H-reflex Responses to High-Velocity Low-Amplitude Manipulation
1 other identifier
interventional
28
0 countries
N/A
Brief Summary
High-Velocity Low-Amplitude (HVLA) manipulation is a known technique of the Osteopathic Manipulative Treatment (OMT) for somatic dysfunction (SD), and heart rate variability and H-reflex response are possible variables to assess its neurophysiological effects. Somatic dysfunction is an impairment or altered function of related components of the somatic system. Studies show a transient attenuation of α-motor neuron excitability after HVLA manipulation in asymptomatic participants. According to studies, HVLA spinal manipulation increases joint mobility by blocking afferent impulses in the muscle spindle and the small-diameter free nerve, decreasing the γ-motor neuron activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started May 2012
Longer than P75 for not_applicable low-back-pain
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
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedApril 2, 2015
March 1, 2015
2.6 years
March 18, 2015
March 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
H-reflex measured by the electroneurophysiologic
Electroneurophysiologic
Within one day
Study Arms (2)
HVLA manipulation
EXPERIMENTALOsteopathic high velocity, and low amplitude spinal lumbar manipulation
Sham Spinal lumbar manipulation
SHAM COMPARATORJust position in the side lying and not performed the high velocity and low amplitude
Interventions
participant is laying on the left side, the practitioner stands in front of the participant's abdomen. The practitioner contacts the interspinous space of the L5-S1 level with the caudal; with the cephalic hand, the practitioner rotates the participant's upper body until a sense of tension is palpated at the L5-S1 segment. The practitioner places his cephalic hand at interspinous, brings participant's leg to a flexion and places the foot at the popliteal fossa, places the forearm at the participant's deltopectoral groove and the caudal forearm at the gluteal region. Following the participant's expiration, the practitioner brings the L5-S1 level to the restrictive barrier by rotating the trunk and hips to opposite directions.
Eligibility Criteria
You may qualify if:
- participants of both gender,
- aged between 20 and 50 years,
- healthy participants and
- participants diagnosed with non-specific chronic low back pain and healthy participants.
You may not qualify if:
- participants referring radiating pain to the lower limbs and any other symptoms compatible with nerve root entrapment, knee or hip degenerative diseases and abdominal pain
- participants from whom it was not possible to record the H-reflex and
- participants with absolute contraindication to HVLA manipulation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandro Groisman, Ms
IBO
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DO
Study Record Dates
First Submitted
March 18, 2015
First Posted
April 2, 2015
Study Start
May 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 2, 2015
Record last verified: 2015-03