Clinical trial NCT01438203: Thrust Manipulation Versus Non-Thrust Manipulation
Official title: Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mechanical Low Back Pain
Keywords: manipulation
mobilization
low back pain
treatment
Lead sponsor: Walsh University
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oswestry disability index
timeFrame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.
Other outcomes:
Locations:
city: North Canton
country: United States
facility: Walsh University
state: Ohio
Study officials:
affiliation: Walsh University
name: Chad E Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.