Low Back PainNCT06907394
Osteopathic Manipulations of Post Cesarean Section Adhesions on Low Back Pain
A study testing Osteopathic Manipulations in people with Low Back Pain and Cesarean Section Complications, run by Cairo University at 1 site in Egypt.
Trial summary
Chronic low back pain post cesarean section adhesions represents a restricting dysfunction, mainly influences abdominal fascia that leads to major welfare and economic restrictions. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Low Back Pain, Cesarean Section Complications
- What is being tested?
- Osteopathic Manipulations
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Apr 2026
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- They suffered from low back pain and undergoes cesarean section at least 6 months before entry into study.
- Their body mass index (BMI) will be ≤ 25 kg /m2.
- Their age will range from 20 to 35 years.
- They would not use any other analgesic drugs during the study period.
Who cannot join
- Pregnancy or suspected pregnancy.
- Recent abdominal surgery
- Patients with severe spinal pathology (cauda equine syndrome, spinal canal stenosis, fracture of spine, discitis, infectious disease of spine).
- Cancer.
- Abdominal and pelvic infection, open wound, burn and skin irritation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mitghamer Hospital, Mitghamer city, Qalyubia Governate
Al Maţmar, Qalubyia, 35611
About this study
Official title: Effect of Osteopathic Manipulations of Post Cesarean Section Adhesions on Low Back Pain
Chronic low back pain post cesarean section adhesions represents a restricting dysfunction, mainly influences abdominal fascia that leads to major welfare and economic restrictions. Osteopathic manipulation is a drug-free non-invasive is the therapeutic application of manually guided forces to improve physiologic function and support homeostasis. The purpose of the current study is to determine the effect of osteopathic manipulations of post cesarean section adhesions on low back pain
Read the detailed description
Chronic low back pain is a common musculoskeletal disorder affects adults with 84% prevalence. It influences lower back, and lasts at least 12 weeks. Where increased annual cesarean section rates up to 19.1% associated with scar, pelvic, abdominal and low back pain disorders. From the fascial point of view, abdominal muscles are in continuity with the thoracolumbar fascia and the pelvic floor. It has been demonstrated that they work with great synergy and guaranteed by fascial continuity .
Osteopathic manipulative technique consists of a range of direct, indirect, combined, fluid and reflex-based manual techniques that are applied specifically to a joint or non-specifically to a body area. Direct techniques apply thrust, impulse, muscle contraction, fascial loading or passive range of motion .The purpose of the current study is to determine the effect of osteopathic manipulations of post cesarean section adhesions on low back pain. Up on that 30 post cesarean women suffering from low back pain at least for 6 months from the Outpatient Clinic of Mitghamer Hospital, El-Daqahlia. Their age range 20-35 years old, BMI range≤ 25 kg /m2. They will be allocated into control group will receive analgesics. Study group will receive four weeks of analgesics, plus osteopathic manipulations once per week.
- Conditions
- Low Back Pain, Cesarean Section Complications
- Being tested
- Osteopathic Manipulations, Control Group
- Keywords
- Osteopathic Manipulation, Low Back Pain, Post Cesarean Section Adhesions, Visual Analogue Scale, Oswestry Low Back Disability Questionnaire, Modified Schober Test
- 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.
Osteopathic ManipulationsOther
Osteopathic Manipulations (a. Myofascial release technique: Direct scar release+ Indirect scar release 'Fascial unwinding'; b. Grand Maneuver; Visceral manipulations of uterus
Control GroupOther
Paracetamol tablets
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Fifteen Females will receive only analgesic drugs for four weeks. Receives: Other: Control Group |
| Study Group | Experimental | Fifteen females will receive osteopathic manipulations once weekly along four weeks, plus analgesic drugs for four weeks. Receives: Other: Osteopathic Manipulations; Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
a self-reported pain measurement a widely utilized scale in rehabilitation. It has been shown to be valid and reliable, and its ratio scale properties make VAS the optional tool for describing pain intensity
Measured: Pre-treatment, and Post-treatment of the the study treatment program afetr 4-weeks).
Secondary outcomes (2)
Oswestry Low Back Disability Questionnaire
An extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. It consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability). Each question is scored from 0-5 (minimum to maximum).The point total from each section is summed and the then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability.
Measured: Pre-treatment, and Post-treatment of the the study treatment program after 4-weeks).
Modified Schober Test
The Modified Schober test is designed to measure the range of lumbar flexion in patients. The positive Schober test result is when the distance between the two lines does not increase by at least 5cm when the person bends forward. The normative values were found to be 6.85 ±1.18 cm for flexion, and 2.42±0.74 cm for extension.
