Mobilization for Post Partum Low Back Pain

• ClinicalTrials.gov Identifier: NCT02088463
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Last Update Posted: April 15, 2016
• Sponsor: Cairo University
• Information provided by (Responsible Party): Dr. Dalia Mohamed Kame, Cairo University

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Egypt

Faculty of Physical Therapy

Cairo, Giza, Egypt, 12612

Sponsors and Collaborators

Cairo University

Investigators

• Principal Investigator: Dalia Shewitta, PhD; Assocciate Professor of Physical Therapy

More Information

• 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
• 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:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations