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

Primary Purpose

Chronic Low Back Pain, Central Sensitisation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy
Strengthening exercises
Sponsored by
Marwa Elsayed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Cognitive Behavioural Therapy, Flexion Relaxation Phenomenon, Electromyography, Biofeedback, Functional Training

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MTI University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Behavioural Therapy

Strengthening and Core Stability

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 23, 2018
Last Updated
March 15, 2023
Sponsor
Marwa Elsayed
Collaborators
MTI University
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1. Study Identification

Unique Protocol Identification Number
NCT03863808
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marwa Elsayed
Collaborators
MTI University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
PURPOSE: The main objectives of the study are: To find the efficacy of using cognitive behavioural therapy on chronic low back pain with central sensitization. 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"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Central Sensitisation
Keywords
Cognitive Behavioural Therapy, Flexion Relaxation Phenomenon, Electromyography, Biofeedback, Functional Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioural Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Strengthening and Core Stability
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Other Intervention Name(s)
SEMG Biofeedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Strengthening exercises
Intervention Description
Strengthening exercises in a gradual manner to the Multifidus and Transversus Abdominis muscles.
Primary Outcome Measure Information:
Title
The Oswestry disability index
Description
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
Secondary Outcome Measure Information:
Title
The fear avoidance beliefs questionnaire
Description
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
Other Pre-specified Outcome Measures:
Title
The numerical rating scale (NRS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18- 50. 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.
Facility Information:
Facility Name
MTI University
City
Cairo
State/Province
Mokattam
ZIP/Postal Code
11585
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Only consented information will be shared.
Citations:
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
Results Reference
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Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization

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