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Completed

NCT Number: NCT03863808

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

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"

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Key information

Conditions

Chronic Low Back Pain Central Sensitisation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MTI University

Cairo, Mokattam, 11585, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SEMG Biofeedback

Strengthening Exercises

Other

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

Primary outcomes

  1. 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

  1. The fear avoidance beliefs questionnaire

    Time frame: Upto 24 weeks of treatment

    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.

Other outcomes

  1. The numerical rating scale (NRS)

    Time frame: Upto 24 weeks of treatment

    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.

Sponsors and collaborators

Lead sponsor

Marwa Elsayed

Other

Collaborators

  • MTI University

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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