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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Palmer College of Chiropractic
ClinicalTrials.gov Identifier:
NCT00830596
First received: January 27, 2009
Last updated: July 27, 2012
Last verified: July 2010

January 27, 2009
July 27, 2012
July 2007
June 2012   (final data collection date for primary outcome measure)
Sensorimotor Functions [ Time Frame: 2 weeks, 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00830596 on ClinicalTrials.gov Archive Site
Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 2 weeks, 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients
Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients

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.

In collaboration with the University of Iowa, the Palmer Center for Chiropractic Research will pursue the following specific aims: 1) To determine the immediate pre-to-post changes from 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; 2) 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; 3) To determine the effects of 6 weeks (12 applications @ 2 per week) of HVLA-SM and LVVA-SM to the lumbo-pelvic region on sensorimotor function as measured by: Lumbo-pelvic repositioning ability, standing postural sway, and response to sudden truck loading; 4) To explore whether changes in sensorimotor function are associated with changes in self-reported back pain intensity, related disability, or health status at 2 weeks (after 4 SM Visits) and at 6 weeks (after 12 SM Visits); 5) To determine if sensorimotor function changes are greater in patients a priori clinically classified as being most appropriate for manipulation.; 6)Describe the sensorimotor and clinical effects of 4 weeks of full spine and extremity (clinician's choice) care following 2 weeks of receiving light effleurage and a sham mechanically assisted adjustment for participants with low back pain; and 7) To explore if there is an association between: a. DC characterization of the quality of the SM (as rated on a survey) and the biomechanics of the SM (as measured by the force-time profile, biomechanical assessments, and videotape), and b. DC and participant characterization of quality of the SM (as rated on surveys).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • Other: 1
    High velocity, low amplitude lumbo-pelvic manipulation
  • Other: LVVA-SM
    Low velocity, variable amplitude lumbo-pelvic manipulation
  • Other: light effleurage followed by SMT
    2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation
  • Active Comparator: 1
    High velocity, low amplitude lumbo-pelvic manipulation
    Intervention: Other: 1
  • Active Comparator: 2
    Low velocity, variable amplitude lumbo-pelvic manipulation
    Intervention: Other: LVVA-SM
  • Placebo Comparator: 3
    Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks
    Intervention: Other: light effleurage followed by SMT
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
219
July 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00830596
Palmer_College, U19AT004137
Yes
Palmer College of Chiropractic
Palmer College of Chiropractic
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Christine G Choate, DC, PhD Palmer College of Chiropractic
Palmer College of Chiropractic
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP