Thrust Manipulation Versus Non-Thrust Manipulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chad Cook, Walsh University
ClinicalTrials.gov Identifier:
NCT01438203
First received: September 19, 2011
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

The objective of this study is to investigate the comparative benefit of thrust and non-thrust manipulation on a population of patients with low back pain. The investigators hypothesize that there will be no difference in 4 week outcomes or greater, between the two groups.


Condition Intervention Phase
Mechanical Low Back Pain
Procedure: Thrust manipulation
Procedure: Non-thrust manipulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Walsh University:

Primary Outcome Measures:
  • Oswestry disability index [ Time Frame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks. ] [ Designated as safety issue: No ]
    Change score


Secondary Outcome Measures:
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks. ] [ Designated as safety issue: No ]
    Change score


Enrollment: 149
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thrust manipulation
Clinicians will use thrust manipulation at a targeted level to provide the treatment on selected individuals
Procedure: Thrust manipulation
Thrust manipulation is a passive procedure which involves a high velocity low amplitude thrust to the spinal region
Other Name: Manipualtion (Manip)
Active Comparator: Non-thrust manipulation
Clinicians will apply non-thrust manipulation (targeted) as performed in a clinical manner for treatment for included individuals
Procedure: Non-thrust manipulation
Non-thrust manipulation involves a low amplitude, low speed mobilization to the targeted region while adjusting the procedure based on patient feedback
Other Name: Mobilization (Mob)

Detailed Description:

Thrust manipulation is considered traditional spinal manipulation. Nonthrust manipulation is considered mobilization. The mobilization will be used in a similar manner as in clinical practice and this differs from past studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients, age 18 and older, with mechanically producible low back pain, who attend care at a physical therapy outpatient setting, will be screened for eligibility for the study.
  • For patients to meet inclusion requirements, they had to display a within session change in pain and/or range of motion during the assessment phase of the clinical examination. In other words, as the clinician performed their assessment and applied a passive accessory assessment technique, the pain and/or range of motion improved during that session, which suggests a favorable outcome using a comparable treatment technique. This is hallmark clinical finding in the patient response model and has been proposed as both a predictor of a positive outcome and as a prognostic variable toward long-term improvements in impairments.

Exclusion Criteria:

  • The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
  • Signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°
  • Muscle weakness involving a major muscle group of the lower extremity,
  • Diminished lower extremity muscle stretch reflex
  • Diminished or absent sensation to pinprick in any lower extremity dermatome)
  • Other exclusion criteria included prior surgery to the lumbar spine and current pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438203

Locations
United States, Ohio
Walsh University
North Canton, Ohio, United States, 44720
Sponsors and Collaborators
Walsh University
Investigators
Principal Investigator: Chad E Cook, PhD Walsh University
  More Information

No publications provided by Walsh University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chad Cook, Principal Investigator, Walsh University
ClinicalTrials.gov Identifier: NCT01438203     History of Changes
Other Study ID Numbers: Walsh 10-24
Study First Received: September 19, 2011
Last Updated: August 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Walsh University:
manipulation
mobilization
low back pain
treatment

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014