Measured: Pre-treatment, and Post-treatment of the the study treatment program after4-weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
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
- Model description
- Randomized, Pre/Posttreatment, Controlled Trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Helmy Mohamed Faiyad, Cairo University
- Investigators
- Khadija S Abdulaziz, PHD, Study chair, Professor of Physical Therapy for Woman's HealthMohamed A Abo Elainin, PHD, Study director, Consultant of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907394
- Sponsor's protocol ID
- P.T.REC/012/003148
- Status last verified
- May 2026
- First submitted
- 26 Mar 2025
- Last updated
- 28 May 2026
- 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Manipulations of Post Cesarean Section Adhesions on Low Back Pain
- ClinicalTrials.gov ID
- NCT06907394
- Acronym / sponsor ID
- P.T.REC/012/003148
- Conditions
- Low Back Pain, Cesarean Section Complications
- Keywords
- Osteopathic Manipulation, Low Back Pain, Post Cesarean Section Adhesions, Visual Analogue Scale, Oswestry Low Back Disability Questionnaire, Modified Schober Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 2 Apr 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.
Chronic low back pain post cesarean section adhesions represents a restricting dysfunction, mainly influences abdominal fascia that leads to major welfare and economic restrictions. Osteopathic manipulation is a drug-free non-invasive is the therapeutic application of manually guided forces to improve physiologic function and support homeostasis. The purpose of the current study is to determine the effect of osteopathic manipulations of post cesarean section adhesions on low back pain
Detailed description
Chronic low back pain is a common musculoskeletal disorder affects adults with 84% prevalence. It influences lower back, and lasts at least 12 weeks. Where increased annual cesarean section rates up to 19.1% associated with scar, pelvic, abdominal and low back pain disorders. From the fascial point of view, abdominal muscles are in continuity with the thoracolumbar fascia and the pelvic floor. It has been demonstrated that they work with great synergy and guaranteed by fascial continuity .
Osteopathic manipulative technique consists of a range of direct, indirect, combined, fluid and reflex-based manual techniques that are applied specifically to a joint or non-specifically to a body area. Direct techniques apply thrust, impulse, muscle contraction, fascial loading or passive range of motion .The purpose of the current study is to determine the effect of osteopathic manipulations of post cesarean section adhesions on low back pain. Up on that 30 post cesarean women suffering from low back pain at least for 6 months from the Outpatient Clinic of Mitghamer Hospital, El-Daqahlia. Their age range 20-35 years old, BMI range≤ 25 kg /m2. They will be allocated into control group will receive analgesics. Study group will receive four weeks of analgesics, plus osteopathic manipulations once per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Pre/Posttreatment, Controlled Trial.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Control GroupFifteen Females will receive only analgesic drugs for four weeks. |
| Study Group | Experimental | Other: Osteopathic Manipulations, Other: Control GroupFifteen females will receive osteopathic manipulations once weekly along four weeks, plus analgesic drugs for four weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- They suffered from low back pain and undergoes cesarean section at least 6 months before entry into study.
- Their body mass index (BMI) will be ≤ 25 kg /m2.
- Their age will range from 20 to 35 years.
- They would not use any other analgesic drugs during the study period.
Key exclusion criteria (5 listed)
- Pregnancy or suspected pregnancy.
- Recent abdominal surgery
- Patients with severe spinal pathology (cauda equine syndrome, spinal canal stenosis, fracture of spine, discitis, infectious disease of spine).
- Cancer.
- Abdominal and pelvic infection, open wound, burn and skin irritation.
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 |
|---|---|---|
| Osteopathic ManipulationsOsteopathic Manipulations (a. Myofascial release technique: Direct scar release+ Indirect scar release 'Fascial unwinding'; b. Grand Maneuver; Visceral manipulations of uterus | Other | Study Group |
| Control GroupParacetamol tablets | Other | Control Group, Study Group |
Primary outcome
Visual analogue scale
Time frame: Pre-treatment, and Post-treatment of the the study treatment program afetr 4-weeks).
a self-reported pain measurement a widely utilized scale in rehabilitation. It has been shown to be valid and reliable, and its ratio scale properties make VAS the optional tool for describing pain intensity
2 secondary outcomes
Oswestry Low Back Disability Questionnaire
Time frame: Pre-treatment, and Post-treatment of the the study treatment program after 4-weeks).
Modified Schober Test
Time frame: Pre-treatment, and Post-treatment of the the study treatment program after4-weeks).
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 28 May 2026.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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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
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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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. This study is not recruiting at the moment.
Khadija S Abdulaziz, PHD study chair
Professor of Physical Therapy for Woman's Health
Mohamed A Abo Elainin, PHD study director
Consultant of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulations in people with Low Back Pain and Cesarean Section Complications, 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 4 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: finished, as of the sponsor's last update on 28 May 2026. 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. Some participants in this study may receive a placebo. 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?
Visual analogue scale (time frame: Pre-treatment, and Post-treatment of the the study treatment program afetr 4-weeks).). 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 28 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.