Biomechanical Changes in Women With Chronic Pelvic Pain

NCT03740932 | Completed

• 1 other identifier: P.T.REC/012/001887
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pelvic pain (CPP), a frequent complaint in clinical gynaecology, is defined as cyclic or acyclic pain located in the pelvis, persisting for 6 months or more, and severe enough to cause functional incapacity that requires medical or surgical treatment (or both). Chronic pelvic pain is the reason for approximately 10% of all gynaecologic consultations

Conditions

Pelvic Pain

Outcome Measures

Primary Outcomes (5)

• body mass index

  BMI in kg/m\^2

  3 months

• Satisfaction assessed by the VAS

  Degrees of menstrual pain will be assessed using a VAS, which was a method of representing subjects' pain on a 10 cm linear scale. Score of 0 meant 'no pain' and 10 meant 'worst pain'. Tomeasure specific symptoms, such as the s

  3 months

• Pelvic tilt in degrees:

  The blocks are released and the rods are placed over the crest of the ilium. The blocks are then pressed firmly toward the midline. Read the angle from the level. If the gauge reads over 21/2°, the result is listed as positive.Anterior pelvic tilting angle: PALM was used for measuring pelvic tilting angle. A mark was put on a point just inferior to ASIS; another mark was put just inferior to PSIS. The callipers of the PALM were put on these two points

  3 months

• jaw movement

  Maximal vertical mouth opening (MIO): From sitting position, with the use of the calliper, the distance between the incisal edges along the midline of the upper and lower central incisors without pain was measured, by placing one end of the poley gauge against the incisal edge of one of the upper central incisors, and the other end against the incisal edge of the opposing lower incisor. The distance recorded in millimeters, the subjects was instructed to" open your mouth as wide as possible without causing pain or discomfort". The poley gauge was sterilized with antiseptic solution before and after each measure

  3 months

• Spinal curves Measurement

  spinal inclinations followed standardized procedure. Initially, with the subject in prone lying, reference points were marked at the left and right posterior superior iliac spines (PSIS) and at the intersection of the line joining them over the sacral surface and the vertical line of the spine. Also marked were the interspaces of L5-S1, T12-LI and TI-T2. All measurements of spinal inclinations were taken with the subject in erect standing, with feet together, hands by the sides, head erect and eyes focused directly ahead.For the sagittal curves of the spine, the inclinometer was placed along the slope of the vertebrae at each of the levels of the three marked interspaces, so that the zero reading of the inclinometer matched the marked point. The vertically hanging needle of the inclinometer indicated the angles of inclination of these three levels. From these values, the angles of lordosis and kyphosis were determined

  3 months

Study Arms (3)

Study group (group A):

It will consist of 30 subjects who will have cyclic pelvic pain

Diagnostic Test: Study group (group A)

Study group (group B):

It will consist of 30 subjects who will have non cyclic pelvic pain.

Diagnostic Test: Study group (group A)

Control group (group C):

It will consist of 30 subjects normal women who will not having pelvic pain.

Diagnostic Test: Study group (group A)

Interventions

Study group (group A) DIAGNOSTIC_TEST

Maximal vertical mouth opening (MIO): From sitting position, with the use of the calliper, the distance between the incisal edges along the midline of the upper and lower central incisors without pain was measured, by placing one end of the poley gauge against the incisal edge of one of the upper central incisors, and the other end against the incisal edge of the opposing lower incisor. The distance recorded in millimetres, the subjects was instructed to" open your mouth as wide as possible without causing pain or discomfort". The poley gauge was sterilized with antiseptic solution before and after each measure

Control group (group C):; Study group (group A):; Study group (group B):

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

90 women will participate in this study, thirty women diagnosed as having cyclic pelvic pain and thirty women diagnosed as having non cyclic pelvic pain thirty women normal women will not having pelvic pain. They will be selected from outpatient clinic of obstetrics and Gynaecology department in El-Hosary family health Centre. All participants will be given a full explanation of the protocol of the study and informed consent form will be signed from each subject before participating in the study (

You may qualify if:

• The age of the participants will be ranged from 20 to 40 years.
• Their body mass index will be ranged from 20 to 25 kg/m2.
• They will have regular menstrual cycle.
• They will not receive any hormonal therapy or taking any regular drugs.

You may not qualify if:

• Bone disease.
• Discogenic state with radiculopathy or not.
• Systemic disease of musculoskeletal system.
• Any sensory problems.
• Previous vertebral fractures.
• Major spinal structural abnormality.
• Major jaw abnormality.
• Any jaw orthotics or prosthesis.
• Missing teeth.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Rovan Elbesh

Giza, Egypt

Location

Related Publications (1)

• Kamal EE, Hamada HA, Ashour RS, Yousef AM, Elbesh RM. Biomechanical changes in females with poly cystic ovarian syndrome: a case-control study. Sci Rep. 2025 Apr 1;15(1):11190. doi: 10.1038/s41598-025-93481-9.

  PMID: 40169684 DERIVED

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 14, 2018
• Study Start: September 8, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 11, 2020
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

EG (1)