Clinical trial NCT00830596: Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients
Official title: Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2009-01-28
Enrollment: 221
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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;

Eligibility criteria: 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

Primary outcomes:
measure: Postural Sway
timeFrame: Baseline and 2 weeks
measure: Postural Sway Speed
timeFrame: Baseline and 2 weeks
measure: Response to Sudden Load, Anterior Movement in Center of Pressure Excursion in SL
timeFrame: Baseline and 2 weeks
measure: Response to Sudden Load, Peak Muscle Response Per Side
timeFrame: Baseline and 2 weeks
measure: Response to Sudden Load Response Times
timeFrame: Baseline and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Davenport
country: United States
facility: Palmer College of Chiropractic
state: Iowa
Study officials:
affiliation: Palmer College of Chiropractic
name: Christine Goertz, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.