Low Back PainNCT00739570
The Effect of Manipulations of the Lumbar Spine on Six Different Outcome Measures
A study testing AAI signature IV AMCT in people with Low Back Pain, run by Université du Québec a Montréal at 1 site in Canada.
Trial summary
1. Evaluation of the effect of a chiropractic adjustment (Manually Assisted Mechanical Force)on 2. surface Static EMG 3. Paraspinal cutaneous temperature 4. Range of Motion 5. Dynamic EMG 6. Blood hormones (Interleukin-6 and C-Reactive protein) Read more about this study
- Who is it for?
- Ages 18 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- AAI signature IV AMCT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Aug 2008
- 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 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants
- Written informed consent was obtained from all participants.
- Control group
- The inclusion criterion:
- All participants were receiving maintenance chiropractic care
- All participants would not have any treatment during the two week span of the research project
Show all 11Show fewer
- All participants were examined and x-rayed and were evaluated for all the same outcome measures.
- Treatment group:
- All participants were recruited via an announcement in the newspaper, Le Messager de LaSalle, during the period from July 6th to the 20th 2008.
- The participants were suffering from a chronic low back condition of at least three months in duration.
- All participants were examined and x-rayed and were evaluated for all the same outcome measures.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Manipulations of the Lumbar Spine on Six Different Outcome Measures.
- Evaluation of the effect of a chiropractic adjustment (Manually Assisted Mechanical Force)on
- surface Static EMG
- Paraspinal cutaneous temperature
- Range of Motion
- Dynamic EMG
- Blood hormones (Interleukin-6 and C-Reactive protein)
Read the detailed description
The chiropractic profession utilizes different outcome measures to evaluate and validate the chiropractic adjustments or the necessity for care. Some of these outcome measures have never been compared to each other under the same treatment and trials. In addition, blood analysis was added to measure the change in the inflammatory processes for the treatment period.
Outcome measures The outcome measures that we measured are: activities of daily living questionnaire (Oswestry disability index) , Interleukin-6 (IL-6), C-Reactive Protein (CRP), lateral bending x-ray analysis, heart rate variability (HRV), paraspinal temperature, paraspinal surface EMG (sEMG) static and dynamic (flexion, lateral bending and rotation) and the range of motion (ROM) in flexion and extension.
Activities of daily living questionnaire The modified Oswestry disability index 25 was utilized. It comprises ten questions that evaluate the capacity of the patient to function doing his daily activities and how the patient rates himself on a scale from A to F. The value of A= 0 and each subsequent letter as an ascending numerical value, B=1 to F=5. The maximum total for all ten questions is 50. The total for all the answers is tabulated and multiplied by two to give a percentage of dysfunction due to lumbar pain.
Blood Samples The blood samples were collected for Interleukin-6 (IL-6) and for C-Reactive Protein (CRP), by a trained nurse with a valid license for the province of Quebec. The IL-6 blood sample was collected in a lavender tube (4.0 ml, BD Vacutainer, K2 EDTA, lot 7344830, BD, Franklin Lakes, New Jersey, USA) and the sample was left at room temperature for 15 minutes then it was centrifuge for 15 minutes at 1000g, it was immediately decanted and the plasma was transferred via disposable transfer pipette ( Category number 13-711-7 Fisher Scientific, Pittsburgh, Pennsylvania, USA) into Eppendorf tubes (Sarstedt, Nümbrecth, Germany), the tube was closed and the tube was put on dry ice until it was delivered at the laboratory of the Hôpital St-Luc in Montréal. The CRP blood sample was collected in a yellow tube (5.0 ml, BD Vacutainer, SST, lot 8032322, BD, Franklin Lakes, New Jersey, USA) and the sample was left at room temperature for 15 minutes then it was centrifuge for 15 minutes at 1000g, it was immediately decanted and the serum was transferred via disposable transfer pipette ( Category number 13-711-7Fisher Scientific, Pittsburgh, Pennsylvania, USA) into Eppendorf tubes (Sarstedt, Nümbrecth, Germany), the tube was closed and the tube was put on dry ice until it was delivered at the laboratory of the Hôpital St-Luc in Montréal. All the needles were disposed after a single use in a biohazard container (BD, Sharps collector, reference number 305648, lot 7103001, BD Medical, Oakville, Ontario) provided by the Centre Local de Services de Santé (C.L.S.C.), an organism from the Quebec Ministry of Health. The analyses were performed at the laboratory of Hôpital St-Luc in Montreal under the supervision of Dr. Line Labrecque PhD in biochemistry. The results were provided by electronic means with the patient's code.
