Chronic Non Specific Mechanical Low Back PainNCT06198660
PRT Versus CBT on Chronic Non Specific LBP
A study testing positional release technique, cognitive behavioral therapy and conventional therapy only in people with Chronic Non Specific Mechanical Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare between the effect of positional release technique and cognitive behavioral therapy in patients with chronic non specific low back pain. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Chronic Non Specific Mechanical Low Back Pain
- What is being tested?
- positional release technique, cognitive behavioral therapy and conventional therapy only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2023to Dec 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients will be clinically diagnosed with chronic non specific low back pain .
- Their ages will range from 20to40years old.
- body mass index will range from 18 to 30 kg/cm².
- Cognitive score will be 23 or above .
- Voluntary acceptance of participation in this study.
Who cannot join
- Lumbar canal stenosis
- Lumbar discogenic lesions
- Lumbar infections,tumors.arthiritis
- Patients with decreased range of motion due to congenital anamolies.
- Cognitive and emotional disturbances
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Horus University
Damietta, New Damietta
Nosaiba Eissa, 01005305615, neissa@horus.edu.eg
About this study
Official title: Positional Release Technique Versus Cognitive Behavioral Therapy on Chronic Non Specific Low Back Pain
The goal of this clinical trial is to compare between the effect of positional release technique and cognitive behavioral therapy in patients with chronic non specific low back pain.
The main question aims to answer :Is there any differences of using positional release techniques versus cognitive behavioral therapy on patients with chronic low back pain?
Read the detailed description
Design of the study :
Pretest-posttest randomized controlled trial.
Subjects selection :
sixty patients their age between 25-45 years of both genders with chronic non specific low back pain will participate in this study according tosample size calculation.
- Being tested
- positional release technique, cognitive behavioral therapy, conventional therapy only
- Keywords
- positional release, cognitive behavioral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positional release techniqueOther
positional release techniques in addition to conventional therapy two sessions per week for 6 weeks
cognitive behavioral therapyOther
cognitive behavioral therapy in addition to conventional therapy two sessions per week for 6 weeks
conventional therapy onlyOther
conventional therapy two sessions for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| positional release | Experimental | positional release techniques in addition to conventional physical therapy Receives: Other: positional release technique |
| cognitive behavioral therapy | Experimental | cognitive behavioral therapy in addition to conventional physical therapy Receives: Other: cognitive behavioral therapy |
| conventional physical therapy | Active comparator | conventional physical therapy in control group Receives: Other: positional release technique; Other: cognitive behavioral therapy; Other: conventional therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
pressure algometer
change in pain pressure threshold .with unit of measurement kg/cm2
Measured: pre intervention and immediately after intervention
Secondary outcomes (1)
the arabic version of oswestry disability questionnaire
the patients choose one out of six senteces 10 multiple choise questions for back pain higher scores indicate great pain
Measured: pre intervention and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non Specific Mechanical Low Back PainStudies 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
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nosaiba Ahmed fahmy Eissa, Cairo University
- Investigators
- Nosaiba Eissa, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198660
- Sponsor's protocol ID
- PRT V CBT IN CNLBP
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positional Release Technique Versus Cognitive Behavioral Therapy on Chronic Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06198660
- Acronym / sponsor ID
- PRT V CBT IN CNLBP
- Keywords
- positional release, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jan 2024 (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 goal of this clinical trial is to compare between the effect of positional release technique and cognitive behavioral therapy in patients with chronic non specific low back pain.
The main question aims to answer :Is there any differences of using positional release techniques versus cognitive behavioral therapy on patients with chronic low back pain?
Detailed description
Design of the study :
Pretest-posttest randomized controlled trial.
Subjects selection :
sixty patients their age between 25-45 years of both genders with chronic non specific low back pain will participate in this study according tosample size calculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| positional release | Experimental | Other: positional release techniquepositional release techniques in addition to conventional physical therapy |
| cognitive behavioral therapy | Experimental | Other: cognitive behavioral therapycognitive behavioral therapy in addition to conventional physical therapy |
| conventional physical therapy | Active comparator | Other: positional release technique, Other: cognitive behavioral therapy, Other: conventional therapy onlyconventional physical therapy in control group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All patients will be clinically diagnosed with chronic non specific low back pain .
- Their ages will range from 20to40years old.
- body mass index will range from 18 to 30 kg/cm².
- Cognitive score will be 23 or above .
- Voluntary acceptance of participation in this study.
Key exclusion criteria (5 listed)
- Lumbar canal stenosis
- Lumbar discogenic lesions
- Lumbar infections,tumors.arthiritis
- Patients with decreased range of motion due to congenital anamolies.
- Cognitive and emotional disturbances
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 |
|---|---|---|
| positional release techniquepositional release techniques in addition to conventional therapy two sessions per week for 6 weeks | Other | conventional physical therapy, positional release |
| cognitive behavioral therapycognitive behavioral therapy in addition to conventional therapy two sessions per week for 6 weeks | Other | cognitive behavioral therapy, conventional physical therapy |
| conventional therapy onlyconventional therapy two sessions for 6 weeks | Other | conventional physical therapy |
Primary outcome
pressure algometer
Time frame: pre intervention and immediately after intervention
change in pain pressure threshold .with unit of measurement kg/cm2
1 secondary outcome
the arabic version of oswestry disability questionnaire
Time frame: pre intervention and immediately after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
Related trials for Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability by Numerical Pain Rating Scale and Modified Oswestry Disability Index Respectively.
Chronic Non Specific Mechanical Low Back Pain
Active, not recruiting
The Effect of Core Stabilization Exercises Applied With Virtual Reality-Based Telerehabilitation in the Treatment of Chronic Low Back Pain
Low Back Pain, Low Back Pain, Mechanical
Not yet recruiting
Effects of a Protocol of Hip Flexor Stretching on Chronic Mechanical, Non-specific LBP.
Pain, Musculoskeletal Manipulations
Recruiting
Effects of Foundation and Functional Inspiratory Muscle Training in Non-Specific Chronic Low Back Pain
Low Back Pain, Mechanical, Low Back Pain, Chronic
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.
Nosaiba Eissa principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positional release technique, cognitive behavioral therapy and conventional therapy only in people with Chronic Non Specific Mechanical Low Back Pain, 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 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nosaiba Eissa (01005305615, neissa@horus.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure algometer (time frame: pre intervention and immediately after intervention). 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 12 Jan 2024.