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

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

Sponsors

Lead sponsor: Marwa Elsayed

Collaborator: MTI University

Source MTI University
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"

Overall Status Active, not recruiting
Start Date November 2, 2017
Completion Date May 1, 2019
Primary Completion Date April 1, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The Oswestry disability index Upto 24 weeks of treatment
Secondary Outcome
Measure Time Frame
The fear avoidance beliefs questionnaire Upto 24 weeks of treatment
Enrollment 30
Condition
Intervention

Intervention type: Behavioral

Intervention name: Cognitive Behavioural Therapy

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 group label: Cognitive Behavioural Therapy

Other name: SEMG Biofeedback

Intervention type: Other

Intervention name: Strengthening exercises

Description: Strengthening exercises in a gradual manner to the Multifidus and Transversus Abdominis muscles.

Arm group label: Strengthening and Core Stability

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.

Gender: All

Minimum age: 18 Years

Maximum age: 50 Years

Healthy volunteers: No

Location
facility MTI University
Location Countries

Egypt

Verification Date

March 2019

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: MTI University

Investigator full name: Marwa Elsayed

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

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Cognitive Behavioural Therapy

Arm group type: Experimental

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 group label: Strengthening and Core Stability

Arm group type: Active Comparator

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.

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov