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

NCT ID: NCT03863808

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2019-10-18

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"

Conditions

Chronic Low Back Pain; Central Sensitisation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioural Therapy

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.

Group Type: EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type: 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.

Strengthening and Core Stability

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.

Group Type: ACTIVE_COMPARATOR

Strengthening exercises

Intervention Type: OTHER

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

Interventions

Cognitive Behavioural Therapy

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: BEHAVIORAL

Strengthening exercises

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

Intervention Type: OTHER

Other Intervention Names

SEMG Biofeedback

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MTI University

OTHER

Sponsor Role: collaborator

Marwa Elsayed

OTHER

Sponsor Role: lead

Responsible Party

Marwa Elsayed

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

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

MTI University

Cairo, Mokattam, Egypt

Countries

Egypt

References

. 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

Reference Type: RESULT

Other Identifiers

118992148

Identifier Type: -

Identifier Source: org_study_id