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

September 19, 2011
August 31, 2012
February 2011
February 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01438203 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Thrust Manipulation Versus Non-Thrust Manipulation
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Mechanical Low Back Pain
  • 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)
  • 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)
  • Experimental: Thrust manipulation
    Clinicians will use thrust manipulation at a targeted level to provide the treatment on selected individuals
    Intervention: Procedure: Thrust manipulation
  • Active Comparator: Non-thrust manipulation
    Clinicians will apply non-thrust manipulation (targeted) as performed in a clinical manner for treatment for included individuals
    Intervention: Procedure: Non-thrust manipulation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01438203
Walsh 10-24
No
Chad Cook, Walsh University
Walsh University
Not Provided
Principal Investigator: Chad E Cook, PhD Walsh University
Walsh University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP