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

NCT ID: NCT04938739

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-02-28

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.

Conditions

Low Back Pain, Mechanical

Study Design

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

Study Groups

Cognitive Behavioral therapy

to modify any erroneous beliefs about pain and disability and to promote coping strategies and self-efficacy through a graded activity.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Home program exercises

Intervention Type: 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.

Interventions

Cognitive 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.

Intervention Type: OTHER

Home 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Manar Abd El galil Aneis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manar Abdelgalil, Abdelgalil

Role: PRINCIPAL_INVESTIGATOR

Horus University in Egypt

Locations

Outpatient clinic - Faculty of Physical Therapy - Cairo University

Dokki, , Egypt

Countries

Egypt

Other Identifiers

Manis_MSc

Identifier Type: -

Identifier Source: org_study_id