Effects of Muscle Energy Techniques Versus Core Stability Exercises in Pelvic Girdle Pain

March 15, 2023 updated by: Riphah International University
PGP is referred to as a specific form of LBP which occurs isolatedly as well as in combination with lumbar back pain. PGP localized to the anterior or posterior pelvis, most commonly located between the posterior iliac crest and gluteal folds especially around the SI joint. Pelvic girdle pain radiated to the posterior thigh

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

Pelvic girdle pain (PGP) is known to be a musculoskeletal disorders which affects the pelvic bone. PGP is referred to as a specific form of LBP which occurs isolatedly as well as in combination with lumbar back pain. PGP localized to the anterior or posterior pelvis, most commonly located between the posterior iliac crest and gluteal folds especially around the SI joint. Pelvic girdle pain radiated to the posterior thigh. Moreover, it can also cause pain in the symphysis (1). Compared to lower back pain, PGP is substantially more painful and linked with functional limitations as standing, walking, sitting and changing positions are less tolerable in such patients (2). PGP is musculoskeletal in nature and is not caused by gynecological or urological conditions (3). Despite the fact that the cause of PGP is unknown, it is considered that it occurs due to many reasons such as trauma, arthritis, anatomical fault or it can be associated with pregnancy (4

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.
57

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 05499
        • Ghurki Trust Teaching Hospital.

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

All

Description

Inclusion Criteria:

  • Females of 25 to 40 years were included in this study.(20)
  • Female patients who gave birth at least 6 months before.(20)
  • Females who gave birth through vaginal delivery.(20)
  • Females with at least three positive pain provocative tests such as posterior pelvic pain provocation test (P4), active straight leg raise test (ASLR), thigh thrust, Patrick's Faber test, Gaenslen's test and distraction test.(20)
  • History of pain around the pelvic girdle, lower back or between the posterior iliac crest and the gluteal fold, difficulty in walking and/or pain when putting weight on one leg

Exclusion Criteria:

  • Females who suffered from grade 3 or 4 vaginal tears during their pregnancy (20)
  • Females who underwent episiotomy during delivery (20)
  • Females who delivered through caesarean section (20)
  • Postpartum females with a history of trauma to the pelvic region (20)
  • Postpartum females with a history of pelvic surgery
  • Postpartum females with a history of other orthopedic disorders

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: Parallel Assignment
  • Masking: None (Open Label)

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: Group A
Group A: 20 patients were included in this group. This studygroup was assigned with basic treatment protocol with 15 minutes of TENS and thermal therapy for 10 minutes followed by muscle energy technique (Post facilitation stretching exercises). The intervention was given three days per weekfor six weeks. Each total session lasted for 45minutes. METs were applied for the weakened muscles.
Other: Muscle energy techniques
Group A: 20 patients were included in this group. This studygroup was assigned with basic treatment protocol with 15 minutes of TENS and thermal therapy for 10 minutes followed by muscle energy technique (Post facilitation stretching exercises). The intervention was given three days per weekfor six weeks. Each total session lasted for 45minutes. METs were applied for the weakened muscles. (21). Group B: 20 Patients of this group were given core stability exercises by the female physical therapist in three different levels. Each level continued for a duration of two weeks in which the patients were trained for the exercises. The patients were provided sessions thrice per week with 2 sets of 10 repetitions and a hold of 10 second after TENS for 15 minutes and thermal therapy for 10 minutes
Other Names:
  • core stability exercises
Active Comparator: Group B
Group B: 20 Patients of this group were given core stability exercises by the female physical therapist in three different levels. Each level continued for a duration of two weeks in which the patients were trained for the exercises. The patients were provided sessions thrice per week with 2 sets of 10 repetitions and a hold of 10 second after TENS for 15 minutes and thermal therapy for 10 minutes.
Other: Muscle energy techniques
Group A: 20 patients were included in this group. This studygroup was assigned with basic treatment protocol with 15 minutes of TENS and thermal therapy for 10 minutes followed by muscle energy technique (Post facilitation stretching exercises). The intervention was given three days per weekfor six weeks. Each total session lasted for 45minutes. METs were applied for the weakened muscles. (21). Group B: 20 Patients of this group were given core stability exercises by the female physical therapist in three different levels. Each level continued for a duration of two weeks in which the patients were trained for the exercises. The patients were provided sessions thrice per week with 2 sets of 10 repetitions and a hold of 10 second after TENS for 15 minutes and thermal therapy for 10 minutes
Other Names:
  • core stability exercises

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
VISUAL ANALOGUE SCALE
Time Frame: 12 weeks
Visual Analogue scale is a numeric scale ranging from 1 to 10. These ranges show the intensity of pain where 1 shows no pain and 10 shows worst pain imaginations. It is a very reliable and valid tool with test-retest reliability of r = 0.96 and validity correlations of 0.86 to 0.95.
12 weeks
OSWESTRY DISABILITY INDEX
Time Frame: 12 weeks
Oswestry Disability Index was calculated in order to find out the disability among patients. ODI evaluates disability related to Activities of Daily Living. This is considered to be the best tool for evaluating low back issues. It encompasses 10 questions with each question scoring five. Questions related to pain, personal care, walking, standing, lifting, sitting, sex life, sleeping, social life and travelling are included. The interpretation shows minimal disability if the patient score is 0-20%, moderate disability if the score is 20-40%, 40 - 60% severe disability, 60 - 80% crippled and 80 - 100 % depicting that the patient is either bed bound or overly expressing the symptoms
12 weeks
SF - 36
Time Frame: 12 weeks
This questionnaire is used to assess the functional performance in different domains of life like physical, body pain, mental, social and psychological. The questionnaire encompasses questions based on 7 domains of life. The minimum score of SF-36 is 0 which means that the functional performance is worst whereas the highest score is 100 which means that functional performance is best
12 weeks

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.
Riphah International 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: Sobia Kanwal, tDpt, Riphah IU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
February 2, 2022

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.
December 30, 2022

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.
December 30, 2022

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 15, 2023

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 15, 2023

First Posted (Actual)

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 28, 2023

Study Record Updates

Last Update Posted (Actual)

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.
March 28, 2023

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.
March 15, 2023

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.
March 1, 2023

More Information

Terms related to this study

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.
  • REC/RCR & AHS/22/0546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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