Chronic Low Back Pain Clinical Trial
Official title:
Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization
Verified date | March 2023 |
Source | MTI University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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"
Status | Completed |
Enrollment | 30 |
Est. completion date | October 18, 2019 |
Est. primary completion date | August 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | MTI University | Cairo | Mokattam |
Lead Sponsor | Collaborator |
---|---|
Marwa Elsayed | MTI University |
Egypt,
. 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). Ar
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The numerical rating scale (NRS) | The NRS evaluates levels of pain intensity using an 11-point scale (range 0-10), with 0 being classified as "no pain" and 10 "pain as bad as could be." Pain evaluation was assessed verbally by having people report pain intensity for the last 7 days as a criterion for inclusion in the study. | Upto 24 weeks of treatment | |
Primary | The Oswestry disability index | The Oswestry Disability Index (ODI) is one of the most commonly used outcome measures for individuals with low back pain (LBP) (Fairbank JC, 2000) .The ODI shows good construct validity; internal consistency is rated as acceptable; test-retest reliability and responsiveness have been shown to be high; and burden of administration is low. The ODI is a self-administered questionnaire that requires 5 minutes to complete and 1 minute to score. | Upto 24 weeks of treatment | |
Secondary | The fear avoidance beliefs questionnaire | FABQ was developed by Waddell to investigate fear-avoidance beliefs among LBP patients in the clinical setting. This survey can help predict those that have a high pain avoidance behavior. The FABQ consists of 2 subscales, which are reflected in the division of the outcome form into 2 separate sections. The first subscale (items 1-5) is the Physical Activity subscale (FABQPA), and the second subscale (items 6-16) is the Work subscale (FABQW). Scoring the Physical Activity subscale (FABQPA) Sum items 2, 3, 4, and 5 (the score circled by the patient for these items). Scoring the Work subscale (FABQW) Sum items 6, 7, 9, 10, 11, 12, and 15. | Upto 24 weeks of treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03243084 -
Transcranial Alternating Current Stimulation in Back Pain- Pilot Sudy
|
N/A | |
Suspended |
NCT04735185 -
Stem Cells vs. Steroids for Discogenic Back Pain
|
N/A | |
Completed |
NCT03162952 -
RAND Center of Excellence for the Study of Appropriateness of Care in CAM
|
||
Completed |
NCT03240146 -
Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain
|
N/A | |
Completed |
NCT05282589 -
Lumbopelvic Manipulation Effects on Fatigue in Chronic Low Back Pain Patients
|
N/A | |
Completed |
NCT03637998 -
Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain
|
N/A | |
Recruiting |
NCT02289170 -
Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)
|
N/A | |
Active, not recruiting |
NCT01944163 -
The IMPACT of a Referral Model for Axial Spondyloarthritis in Young Patients With Chronic Low Back Pain
|
N/A | |
Completed |
NCT02231554 -
Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT02063503 -
Identification of Prognostic Indicators for Rehabilitation in Chronic Nonspecific Low Back Pain Patients
|
N/A | |
Completed |
NCT01704677 -
Lumbar Disc Prosthesis Versus Multidisciplinary Rehabilitation; 8-year Follow-up
|
N/A | |
Terminated |
NCT01620775 -
MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain
|
N/A | |
Completed |
NCT01490905 -
A Double Blind Placebo Study to Determine the Effectiveness of Theramine on the Management of Chronic Back Pain
|
Phase 4 | |
Completed |
NCT01177280 -
Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Chronic Low Back Pain Patients Taking Opioid Analgesics and Associated Economic Outcomes
|
N/A | |
Completed |
NCT01177241 -
Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids
|
N/A | |
Completed |
NCT01177254 -
Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions
|
N/A | |
Completed |
NCT00984815 -
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
|
Phase 3 | |
Completed |
NCT00761150 -
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
|
Phase 3 | |
Completed |
NCT00763321 -
Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
|
Phase 3 | |
Completed |
NCT00767806 -
A Study for Patient With Chronic Low Back Pain
|
Phase 3 |