Thrust Manipulation Versus Non-Thrust Manipulation

Mechanical Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438203
• Other study ID #: Walsh 10-24
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2011
• Last updated: August 31, 2012
• Start date: February 2011
• Est. completion date: February 2012

Study information

• Verified date: August 2012
• Source: Walsh University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain
• Mechanical Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	Walsh University	North Canton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Walsh University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry disability index	Change score	Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.	No
Secondary	Numeric Pain Rating Scale (NPRS)	Change score	Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.	No