An interventional study of Cognitive Behavioural Therapy and Strengthening exercises in Chronic Low Back Pain and Central Sensitisation, sponsored by Marwa Elsayed. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-03-17.
Sponsored by Marwa Elsayed · Not applicable, Interventional, and Treatment
PURPOSE:
The main objectives of the study are:
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"
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →This is the only study on the registry with Marwa Elsayed as lead sponsor.
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Exclusion Criteria:
Following assessment a one on one session will be given comprising education cognitively targeting false ideas and beliefs on the nature of pain, differentiating nociception due to a painful stimulus and the transition of such a stimulus to a centrally sensitized experience due to misinformation, maladaptive behaviour and fear avoidance. Upon completion of the session assessment using the NPQ will be done to assess the understanding of the patient and further address any shortcomings in future exercise sessions. Another SEMG recording of the Flexion Relaxation phenomenon will be upon completion of the educational session and a SEMG biofeedback session will begin to help the patient regain their sense of control over their body and function. After the SEMG biofeedback session a graded exposure exercise program of strengthening and functional training starting from the least feared movements to the most over 10 sessions over 5 weeks.
Behavioral: Cognitive Behavioural Therapy
Following assessment 12 sessions over 6 weeks will start, focusing on strengthening exercises of the transversus abdominis and lumbar multifidus muscles (Angela Searle, 2015). Exercises will be graduated according to the patient pain tolerance.
Other: Strengthening exercises
Following assessment a one on one session will be given comprising education cognitively targeting false ideas and beliefs on the nature of pain, differentiating nociception due to a painful stimulus and the transition of such a stimulus to a centrally sensitized experience due to misinformation, maladaptive behaviour and fear avoidance. Upon completion of the session assessment using the NPQ will be done to assess the understanding of the patient and further address any shortcomings in future exercise sessions. Another SEMG recording of the Flexion Relaxation phenomenon will be upon completion of the educational session and a SEMG biofeedback session will begin to help the patient regain their sense of control over their body and function. After the SEMG biofeedback session a graded exposure exercise program of strengthening and functional training starting from the least feared movements to the most over 10 sessions over 5 weeks.
Also known as: SEMG Biofeedback
Strengthening exercises in a gradual manner to the Multifidus and Transversus Abdominis muscles.
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.
Time frame: Upto 24 weeks of treatment
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.
Time frame: Upto 24 weeks of treatment
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.
Time frame: Upto 24 weeks of treatment
Plan to share: Undecided — Only consented information will be shared.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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