Pelvic AdhesionsNCT06658210
Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pelvic Adhesions
A study testing soft tissue mobilization with pelvic floor muscle exercises and soft tissue mobilization without pelvic floor muscle exercises in people with Pelvic Adhesions and Post Hysterectomy Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Adhesions are permanent tissue connections that are created by fibrin deposition between different tissue planes or organs. They are a part of the internal healing process and inflammatory reactions that go through several overlapping phases, including the proliferative phase, remodeling phase, and… Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Pelvic Adhesions, Post Hysterectomy Pain
- What is being tested?
- soft tissue mobilization with pelvic floor muscle exercises and soft tissue mobilization without pelvic floor muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 20 Dec 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Married women
- Age 40-60 years
- BMI below 30 (13)
- Women with post-operative pelvic adhesions (14)
- Women after hysterectomy (3 months after surgery)
Who cannot join
- Women with any other surgery
- Women with failed pelvic surgery (14)
- Post-operative women with open wound (unhealed suture site) (14)
- Women with uncontrolled hypertension, thrombophlebitis, hematoma, osteomyelitis, myositis ossificans and malignancy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Hanif Medical centre and Polyclinic
Lahore, Punjab Province
Hunaida Iftikhar, MSPT*, 923044147363, hunaidairfan98@gmail.com
About this study
Official title: Combined Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pain, Sexual Life Quality and Functional Mobility in Women With Post-operative Adhesions After Hysterectomy
Adhesions are permanent tissue connections that are created by fibrin deposition between different tissue planes or organs. They are a part of the internal healing process and inflammatory reactions that go through several overlapping phases, including the proliferative phase, remodeling phase, and hemostasis/inflammatory phase. Adhesions are typically the body's defense mechanisms against various triggers of inflammation, including physical, chemical, and infections. These triggers can have unfavorable consequences, including chronic pain, obstruction (particularly bowel), functional impairment, and infertility. This may cause adjacent structures to lose their flexibility and mobility. The nonsurgical treatment of symptoms thought to be associated with adhesions has centered on several methods of soft tissue scar removal.
Read the detailed description
This study will be randomized controlled trial and will be conducted in Hanif medical center and poly clinic and Lady willingdon hospital. The total duration of treatment will be 10 week.
Non-probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive soft tissue mobilization of pelvic area with pelvic floor muscle exercises and Group B will receive soft tissue mobilization of pelvic area without pelvic floor muscle exercises after heating for 10 minutes as baseline treatment. The tools that will be used are Numeric Pain Rating Scale (NPRS), Female Sexual Function Index (FSFI) and Functional status questionnaire (FSQ). After data collection data will be analyzed by using SPSS version 25.
- Conditions
- Pelvic Adhesions, Post Hysterectomy Pain
- Being tested
- soft tissue mobilization with pelvic floor muscle exercises, soft tissue mobilization without pelvic floor muscle exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft tissue mobilization with pelvic floor muscle exercisesOther
Group A will receive soft tissue mobilization and pelvic floor muscle exercises. Soft tissue mobilization technique will include abdominal myofascial release/trigger point release and deep scar mobilization to decrease pain and improve scar mobility
soft tissue mobilization without pelvic floor muscle exercisesOther
Group B will receive soft tissue mobilization technique without pelvic floor exercises.
