- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02088463
Mobilization for Post Partum Low Back Pain
April 14, 2016 updated by: Dr. Dalia Mohamed Kame, Cairo University
Efficacy of Lumbar Mobilization on Postpartum Low Back Pain in Egyptian Females: A Randomized Control Trial
The study was conducted to the following purposes
- To investigate the effect of lumbar mobilization on muscle activity in postpartum mechanical low back pain.
- To investigate the effect of lumbar mobilization on pain intensity in postpartum mechanical low back pain patients.
- To investigate the effect lumbar mobilization on functional disability in postpartum mechanical low back pain patients.
- To compare between the effects of lumbar mobilization, tactile stimulation (placebo treatment) and traditional treatment in postpartum mechanical low back pain patients.
Study Overview
Status
Completed
Conditions
Detailed Description
all participants divided randomly into three groups, Group A (Study group) received PA lumbar mobilization plus traditional treatment which consisted of Ultrasonic and Infra-red.
Group B (Placebo group) received placebo mobilization plus traditional treatment.
Group C (Control group) received traditional treatment only
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Giza
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Cairo, Giza, Egypt, 12612
- Faculty of physical therapy
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Females with LBP lasting more than 3 months since their delivery
- their age range 25-35 years old with body mass index (BMI) less than 30kg/m2
Exclusion Criteria:
- medical conditions that don't allow the subject to lie prone comfortably as, cardiovascular disease, uncontrolled hypertension, abdominal hernia, severe respiratory diseases, as well as problems in the back e.g. previous low back surgery, spinal malignancy. In addition to known rheumatic joint disease, and upper or lower motor neuron lesion that affects lower limbs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobilization (manual therapy)
Mobilization (manual therapy) posterior- anterior at the L3 for 2 minutes in addition to the traditional treatment in the form of infra-red and ultrasound.
The treatment duration for the three groups was 3 times/week for 4 weeks.
|
mobilization is one of the manual therapy or treatments with the application of a gentle oscillatory passive movement to the spinal region specifically at the level of L3 in this study at the posterio-anterior direction.
Other Names:
ultrasound and infrared are the traditional treatment for low back pain , they are electrical modalities used in the field of physiotherapy to decrease the inflammation and the pain in musculoskeletal systems
Other Names:
|
Placebo Comparator: placebo mobilization
placebo mobilization applied without force application.
The treatment duration for the three groups was 3 times/week for 4 weeks
|
ultrasound and infrared are the traditional treatment for low back pain , they are electrical modalities used in the field of physiotherapy to decrease the inflammation and the pain in musculoskeletal systems
Other Names:
placebo mobilization is a tactile stimulation at the same level L3 without application of any force.
Other Names:
|
Other: Ultrasound and infrared therapy
ultrasound and infrared are a traditional treatment for low back painThe treatment duration for the three groups was 3 times/week for 4 weeks.
|
ultrasound and infrared are the traditional treatment for low back pain , they are electrical modalities used in the field of physiotherapy to decrease the inflammation and the pain in musculoskeletal systems
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: after 4 weeks from starting the intervention
|
each case assessed two times pre- post intervention, intervention was lasted for 4 weeks
|
after 4 weeks from starting the intervention
|
functional disability
Time Frame: after 4 weeks from starting the intervention
|
each case assessed two times pre-post intervention, intervention lasted for 4 weeks
|
after 4 weeks from starting the intervention
|
back muscle activity
Time Frame: after 4 weeks from starting the intervention
|
each case assessed two time pre- post intervention, intervention lasted for 4 weeks
|
after 4 weeks from starting the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dalia Shewitta, PhD, Assocciate Professor of Physical Therapy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
March 5, 2014
First Submitted That Met QC Criteria
March 14, 2014
First Posted (Estimate)
March 17, 2014
Study Record Updates
Last Update Posted (Estimate)
April 15, 2016
Last Update Submitted That Met QC Criteria
April 14, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/00368
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.
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