Thrust Manipulation Versus Non-Thrust Manipulation

August 31, 2012 updated by: Chad Cook, Walsh University

Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Walsh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Mobilization (Mob)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry disability index
Time Frame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.
Change score
Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.
Change score
Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walsh University

Investigators

  • Principal Investigator: Chad E Cook, PhD, Walsh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Walsh 10-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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