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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04938739
Enrollment
30
Registered
2021-06-24
Start date
2020-12-01
Completion date
2021-02-28
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Mechanical

Brief summary

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

Detailed description

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.

Interventions

OTHERCognitive Behavioral Therapy

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.

OTHERHome program exercises

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

1. Thirty patients with non-specific chronic low back pain from both sexes will be included. 2. Subjects with normal body mass index (18 to 25). 3. The age of patients range from 20 to 35 years. 4. Duration of pain more than 3 months up to 2 years. 5. 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: 1. Lumbar canal stenosis. 2. Lumbar discogenic lesions. 3. Any inflammatory arthritis, tumors, infection involving the lumbar spine. 4. Patients with decreased range of motion secondary to congenital anomalies, muscular contracture or bony block. 5. Previous lumbar surgery or trauma. 6. Subjects with a history of any neurologic disease. 7. Cauda equina Syndrome. 8. Patients suffering from psychological, cognitive or emotional disturbance. 9. Patients who had previously participated in cognitive behavioral therapy. 10. Deafness and blindness.

Design outcomes

Primary

MeasureTime frameDescription
Assessing the change in pain intensityBaseline and 6 weeks post-interventionAssessment 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
Assessing the change in back functionBaseline and 6 weeks post-interventionAssessment 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

MeasureTime frameDescription
Assessing the change in anxiety related to painBaseline and 6 weeks post-interventionAssessment 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026