Mobilization for Post Partum Low Back Pain

Low Back Pain, Mechanical Clinical Trial

Official title:

Efficacy of Lumbar Mobilization on Postpartum Low Back Pain in Egyptian Females: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088463
• Other study ID #: P.T.REC/012/00368
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: April 14, 2016
• Start date: December 2012
• Est. completion date: October 2013

Study information

• Verified date: April 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

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.
• Placebo mobilization
placebo mobilization is a tactile stimulation at the same level L3 without application of any force.

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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	each case assessed two times pre- post intervention, intervention was lasted for 4 weeks	after 4 weeks from starting the intervention	Yes
Primary	functional disability	each case assessed two times pre-post intervention, intervention lasted for 4 weeks	after 4 weeks from starting the intervention	Yes
Primary	back muscle activity	each case assessed two time pre- post intervention, intervention lasted for 4 weeks	after 4 weeks from starting the intervention	Yes