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Patient Response to Spinal Manipulation (PRiSM)

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ClinicalTrials.gov Identifier: NCT01670292
Recruitment Status : Completed
First Posted : August 22, 2012
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a biomechanical study which is Project 1 in the Developmental Center for Clinical and Translational Research in Chiropractic (DCRC I) (NIH/NCCAM grant 1 U19 AT004663-01; principal investigator Christine Goertz, DC, PhD). This study is designed to monitor both physiological and patient self-report outcome variables. In addition, as there is little quantitative information on Spinal Manipulation Technique procedures reported in clinical trials, the study is designed to collect preliminary kinetic measures of the spinal manipulation technique delivery (i.e. force-time profiles).

Condition or disease Intervention/treatment
Low Back Pain Other: HVLA-SM

Detailed Description:

Participants with narrowly defined chronic low back pain will be included in this study. Each participant will be treated 12 times over the course of 6 weeks. The following data will be collected: participant characteristics that may predict outcome or be modifiers of force used by provider (gender, age, height, weight, and Body Mass Index); spinal segment load during the pre-load and thrusting phases (force and moment in the pre-load phase, peak load, and loading rate); physiological measures (posterior-anterior global stiffness and flexion-relaxation); patient-centered outcomes of back pain and function; and adverse events.

Study participants (n= 80) will be recruited from the Quad Cities metro area. A team of experienced chiropractic clinicians working at the Palmer Center for Chiropractic Research will treat study participants. Each of the study participants will receive 2 High Velocity Low Amplitude Spinal Manipulation treatment visits per week over a 6 week period. The physiological assessments will be performed immediately before and after Spinal Manipulation delivery during treatment visits 1, 5 & 12 (6 sets of assessments in total). During these same treatment visits, we will also capture the kinetic measures during Spinal Manipulation delivery for spinal segment load analysis. Participant patient-centered outcomes will be measured at baseline 1, and treatment visits 6 and 13. For simplicity, data collection time points will be named as baseline, after 2 weeks, and after 6 weeks.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Response to Spinal Manipulation
Study Start Date : September 2012
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: HVLA-SM
Experimental High Velocity Low Amplitude Spinal Manipulation
Other: HVLA-SM
High Velocity Low Amplitude Spinal Manipulation


Outcome Measures

Primary Outcome Measures :
  1. Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ) [ Time Frame: Baseline to 6 weeks ]

    VAS - Visual Analog Scale - Scale: 0-100 mm (anchors: 0 mm = No Pain, 100 mm = Worst Imaginable Pain). VAS Interpretation: A higher score indicates greater pain intensity. In this study, improvement of 30% from the baseline value was considered clinically significant.

    RMDQ - Roland Morris disability questionnaire - Scale: 0 (no disability) to 24 (maximum disability). RMDQ Interpretation: Greater levels of disability are reflected by higher scores. In this study, improvement of 30% from the baseline value was considered clinically significant.


  2. Lumbar-spine Stiffness (LSS) [ Time Frame: Baseline, 2 weeks, 6 weeks ]

    LSS* contains 5 variables: global stiffness (GS, unit: Newton/mm) at L3 from 1) hand palpation 2) a hand-held device & 3) an automated indenter device; global stiffness variation (GSV, unit: Newton/mm) between GS from L1 to L5 from 4) hand palpation & 5) a hand-held device.

    *LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.


  3. Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation [ Time Frame: Baseline, 2 weeks, 6 weeks ]

    LSS contains 2 variables: Palpatory and Handheld device - normalized global stiffness variation (nGSV, unitless).

    LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, lower than normal.


  4. Flexion-Relaxation Ratio (FRR) [ Time Frame: Baseline, 2 weeks, 6 weeks ]

    FRR contains 4 variables, which are the average right and left back muscle FRR obtained using 1) maximum EMG during flexion, and 2) maximum EMG during extension to normalize EMG during full flexion; and asymmetry between the right and left back muscle FRRs using 3) maximum EMG during flexion, and 4) maximum EMG during extension to normalize EMG during full flexion

    FRR Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal.



Secondary Outcome Measures :
  1. Kinetic Measure - Spinal Segment Load (SSL) Force [ Time Frame: 6 weeks ]

    SSL* contains variables: maximum amplitude (Newton) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).

    *Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.

    Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.


  2. Kinetic Measure - Spinal Segment Load (SSL) Moment [ Time Frame: 6 weeks ]

    SSL* contains variables: maximum amplitude (Newton*Meter for moment) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).

    *Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.

    Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.


  3. Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force [ Time Frame: 6 weeks ]

    SSL* contains variables: rate of loading for force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).

    *Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.

    Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.


  4. Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment [ Time Frame: 6 weeks ]

    SSL* contains variables: rate of loading for moment in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).

    *Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.

    Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6.


