Pelvic Congestive SyndromeNCT05979766
Manual Lymphatic Drainage vs Marian Clark Drainage in Pcs
A study testing Manual lymphatic drainage versus marian clark drainage in people with Pelvic Congestive Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Pelvic congestion syndrome is a debilitating and potentially life threatening disorder of the pelvic region there is a constant hindrance in patient's daily professional and personal life due to the chronic pain. it can provide a definite way to improve pelvic congestion and quality of life. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Pelvic Congestive Syndrome
- What is being tested?
- Manual lymphatic drainage versus marian clark drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Dec 2022to Aug 2023
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Multiparous women
- Age ranging 20 to 50
- Ovarian veins >4mm in diameter on Ultrasound Chronic pelvic pain/pressure for more than 6 months.
- Dull, aching or "dragging" pain in the pelvis or lower back, particularly on standing and worse around the time of your menstrual period.
- Pelvic pain that worsens as the day goes on, particularly if much time is spent standing dyspareunia
- Swollen veins in pelvic region, butt, thighs, vulva and vagina.
- Associated Irritable bladder/Irritable bowel present
Who cannot join
- Pelvic pain due to other organic cause like uterine fibroids, Endometriosis, Ovarian cyst pelvic pain due to neurological or musculoskeletal disorder
- Uterine prolapse
- Pelvic cancer
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah hospital
Lahore, Punjab Province
Hafiza Neelam Muneeb, PT, +92 320 4097476, hafiza.neelam@riphah.edu.pk
Maira Imran Butt, MS-WHPT
About this study
Official title: Effects of Manual Lymphatic Drainage Versus Marian Clark Drainage on Pain and Disability in Patients With Pelvic Congestion Syndrome
Pelvic congestion syndrome is a debilitating and potentially life threatening disorder of the pelvic region there is a constant hindrance in patient's daily professional and personal life due to the chronic pain. it can provide a definite way to improve pelvic congestion and quality of life. In this way it can benefit a large percentage of community females suffering from pelvic congestion syndrome and disability. This can grow at large length in favour of patients, clinicians and overall women health.
Read the detailed description
As per researcher's knowledge there are limited researches in which efficacy of manual lymphatic drainage in pelvic congestion syndrome are analyzed furthermore my comparative intervention i.e Marian Clark drainage is a rarely used osteopathic technique and not much studies have been conducted on it. This study helped to in identifying the effect of manual lymphatic drainage versus Marian Clark drainage on pain and disability in patients with pelvic congestion syndrome.
- Conditions
- Pelvic Congestive Syndrome
- Being tested
- Manual lymphatic drainage versus marian clark drainage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lymphatic drainage versus marian clark drainageOther
Manual lymphatic drainage versus marian clark drainage
| Study group | Role | What they receive |
|---|---|---|
| Manual lymphatic drainage vs marian clark drainage | Active comparator | Effect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome Receives: Other: Manual lymphatic drainage versus marian clark drainage |
| Manual lymphatic drainage versus marian clark drainage | Active comparator | Effect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome Receives: Other: Manual lymphatic drainage versus marian clark drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual lymphatic drainage
Treatment protocol to group A
It consists of 15 patients who will receive manual lymphatic drainage 4 sessions per week for 12 weeks
Manual Lymph Drainage Techniques for Pelvic Decongestion
Step 1: short neck treatment (supraclavicular fossa or SCF)
Step 2: (two parts: visceral, deep)
Visceral:
Deep: Treatment of the thoracic duct, cisterna Chyli
Deep Abdominal Manual lymphatic drainage
Step-3. Treatment of right Axillary Lymph nodes
Step-4. Establish the Right inguino-Axillary Anastomosis.
Step-5. Decongest the right ipsilateral lower abdomen and suprapubic area
Step-6 Treatment of Left Axillary Lymph nodes
Step-7. Establish the Left inguino-Axillary Anastomosis.
Step-8. Decongest the Let ipsilateral lower abdomen and suprapubic area
Measured: 6 months
Marian clark drainage
It consists of 15 patients who will receive Marian clark drainage 4 sessions per week for 12 weeks each session will continue till therapist feels palpable change in congestion in pelvic area medial to Anterior superior Iliac spine.
