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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014