Effects of Active Tissue Release Techniques on Groin Pain in 2nd Trimester of Pregnancy

NCT ID: NCT06340126

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-10-05

Brief Summary

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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

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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

Conditions

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Groin Strain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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active tissue release technique group

The group will be treated by active release techniques for 4 weeks, 3 sessions per week. One session will be for 10 minutes. Before each session, an ice pack is applied to the groin area for inflammation if present.

Group Type EXPERIMENTAL

Active release techniques

Intervention Type OTHER

Active release techniques are soft tissue systems or movement-based techniques. It is used to treat muscles, nerves, fascia, ligaments, and tendons.

Relaxation exercises Group

Group B will be treated by relaxation exercises only. Relaxation exercises include breathing exercises, pelvic floor exercises, and postural exercises.

Group Type ACTIVE_COMPARATOR

Relaxation exercises

Intervention Type OTHER

Relaxation exercises include breathing exercises, pelvic floor exercises, and postural exercises. Exercises will be done in a sitting position

Interventions

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Active release techniques

Active release techniques are soft tissue systems or movement-based techniques. It is used to treat muscles, nerves, fascia, ligaments, and tendons.

Intervention Type OTHER

Relaxation exercises

Relaxation exercises include breathing exercises, pelvic floor exercises, and postural exercises. Exercises will be done in a sitting position

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khadija shamas, MS*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University, Lahore, Pakistan

Locations

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Prime Care Hospital

Faisalābad, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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Shiri R, Coggon D, Falah-Hassani K. Exercise for the prevention of low back and pelvic girdle pain in pregnancy: A meta-analysis of randomized controlled trials. Eur J Pain. 2018 Jan;22(1):19-27. doi: 10.1002/ejp.1096. Epub 2017 Sep 4.

Reference Type BACKGROUND
PMID: 28869318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20952244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37685401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7830145 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26422811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27661020 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/23/0567

Identifier Type: -

Identifier Source: org_study_id

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