- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06907394
Osteopathic Manipulations of Post Cesarean Section Adhesions on Low Back Pain
Effect of Osteopathic Manipulations of Post Cesarean Section Adhesions on Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Qalubyia
-
Al Maţmar, Qalubyia, Egypt, 35611
- Mitghamer Hospital, Mitghamer city, Qalyubia Governate
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control Group
Fifteen Females will receive only analgesic drugs for four weeks.
|
Paracetamol tablets
|
|
Experimental: Study Group
Fifteen females will receive osteopathic manipulations once weekly along four weeks, plus analgesic drugs for four weeks.
|
Paracetamol tablets
Osteopathic Manipulations (a.
Myofascial release technique: Direct scar release+ Indirect scar release 'Fascial unwinding'; b.
Grand Maneuver; Visceral manipulations of uterus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Pre-treatment, and Post-treatment of the the study treatment program afetr 4-weeks).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Low Back Disability Questionnaire
Time Frame: Pre-treatment, and Post-treatment of the the study treatment program after 4-weeks).
|
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.
|
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).
|
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.
|
Pre-treatment, and Post-treatment of the the study treatment program after4-weeks).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Khadija S Abdulaziz, PHD, Professor of Physical Therapy for Woman's Health
- Study Director: Mohamed A Abo Elainin, PHD, Consultant of Obstetrics and Gynecology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Istanbul UniversityIstinye UniversityCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, PosturalTurkey
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
General Incorporated Foundation Ryukyuseimeisaiseikai...CompletedChronic Low Back Pain | Non-specific Low Back Pain | Low Back Pain (LBP)Japan
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Pamukkale UniversityCompletedLow Back Disorder | Low Back Pain (LBP)Turkey
-
MMJ Labs LLCNational Institute on Drug Abuse (NIDA); Sport and Spine Rehab Clinical Research...CompletedChronic Low-back Pain | Pain, Intractable | Acute Low-back PainUnited States
Clinical Trials on Control Group
-
Tasly Pharmaceutical Group Co., LtdCompleted
-
Chengdu Sport UniversityNot yet recruiting
-
Hanlim Pharm. Co., Ltd.Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
International University of La RiojaCompletedPsychosis | Therapy | PsychologicalSpain
-
The First Affiliated Hospital of Zhejiang Chinese...Not yet recruitingAdolescent Idiopathic ScoliosisChina
-
The University of Hong Konghong Kong Cancer FundCompletedBreast Cancer | Yoga Therapy | Shoulder Joint Motion | Scar Contracture
-
Romanian Society of Anesthesia and Intensive CareUniversity of Medicine and Pharmacy "Victor Babes" Timisoara; Timişoara County...Completed
-
Helse Stavanger HFUniversity of Oslo; Oslo University Hospital; University College, London; Aalborg... and other collaboratorsNot yet recruitingPTSD | Personality Disorder, Borderline | Personality Disorder | Personality Trait | PTSD - Post Traumatic Stress Disorder | Personality Type | PTSD and Trauma-related Symptoms | Personality Disorder, Avoidant | Affect Consciousness | Mentalization | Reflective FunctioningNorway