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

NCT03863808 | Completed DMC

• 1 other identifier: 118992148
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: The main objectives of the study are:

1. 1.To find the efficacy of using cognitive behavioural therapy on chronic low back pain with central sensitization.
2. 2.To assist in planning an ideal physical therapy rehabilitation program for these patients.

Conditions

Chronic Low Back Pain; Central Sensitisation

Keywords

Cognitive Behavioural Therapy; Flexion Relaxation Phenomenon; Electromyography; Biofeedback; Functional Training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The fear avoidance beliefs questionnaire

  Upto 24 weeks of treatment

Other Outcomes (1)

• The numerical rating scale (NRS)

  Upto 24 weeks of treatment

Study Arms (2)

Cognitive Behavioural Therapy

EXPERIMENTAL

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

Strengthening and Core Stability

ACTIVE COMPARATOR

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

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

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

Cognitive Behavioural Therapy

Strengthening exercises OTHER

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

Strengthening and Core Stability

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marwa Elsayed: lead
• MTI University: collaborator

Study Sites (1)

MTI University

Cairo, Mokattam, 11585, Egypt

Location

Related Publications (1)

• . 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

  RESULT

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain with sensitization.

Study Record Dates

• First Submitted: September 23, 2018
• First Posted: March 5, 2019
• Study Start: November 2, 2017
• Primary Completion: August 15, 2019
• Study Completion: October 18, 2019
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

EG (1)