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

Primary Purpose

Dysmenorrhea

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

integrated neuromuscular inhibition technique

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

17 Years - 24 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group (A)

Group (B)

Arm Description

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.

control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

function

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)

muscle amplitude will be measured by surface electromyography for upper trapezius

Full Information

NCT ID

NCT05461846

First Posted

July 11, 2022

Last Updated

July 14, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05461846

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2022 (Anticipated)

Primary Completion Date

April 1, 2023 (Anticipated)

Study Completion Date

June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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 .

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysmenorrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group (A)

Arm Type

Experimental

Arm Description

Arm Title

Group (B)

Arm Type

No Intervention

Arm Description

control group

Intervention Type

Other

Intervention Name(s)

integrated neuromuscular inhibition technique

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain intensity

Description

Time Frame

up to 2 months

Secondary Outcome Measure Information:

Title

function

Description

Oswestery Disability Index will be used to assess level of functional disability for both groups before and at the end of the study

Time Frame

up to 2 months

Title

muscle amplitude in the form of normalized root mean square (RMS)

Description

muscle amplitude will be measured by surface electromyography for upper trapezius

Time Frame

up to 2 months

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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