| Study group | Role | What they receive |
|---|---|---|
| soft tissue mobilization with pelvic floor muscle exercises | Experimental | soft tissue mobilization with pelvic floor muscle exercises Receives: Other: soft tissue mobilization with pelvic floor muscle exercises |
| soft tissue mobilization without pelvic floor muscle exercises | Experimental | soft tissue mobilization without pelvic floor muscle exercises Receives: Other: soft tissue mobilization without pelvic floor muscle 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 version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
Measured: 6 weeks
Female sexual function index
The FSFI questionnaire consists of 19 close-ended questions related to sexual activity and includes six domains:
- Sexual desire (question number 1-2)
- Sexual arousal (question number 3-6)
- Lubrication (question number 7-10)
- Orgasm (question number 11-13)
- Sexual satisfaction (question number 14-19)
Measured: 6 weeks
Functional status questionnaire
The Functional Status Questionnaire (FSQ) is a brief, self-administered questionnaire developed by researchers from Boston's Beth Israel Hospital and the University of California at Los Angeles. The FSQ was designed to screen for disability and to monitor clinically meaningful change in function.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Feb 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pelvic AdhesionsStudies 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
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hunaida Iftikhar Hunaida Iftikhar, MSPT*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658210
- Sponsor's protocol ID
- Hunaida Iftikhar
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lang J, Ma D, Xiang Y, Hua K, Liu K, Pan L, Wang P, Yao S, Zhao F, Cheng W, Cui M, Guo H, Guo R, Hong L, Li P, Liu M, Meng Y, Wang H, Wang J, Wang W, Wu M, Yang X, Zhang J. Chinese expert consensus on the prevention of abdominal pelvic adhesions after gynecological tumor surgeries. Ann Transl Med. 2020 Feb;8(4):79. doi: 10.21037/atm.2020.02.53.
PubMed 32175372Hu Q, Xia X, Kang X, Song P, Liu Z, Wang M, Lu X, Guan W, Liu S. A review of physiological and cellular mechanisms underlying fibrotic postoperative adhesion. Int J Biol Sci. 2021 Jan 1;17(1):298-306. doi: 10.7150/ijbs.54403. eCollection 2021.
PubMed 33390851Li YT, Liu CH, Wang PH. Pelvic adhesion: A challenge of all gynecologic surgeries. J Chin Med Assoc. 2022 Aug 1;85(8):813-814. doi: 10.1097/JCMA.0000000000000756. Epub 2022 Aug 19. No abstract available.
PubMed 35648144
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Soft Tissue Mobilization and Pelvic Floor Muscle Exercises on Pain, Sexual Life Quality and Functional Mobility in Women With Post-operative Adhesions After Hysterectomy
- ClinicalTrials.gov ID
- NCT06658210
- Acronym / sponsor ID
- Hunaida Iftikhar
- Conditions
- Pelvic Adhesions, Post Hysterectomy Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 26 Oct 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.
Adhesions are permanent tissue connections that are created by fibrin deposition between different tissue planes or organs. They are a part of the internal healing process and inflammatory reactions that go through several overlapping phases, including the proliferative phase, remodeling phase, and hemostasis/inflammatory phase. Adhesions are typically the body's defense mechanisms against various triggers of inflammation, including physical, chemical, and infections. These triggers can have unfavorable consequences, including chronic pain, obstruction (particularly bowel), functional impairment, and infertility. This may cause adjacent structures to lose their flexibility and mobility. The nonsurgical treatment of symptoms thought to be associated with adhesions has centered on several methods of soft tissue scar removal.
Detailed description
This study will be randomized controlled trial and will be conducted in Hanif medical center and poly clinic and Lady willingdon hospital. The total duration of treatment will be 10 week.
