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Completed

NCT Number: NCT06340126

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

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.

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Key information

Conditions

Groin Strain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Prime Care Hospital

Faisalābad, Punjab Province, 38000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Relaxation exercises

Other

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

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: up to 4 weeks

    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.

  2. The Quebec questionnaire:

    Time frame: up to 4 weeks

    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

  3. Goniometer: To measure range of motion:

    Time frame: up to 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Active Tissue Release Techniques on Groin Pain, Hip Range of Motion, and Functional Disability in 2nd Trimester of Pregnancy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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