Groin StrainNCT06340126
Effects of Active Tissue Release Techniques on Groin Pain in 2nd Trimester of Pregnancy
A study testing Active release techniques and Relaxation exercises in people with Groin Strain, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Groin Strain
- What is being tested?
- Active release techniques and Relaxation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 5 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pain in the groin area/ Round Ligament pain
- NPRS scores between 4 to 10
- Functional activities scoring between 50 to 90 at Quebec score
Who cannot join
- Any diagnosed pathology like infection , malignancy ,inflammation
- Any structural deformity of lumbar and pelvic girdle,
- Any inguinal or lumbar surgery
- High risk pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Active Tissue Release Techniques on Groin Pain, Hip Range of Motion, and Functional Disability 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.
Read the 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
- Conditions
- Groin Strain
- Being tested
- Active release techniques, Relaxation exercises
- Keywords
- Backache, Pregnancy
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active release techniquesOther
Active release techniques are soft tissue systems or movement-based techniques. It is used to treat muscles, nerves, fascia, ligaments, and tendons.
Relaxation exercisesOther
Relaxation exercises include breathing exercises, pelvic floor exercises, and postural exercises. Exercises will be done in a sitting position
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Apr 2024
- Primary completion20 Sep 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Groin StrainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khadija shamas, MS*, Principal investigator, Riphah International University, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340126
- Sponsor's protocol ID
- REC/RCR & AHS/23/0567
- Status last verified
- Nov 2024
- First submitted
- 25 Mar 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28869318Weir 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.
PubMed 20952244Cotellessa 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.
PubMed 37685401Andrews 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.
PubMed 7830145Liddle 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.
PubMed 26422811Hall 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.
PubMed 27661020
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Active Tissue Release Techniques on Groin Pain, Hip Range of Motion, and Functional Disability in 2nd Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT06340126
- Acronym / sponsor ID
- REC/RCR & AHS/23/0567
- Conditions
- Groin Strain
- Keywords
- Backache, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tissue release technique group | Experimental | Other: Active release techniquesThe 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. |
| Relaxation exercises Group | Active comparator | Other: Relaxation exercisesGroup B will be treated by relaxation exercises only. Relaxation exercises include breathing exercises, pelvic floor exercises, and postural exercises. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pain in the groin area/ Round Ligament pain
- NPRS scores between 4 to 10
- Functional activities scoring between 50 to 90 at Quebec score
Key exclusion criteria (4 listed)
- Any diagnosed pathology like infection , malignancy ,inflammation
- Any structural deformity of lumbar and pelvic girdle,
- Any inguinal or lumbar surgery
- High risk pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active release techniquesActive release techniques are soft tissue systems or movement-based techniques. It is used to treat muscles, nerves, fascia, ligaments, and tendons. | Other | active tissue release technique group |
| Relaxation exercisesRelaxation exercises include breathing exercises, pelvic floor exercises, and postural exercises. Exercises will be done in a sitting position | Other | Relaxation exercises Group |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 28869318Shiri 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.
- Background: PubMed 20952244Weir 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.
- Background: PubMed 37685401Cotellessa 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.
- Background: PubMed 7830145Andrews 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.
- Background: PubMed 26422811Liddle 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.
- Background: PubMed 27661020Hall 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khadija shamas, MS* principal investigator
Riphah International University, Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active release techniques and Relaxation exercises in people with Groin Strain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06340126, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.