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Mobilization for Post Partum Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088463
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Dalia Mohamed Kame, Cairo University

Brief Summary:

The study was conducted to the following purposes

  1. To investigate the effect of lumbar mobilization on muscle activity in postpartum mechanical low back pain.
  2. To investigate the effect of lumbar mobilization on pain intensity in postpartum mechanical low back pain patients.
  3. To investigate the effect lumbar mobilization on functional disability in postpartum mechanical low back pain patients.
  4. To compare between the effects of lumbar mobilization, tactile stimulation (placebo treatment) and traditional treatment in postpartum mechanical low back pain patients.

Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Procedure: mobilization (manual therapy) Procedure: Placebo mobilization Device: Ultrasound and infrared devices Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Lumbar Mobilization on Postpartum Low Back Pain in Egyptian Females: A Randomized Control Trial
Study Start Date : December 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


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.
Procedure: mobilization (manual therapy)
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 Name: PA mobilization

Device: Ultrasound and infrared devices
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 Name: US & IR

Placebo Comparator: placebo mobilization
placebo mobilization applied without force application. The treatment duration for the three groups was 3 times/week for 4 weeks
Procedure: Placebo mobilization
placebo mobilization is a tactile stimulation at the same level L3 without application of any force.
Other Name: tactile stimulation

Device: Ultrasound and infrared devices
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 Name: US & IR

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.
Device: Ultrasound and infrared devices
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 Name: US & IR




Primary Outcome Measures :
  1. 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

  2. functional disability [ Time Frame: after 4 weeks from starting the intervention ]
    each case assessed two times pre-post intervention, intervention lasted for 4 weeks

  3. 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



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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088463


Locations
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Egypt
Faculty of Physical Therapy
Cairo, Giza, Egypt, 12612
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Dalia Shewitta, PhD Assocciate Professor of Physical Therapy
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Responsible Party: Dr. Dalia Mohamed Kame, Associate Professor of Physical Therapy, Cairo University
ClinicalTrials.gov Identifier: NCT02088463    
Other Study ID Numbers: P.T.REC/012/00368
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Keywords provided by Dr. Dalia Mohamed Kame, Cairo University:
Mechanical LBP
Mobilization
Postpartum
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations