NCT02088463

Brief Summary

The study was conducted to the following purposes

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

March 5, 2014

Last Update Submit

April 14, 2016

Conditions

Low Back Pain, Mechanical

Keywords

Mechanical LBPMobilizationPostpartum

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    each case assessed two times pre- post intervention, intervention was lasted for 4 weeks

    after 4 weeks from starting the intervention

  • functional disability

    each case assessed two times pre-post intervention, intervention lasted for 4 weeks

    after 4 weeks from starting the intervention

  • back muscle activity

    each case assessed two time pre- post intervention, intervention lasted for 4 weeks

    after 4 weeks from starting the intervention

Study Arms (3)

Mobilization (manual therapy)

EXPERIMENTAL

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)Device: Ultrasound and infrared devices

placebo mobilization

PLACEBO COMPARATOR

placebo mobilization applied without force application. The treatment duration for the three groups was 3 times/week for 4 weeks

Procedure: Placebo mobilizationDevice: Ultrasound and infrared devices

Ultrasound and infrared therapy

OTHER

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

Interventions

mobilization (manual therapy)PROCEDURE

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.

Also known as: PA mobilization
Mobilization (manual therapy)
Placebo mobilizationPROCEDURE

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

Also known as: tactile stimulation
placebo mobilization
Ultrasound and infrared devicesDEVICE

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

Also known as: US & IR
Mobilization (manual therapy)Ultrasound and infrared therapyplacebo mobilization

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, Giza Governorate, 12612, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal ManipulationsUltrasonography

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Dalia Shewitta, PhD

    Assocciate Professor of Physical Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 17, 2014

Study Start

December 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

EG(1)