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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05787158
Other study ID # REC/RCR & AHS/22/0546
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2022
Est. completion date December 30, 2022

Study information

Verified date March 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 25 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Ghurki Trust Teaching Hospital. Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks
Primary 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 12 weeks
Primary 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 12 weeks
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