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

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 12612
        • Faculty of Physical Therapy

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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
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 Names:
  • US & IR
Procedure: Placebo mobilization
placebo mobilization is a tactile stimulation at the same level L3 without application of any force.
Other Names:
  • tactile stimulation
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.
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 Names:
  • US & IR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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