The Effect of Manipulations of the Lumbar Spine on Six Different Outcome Measures
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

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)
    

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.
    

Intervention name(s): AAI signature IV AMCT
Intervention type(s): Device
Intervention description(s): Chiropractic adjustments of the lumbar spine following the activator basic scan protocol
Other intervention name(s): Activator adjusting instrument signature series version IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Activator; EMG; Thermography; Diagnostic; X-Rays