NCT05088837

Brief Summary

Sacroiliac pain is a huge problem in women during pregnancy and postpartum period. Muscle energy technique has potential effect in decreasing the pain and disability

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

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

February 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

October 8, 2021

Last Update Submit

October 19, 2021

Conditions

Keywords

Muscle energy techniquesacroiliac dysfunctionice and heat pack

Outcome Measures

Primary Outcomes (1)

  • visual analog scale Visual anlage scale

    It was used for determining pain intensity before and after the treatment course for each patients in both groups (A\&B). Visual analogue scale is a-10 centimeters line, at one end was written (no pain = zero) and at the other end was written (worst pain the patient ever felt = 10)

    4 weeks

Secondary Outcomes (1)

  • Oswestry disability index

    4 weeks

Study Arms (2)

muscle energy technique

EXPERIMENTAL

muscle energy technique was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles, it was done 3 times per session for 12 sessions.

Other: muscle energy technique

ice and heat packs

EXPERIMENTAL

Alternating ice and heat (20 min , 10 heat,10 cold),3times per week for 12sessions.

Other: ice and heat packs

Interventions

MET was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles. the limb was taken very slightly beyond the restriction barrier and was held there for 10-30 seconds, it was done 3 times per session for 12 sessions.

muscle energy technique

Applying 20 minutes: 10 minutes hot,10 minutes cold on sacroiliac area, 3 times per week for 12 sessions

ice and heat packs

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages ranged from 20 to 40 years .
  • Their BMI was ranged from 25-30 kg / m2

You may not qualify if:

  • hip fracture,
  • SIJ infection.
  • scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghada Ebrahim Elrefaye

Giza, 12613, Egypt

Location

MeSH Terms

Interventions

Ice

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsEnvironmentEcological and Environmental PhenomenaBiological PhenomenaWeatherMeteorological ConceptsEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An independent individual randomly appointed to all participants to either group (A) (n=20) or group (B) (n=20) by numbers that were picked from the closed envelopes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week. Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Study Record Dates

First Submitted

October 8, 2021

First Posted

October 22, 2021

Study Start

February 1, 2020

Primary Completion

June 30, 2020

Study Completion

July 30, 2020

Last Updated

October 22, 2021

Record last verified: 2021-10

Locations