X-ray analysis The participants were x-rayed for the lumbar spine. AP lateral bending films in the left and right lateral bending position 27, 28, 29 were taken in the end position of the movement as the patient would stop once the end position was reached; the central ray was going through an area seven to eight centimeters above the top of the iliac crest. The lateral film was done with the central ray going through L-5. The radiographs were analyzed by two independent chiropractors, one chiropractor did the pre treatment analysis and the other chiropractor did the post analysis. The treating chiropractor was allowed to view the radiographs, for the purpose of treatment, after the initial analyses were terminated.
HRV measurement and analysis. A commercially available heart rate monitor (Suunto watch, model T6, FitzWright Company Ltd., Langley, BC, Canada) was used. The data recordings obtained from the heart rate monitor were analyzed for a five minute interval starting at the 80 Hz mark, in order to eliminate "bruit" from the initial positioning of the subject on the table, finishing at the 380 Hz mark,. The analysis was performed with a personal computer using custom software 15 (Kubios, Biosignal Analysis and Medical Imaging Group, Department of Physics, University of Kuopio, Kuopio, Finland) for several HRV parameters, as described below. As well, as mentioned above, there were no attempts to blind the assessment since the data were recorded directly into the heart rate monitor. Thus, the examiner could not know the value during measurement. The risk of influencing HRV was kept to a minimum by insuring that the interaction, between the subject and the examiner, limited itself to the installation and removal of the recording apparatus.
HRV Variables. The following variables were evaluated, mean R-R interval (Mean RR), the standard deviation between r-r intervals (SDNN), the number of pairs of adjacent NN intervals differing by more than 50 ms (NN 50 Count) and the proportion of NN intervals differing by more than 50 ms = NN50 divided by total number of NN intervals (pNN 50%), the very low frequency between (VLF); the normalized spectral components between 0 and 0.04 Hz , the low frequency (LF); similarly, the normalized spectral components between 0.04 and 0.15 Hz, the high frequency (HF); the normalized spectral power components were summed between 0.15 and 0.4 Hz and the ratio LF/HF 16. The HF band is related to the parasympathetic nervous system efferent activity 17 and is synchronized to respiratory rhythms 16. The LF band is related to both the sympathetic nervous system and parasympathetic nervous system efferent activity 18 and the cardiac sympathetic and parasympathetic nerve activity 16. The VLF band is not well defined but appears to be related to thermoregulation 16 renin-angiotensin-aldosterone systems 19-20, parasympathetic mechanisms 21, both the parasympathetic 21 and sympathetic branches of ANS affect VLF 22 and the humoral system 23, 24. The LF/HF ratio is used to indicate balance between the sympathetic nervous system and parasympathetic nervous system efferent tone 18. Thus, a change in this score might indicate either a parasympathetic nervous system or a sympathetic nervous system tonal change.
Myovision Instrumentation package The sEMG static and dynamic were connected to the Myovision 8000™ performance multi function sEMG (serial number 833830, Precision Biometrics Inc. 981-A Industrial Road San Carlos, California, USA. 94070). The thermal, ROM probes and the Myovision 8000™ were connected in the vision port 2 (serial number H002973, Precision Biometrics Inc. 981-A Industrial Road San Carlos, California, USA. 94070). The Vision port™ was connected to the computer via a USB connector.
