Clinical trial NCT01670292: Patient Response to Spinal Manipulation
Official title: Patient Response to Spinal Manipulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2012-08-22
Enrollment: 82
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)
timeFrame: Baseline to 6 weeks
measure: Lumbar-spine Stiffness (LSS)
timeFrame: Baseline, 2 weeks, 6 weeks
measure: Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation
timeFrame: Baseline, 2 weeks, 6 weeks
measure: Flexion-Relaxation Ratio (FRR)
timeFrame: Baseline, 2 weeks, 6 weeks
Secondary outcomes:
measure: Kinetic Measure - Spinal Segment Load (SSL) Force
timeFrame: 6 weeks
measure: Kinetic Measure - Spinal Segment Load (SSL) Moment
timeFrame: 6 weeks
measure: Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force
timeFrame: 6 weeks
measure: Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment
timeFrame: 6 weeks
measure: PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale
timeFrame: Baseline, 2 weeks, 6 weeks
measure: PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS
timeFrame: Baseline, 2 weeks, 6 weeks
measure: Bothersomeness
timeFrame: Baseline, 2 weeks, 6 weeks
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Palmer College of Chiropractic
state: Iowa
Study officials:
affiliation: Palmer College of Chiropractic
name: Ting Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.