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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830596
First Posted: January 28, 2009
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Palmer College of Chiropractic
January 27, 2009
January 28, 2009
April 18, 2017
September 25, 2017
September 25, 2017
July 2007
June 2012   (Final data collection date for primary outcome measure)
  • Postural Sway [ Time Frame: Baseline and 2 weeks ]

    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.

  • Postural Sway Speed [ Time Frame: Baseline and 2 weeks ]

    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.

  • Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL [ Time Frame: Baseline and 2 weeks ]
    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
  • Response to Sudden Load, Peak Muscle Response Per Side [ Time Frame: Baseline and 2 weeks ]
    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)
  • Response to Sudden Load Response Times [ Time Frame: Baseline and 2 weeks ]
    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)
Sensorimotor Functions [ Time Frame: 2 weeks, 6 weeks ]
Complete list of historical versions of study NCT00830596 on ClinicalTrials.gov Archive Site
Not Provided
Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: 2 weeks, 6 weeks ]
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 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;
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • Other: HVLA-SM
    High velocity, low amplitude lumbo-pelvic manipulation
  • Other: LVVA-SM
    Low velocity, variable amplitude lumbo-pelvic manipulation
  • 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 Name: light effleurage followed by SMT
  • Active Comparator: HVLA-SM
    High velocity, low amplitude lumbo-pelvic manipulation
    Intervention: Other: HVLA-SM
  • Active Comparator: LVVA-SM
    Low velocity, variable amplitude lumbo-pelvic manipulation
    Intervention: Other: LVVA-SM
  • Placebo Comparator: Sham Intervention
    Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks
    Intervention: Other: Sham Intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
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
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00830596
D2P3
U19AT004137 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
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.
Palmer College of Chiropractic
Palmer College of Chiropractic
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Christine Goertz, DC, PhD Palmer College of Chiropractic
Palmer College of Chiropractic
July 2017

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