Low Back PainNCT06785363
The Study Focuses on the Release of the Iliolumbar Ligament Using a Pumped Technique, Addressing Its Tightness Caused by Excessive Anterior Pelvic Tilt During Pregnancy. This Condition Often Results in Low Back Pain and Mechanical Dysfunction of the Lumbar and Sacroiliac Regions.
A study testing pumped technique for ilio-lumbar ligament release and Hot Packs in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The iliolumbar ligament, one of the sacroiliac ligaments, has been identified in recent research as a contributor to low back pain when tight. During pregnancy, hormonal changes and postural changes can cause this ligament to tighten, leading to pain. Read more about this study
- Who is it for?
- Ages 25 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- pumped technique for ilio-lumbar ligament release and Hot Packs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- the women are delivery within 3 months. 3- Their BMI must be less than 30 Kg\m 2 . 4- Its included primipara or multipara. 5- Its included be normal vaginal labor delivery or caesarian section.
Who cannot join
- Clinical diagnosis by Lumbar disc prolapse.
- Clinical diagnosis by Lumbar spondylolysis and spondlysis.
- Clinical diagnosis by back trauma or fracture.
- Clinical diagnosis by Lumbar canal stenosis.
- Clinical diagnosis by Rheumatoid arthritis.
- Clinical diagnosis by Malignancy.
Show all 10Show fewer
- Clinical diagnosis by any deformity for low limb.
- Clinical diagnosis by Scoliosis.
- Taking analgesic drugs.
- Clinical diagnosis by Deep vein thrombosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Pumped Technique for Ilio-lumber Ligament Release on Postnatal Low Back Pain
The iliolumbar ligament, one of the sacroiliac ligaments, has been identified in recent research as a contributor to low back pain when tight. During pregnancy, hormonal changes and postural changes can cause this ligament to tighten, leading to pain. Releasing the iliolumbar ligament can reduce low back pain and restore normal mechanical function.
Read the detailed description
Group A (Control group) It will be consisted of postnatal women and will be treated by hot packs for 20 minutes three times per week for 8 weeks.
Group B (study group) the participant will treated by hot packs for 20 min in additional to pumping technique for iliolumbar ligament release for 30 min. 3 times per week for 8 weeks.
- Conditions
- Low Back Pain
- Being tested
- pumped technique for ilio-lumbar ligament release, Hot Packs
- Keywords
- low back pain, lumbar and sacroiliac pain, iliolumbar ligament disorder
- 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.
pumped technique for ilio-lumbar ligament releaseOther
Patient position: the patient lying supine or side lying Therapist position: standing on one side of patient. Hand grip: one hand placed on posterior region of iliac crest (close to attachment of ilio-lumbar ligament) while other hand stabilize the medial part of thigh. Therapist force: therapist pulling patient's thigh posteriorly.
Hot PacksOther
postnatal women will be treated by hot packs for 20 minutes three times per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pumped technique for iliolumbar ligament release | Experimental | Not described Receives: Other: pumped technique for ilio-lumbar ligament release |
| Hot packs | Active comparator | postnatal women will be treated by hot packs for 20 minutes three times per week for 8 weeks. Receives: Other: Hot Packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS):
It will be used to assess the severity of low back pain in women from both groups A and B before and after treatment. The scoring ranges from 1, indicating the least pain and discomfort, to 10, representing the most severe pain and discomfort.
Measured: 8 weeks
Goniometer
It will be used to assess lumbar flexion range of motion for each woman in both groups A and B before and after treatment.
Measured: 8 weeks
Inclinometer
It will be used to assess lumbar curvature for each woman in both groups A and B before and after treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start1 Oct 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moataz Abdelaal Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785363
- Sponsor's protocol ID
- P.T.Rec/012/005571
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pumped Technique for Ilio-lumber Ligament Release on Postnatal Low Back Pain
- ClinicalTrials.gov ID
- NCT06785363
- Acronym / sponsor ID
- P.T.Rec/012/005571
- Conditions
- Low Back Pain
- Keywords
- low back pain, lumbar and sacroiliac pain, iliolumbar ligament disorder
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 21 Jan 2025 (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 iliolumbar ligament, one of the sacroiliac ligaments, has been identified in recent research as a contributor to low back pain when tight. During pregnancy, hormonal changes and postural changes can cause this ligament to tighten, leading to pain. Releasing the iliolumbar ligament can reduce low back pain and restore normal mechanical function.
Detailed description
Group A (Control group) It will be consisted of postnatal women and will be treated by hot packs for 20 minutes three times per week for 8 weeks.
Group B (study group) the participant will treated by hot packs for 20 min in additional to pumping technique for iliolumbar ligament release for 30 min. 3 times per week for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pumped technique for iliolumbar ligament release | Experimental | Other: pumped technique for ilio-lumbar ligament release |
| Hot packs | Active comparator | Other: Hot Packspostnatal women will be treated by hot packs for 20 minutes three times per week for 8 weeks. |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1- the women are delivery within 3 months. 3- Their BMI must be less than 30 Kg\m 2 . 4- Its included primipara or multipara. 5- Its included be normal vaginal labor delivery or caesarian section.
Key exclusion criteria (10 listed)
- Clinical diagnosis by Lumbar disc prolapse.
- Clinical diagnosis by Lumbar spondylolysis and spondlysis.
- Clinical diagnosis by back trauma or fracture.
- Clinical diagnosis by Lumbar canal stenosis.
- Clinical diagnosis by Rheumatoid arthritis.
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 |
|---|---|---|
| pumped technique for ilio-lumbar ligament releasePatient position: the patient lying supine or side lying Therapist position: standing on one side of patient. Hand grip: one hand placed on posterior region of iliac crest (close to attachment of ilio-lumbar ligament) while other hand stabilize the medial part of thigh. Therapist force: therapist pulling patient's thigh posteriorly. | Other | Pumped technique for iliolumbar ligament release |
| Hot Packspostnatal women will be treated by hot packs for 20 minutes three times per week for 8 weeks. | Other | Hot packs |
Primary outcome
Visual analog scale (VAS):
Time frame: 8 weeks
It will be used to assess the severity of low back pain in women from both groups A and B before and after treatment. The scoring ranges from 1, indicating the least pain and discomfort, to 10, representing the most severe pain and discomfort.
Goniometer
Time frame: 8 weeks
It will be used to assess lumbar flexion range of motion for each woman in both groups A and B before and after treatment.
Inclinometer
Time frame: 8 weeks
It will be used to assess lumbar curvature for each woman in both groups A and B before and after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pumped technique for ilio-lumbar ligament release and Hot Packs in people with 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 1 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 30 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual analog scale (VAS): (time frame: 8 weeks). The study lists 3 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 30 Jan 2025.