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Completed

NCT Number: NCT01438203

Thrust Manipulation Versus Non-Thrust Manipulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Walsh University

North Canton, Ohio, 44720, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thrust manipulation

Procedure

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

Other names: Manipualtion (Manip)

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

Other names: Mobilization (Mob)

Primary outcomes

  1. Oswestry disability index

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

    Change score

Secondary outcomes

  1. Numeric Pain Rating Scale (NPRS)

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

    Change score

Sponsors and collaborators

Lead sponsor

Walsh University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2011
Registry last updated
Sep 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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