NCT03980106

Brief Summary

This a cross-over study to compare the effect of two different muscle energy techniques (MET) including post-isometric inhibition and reciprocal inhibition on the spinal reflex excitability. The study contains two experimental groups, while one group will receive post-isometric inhibition MET in the first stage and reciprocal inhibition MET in the second stage, the other group will receive reciprocal inhibition MET in the first stage and post-isometric inhibition MET in the second stage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

June 6, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

June 5, 2019

Last Update Submit

March 30, 2020

Conditions

Keywords

Spinal Reflex ExcitabilityMuscle RelaxationH reflex

Outcome Measures

Primary Outcomes (2)

  • Change in H Reflex Amplitude

    H reflex or Hoffman's reflex is a refectory reaction of muscles after electrical stimulation of sensory fibers (Ia afferent from muscle spindles) in their innervated nerves (here is Tibial N),

    First measurement (Base-line), second measurement after 30 minutes (Pre-test), third measurement after 20 minutes (first post-test), forth measurement after 20 minutes (second post-test)

  • Change in M wave Amplitude

    M- wave is a compound muscle action potential, which is produce by the electrical stimulation of motor nerve fibers (here is Tibial N)

    First measurement (Base-line), second measurement after 30 minutes (Pre-test), third measurement after 20 minutes (first post-test), forth measurement after 20 minutes (second post-test)

Study Arms (2)

Experimental RI-PI

EXPERIMENTAL

They receive the Reciprocal Inhibition (RI) technique in the first stage and then the Post-isometric Inhibition (PI) technique in the second stage.

Other: Reciprocal Inhibition Muscle Energy TechniqueOther: Post-Isometric Inhibition Muscle Energy Technique

Experimental PI-RI

EXPERIMENTAL

They receive the Post-isometric Inhibition (PI) technique in the first stage and then the Reciprocal Inhibition (RI) technique in the second stage.

Other: Reciprocal Inhibition Muscle Energy TechniqueOther: Post-Isometric Inhibition Muscle Energy Technique

Interventions

In this technique, the subject will be asked to contract antagonist muscles against a moderate resistant force provided by the therapist to inhibit the contraction of the agonist muscle.

Experimental PI-RIExperimental RI-PI

In this technique, the subject will be asked to contract agonist muscles against a moderate resistant force provided by the therapist to inhibit the contraction of the agonist muscle.

Experimental PI-RIExperimental RI-PI

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • without current low back pain

You may not qualify if:

  • Suffering from pain in the cervical, thoracic and lumbar spine,
  • Presenting signs of radiculopathy or peripheral neuropathy such as specific patterns of numbness and muscle weakness,
  • Any history or signs of joint instability, healing fractures, malignancy, open wounds, sutures, severe rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Georgia

Dahlonega, Georgia, 30597, United States

RECRUITING

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammad R Nourbakhsh

    Professor of Physical Therapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad R Nourbakhsh

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Physical Therapy

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 10, 2019

Study Start

June 6, 2020

Primary Completion

August 15, 2020

Study Completion

September 30, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

No Plan to share individual participant data to other researchers.

Locations