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

NCT06340126 | Completed

• 1 other identifier: REC/RCR & AHS/23/0567
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Groin Strain

Keywords

Backache; Pregnancy

Outcome Measures

Primary Outcomes (3)

• Numeric Pain Rating Scale

  The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes. Changes from Baseline to 4 week.

  up to 4 weeks

• The Quebec questionnaire:

  The Quebec questionnaire is a condition-specific questionnaire developed to measure the level of functional disability for patients with groin pain. The original purpose of the questionnaire is to take into account the functional limitations related to pain, to monitor the progress of individual patients and to compare the evolution of groin pain subjects incorporated in rehabilitation programs

  up to 4 weeks

• Goniometer: To measure range of motion:

  A goniometer is a device that measures an angle or permits the rotation of an object to a definite position the range of motion is the measurement of movement around a specific joint or body part.

  up to 4 weeks

Study Arms (2)

active tissue release technique group

EXPERIMENTAL

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.

Other: Active release techniques

Relaxation exercises Group

ACTIVE COMPARATOR

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

Other: Relaxation exercises

Interventions

Active release techniques OTHER

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

active tissue release technique group

Relaxation exercises OTHER

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

Relaxation exercises Group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Prime Care Hospital

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 28869318 BACKGROUND

• 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.

  PMID: 20952244 BACKGROUND

• 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.

  PMID: 37685401 BACKGROUND

• 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.

  PMID: 7830145 BACKGROUND

• 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.

  PMID: 26422811 BACKGROUND

• 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.

  PMID: 27661020 BACKGROUND

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Khadija shamas, MS*

  Riphah International University, Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: April 1, 2024
• Primary Completion: September 20, 2024
• Study Completion: October 5, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)