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Patient Response to Spinal Manipulation (PRiSM)

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HVLA-SM

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Palmer College of Chiropractic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Experimental: HVLA-SM

Arm Description

Experimental High Velocity Low Amplitude Spinal Manipulation

Outcomes

Primary Outcome Measures

Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)

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.

Lumbar-spine Stiffness (LSS)

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.

Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation

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.

Flexion-Relaxation Ratio (FRR)

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

Kinetic Measure - Spinal Segment Load (SSL) Force

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.

Kinetic Measure - Spinal Segment Load (SSL) Moment

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.

Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force

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.

Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment

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.

PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale

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.

PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS

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.

Bothersomeness

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)

Full Information

NCT ID

NCT01670292

First Posted

August 2, 2012

Last Updated

October 25, 2017

Sponsor

Palmer College of Chiropractic

Collaborators

University of Iowa, National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT01670292

Brief Title

Patient Response to Spinal Manipulation

Acronym

PRiSM

Official Title

Patient Response to Spinal Manipulation

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Palmer College of Chiropractic

Collaborators

University of Iowa, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental: HVLA-SM

Arm Type

Other

Arm Description

Experimental High Velocity Low Amplitude Spinal Manipulation

Intervention Type

Other

Intervention Name(s)

HVLA-SM

Intervention Description

High Velocity Low Amplitude Spinal Manipulation

Primary Outcome Measure Information:

Title

Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)

Description

Time Frame

Baseline to 6 weeks

Title

Lumbar-spine Stiffness (LSS)

Description

Time Frame

Baseline, 2 weeks, 6 weeks

Title

Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation

Description

Time Frame

Baseline, 2 weeks, 6 weeks

Title

Flexion-Relaxation Ratio (FRR)

Description

Time Frame

Baseline, 2 weeks, 6 weeks

Secondary Outcome Measure Information:

Title

Kinetic Measure - Spinal Segment Load (SSL) Force

Description

Time Frame

6 weeks

Title

Kinetic Measure - Spinal Segment Load (SSL) Moment

Description

Time Frame

6 weeks

Title

Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force

Description

Time Frame

6 weeks

Title

Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment

Description

Time Frame

6 weeks

Title

PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale

Description

Time Frame

Baseline, 2 weeks, 6 weeks

Title

PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS

Description

Time Frame

Baseline, 2 weeks, 6 weeks

Title

Bothersomeness

Description

Time Frame

Baseline, 2 weeks, 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ting Xia, PhD

Organizational Affiliation

Palmer College of Chiropractic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Palmer College of Chiropractic

City

Davenport

State/Province

Iowa

ZIP/Postal Code

52803

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

25106673

Citation

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.

Results Reference

background

PubMed Identifier

26500365

Citation

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.

Results Reference

background

PubMed Identifier

28599647

Citation

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.

Results Reference

derived

Links:

URL

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4139615/

Description

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

URL

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4593036/

Description

What is the pain source? A case report of a patient with low back pain and bilateral hip osteonecrosis.

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Patient Response to Spinal Manipulation

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