NCT02406807

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

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable low-back-pain

Status
completed

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

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

2.6 years

First QC Date

March 18, 2015

Last Update Submit

March 30, 2015

Conditions

Keywords

chronic low back painHVLA manipulation

Outcome Measures

Primary Outcomes (1)

  • H-reflex measured by the electroneurophysiologic

    Electroneurophysiologic

    Within one day

Study Arms (2)

HVLA manipulation

EXPERIMENTAL

Osteopathic high velocity, and low amplitude spinal lumbar manipulation

Other: HVLA manipulation

Sham Spinal lumbar manipulation

SHAM COMPARATOR

Just position in the side lying and not performed the high velocity and low amplitude

Other: Sham Spinal lumbar manipulation

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.

HVLA manipulation

Sham manipulation

Sham Spinal lumbar manipulation

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sandro Groisman, Ms

    IBO

    PRINCIPAL INVESTIGATOR

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