NCT05979766

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

July 31, 2023

Last Update Submit

July 31, 2023

Conditions

Pelvic Congestive Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    6 months

Study Arms (2)

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

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

Other: Manual lymphatic drainage versus marian clark drainage

Interventions

Manual lymphatic drainage versus marian clark drainageOTHER

Manual lymphatic drainage versus marian clark drainage

Manual lymphatic drainage versus marian clark drainageManual lymphatic drainage vs marian clark drainage

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Study Officials

  • Hafiza Neelam Muneeb, Ms

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

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

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 7, 2023

Study Start

December 5, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

August 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)