Relaxation; JointNCT03980106
Comparing the Reciprocal Inhibition Method and Post-isometric Inhibition Method of Muscle Energy Technique on the Spinal Reflex Excitability in Healthy Subjects
A study testing Reciprocal Inhibition Muscle Energy Technique and Post-Isometric Inhibition Muscle Energy Technique in people with Relaxation; Joint and Limitation, Mobility, run by University of North Georgia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Relaxation; Joint, Limitation, Mobility, Relaxation; Lumbosacral
- What is being tested?
- Reciprocal Inhibition Muscle Energy Technique and Post-Isometric Inhibition Muscle Energy Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- without current low back pain
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of North Georgia
Dahlonega, Georgia, 30597
University of N Georgia, 706-864-1766, reza.nourbakhsh@ung.edu
About this study
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.
Read the detailed description
Reciprocal inhibition MET works based on the two mechanisms a) voluntary activation of agonist muscle that is simultaneously accompanied by the inhibition of the antagonist muscles or b) the activation of muscle spindle which causes a reflexive contraction in the agonist muscle (known as the stretch reflex) and relaxation of the antagonist muscles. By using this method, the activation of agonist muscles may inhibit or deactivate the antagonist muscles which may permit the therapist to introduce further ROM to the affected joint.
The other method of MET is post-isometric relaxation which works based on the two mechanisms including; 1) activation of Golgi Tendon Organs (GTO) that located between the muscle belly and its tendon and 2) presetting muscle spindles by muscle contraction witch project information to the spinal cord via afferent type II fibers and through a complex central control systems, the spindle is preset to adjust the tone of the muscle. It seems that moderate isometric contraction of muscle may preset the muscle spindle and cause a post-isometric relaxation within the agonist muscles which now can be stretched further, and this may permit the therapist to introduce further ROM to the affected joint and help to improve joint mobilization.
- Being tested
- Reciprocal Inhibition Muscle Energy Technique, Post-Isometric Inhibition Muscle Energy Technique
- Keywords
- Spinal Reflex Excitability, Muscle Relaxation, H reflex
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reciprocal Inhibition Muscle Energy TechniqueOther
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.
Post-Isometric Inhibition Muscle Energy TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Reciprocal Inhibition Muscle Energy Technique; Other: 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. Receives: Other: Reciprocal Inhibition Muscle Energy Technique; Other: Post-Isometric Inhibition Muscle Energy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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),
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start6 Jun 2020 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relaxation; JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad(Reza) Nourbakhsh, University of North Georgia
- Investigators
- Mohammad R Nourbakhsh, Principal investigator, Professor of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980106
- Sponsor's protocol ID
- IRB 2019-026
- Status last verified
- Mar 2020
- First submitted
- 5 Jun 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Plan to share individual participant data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Reciprocal Inhibition Method and Post-isometric Inhibition Method of Muscle Energy Technique on the Spinal Reflex Excitability in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03980106
- Acronym / sponsor ID
- IRB 2019-026
- Keywords
- Spinal Reflex Excitability, Muscle Relaxation, H reflex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of North GeorgiaUniversity, hospital or other
- Study start
- 6 Jun 2020 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Reciprocal inhibition MET works based on the two mechanisms a) voluntary activation of agonist muscle that is simultaneously accompanied by the inhibition of the antagonist muscles or b) the activation of muscle spindle which causes a reflexive contraction in the agonist muscle (known as the stretch reflex) and relaxation of the antagonist muscles. By using this method, the activation of agonist muscles may inhibit or deactivate the antagonist muscles which may permit the therapist to introduce further ROM to the affected joint.
The other method of MET is post-isometric relaxation which works based on the two mechanisms including; 1) activation of Golgi Tendon Organs (GTO) that located between the muscle belly and its tendon and 2) presetting muscle spindles by muscle contraction witch project information to the spinal cord via afferent type II fibers and through a complex central control systems, the spindle is preset to adjust the tone of the muscle. It seems that moderate isometric contraction of muscle may preset the muscle spindle and cause a post-isometric relaxation within the agonist muscles which now can be stretched further, and this may permit the therapist to introduce further ROM to the affected joint and help to improve joint mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental RI-PI | Experimental | Other: Reciprocal Inhibition Muscle Energy Technique, Other: Post-Isometric Inhibition Muscle Energy TechniqueThey receive the Reciprocal Inhibition (RI) technique in the first stage and then the Post-isometric Inhibition (PI) technique in the second stage. |
| Experimental PI-RI | Experimental | Other: Reciprocal Inhibition Muscle Energy Technique, Other: Post-Isometric Inhibition Muscle Energy TechniqueThey receive the Post-isometric Inhibition (PI) technique in the first stage and then the Reciprocal Inhibition (RI) technique in the second stage. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- without current low back pain
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reciprocal Inhibition Muscle Energy TechniqueIn 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. | Other | Experimental PI-RI, Experimental RI-PI |
| Post-Isometric Inhibition Muscle Energy TechniqueIn 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. | Other | Experimental PI-RI, Experimental RI-PI |
Primary outcome
Change in H Reflex Amplitude
Time frame: 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)
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),
Change in M wave Amplitude
Time frame: 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)
M- wave is a compound muscle action potential, which is produce by the electrical stimulation of motor nerve fibers (here is Tibial N)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: No. No Plan to share individual participant data to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad R Nourbakhsh principal investigator
Professor of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reciprocal Inhibition Muscle Energy Technique and Post-Isometric Inhibition Muscle Energy Technique in people with Relaxation; Joint and Limitation, Mobility, run by University of North Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad R Nourbakhsh (7068641766, reza.nourbakhsh@ung.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in H Reflex Amplitude (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.