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

Low Back Pain, Mechanical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04938739
• Other study ID #: Manis_MSc
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic - Faculty of Physical Therapy - Cairo University	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the change in pain intensity	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	Baseline and 6 weeks post-intervention
Primary	Assessing the change in back function	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.	Baseline and 6 weeks post-intervention
Secondary	Assessing the change in anxiety related to pain	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.	Baseline and 6 weeks post-intervention