- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05787158
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
57
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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:
|
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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
- Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.
- Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.
- Teymuri Z, Hosseinifar M, Sirousi M. The Effect of Stabilization Exercises on Pain, Disability, and Pelvic Floor Muscle Function in Postpartum Lumbopelvic Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Dec;97(12):885-891. doi: 10.1097/PHM.0000000000000993.
- Almousa S, Lamprianidou E, Kitsoulis G. The effectiveness of stabilising exercises in pelvic girdle pain during pregnancy and after delivery: A systematic review. Physiother Res Int. 2018 Jan;23(1). doi: 10.1002/pri.1699. Epub 2017 Nov 8.
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)
February 2, 2022
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
March 15, 2023
First Submitted That Met QC Criteria
March 15, 2023
First Posted (Actual)
March 28, 2023
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 15, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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