Effect of Integrated Neuromuscular Inhibition Technique in Females With Menstrual Low Back Pain

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05461846

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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 .

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea	Other: integrated neuromuscular inhibition technique	N/A

Detailed 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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Integrated Neuromuscular Inhibition Technique on Pain, Function and Muscle Activity in Females With Menstrual Low Back Pain

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group (A) The integrated neuromuscular inhibition technique (INIT) 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.	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.
No Intervention: Group (B) control group

Arm

Intervention/Treatment

Experimental: Group (A)

The integrated neuromuscular inhibition technique (INIT) 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.

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.

No Intervention: Group (B)

control group

Outcome Measures

Primary Outcome Measures

Pain intensity [up to 2 months]
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.

Secondary Outcome Measures

function [up to 2 months]
Oswestery Disability Index will be used to assess level of functional disability for both groups before and at the end of the study
muscle amplitude in the form of normalized root mean square (RMS) [up to 2 months]
muscle amplitude will be measured by surface electromyography for upper trapezius

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 24 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Thirty adolescent females suffering from menstrual low back pain.
Their age will be ranged from 17 to 24 years.
Their body mass index will be ranged from 20 to 25 kg/m2.

Exclusion Criteria:

Personal and individual differences between the subjects.
Psychological and physical status of subjects which may affect the treatment and evaluation stage.
Environmental factors which may affect the subject's response

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hend Hamdy, lecturer of pt for basic science, Cairo University

ClinicalTrials.gov Identifier:

NCT05461846

Other Study ID Numbers:

p.T.RCE/012/003493

First Posted:

Jul 18, 2022

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Dysmenorrhea

Study Results

No Results Posted as of Jul 18, 2022