Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

Not Applicable

Terminated

• Conditions: Backache; Mechanical Low Back Pain; Low Back Pain

• Registration Number: NCT02276794
• Lead Sponsor: Federal University of Health Science of Porto Alegre

Brief Summary

This study aims to verify the effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain.

Detailed Description

Forty individuals with chronic low back pain will be randomly assigned, by a researcher not involved in data collection, to two treatment groups: Thrust manipulation (side-lying rotational manipulation standardized to the L4-L5 level) or non-thrust manipulation (side-lying grade III rotational non-thrust manipulation). A single treatment session will be provided.

Outcome measurement will be conducted immediately after the treatment session. Data will be collected by a blinded assessor. Between-group differences will be calculated by constructing mixed linear models following an intention-to-treat principle.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-28
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Age greater than 18 years
• Chronic Low back pain (pain lasting for at least 12 weeks)
• NPRS ≥ 3

Exclusion Criteria

• Previous surgery or fracture at the lumbar spine
• Pregnancy
• Inflammatory disorders
• Symptoms distal to the gluteal line
• Having received manipulative treatment in the past four weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain	Up to 10 minutes after intervention	Pain will me measured Up to 10 minutes after intervention by an 11 point (0-11) Numeric Pain Rating Scale (NPRS)

Secondary Outcome Measures

Name	Time	Method
Global Perceived Effect	Up to 10 minutes after intervention	Global Perceived effect will be measured by an 11 point (-5-+5) Global Perceived Effect (GPE)
Lumbar joint position sense	Up to 10 minutes after intervention	Lumbar joint position sense will be measured by a isokinetic dynamometer (BIODEX System 4 Pro™, Shirley, NY)
Peak plantar pressure	Up to 10 minutes after intervention	Peak plantar pressure will be measured by a digital baropodometer (FootWork Pro)
Center of Pressure displacement	Up to 10 minutes after intervention	CoP displacement will be measured by a digital baropodometer (FootWork Pro) by means of stabilometry

Trial Locations

Locations (1)

Federal University of Health Sciences of Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do sul, Brazil