Thrust Manipulation Versus Non-Thrust Manipulation

NCT01438203 | Completed Phase 2

• 1 other identifier: Walsh 10-24
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Low Back Pain

Keywords

manipulation; mobilization; low back pain; treatment

Outcome Measures

Primary Outcomes (1)

• Oswestry disability index

  Change score

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

Secondary Outcomes (1)

• Numeric Pain Rating Scale (NPRS)

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

Study Arms (2)

Thrust manipulation

EXPERIMENTAL

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

Procedure: Thrust manipulation

Non-thrust manipulation

ACTIVE COMPARATOR

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

Procedure: Non-thrust manipulation

Interventions

Thrust manipulation PROCEDURE

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

Also known as: Manipualtion (Manip)

Thrust manipulation

Non-thrust manipulation PROCEDURE

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

Also known as: Mobilization (Mob)

Non-thrust manipulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Walsh University: lead

Study Sites (1)

Walsh University

North Canton, Ohio, 44720, United States

Location

Related Publications (1)

• 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.

  PMID: 22879443 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Mob protein, Bacteria

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chad E Cook, PhD

  Walsh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 22, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 5, 2012

Record last verified: 2012-08

Locations

US (1)