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Thrust Manipulation Versus Non-Thrust Manipulation

Primary Purpose

Mechanical Low Back Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Thrust manipulation

Non-thrust manipulation

About this trial

This is an interventional treatment trial for Mechanical Low Back Pain focused on measuring manipulation, mobilization, low back pain, treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Walsh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thrust manipulation

Non-thrust manipulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Oswestry disability index

Change score

Secondary Outcome Measures

Numeric Pain Rating Scale (NPRS)

Change score

Full Information

NCT ID

NCT01438203

First Posted

September 19, 2011

Last Updated

August 31, 2012

Sponsor

Walsh University

1. Study Identification

Unique Protocol Identification Number

NCT01438203

Brief Title

Thrust Manipulation Versus Non-Thrust Manipulation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Walsh University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mechanical Low Back Pain

Keywords

manipulation, mobilization, low back pain, treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

149 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Thrust manipulation

Arm Type

Experimental

Arm Description

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

Arm Title

Non-thrust manipulation

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Thrust manipulation

Other Intervention Name(s)

Manipualtion (Manip)

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Non-thrust manipulation

Other Intervention Name(s)

Mobilization (Mob)

Intervention Description

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

Primary Outcome Measure Information:

Title

Oswestry disability index

Description

Change score

Time Frame

Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.

Secondary Outcome Measure Information:

Title

Numeric Pain Rating Scale (NPRS)

Description

Change score

Time Frame

Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chad E Cook, PhD

Organizational Affiliation

Walsh University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Walsh University

City

North Canton

State/Province

Ohio

ZIP/Postal Code

44720

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22879443

Citation

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.

Results Reference

derived

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Thrust Manipulation Versus Non-Thrust Manipulation

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