- Stand to the side of the patient
- Patient semiprone on all fours
- Hook fingers medial to both Anterior superior Iliac spine
- Pull hands cephalad (traction)
- Patient arches back like a cat
- Encourage this movement with cephalad rocking
- Repeat for several minutes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start5 Dec 2022
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Congestive SyndromeStudies 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
- Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Neelam Muneeb, Ms, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979766
- Sponsor's protocol ID
- RiphahIUmib
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Lymphatic Drainage Versus Marian Clark Drainage on Pain and Disability in Patients With Pelvic Congestion Syndrome
- ClinicalTrials.gov ID
- NCT05979766
- Acronym / sponsor ID
- RiphahIUmib
- Conditions
- Pelvic Congestive Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 7 Aug 2023 (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.
Pelvic congestion syndrome is a debilitating and potentially life threatening disorder of the pelvic region there is a constant hindrance in patient's daily professional and personal life due to the chronic pain. it can provide a definite way to improve pelvic congestion and quality of life. In this way it can benefit a large percentage of community females suffering from pelvic congestion syndrome and disability. This can grow at large length in favour of patients, clinicians and overall women health.
Detailed description
As per researcher's knowledge there are limited researches in which efficacy of manual lymphatic drainage in pelvic congestion syndrome are analyzed furthermore my comparative intervention i.e Marian Clark drainage is a rarely used osteopathic technique and not much studies have been conducted on it. This study helped to in identifying the effect of manual lymphatic drainage versus Marian Clark drainage on pain and disability in patients with pelvic congestion syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual lymphatic drainage vs marian clark drainage | Active comparator | Other: Manual lymphatic drainage versus marian clark drainageEffect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome |
| Manual lymphatic drainage versus marian clark drainage | Active comparator | Other: Manual lymphatic drainage versus marian clark drainageEffect of Marian Clark drainage and manual lymphatic drainage in women suffering from pelvic congestion syndrome |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Multiparous women
- Age ranging 20 to 50
- Ovarian veins >4mm in diameter on Ultrasound Chronic pelvic pain/pressure for more than 6 months.
- Dull, aching or "dragging" pain in the pelvis or lower back, particularly on standing and worse around the time of your menstrual period.
- Pelvic pain that worsens as the day goes on, particularly if much time is spent standing dyspareunia
Key exclusion criteria (3 listed)
- Pelvic pain due to other organic cause like uterine fibroids, Endometriosis, Ovarian cyst pelvic pain due to neurological or musculoskeletal disorder
- Uterine prolapse
- Pelvic cancer
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 |
|---|---|---|
| Manual lymphatic drainage versus marian clark drainageManual lymphatic drainage versus marian clark drainage | Other | Manual lymphatic drainage versus marian clark drainage, Manual lymphatic drainage vs marian clark drainage |
Primary outcome
Manual lymphatic drainage
Time frame: 6 months
Treatment protocol to group A It consists of 15 patients who will receive manual lymphatic drainage 4 sessions per week for 12 weeks Manual Lymph Drainage Techniques for Pelvic Decongestion Step 1: short neck treatment (supraclavicular fossa or SCF) Step 2: (two parts: visceral, deep) Visceral: Deep: Treatment of the thoracic duct, cisterna Chyli Deep Abdominal Manual lymphatic drainage Step-3. Treatment of right Axillary Lymph nodes Step-4. Establish the Right inguino-Axillary Anastomosis. Step-5. Decongest the right ipsilateral lower abdomen and suprapubic area Step-6 Treatment of Left Axillary Lymph nodes Step-7. Establish the Left inguino-Axillary Anastomosis. Step-8. Decongest the Let ipsilateral lower abdomen and suprapubic area
Marian clark drainage
Time frame: 6 months
It consists of 15 patients who will receive Marian clark drainage 4 sessions per week for 12 weeks each session will continue till therapist feels palpable change in congestion in pelvic area medial to Anterior superior Iliac spine. * Stand to the side of the patient * Patient semiprone on all fours * Hook fingers medial to both Anterior superior Iliac spine * Pull hands cephalad (traction) * Patient arches back like a cat * Encourage this movement with cephalad rocking * Repeat for several minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Hafiza Neelam Muneeb, Ms 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 Manual lymphatic drainage versus marian clark drainage in people with Pelvic Congestive Syndrome, 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 7 inclusion and 3 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 7 Aug 2023. 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 Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual lymphatic drainage (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.