  5. PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale [ Time Frame: Baseline, 2 weeks, 6 weeks ]

    1) The questionnaire contains 7 PROMIS-29 specific items: Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction with Participation in Social Role (anchors: 1= 'Not at all', 5= 'Very much', higher score is worse).

    Each PROMIS-29 specific item is reported in raw score (4-20) and scored in T-score (T), which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 for a population.

    On the T-score metric & interpretation:

    • A score of 40 is one SD lower than the mean of the reference population.
    • A score of 60 is one SD higher than the mean of the reference population.
    • For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

  6. PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    1) The PROMIS questionnaire contains 1 PROMIS global item: Pain NRS, Scale: 0-10 (anchors: 0 = No Pain, 10 = Worst Imaginable Pain, higher score is worse). The PROMIS global item is not scored but reported in raw score.

  7. Bothersomeness [ Time Frame: Baseline, 2 weeks, 6 weeks ]

    Question asked of participants: "During the past week, how bothersome have each of the following symptoms been?" The bothersomeness questionnaire contains two items: a) low back pain & b) leg pain (sciatica).

    Scale: 0-10 (anchors: 0 = Not at all bothersome, 10 = Extremely bothersome)



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • NRS score, AVERAGE within the past 24 hours
  • Must be ≥4 at the phone screen or baseline 1 visit
  • Must be ≥2 at phone screen, baseline 1 and baseline 2 visits
  • Roland Morris Disability ≥6
  • Age 21-65
  • Signed informed consent document
  • Chronic (12+ weeks) low back pain

Exclusion Criteria:

  • Compliance concerns
  • No manipulable lesion in L1-L5 or SI joints
  • The absence of typical palpatory characteristics as well as the absence of a global assessment that would indicate that spinal manipulation is likely to generate a positive therapeutic effect, even without the presence of standard palpatory findings
  • Ongoing treatment for low back pain by outside provider
  • Comorbid conditions
  • Serious concomitant illness
  • Inflammatory or destructive spinal tissue change
  • Ankylosing Spondylytis
  • Fibromyalgia
  • Rheumatoid Arthritis
  • Confirmed or suspected disc herniation with neurological signs
  • Neuromuscular disease (e.g. Parkinson's, Muscular Dystrophy, Cerebral Palsy, or Myasthenia gravis
  • Spinal surgery <6 months
  • Suspicion of drug or alcohol dependence or abuse
  • Uncontrolled hypertension
  • Lower extremity peripheral arterial disease
  • Undetermined, infections or visceral source of low back pain
  • Other comorbid conditions prohibiting treatment and/or testing
  • Safety concerns
  • Bleeding disorders
  • Contraindications to High Velocity Low Amplitude Spinal Manipulation
  • Inability to tolerate or obtain positon for flexion-relaxation test without condition aggravation
  • Inability to tolerate or perform/receive any study procedure without condition aggravation
  • Quebec Task Force (QTF) criterion 4-11:
  • QTF 4: Pain + radiation to upper/lower limb with neurologic signs
  • QTF 5: Presumptive compression of a spinal nerve root on a simple roentgenogram
  • QTF 6: Compression of a spinal nerve root confirmed by specific imaging techniques
  • QTF 7: Spinal Stenosis
  • QTF 8: Postsurgical status, 1-6 months after intervention
  • QTF 9: Postsurgical status, >6 months after intervention
  • QTF 10: Chronic pain syndrome
  • QTF 11: Other diagnoses
  • Pregnancy
  • Pacemaker or defibrillator
  • Inability to read or verbally comprehend English
  • Joint replacement
  • Use of spinal manipulation within past 4 weeks
  • Sensitivity to adhesive
  • Diagnostic procedures other than x-ray/UA necessary
  • BDI-II ≥29
  • Retention of legal advice and open or pending case related to low back pain
  • BMI ≥40
  • Unwilling to have low back and wrist shaved
  • Moving from Quad Cities area within next 8 weeks
  • Unwilling to postpone treatments for low back pain from another provider
  • Seeking or receiving compensation for any disability
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670292


Locations
United States, Iowa
Palmer College of Chiropractic
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Palmer College of Chiropractic
University of Iowa
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Ting Xia, PhD Palmer College of Chiropractic
More Information

Additional Information:
Publications:
Responsible Party: Palmer College of Chiropractic
ClinicalTrials.gov Identifier: NCT01670292     History of Changes
Other Study ID Numbers: PRiSM Study
U19AT004663 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2012    Key Record Dates
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Once the resulting manuscripts have been published, data sets will be provided for public access. Potential investigators can contact one of the Co-PIs to present their hypothesis, study design, instruments and/or data on which to focus, and resources required. Depending upon the needs and desires of the requesting party, the data that are shared may include analytic tables or de-identified or limited data sets that are transmitted to the requesting parties for additional analyses.

Keywords provided by Palmer College of Chiropractic:
Low Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms