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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05461846
Other study ID # p.T.RCE/012/003493
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date June 1, 2023

Study information

Verified date July 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dysmenorrhea is a common problem in women of reproductive age. Primary dysmenorrhea is defined as recurrent, cramping pain occurring with menses in the absence of identifiable pelvic pathology .


Description:

Primary dysmenorrhea is characterized by a crampy supra-pubic pain that begins somewhere between several hours before and a few hours after the onset of the menstrual bleeding. Symptoms peak with maximum blood flow and usually last less than one day, but the pain may persist up to 2 to 3 days. Symptoms are more or less reproducible from one menstrual period to the other. The pain is characteristically colicky and located in the midline of the lower abdomen and may extend to lower quadrants, the lumbar area, and the thighs. Menstrual low back pain (LBP) is one of the common complaints among women. Previous studies have indicated that more than 40% to 50% of the population experience LBP during the menstrual phase (days 1-6) of the menstrual cycle .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date June 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 17 Years to 24 Years
Eligibility Inclusion Criteria: 1. Thirty adolescent females suffering from menstrual low back pain. 2. Their age will be ranged from 17 to 24 years. 3. Their body mass index will be ranged from 20 to 25 kg/m2. Exclusion Criteria: 1. Personal and individual differences between the subjects. 2. Psychological and physical status of subjects which may affect the treatment and evaluation stage. 3. Environmental factors which may affect the subject's response

Study Design


Related Conditions & MeSH terms


Intervention

Other:
integrated neuromuscular inhibition technique
is a manual deactivation trigger points technique and includes the application of ischemic pressure and stretch, the muscle energy technique and the Strain-counterstrain technique.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity The pain intensity will be assessed through visual analogue scale (VAS) for both groups before and after the end of treatment program. Each woman will be asked to mark a point on the line between the extremes that related to her pain intensity. up to 2 months
Secondary function Oswestery Disability Index will be used to assess level of functional disability for both groups before and at the end of the study up to 2 months
Secondary muscle amplitude in the form of normalized root mean square (RMS) muscle amplitude will be measured by surface electromyography for upper trapezius up to 2 months
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