Back to resultsMobilization for Post Partum Low Back Pain
Primary Purpose
Low Back Pain, Mechanical
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mobilization (manual therapy)
Placebo mobilization
Ultrasound and infrared devices
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical focused on measuring Mechanical LBP, Mobilization, Postpartum
Eligibility Criteria
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
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
Mobilization (manual therapy)
placebo mobilization
Ultrasound and infrared therapy
Arm Description
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.
placebo mobilization applied without force application. The treatment duration for the three groups was 3 times/week for 4 weeks
ultrasound and infrared are a traditional treatment for low back painThe treatment duration for the three groups was 3 times/week for 4 weeks.
Outcomes
Primary Outcome Measures
Pain intensity
each case assessed two times pre- post intervention, intervention was lasted for 4 weeks
functional disability
each case assessed two times pre-post intervention, intervention lasted for 4 weeks
back muscle activity
each case assessed two time pre- post intervention, intervention lasted for 4 weeks
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02088463
Brief Title
Mobilization for Post Partum Low Back Pain
Official Title
Efficacy of Lumbar Mobilization on Postpartum Low Back Pain in Egyptian Females: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical
Keywords
Mechanical LBP, Mobilization, Postpartum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobilization (manual therapy)
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo mobilization
Arm Type
Placebo Comparator
Arm Description
placebo mobilization applied without force application. The treatment duration for the three groups was 3 times/week for 4 weeks
Arm Title
Ultrasound and infrared therapy
Arm Type
Other
Arm Description
ultrasound and infrared are a traditional treatment for low back painThe treatment duration for the three groups was 3 times/week for 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
mobilization (manual therapy)
Other Intervention Name(s)
PA mobilization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo mobilization
Other Intervention Name(s)
tactile stimulation
Intervention Description
placebo mobilization is a tactile stimulation at the same level L3 without application of any force.
Intervention Type
Device
Intervention Name(s)
Ultrasound and infrared devices
Other Intervention Name(s)
US & IR
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity
Description
each case assessed two times pre- post intervention, intervention was lasted for 4 weeks
Time Frame
after 4 weeks from starting the intervention
Title
functional disability
Description
each case assessed two times pre-post intervention, intervention lasted for 4 weeks
Time Frame
after 4 weeks from starting the intervention
Title
back muscle activity
Description
each case assessed two time pre- post intervention, intervention lasted for 4 weeks
Time Frame
after 4 weeks from starting the intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalia Shewitta, PhD
Organizational Affiliation
Assocciate Professor of Physical Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
State/Province
Giza
ZIP/Postal Code
12612
Country
Egypt
12. IPD Sharing Statement
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Mobilization for Post Partum Low Back Pain
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