Muscle Energy Technique and Stretching Exercise in Working Pregnant Women With Piriformis Syndrome

June 14, 2023 updated by: Riphah International University

Effects of Muscle Energy Technique and Stretching Exercise on Pain, Hip Joint Range of Motion and Function in Working Pregnant Women With Piriformis Syndrome

Piriformis syndrome is a neuro muscular disorder which occur due to the compression and irritation of the sciatic nerve by the piriformis muscle causing pain, tingling, and numbness in the buttocks and along the sciatic nerve. Muscle energy technique is one of manual technique in which the muscle uses its own energy in the form of isometric contraction to relax the muscle by the autogenic inhibition of reciprocal inhibition. Reciprocal inhibition in muscle energy technique was succeeded in relieving pain and improves flexibility.

Study Overview

Status

Status

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

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

Piriformis syndrome is a neuro muscular disorder which occur due to the compression and irritation of the sciatic nerve by the piriformis muscle causing pain, tingling, and numbness in the buttocks and along the sciatic nerve. Muscle energy technique is one of manual technique in which the muscle uses its own energy in the form of isometric contraction to relax the muscle by the autogenic inhibition of reciprocal inhibition. Reciprocal inhibition in muscle energy technique was succeeded in relieving pain and improves flexibility. Stretching exercises improves physical performance ability, prevents injury, reduces muscle pain and increases flexibility. Both muscle energy technique and stretching has shown significant improvement in reducing pain and lower extremity function and increase range of motion.

Randomized clinical trial will be conducted. Sample size of 30 patients will be taken. Non probability convenient sampling will be used.A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups, to either the muscle energy technique group or stretching exercises group.Treatment will be given twice a week for twelve treatment session..Numeric pain rating scale will be used to measure the intensity of pain,Lower extremity functional scale will be used to access lower extremity function. Standard goniometer is used to measure hip joint range of motion.All participants in both groups will be evaluated before and after treatment programme.Total duration of study will be six months.Data will be analyzed by using SPSS 25. Key words Muscle energy technique,Stretching exercises,Piriformis syndrome,Pain,Range of motion

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 (Estimated)

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.
30

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54660
        • Recruiting
        • Lady Willington
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 25-45 years .
  • Tenderness of piriformis muscle.
  • Chronic non-specific low back pain patients.
  • Women in second trimester of pregnancy
  • Multiparous women
  • SLR positive below 60 degrees .
  • VAS score: 6-10
  • Internal rotation of hip less than 45 degrees.

Exclusion Criteria:

  • SLR negative test
  • Skin allergy
  • Pre-eclampsia
  • Gestational diabetes mellitus
  • Clinical diagnosis of osteoarthritis or history of fracture of lower extremities

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: Double

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: muscle energy technique
Other: muscle energy technique

Group 1: Group 2:

Muscle energy technique (Reciprocal inhibition) Stretching exercises Static stretching 2 weeks (twelve treatment session) patient supine, the treated leg is placed into flexion at the hip and knee, so that the foot rests on the table lateral to the contra-lateral knee (the leg on the side to be treated is crossed over the other, straight leg).

  • The angle of hip flexion should not exceed 60 degree.
  • The practitioner places one hand on the contra-lateral ASIS to prevent pelvis motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis for 7-10 seconds.
Active Comparator: stretching exercise
stretching exercises along with piriformis stretch
Other: stretching exercise

Following the contraction the practitioner eases the treated side leg into adduction until a sense of resistance is noted; this is held for 10-30 seconds. 2 week (twelve treatment session) practitioner manual stretches the piriformis:

  • The patient lies in supine position the affected leg is placed into flexion at hip and knee so that the foot rests on the table lateral to the contra-lateral knee.
  • The practitioner places one hand over the contra-lateral ASIS to stabilize the pelvis during the exercise and passively abducts and internally rotates the hip medially till the pain is bearable.
  • The process is repeated 3-5 times with a 30

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
Numeric pain rating scale
Time Frame: 6months
Measurement of pain intensity was done by using numeric pain rating scale.it is reliable and valid.subjects were explained about the scale and instructed to indicate the intensity of current,best and worst pain on a scale of zero(no pain) to ten(worst pain)
6months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurements of pain Intensity
Time Frame: 6months

measurement were taking at pre intervention and post intervention after the end of second week intervention.(10) Lower extremity functional scale Lower extremity functional scale is a questionnaire containing twenty question about persons ability to perform everyday task.The LEFS can be used by clinician as a measure of patients initial function,ongoing progress and out come as well as to set functional goals.

The LEFS has maximum scores of 80 points where lower the score greater disability
6months

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: Hafiza Neelam, MS, Riphah International University

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, 2023

Primary Completion (Estimated)

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.
August 20, 2023

Study Completion (Estimated)

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.
August 20, 2023

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).
June 14, 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.
June 14, 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.
June 23, 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.
June 23, 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.
June 14, 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.
June 1, 2023

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.
  • REC/RCR&AHS/23/0518

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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