Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery

Something must be done in order to release the tension within the dura mater before any lasting correction of the spine can be effected. Each of the cranial nerves is wrapped in a sheath of dura mater. As they exit the cranial vault they are described by Gray's Anatomy as having a "dural cuff".

Study Overview

• Status: Not yet recruiting
• Conditions: Back Pain
• Intervention / Treatment: Other: cranioscaral treatment

• Study Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

30 women will participate in this study, thirty women diagnosed as having back ar neck pain after surgery.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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group (group A): 15 women take cranioscaral treatment	Other: cranioscaral treatment; dural release
control group (group B): shame group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
a pressure-pain threshold	algometer Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold. It has been noted in pressure-pain threshold studies that the rate at which manual force is applied should be consistent to provide the greatest reliability	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 8, 2023
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 11, 2023

Study Registration Dates

• First Submitted: September 8, 2019
• First Submitted That Met QC Criteria: September 8, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: P.T.REC/012/00191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No