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Clinical Trials/NCT03863808
NCT03863808
Completed
Not Applicable

Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization

Marwa Elsayed1 site in 1 country30 target enrollmentNovember 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Marwa Elsayed
Enrollment
30
Locations
1
Primary Endpoint
The Oswestry disability index
Status
Completed
Last Updated
3 years ago

Overview

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"

Registry
clinicaltrials.gov
Start Date
November 2, 2017
End Date
October 18, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Marwa Elsayed
Responsible Party
Sponsor Investigator
Principal Investigator

Marwa Elsayed

Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain with sensitization.

MTI University

Eligibility Criteria

Inclusion Criteria

  • Age between 18-
  • Patient must have experienced low back pain for at least 3 months.
  • 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) .
  • 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.

Outcomes

Primary Outcomes

The Oswestry disability index

Time Frame: Upto 24 weeks of treatment

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.

Secondary Outcomes

  • The fear avoidance beliefs questionnaire(Upto 24 weeks of treatment)

Study Sites (1)

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