Low Back PainNCT00740558
Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain
A study testing Activator methods technique and Traditional chiropractic adjustment in people with Low Back Pain, run by Université du Québec a Montréal at 2 sites in Canada.
Trial summary
Background The purpose of this study was to examine the heart rate variability (HRV) in the presence or the absence of pain in the lower back (L5), while receiving chiropractic care. Methods A total of 53 healthy participants were randomly assigned to a control, 2 treatment or 2 sham groups (n = 10 per group). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Activator methods technique and Traditional chiropractic adjustment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2004to Jul 2006
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acute low back pain (pain group)
- Maintenance care for the pain free group and the control group
Who cannot join
- For the control group (pain)
- For the non pain group pain
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Chiro-clinique Richard Roy
LaSalle, Quebec, H8N 1X7
Dr Richard Roy et Dr Fafard
LaSalle, Quebec, H8N1X7
About this study
Background
The purpose of this study was to examine the heart rate variability (HRV) in the presence or the absence of pain in the lower back (L5), while receiving chiropractic care.
Methods
A total of 53 healthy participants were randomly assigned to a control, 2 treatment or 2 sham groups (n = 10 per group). Participants underwent an eight-minute acclimatizing period. The HRV tachygram (RR interval) data were recorded directly into a Suunto watch (model T6). The investigators analyzed the five minute pre-treatment and post treatments intervals. The spectral analysis of the tachygram was performed with the Kubios Software (University of Kuopio, Finland).
Read the detailed description
Background The chiropractic profession has in the past utilized research results from other fields of and extrapolated them into their science and clinical interpretation 1-4. More recently, chiropractic researchers looked into autonomic nervous system (ANS) adaptations in an animal model following a mechanical stress to the spinal column 5, a noxious mechanical stimulation 6 or a spinal manipulation 7.
In the human model, several investigations have been done to measure modifications of the heart rate variability (HRV) following cervical 8 and thoracic manipulations 9 or in a multisite clinical study 10 where details of the manipulation site were not provided. The site of interest for the chiropractic intervention was defined at the level of the lumbar spine, left and right L-5. This site was selected because most studies 8-10 measuring HRV have used the cervical or thoracic component of the spine. The effect of the lumbar parasympathetic nervous system has not been evaluated. In these studies 8-10, changes were observed in various HRV variables, while in two of those studies 8, 9, where sham groups were included, the sham conditions did not demonstrate any changes in the reported HRV parameters. There are strong indications that HRV is a good marker of ANS activity 19-24. Thus, in the three above mentioned studies, it appears that chiropractic interventions have an effect on the ANS.
At present, however, no studies to evaluate whether a lumbar spinal manipulation would produce a change in the HRV have been reported. Thus, the present study seeks to measure the effect of a lumbar adjustment, with a manually assisted mechanical force, producing a chiropractic adjustment, in participants without lumbar pain and a traditional adjustment in participants with lumbar pain on HRV. The hypothesis being that a lumbar intervention would have an acute effect on the ANS as demonstrated by the modulation of HRV variables.
- Conditions
- Low Back Pain
- Being tested
- Activator methods technique, Traditional chiropractic adjustment
- Keywords
- HRV, Activator, Chiropractic, VLF, HF, LF, LF/HF
- 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.
Activator methods techniqueProcedure or surgery
Also called Activator methods
Chiropractic adjustment by a manually assisted mechanical force
Traditional chiropractic adjustmentProcedure or surgery
Also called Lumbar roll
Lumbar roll according to the Diversified technique of chiropractic adjusting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Two groups received a traditional chiropractic adjustment of the lumbar 5 and the other group received a manually assisted mechanical force adjustment of the lumbar 5. Receives: Procedure: Activator methods technique; Procedure: Traditional chiropractic adjustment |
| 2 | Sham comparator | The investigators had two groups, one for each chiropractic technique used in the research project and we had a control group Receives: Procedure: Activator methods technique; Procedure: Traditional chiropractic adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean R-R interval, the number of pairs of adjacent NN intervals differing by more than 50 ms, and the proportion of NN intervals differing by more than 50 ms the very low frequency, the low frequency, the high frequency, the LF/HF ratio
Measured: Pre and post measurements of one intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startJul 2004
- Primary completionJul 2006
- Study completionJul 2006
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec a Montréal
- Sponsor type
- University, hospital or other
- Investigators
- Richard A Roy, DCMScPhD(c), Principal investigator, Université du Québec a Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740558
- Sponsor's protocol ID
- 051934
- Status last verified
- Aug 2008
- First submitted
- 22 Aug 2008
- Last updated
- 27 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability Modulation Following a Manipulation in Pain Free Patients Versus Patients in Pain
- ClinicalTrials.gov ID
- NCT00740558
- Acronym / sponsor ID
- 051934
- Conditions
- Low Back Pain
- Keywords
- HRV, Activator, Chiropractic, VLF, HF, LF, LF/HF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Université du Québec a MontréalUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 25 Aug 2008 (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.
