Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients

NCT00830596 | Completed Results DMC

• 2 other identifiers: D2P3U19AT004137
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

HVLA-SM

ACTIVE COMPARATOR

High velocity, low amplitude lumbo-pelvic manipulation

Other: HVLA-SM

LVVA-SM

ACTIVE COMPARATOR

Low velocity, variable amplitude lumbo-pelvic manipulation

Other: LVVA-SM

Sham Intervention

PLACEBO COMPARATOR

Light effleurage and a sham mechanically-assisted chiropractic treatment for 2 weeks followed by full spine manipulation for 4 weeks

Other: Sham Intervention

Interventions

HVLA-SM OTHER

High velocity, low amplitude lumbo-pelvic manipulation

HVLA-SM

LVVA-SM OTHER

Low velocity, variable amplitude lumbo-pelvic manipulation

LVVA-SM

Sham Intervention OTHER

2 weeks of light effleurage and a sham mechanically-assisted chiropractic treatment followed by 4 weeks active care with full spine spinal manipulation

Also known as: light effleurage followed by SMT

Sham Intervention

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Palmer College of Chiropractic

Davenport, Iowa, 52803, United States

Location

Related Publications (5)

• 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.

  PMID: 21708042 BACKGROUND

• 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.

  PMID: 25344427 BACKGROUND

• 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.

  PMID: 23997245 BACKGROUND

• 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.

  PMID: 26319101 RESULT

• 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.

  PMID: 25455834 RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christine Goertz, DC, PhD, Principal Investigator
• Organization: Palmer College of Chiropractic

christine.goertz@palmer.edu

(563) 884-5150

Study Officials

• Christine Goertz, DC, PhD

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: July 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 25, 2017
• Results First Posted: September 25, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)