Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients

Low Back Pain Clinical Trial

— D2P3  

Official title:

Effect of Spinal Manipulation on Sensorimotor Functions in Back Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00830596
• Other study ID #: D2P3
• Secondary ID: U19AT004137
• Status: Completed
• Phase: N/A
• First received: January 27, 2009
• Last updated: July 21, 2017
• Start date: July 2007
• Est. completion date: July 2012

Study information

• Verified date: July 2017
• Source: Palmer College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• HVLA-SM
High velocity, low amplitude lumbo-pelvic manipulation
• LVVA-SM
Low velocity, variable amplitude lumbo-pelvic manipulation
• 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

Locations

Country	Name	City	State
United States	Palmer College of Chiropractic	Davenport	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Palmer College of Chiropractic	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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 Manipul — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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