Background
The purpose of this study was to examine the heart rate variability (HRV) in the presence or the absence of pain in the lower back (L5), while receiving chiropractic care.
Methods
A total of 53 healthy participants were randomly assigned to a control, 2 treatment or 2 sham groups (n = 10 per group). Participants underwent an eight-minute acclimatizing period. The HRV tachygram (RR interval) data were recorded directly into a Suunto watch (model T6). The investigators analyzed the five minute pre-treatment and post treatments intervals. The spectral analysis of the tachygram was performed with the Kubios Software (University of Kuopio, Finland).
Detailed description
Background The chiropractic profession has in the past utilized research results from other fields of and extrapolated them into their science and clinical interpretation 1-4. More recently, chiropractic researchers looked into autonomic nervous system (ANS) adaptations in an animal model following a mechanical stress to the spinal column 5, a noxious mechanical stimulation 6 or a spinal manipulation 7.
In the human model, several investigations have been done to measure modifications of the heart rate variability (HRV) following cervical 8 and thoracic manipulations 9 or in a multisite clinical study 10 where details of the manipulation site were not provided. The site of interest for the chiropractic intervention was defined at the level of the lumbar spine, left and right L-5. This site was selected because most studies 8-10 measuring HRV have used the cervical or thoracic component of the spine. The effect of the lumbar parasympathetic nervous system has not been evaluated. In these studies 8-10, changes were observed in various HRV variables, while in two of those studies 8, 9, where sham groups were included, the sham conditions did not demonstrate any changes in the reported HRV parameters. There are strong indications that HRV is a good marker of ANS activity 19-24. Thus, in the three above mentioned studies, it appears that chiropractic interventions have an effect on the ANS.
At present, however, no studies to evaluate whether a lumbar spinal manipulation would produce a change in the HRV have been reported. Thus, the present study seeks to measure the effect of a lumbar adjustment, with a manually assisted mechanical force, producing a chiropractic adjustment, in participants without lumbar pain and a traditional adjustment in participants with lumbar pain on HRV. The hypothesis being that a lumbar intervention would have an acute effect on the ANS as demonstrated by the modulation of HRV variables.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Activator methods technique, Procedure: Traditional chiropractic adjustmentTwo groups received a traditional chiropractic adjustment of the lumbar 5 and the other group received a manually assisted mechanical force adjustment of the lumbar 5. |
| 2 | Sham comparator | Procedure: Activator methods technique, Procedure: Traditional chiropractic adjustmentThe investigators had two groups, one for each chiropractic technique used in the research project and we had a control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute low back pain (pain group)
- Maintenance care for the pain free group and the control group
Key exclusion criteria (2 listed)
- For the control group (pain)
- For the non pain group pain
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 |
|---|---|---|
| Activator methods techniqueAlso: Activator methodsChiropractic adjustment by a manually assisted mechanical force | Procedure or surgery | 1, 2 |
| Traditional chiropractic adjustmentAlso: Lumbar rollLumbar roll according to the Diversified technique of chiropractic adjusting | Procedure or surgery | 1, 2 |
Primary outcome
Mean R-R interval, the number of pairs of adjacent NN intervals differing by more than 50 ms, and the proportion of NN intervals differing by more than 50 ms the very low frequency, the low frequency, the high frequency, the LF/HF ratio
Time frame: Pre and post measurements of one intervention
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 27 Aug 2008.
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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.
Richard A Roy, DCMScPhD(c) principal investigator
Université du Québec a Montréal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activator methods technique and Traditional chiropractic adjustment in people with Low Back Pain, run by Université du Québec a Montréal at 2 sites in Canada.
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 2 inclusion and 2 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 27 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. 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?
Mean R-R interval, the number of pairs of adjacent NN intervals differing by more than 50 ms, and the proportion of NN intervals differing by more than 50 ms the very low frequency, the low frequency, the high frequency, the LF/HF ratio (time frame: Pre and post measurements of one intervention). 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 27 Aug 2008.