Integrated Neuromuscular Inhibition Versus Instrument Assisted Soft Tissue Mobilization in Chronic Back Pain

October 30, 2023 updated by: Heba Salama Mansour Mousa, Cairo University

Integrated Neuromuscular Inhibition Technique Versus Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Non Specific Low Back Pain

this study will be conducted to identify the difference between the effect of integrated neuromuscular inhibition technique and instrument assisted soft tissue mobilization on back pain, pain threshold, back rang of motion ,back proprioception and back disability in chronic non specific low back pain

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1. The patient's age ranged from 18 to 30 years.(Geogre et al, 2021) 2. Patients with low back pain for more than 3 months (pain felt between T12 and the gluteal fold).

    3. Patient with chronic low back pain 4. Normal body mass index from 18 -25kg/m2.

Exclusion Criteria:

  • The subjects will be excluded if they have any of the followings:

    1. Lumbar discogenic lesions or any inflammatory arthritis, tumors, infection involving the lumbar spine.
    2. Patients with decreased range of motion secondary to congenital anomalies, muscular contracture, or bony block.
    3. Previous lumbar or hip surgery or trauma.
    4. Any hip structural abnormality such as malformations, impingements and degeneration.
    5. Patients With cognitive impairments that would limit their participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A: integrated neuromuscular inhibition technique
Group A: patient will receive integrated neuromuscular inhibition technique and conventional physical therapy program for 3 sessions /week over 4 weeks periods
Other: Experimental: Group A: integrated neuromuscular inhibition technique
will receive integrated neuromuscular inhibition in addition to conventional treatment,INIT which included IC, SCS, and MET for the low back region for the quadratus lumborum( QL) and erector spinae (ES) muscles
Other Names:
  • technique
Experimental: Group B :Instrument assissted soft tissue mobilization
Group B : patient will receive Instrument assissted soft tissue mobilization technique and conventional physical therapy program for 3 sessions /week over 4 weeks periods
Other: Experimental: Group B :Instrument assissted soft tissue mobilization
IASTM performed on lumbar posterior muscle erector spinae (iliocostalis, longissimus), and quadratus lumborum(QL) The IASTM treatment was applied for approximately 20-seconds in a direction parallel to the muscle fibers being treated with the instrument at a 45° angle. Followed immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45° angle for an additional 20-seconds, resulting in a total treatment time of approximately 40 seconds.
Other Names:
  • instrument
Active Comparator: Group C:conventional physical therapy
Group C: patient will receive conventional physical therapy only in the form of ( stretch for hamstring ,illiopoaps ,low back muscle and strenghtning for abdominal ,back muscles and side support exercise and quadriped exercise)
Other: control group C conventional physical therapy
. The control group will applied general exercise. General exercise were applied with stretching exercises and stationary bicycling for 10-15 minutes14, 15) . Three sets of fifteen repetitions will performed, with rest times of 1 minute between sets during 4 weeks.
Other Names:
  • exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change in lumber proprioception
Time Frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
change in lumbar proprioception will be measured by dual inclinometer for 3 group pre-and post-treatment
Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
chang in pain pressure threshold
Time Frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
change in lower back pain threshold will be measured by pressure algometer for 3 group pre-and post-treatment
Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
chang in lumbar rang of motion(ROM)
Time Frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
lumbar ROM will be measured by dual inclinometer pre-treatment and post treatment
Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
functional disability oFlumbar spine
Time Frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
functional disability will be measured by The Arabic version of Oswestry Disability Index.(ODI)
Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
pain level of lumbar spine
Time Frame: Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure
pain level will be measured by visual analoge scale(VAS)
Evaluation will be performed priod to the first treatment session :as a baseline measure,and at least treatment session (after 4 weeks)as a post-treatment measure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/004714

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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