Orthopedic DisorderNCT05047614
Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain
A study of Orthopedic Disorder, run by October 6 University at 1 site in Egypt.
Trial summary
This study is conducted to answer the following question: What is the effect of lumbar repositioning feedback and transverses abdominis training on lumbar proprioception in patients with chronic mechanical low back pain? Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Orthopedic Disorder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Apr 2020to 15 Aug 2022
- 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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with CMLBP referred from orthopedic surgeon with no radicular pain
- Their age is ranged between 35-55 years old (Martim etal.,2008)
- BMI 24-28 kg/m2
Who cannot join
- Patients who have a history of diabetic peripheral neuropathies
- Patients who have a history of sciatica
- Spinal or lower limb deformity or any pathology within the spine.
- Patients who have neurological disorders
- Patients who have a history of previous lumbar surgery
- Patients who have visual problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
October 6 university
Giza, 12511
Mai Hassan, Doctoral, o1019461836, Mai.Hassan.ph@o6u.edu.eg
Hossam Magdy, Doctoral, 01112730605, Hosam.Magdy.PT@o6u.edu.eg
About this study
This study is conducted to answer the following question: What is the effect of lumbar repositioning feedback and transverses abdominis training on lumbar proprioception in patients with chronic mechanical low back pain?
Read the detailed description
Chronic low back pain is a chronic pain syndrome in the lower back region, lasting for at least twelve weeks. Chronic low back pain represents the leading cause of disability worldwide and is a major welfare and economic problem. Low back pain represents a major social and economic problem. The prevalence of chronic low back pain is estimated to range from fifteen to forty-five percent in French healthcare workers. Low back pain symptoms can derive from many potential anatomic sources, such as nerve roots, muscle, fascial structures, bones, joints, intervertebral discs, and organs within the abdominal cavity. Moreover, symptoms can also spawn from aberrant neurological pain processing causing neuropathic low back pain. Low back pain has been associated with motor control dysfunction. Indicators of this dysfunction include decreased contraction of the transversus abdominis and multifidus muscles, the reduced cross-sectional area of the multifidus, and fat infiltration. An association of chronic low back pain with altered muscle recruitment patterns and transversus abdominis activation delay was also found, as well as increased back muscle fatigue and altered kinematic patterns in the hips and lumbar area.
This was further supported in two recent systematic reviews that reported that proprioception deficits were found in patients with chronic low back pain compared to healthy controls
- Conditions
- Orthopedic Disorder
- Being tested
- including sham
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
including shamDevice
Repositiong feedback training and biofeedback pressure training unit
| Study group | Role | What they receive |
|---|---|---|
| Study 1 | Experimental | Twelve patients in study group 1 receiving lumbar repositioning feedback training Receives: Device: including sham |
| Study 2 | Experimental | Twelve patients in study group 2 receiving transverses abdominis training Receives: Device: including sham |
| Study 3 | Experimental | Twelve patients in study group 3 receiving both lumbar repositioning feedback training and tranversus abdominis training Receives: Device: including sham |
| Control | Experimental | Twelve patients in control group receiving conventional lumbar propriception physical therapy program . Receives: Device: including sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure biofeedback unit
Assessment of transversus abdominis activation
Measured: up to 45 days
feedback laser tracker
Assessment of lumbar repositioning error
Measured: up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start19 Apr 2020
- Primary completion2 May 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Hassan Ahmed Desouki, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047614
- Sponsor's protocol ID
- 153145
- Status last verified
- Sep 2021
- First submitted
- 22 Jul 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT05047614
- Acronym / sponsor ID
- 153145
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 19 Apr 2020 (actual)
- Primary completion
- 2 May 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 17 Sep 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.
This study is conducted to answer the following question: What is the effect of lumbar repositioning feedback and transverses abdominis training on lumbar proprioception in patients with chronic mechanical low back pain?
Detailed description
Chronic low back pain is a chronic pain syndrome in the lower back region, lasting for at least twelve weeks. Chronic low back pain represents the leading cause of disability worldwide and is a major welfare and economic problem. Low back pain represents a major social and economic problem. The prevalence of chronic low back pain is estimated to range from fifteen to forty-five percent in French healthcare workers. Low back pain symptoms can derive from many potential anatomic sources, such as nerve roots, muscle, fascial structures, bones, joints, intervertebral discs, and organs within the abdominal cavity. Moreover, symptoms can also spawn from aberrant neurological pain processing causing neuropathic low back pain. Low back pain has been associated with motor control dysfunction. Indicators of this dysfunction include decreased contraction of the transversus abdominis and multifidus muscles, the reduced cross-sectional area of the multifidus, and fat infiltration. An association of chronic low back pain with altered muscle recruitment patterns and transversus abdominis activation delay was also found, as well as increased back muscle fatigue and altered kinematic patterns in the hips and lumbar area.
This was further supported in two recent systematic reviews that reported that proprioception deficits were found in patients with chronic low back pain compared to healthy controls
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study 1 | Experimental | Device: including shamTwelve patients in study group 1 receiving lumbar repositioning feedback training |
| Study 2 | Experimental | Device: including shamTwelve patients in study group 2 receiving transverses abdominis training |
| Study 3 | Experimental | Device: including shamTwelve patients in study group 3 receiving both lumbar repositioning feedback training and tranversus abdominis training |
| Control | Experimental | Device: including shamTwelve patients in control group receiving conventional lumbar propriception physical therapy program . |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with CMLBP referred from orthopedic surgeon with no radicular pain
- Their age is ranged between 35-55 years old (Martim etal.,2008)
- BMI 24-28 kg/m2
Key exclusion criteria (6 listed)
- Patients who have a history of diabetic peripheral neuropathies
- Patients who have a history of sciatica
- Spinal or lower limb deformity or any pathology within the spine.
- Patients who have neurological disorders
- Patients who have a history of previous lumbar surgery
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 |
|---|---|---|
| including shamRepositiong feedback training and biofeedback pressure training unit | Device | Control, Study 1, Study 2, Study 3 |
Primary outcome
Pressure biofeedback unit
Time frame: up to 45 days
Assessment of transversus abdominis activation
feedback laser tracker
Time frame: up to 45 days
Assessment of lumbar repositioning error
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Orthopedic Disorder, run by October 6 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 3 inclusion and 6 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 17 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MAI HASSAN, Doctoral (01019461836, Mai.Hassan.ph@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure biofeedback unit (time frame: up to 45 days). 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 17 Sep 2021.