Back to resultsEffect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
Primary Purpose
Low Back Pain, Mechanical
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Home program exercises
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical
Eligibility Criteria
Inclusion Criteria:
- Thirty patients with non-specific chronic low back pain from both sexes will be included.
- Subjects with normal body mass index (18 to 25).
- The age of patients range from 20 to 35 years.
- Duration of pain more than 3 months up to 2 years.
- 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:
- Lumbar canal stenosis.
- Lumbar discogenic lesions.
- Any inflammatory arthritis, tumors, infection involving the lumbar spine.
- Patients with decreased range of motion secondary to congenital anomalies, muscular contracture or bony block.
- Previous lumbar surgery or trauma.
- Subjects with a history of any neurologic disease.
- Cauda equina Syndrome.
- Patients suffering from psychological, cognitive or emotional disturbance.
- Patients who had previously participated in cognitive behavioral therapy.
- Deafness and blindness.
Sites / Locations
- Outpatient clinic - Faculty of Physical Therapy - Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Behavioral therapy
Home program exercises
Arm Description
to modify any erroneous beliefs about pain and disability and to promote coping strategies and self-efficacy through a graded activity.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04938739
Brief Title
Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
Official Title
Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Behavioral therapy
Arm Type
Experimental
Arm Description
to modify any erroneous beliefs about pain and disability and to promote coping strategies and self-efficacy through a graded activity.
Arm Title
Home program exercises
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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
Intervention Name(s)
Home program exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessing the change in pain intensity
Description
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
Time Frame
Baseline and 6 weeks post-intervention
Title
Assessing the change in back function
Description
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.
Time Frame
Baseline and 6 weeks post-intervention
Secondary Outcome Measure Information:
Title
Assessing the change in anxiety related to pain
Description
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.
Time Frame
Baseline and 6 weeks post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Thirty patients with non-specific chronic low back pain from both sexes will be included.
Subjects with normal body mass index (18 to 25).
The age of patients range from 20 to 35 years.
Duration of pain more than 3 months up to 2 years.
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:
Lumbar canal stenosis.
Lumbar discogenic lesions.
Any inflammatory arthritis, tumors, infection involving the lumbar spine.
Patients with decreased range of motion secondary to congenital anomalies, muscular contracture or bony block.
Previous lumbar surgery or trauma.
Subjects with a history of any neurologic disease.
Cauda equina Syndrome.
Patients suffering from psychological, cognitive or emotional disturbance.
Patients who had previously participated in cognitive behavioral therapy.
Deafness and blindness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manar Abdelgalil, Abdelgalil
Organizational Affiliation
Horus University in Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic - Faculty of Physical Therapy - Cairo University
City
Dokki
ZIP/Postal Code
34518
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
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