Clinical trial NCT06340126: Effects of Active Tissue Release Techniques on Groin Pain in 2nd Trimester of Pregnancy
Official title: Effects of Active Tissue Release Techniques on Groin Pain, Hip Range of Motion, and Functional Disability in 2nd Trimester of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Groin Strain
Keywords: Backache
Pregnancy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will focus on the effects of active tissue release techniques on groin pain, hip range of motion, and functional disability in 2nd trimester of pregnancy. This will be a randomized controlled trial conducted on 30 participants from Prime Care Hospital. Pregnant women in the second trimester aged between 25 to 35 years, who have groin or round ligament pain will be included in this study. A sample of 30 will be divided into 2 groups. Group A will undergo treatment of active release techniques for 10 minutes thrice a week with no home plan of home relaxation exercises. In contrast, Group B will combine treatment of active release technology with home relaxation exercises. Treatment will be given for 4 weeks and pain will be assessed before and after the treatment through (NPRS) scale. Functional disability will be measured before and after the treatment through Quebec scale and Force Disability Scale Questionnaire in both groups.

Detailed description: Groin pain mostly occurs in the first and second trimesters of pregnancy due to round ligament pain because the womb expands and causes stretching of ligaments making it more likely to become strained. The study will be focused on the effects of active tissue release techniques on groin pain, hip range of motion, and functional disability in 2nd trimester of pregnancy. A baseline treatment of ice therapy will be given for 10 minutes to all participants of this study. A sample of 30 will be divided into 2 groups. Group A will undergo treatment of active release techniques for 10 minutes thrice a week with no home plan of home relaxation exercises. In contrast, Group B will combine treatment of active release technology with home relaxation exercises.

Treatment will be given for 4 weeks and pain will be assessed before and after the treatment through (NPRS) scale. Functional disability will be measured before and after the treatment through the Quebec scale and Force Disability Scale Questionnaire in both groups. Recorded values will be analyzed for any change using SPSS

Eligibility criteria: Inclusion Criteria:

* Pain in the groin area/ Round Ligament pain
* NPRS scores between 4 to 10
* Functional activities scoring between 50 to 90 at Quebec score

Exclusion Criteria:

* Any diagnosed pathology like infection , malignancy ,inflammation
* Any structural deformity of lumbar and pelvic girdle,
* Any inguinal or lumbar surgery
* High risk pregnancy

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: up to 4 weeks
measure: The Quebec questionnaire:
timeFrame: up to 4 weeks
measure: Goniometer: To measure range of motion:
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Prime Care Hospital
state: Punjab
Study officials:
affiliation: Riphah International University, Lahore, Pakistan
name: Khadija shamas, MS*
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Weir A, Jansen JA, van de Port IG, Van de Sande HB, Tol JL, Backx FJ. Manual or exercise therapy for long-standing adductor-related groin pain: a randomised controlled clinical trial. Man Ther. 2011 Apr;16(2):148-54. doi: 10.1016/j.math.2010.09.001. Epub 2010 Oct 16.
citation: Cotellessa F, Puce L, Formica M, May MC, Trompetto C, Perrone M, Bertulessi A, Anfossi V, Modenesi R, Marinelli L, Bragazzi NL, Mori L. Effectiveness of a Preventative Program for Groin Pain Syndrome in Elite Youth Soccer Players: A Prospective, Randomized, Controlled, Single-Blind Study. Healthcare (Basel). 2023 Aug 22;11(17):2367. doi: 10.3390/healthcare11172367.
citation: Andrews CM, O'Neill LM. Use of pelvic tilt exercise for ligament pain relief. J Nurse Midwifery. 1994 Nov-Dec;39(6):370-4. doi: 10.1016/0091-2182(94)90156-2.
citation: Liddle SD, Pennick V. Interventions for preventing and treating low-back and pelvic pain during pregnancy. Cochrane Database Syst Rev. 2015 Sep 30;2015(9):CD001139. doi: 10.1002/14651858.CD001139.pub4.
citation: Hall H, Cramer H, Sundberg T, Ward L, Adams J, Moore C, Sibbritt D, Lauche R. The effectiveness of complementary manual therapies for pregnancy-related back and pelvic pain: A systematic review with meta-analysis. Medicine (Baltimore). 2016 Sep;95(38):e4723. doi: 10.1097/MD.0000000000004723.