- Conditions
- Low Back Pain
- Being tested
- AAI signature IV AMCT
- Keywords
- Activator, EMG, Thermography, Diagnostic, X-Rays
- Medical subject headings
- Low Back Pain, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAI signature IV AMCTDevice
Also called Activator adjusting instrument signature series version IV
Chiropractic adjustments of the lumbar spine following the activator basic scan protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Active comparator | Activator chiropractic technique basic scan protocol Receives: Device: AAI signature IV AMCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index, Functional x-rays, Range of Motion, Static EMG, Dynamic EMG, Paraspinal cutaneous temperature,
Measured: August 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2008
- Study completionAug 2008
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT00739570
- Sponsor's protocol ID
- 071970
- Status last verified
- Aug 2008
- First submitted
- 20 Aug 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manipulations of the Lumbar Spine on Six Different Outcome Measures.
- ClinicalTrials.gov ID
- NCT00739570
- Acronym / sponsor ID
- 071970
- Conditions
- Low Back Pain
- Keywords
- Activator, EMG, Thermography, Diagnostic, X-Rays
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Université du Québec a MontréalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 21 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.
- Evaluation of the effect of a chiropractic adjustment (Manually Assisted Mechanical Force)on
- surface Static EMG
- Paraspinal cutaneous temperature
- Range of Motion
- Dynamic EMG
- Blood hormones (Interleukin-6 and C-Reactive protein)
Detailed description
The chiropractic profession utilizes different outcome measures to evaluate and validate the chiropractic adjustments or the necessity for care. Some of these outcome measures have never been compared to each other under the same treatment and trials. In addition, blood analysis was added to measure the change in the inflammatory processes for the treatment period.
Outcome measures The outcome measures that we measured are: activities of daily living questionnaire (Oswestry disability index) , Interleukin-6 (IL-6), C-Reactive Protein (CRP), lateral bending x-ray analysis, heart rate variability (HRV), paraspinal temperature, paraspinal surface EMG (sEMG) static and dynamic (flexion, lateral bending and rotation) and the range of motion (ROM) in flexion and extension.
Activities of daily living questionnaire The modified Oswestry disability index 25 was utilized. It comprises ten questions that evaluate the capacity of the patient to function doing his daily activities and how the patient rates himself on a scale from A to F. The value of A= 0 and each subsequent letter as an ascending numerical value, B=1 to F=5. The maximum total for all ten questions is 50. The total for all the answers is tabulated and multiplied by two to give a percentage of dysfunction due to lumbar pain.
Blood Samples The blood samples were collected for Interleukin-6 (IL-6) and for C-Reactive Protein (CRP), by a trained nurse with a valid license for the province of Quebec. The IL-6 blood sample was collected in a lavender tube (4.0 ml, BD Vacutainer, K2 EDTA, lot 7344830, BD, Franklin Lakes, New Jersey, USA) and the sample was left at room temperature for 15 minutes then it was centrifuge for 15 minutes at 1000g, it was immediately decanted and the plasma was transferred via disposable transfer pipette ( Category number 13-711-7 Fisher Scientific, Pittsburgh, Pennsylvania, USA) into Eppendorf tubes (Sarstedt, Nümbrecth, Germany), the tube was closed and the tube was put on dry ice until it was delivered at the laboratory of the Hôpital St-Luc in Montréal. The CRP blood sample was collected in a yellow tube (5.0 ml, BD Vacutainer, SST, lot 8032322, BD, Franklin Lakes, New Jersey, USA) and the sample was left at room temperature for 15 minutes then it was centrifuge for 15 minutes at 1000g, it was immediately decanted and the serum was transferred via disposable transfer pipette ( Category number 13-711-7Fisher Scientific, Pittsburgh, Pennsylvania, USA) into Eppendorf tubes (Sarstedt, Nümbrecth, Germany), the tube was closed and the tube was put on dry ice until it was delivered at the laboratory of the Hôpital St-Luc in Montréal. All the needles were disposed after a single use in a biohazard container (BD, Sharps collector, reference number 305648, lot 7103001, BD Medical, Oakville, Ontario) provided by the Centre Local de Services de Santé (C.L.S.C.), an organism from the Quebec Ministry of Health. The analyses were performed at the laboratory of Hôpital St-Luc in Montreal under the supervision of Dr. Line Labrecque PhD in biochemistry. The results were provided by electronic means with the patient's code.
