Low Back Pain, MechanicalNCT04938739
Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
A study testing Cognitive Behavioral Therapy and Home program exercises in people with Low Back Pain, Mechanical, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Cognitive Behavioral Therapy and Home program exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic - Faculty of Physical Therapy - Cairo University
Dokki, 34518
About this study
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
Read the 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
- Being tested
- Cognitive Behavioral Therapy, Home program exercises
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyOther
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 exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral therapy | Experimental | to modify any erroneous beliefs about pain and disability and to promote coping strategies and self-efficacy through a graded activity. Receives: Other: Cognitive Behavioral Therapy; Other: Home program exercises |
| Home program exercises | Active comparator | 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. Receives: Other: Home program exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline and 6 weeks post-intervention
Secondary outcomes (1)
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.
Measured: Baseline and 6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Dec 2020
- Primary completion15 Jan 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar Abd El galil Aneis, Cairo University
- Investigators
- Manar Abdelgalil, Abdelgalil, Principal investigator, Horus University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938739
- Sponsor's protocol ID
- Manis_MSc
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT04938739
- Acronym / sponsor ID
- Manis_MSc
- Conditions
- Low Back Pain, Mechanical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral therapy | Experimental | Other: Cognitive Behavioral Therapy, Other: Home program exercisesto modify any erroneous beliefs about pain and disability and to promote coping strategies and self-efficacy through a graded activity. |
| Home program exercises | Active comparator | Other: Home program exercisesPatients 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyThe 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 | Cognitive Behavioral therapy |
| Home program exercisesEach 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. | Other | Cognitive Behavioral therapy, Home program exercises |
Primary outcome
Assessing the change in pain intensity
Time frame: 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
Time frame: 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.
1 secondary outcome
Assessing the change in anxiety related to pain
Time frame: Baseline and 6 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manar Abdelgalil, Abdelgalil principal investigator
Horus University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Home program exercises in people with Low Back Pain, Mechanical, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in pain intensity (time frame: Baseline and 6 weeks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.