Thrust Manipulation Versus Non-Thrust Manipulation

NCT ID: NCT01438203

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mechanical Low Back Pain

Keywords

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manipulation mobilization low back pain treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Thrust manipulation

Clinicians will use thrust manipulation at a targeted level to provide the treatment on selected individuals

Group Type EXPERIMENTAL

Thrust manipulation

Intervention Type PROCEDURE

Thrust manipulation is a passive procedure which involves a high velocity low amplitude thrust to the spinal region

Non-thrust manipulation

Clinicians will apply non-thrust manipulation (targeted) as performed in a clinical manner for treatment for included individuals

Group Type ACTIVE_COMPARATOR

Non-thrust manipulation

Intervention Type PROCEDURE

Non-thrust manipulation involves a low amplitude, low speed mobilization to the targeted region while adjusting the procedure based on patient feedback

Interventions

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Thrust manipulation

Thrust manipulation is a passive procedure which involves a high velocity low amplitude thrust to the spinal region

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Manipualtion (Manip) Mobilization (Mob)

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Walsh University

OTHER

Sponsor Role lead

Responsible Party

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Chad Cook

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chad E Cook, PhD

Role: PRINCIPAL_INVESTIGATOR

Walsh University

Locations

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Walsh University

North Canton, Ohio, United States

Site Status

Countries

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United States

References

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Cook CE, Learman KE, O'Halloran BJ, Showalter CR, Kabbaz VJ, Goode AP, Wright AA. Which prognostic factors for low back pain are generic predictors of outcome across a range of recovery domains? Phys Ther. 2013 Jan;93(1):32-40. doi: 10.2522/ptj.20120216. Epub 2012 Aug 9.

Reference Type DERIVED
PMID: 22879443 (View on PubMed)

Other Identifiers

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Walsh 10-24

Identifier Type: -

Identifier Source: org_study_id