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

Study Overview

• Status: Completed
• Conditions: Low Back Pain, Mechanical
• Intervention / Treatment: Other: Cognitive Behavioral Therapy; Other: Home program exercises

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki, Egypt, 34518
    • Outpatient clinic - Faculty of Physical Therapy - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral therapy; to modify any erroneous beliefs about pain and disability and to promote coping strategies and self-efficacy through a graded activity.	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.; 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Manar Abdelgalil, Abdelgalil, Horus University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Manis_MSc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No