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

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

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Dysmenorrhea
• Intervention / Treatment: Other: integrated neuromuscular inhibition technique

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 24 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (ACTUAL): July 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Back Pain; Low Back Pain; Dysmenorrhea
• Other Study ID Numbers: p.T.RCE/012/003493

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