Muscle Energy Technique and Stretching Exercise in Working Pregnant Women With Piriformis Syndrome
Primary Purpose
Piriformis Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
muscle energy technique
stretching exercise
Sponsored by
About this trial
This is an interventional treatment trial for Piriformis Syndrome focused on measuring muscle energy technique,stretching exercise, pain rom
Eligibility Criteria
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
Sites / Locations
- Lady WillingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
muscle energy technique
stretching exercise
Arm Description
muscle energy technique
stretching exercises along with piriformis stretch
Outcomes
Primary Outcome Measures
Numeric pain rating scale
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)
Secondary Outcome Measures
Measurements of pain Intensity
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
Full Information
NCT ID
NCT05915858
First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05915858
Brief Title
Muscle Energy Technique and Stretching Exercise in Working Pregnant Women With Piriformis Syndrome
Official Title
Effects of Muscle Energy Technique and Stretching Exercise on Pain, Hip Joint Range of Motion and Function in Working Pregnant Women With Piriformis Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
August 20, 2023 (Anticipated)
Study Completion Date
August 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Syndrome
Keywords
muscle energy technique,stretching exercise, pain rom
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
muscle energy technique
Arm Type
Experimental
Arm Description
muscle energy technique
Arm Title
stretching exercise
Arm Type
Active Comparator
Arm Description
stretching exercises along with piriformis stretch
Intervention Type
Other
Intervention Name(s)
muscle energy technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
stretching exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
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)
Time Frame
6months
Secondary Outcome Measure Information:
Title
Measurements of pain Intensity
Description
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
Time Frame
6months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female 25-45age
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hafiza neelam, MS
Phone
03204097476
Email
hafiza.neelam@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Shfaq Naeem, MS*
Phone
03249567535
Email
shafaqshazib@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Neelam, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lady Willington
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54660
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shafaq Naaeem, ms-whpt
Phone
03249567534
Email
shafaqshazib@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Muscle Energy Technique and Stretching Exercise in Working Pregnant Women With Piriformis Syndrome
We'll reach out to this number within 24 hrs