Predicting Patients' Response to Spinal Manipulation

NCT00285649 | Completed Results DMC

• 1 other identifier: U19P3
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic LBP.

Conditions

Low Back Pain

Keywords

Spinal Manipulation

Outcome Measures

Primary Outcomes (1)

• Roland Morris Low Back Pain Disability Questionnaire (RMDQ)

  The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.

  Mean change from baseline to week 3

Study Arms (3)

HVLA-SM

EXPERIMENTAL

HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation

Other: HVLA-SM

LVVA-SM

EXPERIMENTAL

LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation

Other: LVVA-SM

Usual Medical Care

ACTIVE COMPARATOR

Usual Medical Care, Active Comparator, advice, exercises and medications

Other: Usual Medical Care

Interventions

HVLA-SM OTHER

HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation

HVLA-SM

LVVA-SM OTHER

LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation

LVVA-SM

Usual Medical Care OTHER

Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)

Usual Medical Care

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21 to 55
• Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force.
• LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to exclude the greatest proportion of LBP patients that have a favorable natural history of improvement.
• Written Informed Consent
• A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points.

You may not qualify if:

• LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions).
• LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis).
• Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study.
• Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care.
• Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity).
• Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview.
• Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP.
• Inability to read or verbally comprehend English.
• Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility.
• Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded.
• Use of manipulative care for any reason within the past 3 months as determined by history: to exclude the possibility of carryover effects.
• 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: to eliminate confounding effects.

Sponsors & Collaborators

• Palmer College of Chiropractic: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

Palmer Center for Chiropractic Research

Davenport, Iowa, 52803, United States

Location

Related Publications (2)

• Xia T, Long CR, Gudavalli MR, Wilder DG, Vining RD, Rowell RM, Reed WR, DeVocht JW, Goertz CM, Owens EF Jr, Meeker WC. Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation. Spine (Phila Pa 1976). 2016 Jun;41(12):E702-E709. doi: 10.1097/BRS.0000000000001373.

  PMID: 26656041 RESULT

• Hondras MA, Long CR, Haan AG, Spencer LB, Meeker WC. Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center. J Altern Complement Med. 2008 Oct;14(8):983-92. doi: 10.1089/acm.2008.0066.

  PMID: 18990046 DERIVED

Related Links

• Similar Effects of Thrust and Nonthrust Spinal Manipulation Found in Adults With Subacute and Chronic Low Back Pain: A Controlled Trial With Adaptive Allocation.

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: Ting Xia, PhD (Principal Investigator)
• Organization: Palmer College of Chiropractic

Ting.Xia@palmer.edu

563-884-5161

Study Officials

• William C Meeker, DC, M.P.H.

  Palmer Chiropractic College

  PRINCIPAL INVESTIGATOR

• David Wilder, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: July 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: March 1, 2007
• Last Updated: August 16, 2017
• Results First Posted: July 5, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)