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Completed

NCT Number: NCT04938739

Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain

The purpose of the study is to determine the effectiveness of cognitive-behavioral therapy on functional outcomes, pain, and pain-related anxiety in patients with chronic nonspecific low back pain

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Key information

Conditions

Low Back Pain, Mechanical Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic - Faculty of Physical Therapy - Cairo University

Dokki, 34518, Egypt

About this study

Back pain has considerable negative effects on the quality of life of affected individuals. Individuals with new-onset back pain have an increased risk of lower quality of life scores, and the negative effect on quality of life increases with persistent pain. Patients with chronic back pain report a quality of life that is lower than individuals without pain and that is comparable to those of individuals with life-threatening diagnoses. In addition, back pain is associated with worry and fears, particularly about the (sense of) self and socialrelationships and especially when pain persists longer than expected.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Thirty patients with non-specific chronic low back pain from both sexes will be included.
  • Subjects with normal body mass index (18 to 25).
  • The age of patients range from 20 to 35 years.
  • Duration of pain more than 3 months up to 2 years.
  • Normal cognition score 26 or above according to MoCA Scale.7. Highly educated at least high school.

Exclusion criteria

The patients will be excluded if they have any of the followings:

  • Lumbar canal stenosis.
  • Lumbar discogenic lesions.
  • Any inflammatory arthritis, tumors, infection involving the lumbar spine.
  • Patients with decreased range of motion secondary to congenital anomalies, muscular contracture or bony block.
  • Previous lumbar surgery or trauma.
  • Subjects with a history of any neurologic disease.
  • Cauda equina Syndrome.
  • Patients suffering from psychological, cognitive or emotional disturbance.
  • Patients who had previously participated in cognitive behavioral therapy.
  • Deafness and blindness.

Treatment and study plan

Cognitive Behavioral Therapy

Other

The first 6 sessions: the cognitive part was explained with the support of a PowerPoint presentation using diagrams, images, and texts. The therapist explained the lumbar engine behavior, the neurophysiologic basis of pain, the importance of the participant's involvement in the treatment (e.g., coping and motivation), and the maintenance of good ergonomics which was aimed at modifying the physiologic response to the pain system.

The second 12 sessions: concepts viewed in the first session were revised; as well, the operant and respondent parts were explained.

Home program exercises

Other

Each session will include 10 minutes of aerobic activity (walking or stationary bicycle), followed by five types of muscle stretches and eight types of ground exercises aimed at strengthening the lumbar muscles responsible for stabilization.

Primary outcomes

  1. Assessing the change in pain intensity

    Time frame: Baseline and 6 weeks post-intervention

    Assessment via using visual analogue scale A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one

  2. Assessing the change in back function

    Time frame: Baseline and 6 weeks post-intervention

    Assessment via using Oswestry Low Back Pain Disability Index It is a 10-item self assessing questionnaire; each item contains 6 levels of answers that can be scored from 0 to 5.

Secondary outcomes

  1. Assessing the change in anxiety related to pain

    Time frame: Baseline and 6 weeks post-intervention

    Assessment via using pain anxiety symptom scale (PASS) is a 20-item self-report scale that measures components of pain-related anxiety, including cognitive anxiety, escape and avoidance, fearful appraisals of pain, and physiological anxiety.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2021
Registry last updated
Jun 24, 2021

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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