Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients (D2P3)

The long-term goal for this study is to understand the physiological mechanisms of various forms of spinal manipulation in order to refine and improve this therapy for appropriately selected patients. The objective of this study is to assess the effects of high-velocity low-amplitude spinal manipulation and low-velocity variable amplitude spinal manipulation on three types of sensorimotor abilities in patients with low back pain.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: HVLA-SM; Other: LVVA-SM; Other: Sham Intervention

Detailed Description

In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will pursue the following specific aim: To determine the effects of 2 weeks (4 applications @ 2 per week) of HVLA-SM and LVVA-SM to the lumbo-pelvic region, compared to a control group receiving light effleurage and a sham mechanically assisted adjustment, on sensorimotor function as measured by: lumbo-pelvic repositioning ability, standing postural sway and response to sudden trunk loading;

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Palmer College of Chiropractic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 21 to 65 years old
• Low back pain (LBP) score an 11 point numerical rating scale: (must be > 4 at the Phone Screening OR Baseline 1 Visit) AND (must be > 2 at the Phone Screen, Baseline 1 AND Baseline 2 Visits)
• Acute (less than 7 days), sub-acute (7 days to 7 weeks), or chronic (more than 7 weeks) LBP matching classifications 1, 2, or 3 of the Quebec Task Force (QTF) Classification system - QTF 1: Pain without radiation, QTF 2: Pain + radiation to proximal extremity, QTF 3: Pain + radiation to distal extremity, QTF 7: Spinal stenosis
• Written informed consent (ICD1, ICD2 and ICD3)

Exclusion Criteria:

• Ongoing treatment for low back pain by other health care providers - unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy and massage) for the duration of the study period.
• Co-morbidities Bleeding Disorders Bone and Joint Pathology Cauda Equina Syndrome Contra-indication to spinal manipulation, in general Current or Pending Litigation General Poor Health Inflammatory or Destructive tissue changes to the spine Neuromuscular Diseases Obesity Osteoporosis Peripheral Neuropathies Spinal Surgery Suspicion of drug or alcohol abuse Uncontrolled hypertension Vascular claudication
• Quebec Task Force (QTF) on Spinal Disorders 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 8: Postsurgical status, 1-6 months after intervention QTF 9: Postsurgical status, >6 months after intervention 9.1: Asymptomatic 9.2: Symptomatic QTF 10: Chronic pain syndrome QTF 11: Other diagnoses
• Pregnant or nursing women
• Pacemaker
• Inability to read or verbally comprehend English
• Any Joint Replacement
• Use of spinal manipulation within the past 4 weeks. If participants are willing to delay study enrollment until four weeks post spinal manipulative therapy, then we will schedule accordingly until this criterion is met
• Sensitivity to tape used during the biomechanical assessments
• If the Study Clinician believes that diagnostic procedures other than x-rays or dipstick urinalysis are necessary to diagnose a participant's condition, then the participant will be excluded
• Beck Depression Inventory-II greater than or equal to 29
• Retention of legal advice and an open or pending case for a health-related condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HVLA-SM; High velocity, low amplitude lumbo-pelvic manipulation	Other: HVLA-SM; High velocity, low amplitude lumbo-pelvic manipulation
Active Comparator: LVVA-SM; Low velocity, variable amplitude lumbo-pelvic manipulation	Other: LVVA-SM; Low velocity, variable amplitude lumbo-pelvic manipulation
Placebo Comparator: Sham Intervention; Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks	Other: Sham Intervention; 2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation; Other Names: light effleurage followed by SMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural Sway	Changes in sensorimotor function, as measured by postural sway in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Postural sway (AP=mean excursion in the anterior-posterior direction, ML= mean excursion in the medial-to-lateral direction.	Baseline and 2 weeks
Postural Sway Speed	Changes in sensorimotor function, as measured by postural sway speed in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for: Sway Speed=overall center of pressure traveling distance divided by time.	Baseline and 2 weeks
Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL	Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for Response to sudden load [RTSL], ant. COP=anterior movement in center of pressure	Baseline and 2 weeks
Response to Sudden Load, Peak Muscle Response Per Side	Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)	Baseline and 2 weeks
Response to Sudden Load Response Times	Changes in sensorimotor function, as measured by response to sudden load in patients with LBP from baseline to 2 weeks. The adjusted within-group mean changes from baseline to two week follow-up are detailed below for for Response to sudden load [RTSL] (ant. COP=anterior movement in center of pressure, L=left side of erector spinae, R=right side of erector spinae)	Baseline and 2 weeks

Collaborators and Investigators

• Sponsor: Palmer College of Chiropractic
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Christine Goertz, DC, PhD, Palmer College of Chiropractic

Publications and helpful links

General Publications

• Wilder DG, Vining RD, Pohlman KA, Meeker WC, Xia T, Devocht JW, Gudavalli RM, Long CR, Owens EF, Goertz CM. Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial. Trials. 2011 Jun 28;12:161. doi: 10.1186/1745-6215-12-161.
• Vining RD, Salsbury SA, Pohlman KA. Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. Trials. 2014 Oct 24;15:406. doi: 10.1186/1745-6215-15-406.
• Vining R, Potocki E, Seidman M, Morgenthal AP. An evidence-based diagnostic classification system for low back pain. J Can Chiropr Assoc. 2013 Sep;57(3):189-204.
• Goertz CM, Xia T, Long CR, Vining RD, Pohlman KA, DeVocht JW, Gudavalli MR, Owens EF Jr, Meeker WC, Wilder DG. Effects of spinal manipulation on sensorimotor function in low back pain patients--A randomised controlled trial. Man Ther. 2016 Feb;21:183-90. doi: 10.1016/j.math.2015.08.001. Epub 2015 Aug 8.
• Vining RD, Potocki E, McLean I, Seidman M, Morgenthal AP, Boysen J, Goertz C. Prevalence of radiographic findings in individuals with chronic low back pain screened for a randomized controlled trial: secondary analysis and clinical implications. J Manipulative Physiol Ther. 2014 Nov-Dec;37(9):678-87. doi: 10.1016/j.jmpt.2014.10.003. Epub 2014 Nov 1.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 27, 2009
• First Submitted That Met QC Criteria: January 27, 2009
• First Posted (Estimate): January 28, 2009

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: July 21, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: D2P3; U19AT004137 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.