Back to resultsEffects of Muscle Energy Techniques Versus Core Stability Exercises in Pelvic Girdle Pain
Primary Purpose
Pelvic Girdle Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Muscle energy techniques
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Girdle Pain
Eligibility Criteria
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
Sites / Locations
- Ghurki Trust Teaching Hospital.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
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 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.
Outcomes
Primary Outcome Measures
VISUAL ANALOGUE SCALE
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.
OSWESTRY DISABILITY INDEX
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
SF - 36
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05787158
First Posted
March 15, 2023
Last Updated
March 15, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05787158
Brief Title
Effects of Muscle Energy Techniques Versus Core Stability Exercises in Pelvic Girdle Pain
Official Title
Effects of Muscle Energy Techniques Versus Core Stability Exercises in Pelvic Girdle Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
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
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Muscle energy techniques
Other Intervention Name(s)
core stability exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
VISUAL ANALOGUE SCALE
Description
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.
Time Frame
12 weeks
Title
OSWESTRY DISABILITY INDEX
Description
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
Time Frame
12 weeks
Title
SF - 36
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sobia Kanwal, tDpt
Organizational Affiliation
Riphah IU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghurki Trust Teaching Hospital.
City
Lahore
State/Province
Punjab
ZIP/Postal Code
05499
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30839304
Citation
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.
Results Reference
background
PubMed Identifier
30282349
Citation
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.
Results Reference
background
PubMed Identifier
29979205
Citation
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.
Results Reference
background
PubMed Identifier
29115735
Citation
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.
Results Reference
background
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Effects of Muscle Energy Techniques Versus Core Stability Exercises in Pelvic Girdle Pain
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