- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01670292
Patient Response to Spinal Manipulation (PRiSM)
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Iowa
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Davenport, Iowa, United States, 52803
- Palmer College of Chiropractic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Experimental: HVLA-SM
Experimental High Velocity Low Amplitude Spinal Manipulation
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High Velocity Low Amplitude Spinal Manipulation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)
Time Frame: Baseline to 6 weeks
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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. |
Baseline to 6 weeks
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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. |
Baseline, 2 weeks, 6 weeks
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Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation
Time Frame: Baseline, 2 weeks, 6 weeks
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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. |
Baseline, 2 weeks, 6 weeks
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Flexion-Relaxation Ratio (FRR)
Time Frame: Baseline, 2 weeks, 6 weeks
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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. |
Baseline, 2 weeks, 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinetic Measure - Spinal Segment Load (SSL) Force
Time Frame: 6 weeks
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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. |
6 weeks
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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. |
6 weeks
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Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force
Time Frame: 6 weeks
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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. |
6 weeks
|
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. |
6 weeks
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PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale
Time Frame: Baseline, 2 weeks, 6 weeks
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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:
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Baseline, 2 weeks, 6 weeks
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PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS
Time Frame: Baseline, 2 weeks, 6 weeks
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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.
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Baseline, 2 weeks, 6 weeks
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Bothersomeness
Time Frame: Baseline, 2 weeks, 6 weeks
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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) |
Baseline, 2 weeks, 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ting Xia, PhD, Palmer College of Chiropractic
Publications and helpful links
General Publications
- Xia T, Wilder DG, Gudavalli MR, DeVocht JW, Vining RD, Pohlman KA, Kawchuk GN, Long CR, Goertz CM. Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain. BMC Complement Altern Med. 2014 Aug 8;14:292. doi: 10.1186/1472-6882-14-292.
- Minkalis AL, Vining RD. What is the pain source? A case report of a patient with low back pain and bilateral hip osteonecrosis. J Can Chiropr Assoc. 2015 Sep;59(3):300-10.
- Xia T, Long CR, Vining RD, Gudavalli MR, DeVocht JW, Kawchuk GN, Wilder DG, Goertz CM. Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation. BMC Complement Altern Med. 2017 Jun 9;17(1):303. doi: 10.1186/s12906-017-1821-1.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRiSM Study
- U19AT004663 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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