Low Back PainNCT02406807
H-reflex Responses to High-Velocity Low-Amplitude Manipulation
A study testing HVLA manipulation in people with Low Back Pain, run by Instituto Brasileiro de Osteopatia.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- HVLA manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Dec 2014
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: H-reflex Responses to High-Velocity Low-Amplitude Manipulation in Adults With Chronic Non-specific Low Back Pain
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.
Read the detailed 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.
- Conditions
- Low Back Pain
- Being tested
- HVLA manipulation, Sham Spinal lumbar manipulation
- Keywords
- chronic low back pain, HVLA manipulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVLA manipulationOther
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 manipulationOther
Sham manipulation
| Study group | Role | What they receive |
|---|---|---|
| HVLA manipulation | Experimental | Osteopathic high velocity, and low amplitude spinal lumbar manipulation Receives: Other: HVLA manipulation |
| Sham Spinal lumbar manipulation | Sham comparator | Just position in the side lying and not performed the high velocity and low amplitude Receives: Other: Sham Spinal lumbar manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
H-reflex measured by the electroneurophysiologic
Electroneurophysiologic
Measured: Within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Brasileiro de Osteopatia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Groisman, PT, DO, MSc, Instituto Brasileiro de Osteopatia
- Investigators
- Sandro Groisman, Ms, Principal investigator, IBO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406807
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2015
- First submitted
- 18 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H-reflex Responses to High-Velocity Low-Amplitude Manipulation in Adults With Chronic Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT02406807
- Acronym / sponsor ID
- 001
- Conditions
- Low Back Pain
- Keywords
- chronic low back pain, HVLA manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Instituto Brasileiro de OsteopatiaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Apr 2015 (estimated)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HVLA manipulation | Experimental | Other: HVLA manipulationOsteopathic high velocity, and low amplitude spinal lumbar manipulation |
| Sham Spinal lumbar manipulation | Sham comparator | Other: Sham Spinal lumbar manipulationJust position in the side lying and not performed the high velocity and low amplitude |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| HVLA manipulationparticipant 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. | Other | HVLA manipulation |
| Sham Spinal lumbar manipulationSham manipulation | Other | Sham Spinal lumbar manipulation |
Primary outcome
H-reflex measured by the electroneurophysiologic
Time frame: Within one day
Electroneurophysiologic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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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.
Sandro Groisman, Ms principal investigator
IBO
Questions about this trial
What is this clinical trial studying?
A study testing HVLA manipulation in people with Low Back Pain, run by Instituto Brasileiro de Osteopatia.
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 4 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: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H-reflex measured by the electroneurophysiologic (time frame: Within one day). 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 2 Apr 2015.