X-ray analysis The participants were x-rayed for the lumbar spine. AP lateral bending films in the left and right lateral bending position 27, 28, 29 were taken in the end position of the movement as the patient would stop once the end position was reached; the central ray was going through an area seven to eight centimeters above the top of the iliac crest. The lateral film was done with the central ray going through L-5. The radiographs were analyzed by two independent chiropractors, one chiropractor did the pre treatment analysis and the other chiropractor did the post analysis. The treating chiropractor was allowed to view the radiographs, for the purpose of treatment, after the initial analyses were terminated.
HRV measurement and analysis. A commercially available heart rate monitor (Suunto watch, model T6, FitzWright Company Ltd., Langley, BC, Canada) was used. The data recordings obtained from the heart rate monitor were analyzed for a five minute interval starting at the 80 Hz mark, in order to eliminate "bruit" from the initial positioning of the subject on the table, finishing at the 380 Hz mark,. The analysis was performed with a personal computer using custom software 15 (Kubios, Biosignal Analysis and Medical Imaging Group, Department of Physics, University of Kuopio, Kuopio, Finland) for several HRV parameters, as described below. As well, as mentioned above, there were no attempts to blind the assessment since the data were recorded directly into the heart rate monitor. Thus, the examiner could not know the value during measurement. The risk of influencing HRV was kept to a minimum by insuring that the interaction, between the subject and the examiner, limited itself to the installation and removal of the recording apparatus.
HRV Variables. The following variables were evaluated, mean R-R interval (Mean RR), the standard deviation between r-r intervals (SDNN), the number of pairs of adjacent NN intervals differing by more than 50 ms (NN 50 Count) and the proportion of NN intervals differing by more than 50 ms = NN50 divided by total number of NN intervals (pNN 50%), the very low frequency between (VLF); the normalized spectral components between 0 and 0.04 Hz , the low frequency (LF); similarly, the normalized spectral components between 0.04 and 0.15 Hz, the high frequency (HF); the normalized spectral power components were summed between 0.15 and 0.4 Hz and the ratio LF/HF 16. The HF band is related to the parasympathetic nervous system efferent activity 17 and is synchronized to respiratory rhythms 16. The LF band is related to both the sympathetic nervous system and parasympathetic nervous system efferent activity 18 and the cardiac sympathetic and parasympathetic nerve activity 16. The VLF band is not well defined but appears to be related to thermoregulation 16 renin-angiotensin-aldosterone systems 19-20, parasympathetic mechanisms 21, both the parasympathetic 21 and sympathetic branches of ANS affect VLF 22 and the humoral system 23, 24. The LF/HF ratio is used to indicate balance between the sympathetic nervous system and parasympathetic nervous system efferent tone 18. Thus, a change in this score might indicate either a parasympathetic nervous system or a sympathetic nervous system tonal change.
Myovision Instrumentation package The sEMG static and dynamic were connected to the Myovision 8000™ performance multi function sEMG (serial number 833830, Precision Biometrics Inc. 981-A Industrial Road San Carlos, California, USA. 94070). The thermal, ROM probes and the Myovision 8000™ were connected in the vision port 2 (serial number H002973, Precision Biometrics Inc. 981-A Industrial Road San Carlos, California, USA. 94070). The Vision port™ was connected to the computer via a USB connector.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Active comparator | Device: AAI signature IV AMCTActivator chiropractic technique basic scan protocol |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants
- Written informed consent was obtained from all participants.
- Control group
- All participants were receiving maintenance chiropractic care
- All participants would not have any treatment during the two week span of the research project
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AAI signature IV AMCTAlso: Activator adjusting instrument signature series version IVChiropractic adjustments of the lumbar spine following the activator basic scan protocol | Device | 2 |
Primary outcome
Oswestry Disability Index, Functional x-rays, Range of Motion, Static EMG, Dynamic EMG, Paraspinal cutaneous temperature,
Time frame: August 2008
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 25 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAI signature IV AMCT in people with Low Back Pain, run by Université du Québec a Montréal at 1 site 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 11 inclusion and 1 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 25 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 1 site 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. 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?
Oswestry Disability Index, Functional x-rays, Range of Motion, Static EMG, Dynamic EMG, Paraspinal cutaneous temperature, (time frame: August 2008). 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 25 Aug 2008.