the literature. Spine , 1214-22. Dagenais S, C. J. (2008). A systematic review of low back pain cost of illness studies in the United States and internationally. Spine, 8-20. DC, M. V. (2008). Psychometric properties and clinical usefulness of the Oswestry Disability Index. Journal of Chiropractice medicine, 161-163. Delitto. (2005). Research in low back pain: Time to stop seeking the elusive