Patient Response to Spinal Manipulation

NCT01670292 | Completed Results DMC

• 2 other identifiers: PRiSM StudyU19AT004663
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Back Pain

Keywords

Low Back Pain

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline to 6 weeks

• 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.

  Baseline, 2 weeks, 6 weeks

• 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.

  Baseline, 2 weeks, 6 weeks

• 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.

  Baseline, 2 weeks, 6 weeks

Secondary Outcomes (7)

• Kinetic Measure - Spinal Segment Load (SSL) Force

  6 weeks

• Kinetic Measure - Spinal Segment Load (SSL) Moment

  6 weeks

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

  6 weeks

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

  6 weeks

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

  Baseline, 2 weeks, 6 weeks

Study Arms (1)

Experimental: HVLA-SM

OTHER

Experimental High Velocity Low Amplitude Spinal Manipulation

Other: HVLA-SM

Interventions

HVLA-SM OTHER

High Velocity Low Amplitude Spinal Manipulation

Experimental: HVLA-SM

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• University of Iowa: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Palmer College of Chiropractic

Davenport, Iowa, 52803, United States

Location

Related Publications (3)

• 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.

  PMID: 25106673 BACKGROUND

• 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.

  PMID: 26500365 BACKGROUND

• 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.

  PMID: 28599647 DERIVED

Related Links

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

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ting Xia
• Organization: Palmer Center for Chiropractic Research

ting.xia@palmer.edu

563-884-5161

Study Officials

• Ting Xia, PhD

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 22, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 5, 2017
• Results First Posted: December 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)