H-reflex Responses to High-Velocity Low-Amplitude Manipulation

Low Back Pain Clinical Trial

Official title:

H-reflex Responses to High-Velocity Low-Amplitude Manipulation in Adults With Chronic Non-specific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406807
• Other study ID #: 001
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: March 30, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Instituto Brasileiro de Osteopatia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Osteopathic Manipulative Treatment (OMT) is a health science that addresses treatment to somatic dysfunction among other conditions. High-Velocity Low-Amplitude (HVLA) manipulation is a known technique, defined as a quick and short force applied to a segment with movement restriction.

Somatic Dysfunction (SD) is the impaired or altered function of the components of the somatic system: skeletal, articular and myofascial elements with their vascular, lymphatic and neural related structures. The palpatory diagnosis of the SD is based on the presence of any of the 4 TART (Tenderness, Asymmetry, Range of motion and Tissue texture change) criteria, taking into account the information provided about pain and discomfort.

There is no evidence to support the use of the term 'somatic dysfunction' and moreover, the diagnosis is based on palpatory skills. Therefore, the investigators chose the term Restriction of Movement (RM) to describe the subjectivity of the palpatory examination.

HVLA manipulation produces neurophysiological and mechanic effects. The mechanical effects described in the literature are: meniscoids release, intervertebral disc material and segmental adhesions. The neurophysiological effects occur through the stimulation of mechanoreceptors and nociceptors located in the paravertebral tissues, including the skin, muscles, tendons, ligaments, zygapophyseal joints and intervertebral discs. This changes the influx of sensory information into the Central Nervous System (CNS), and this effect can be measured by the H-reflex (reflex analogous to the spinal stretch reflex). Thus, this is a valuable tool in the assessment of α-motor neuron excitability.

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.

Most of the studies analyzed recruited healthy participants, and have found transient attenuation of α-motor neuron activity; but one study found that the manipulation does not affect the H-reflex in healthy participants. These authors attributed the findings to the change of position between intervention and assessment. In addition, the intervention was addressed to sacroiliac joint instead of the L5-S1 segment, as performed in other previous studies.

Another study assessed the effects of manipulation without changing participants' position, but unlike the study of Suter et al., the intervention was addressed to the lumbosacral joint (L5-S1) and they concluded that changing body position does not affect the H-reflex attenuation.

Therefore, the studies show divergent results for HVLA manipulation and H-reflex response, and to better understand the research problem, the investigators conducted a previous study in 20 healthy participants to assess the effects of HVLA manipulation on H-reflex and they found a transient H-reflex attenuation only in six participants.

These findings could have been affected by the presence of RM at the level L5-S1 and also by the presence of dysfunction of the Autonomic Nervous System (ANS), which is processed at medullar level and runs along neural pathways, similar to somatic afferent and efferent information.

To quantify ANS activity, one could use Nerve-Express - a device to assess heart rate variability based on RR (rate-rate) intervals. This method is used because of the major role the ANS plays on the cardiovascular system. Studies have shown the effects of cervical and lumbar HVLA manipulation on heart rate variability and on balancing the ANS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• HVLA manipulation
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.
• Sham Spinal lumbar manipulation
Sham manipulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Osteopatia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H-reflex measured by the electroneurophysiologic	Electroneurophysiologic	Within one day	No