Non-probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive soft tissue mobilization of pelvic area with pelvic floor muscle exercises and Group B will receive soft tissue mobilization of pelvic area without pelvic floor muscle exercises after heating for 10 minutes as baseline treatment. The tools that will be used are Numeric Pain Rating Scale (NPRS), Female Sexual Function Index (FSFI) and Functional status questionnaire (FSQ). After data collection data will be analyzed by using SPSS version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| soft tissue mobilization with pelvic floor muscle exercises | Experimental | Other: soft tissue mobilization with pelvic floor muscle exercisessoft tissue mobilization with pelvic floor muscle exercises |
| soft tissue mobilization without pelvic floor muscle exercises | Experimental | Other: soft tissue mobilization without pelvic floor muscle exercisessoft tissue mobilization without pelvic floor muscle exercises |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Married women
- Age 40-60 years
- BMI below 30 (13)
- Women with post-operative pelvic adhesions (14)
- Women after hysterectomy (3 months after surgery)
Key exclusion criteria (4 listed)
- Women with any other surgery
- Women with failed pelvic surgery (14)
- Post-operative women with open wound (unhealed suture site) (14)
- Women with uncontrolled hypertension, thrombophlebitis, hematoma, osteomyelitis, myositis ossificans and malignancy
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 |
|---|---|---|
| soft tissue mobilization with pelvic floor muscle exercisesGroup A will receive soft tissue mobilization and pelvic floor muscle exercises. Soft tissue mobilization technique will include abdominal myofascial release/trigger point release and deep scar mobilization to decrease pain and improve scar mobility | Other | soft tissue mobilization with pelvic floor muscle exercises |
| soft tissue mobilization without pelvic floor muscle exercisesGroup B will receive soft tissue mobilization technique without pelvic floor exercises. | Other | soft tissue mobilization without pelvic floor muscle exercises |
Primary outcome
Numeric pain rating scale
Time frame: 6 weeks
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
Female sexual function index
Time frame: 6 weeks
The FSFI questionnaire consists of 19 close-ended questions related to sexual activity and includes six domains: * Sexual desire (question number 1-2) * Sexual arousal (question number 3-6) * Lubrication (question number 7-10) * Orgasm (question number 11-13) * Sexual satisfaction (question number 14-19)
Functional status questionnaire
Time frame: 6 weeks
The Functional Status Questionnaire (FSQ) is a brief, self-administered questionnaire developed by researchers from Boston's Beth Israel Hospital and the University of California at Los Angeles. The FSQ was designed to screen for disability and to monitor clinically meaningful change in function.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 32175372Lang J, Ma D, Xiang Y, Hua K, Liu K, Pan L, Wang P, Yao S, Zhao F, Cheng W, Cui M, Guo H, Guo R, Hong L, Li P, Liu M, Meng Y, Wang H, Wang J, Wang W, Wu M, Yang X, Zhang J. Chinese expert consensus on the prevention of abdominal pelvic adhesions after gynecological tumor surgeries. Ann Transl Med. 2020 Feb;8(4):79. doi: 10.21037/atm.2020.02.53.
- Background: PubMed 33390851Hu Q, Xia X, Kang X, Song P, Liu Z, Wang M, Lu X, Guan W, Liu S. A review of physiological and cellular mechanisms underlying fibrotic postoperative adhesion. Int J Biol Sci. 2021 Jan 1;17(1):298-306. doi: 10.7150/ijbs.54403. eCollection 2021.
- Background: PubMed 35648144Li YT, Liu CH, Wang PH. Pelvic adhesion: A challenge of all gynecologic surgeries. J Chin Med Assoc. 2022 Aug 1;85(8):813-814. doi: 10.1097/JCMA.0000000000000756. Epub 2022 Aug 19. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Pelvic Adhesions
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Not yet recruiting
Abdominopelvic Fascial Release for Post-Cesarean Menstrual Pain and Scar Mobility
Dysmenorrhea, Cesarean Section
Recruiting
Role of Saline Infusion Sonohysterography in Detection of Pelvic Adhesions in Infertile Women
Infertile Women With Pelvic Adhesions
Active, not recruitingObservational study
Natural Course of Pain Following Surgery Through an Abdominal Incision
Adhesions Abdominal, Adhesions Pelvic
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.
Hunaida Iftikhar Hunaida Iftikhar, MSPT* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft tissue mobilization with pelvic floor muscle exercises and soft tissue mobilization without pelvic floor muscle exercises in people with Pelvic Adhesions and Post Hysterectomy Pain, 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 5 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: status not confirmed, as of the sponsor's last update on 26 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeela Arif Adeela Arif, Mphil (923320845723, adeela.arif@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 6 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 NCT06658210, which also lists 3 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 26 Oct 2024.