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

Not Applicable

Completed

• Conditions: Low Back Pain, Mechanical
• Interventions: Other: Cognitive Behavioral Therapy; Other: Home program exercises

• Registration Number: NCT04938739
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2020-12-01
• Primary Completion: 2021-01-15
• Study Completion: 2021-02-28
• Status Verified: 2021-06
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-16
• Study First Posted: 2021-06-24
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral therapy	Cognitive Behavioral Therapy	to modify any erroneous beliefs about pain and disability and to promote coping strategies and self-efficacy through a graded activity.
Home program exercises	Home program exercises	Patients in both groups carried out exercise therapy for six weeks. There will be an educational session for each patient to make sure the exercises will be done successfully and supervision once per week.
Cognitive Behavioral therapy	Home program exercises	to modify any erroneous beliefs about pain and disability and to promote coping strategies and self-efficacy through a graded activity.

Primary Outcome Measures

Name	Time	Method
Assessing the change in pain intensity	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
Assessing the change in back function	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 Outcome Measures

Name	Time	Method
Assessing the change in anxiety related to pain	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.

Trial Locations

Locations (1)

Outpatient clinic - Faculty of Physical Therapy - Cairo University; 🇪🇬 Dokki, Egypt