Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

Not Applicable

Terminated

• Conditions: Backache; Mechanical Low Back Pain; Low Back Pain
• Interventions: Other: Thrust Manipulation; Other: Non-thrust manipulation (NTM)

• 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

Arm && Interventions

Group	Intervention	Description
Thrust manipulation (TM)	Thrust Manipulation	The patients allocated to the TM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive a rotational TM technique. The treating therapist will have up to two attempts to perform the TM in each patient. There is no need for cavitation in order to consider the TM successful; the occurence of cavitation, however, will be recorded. A single treatment will be provided.
Non-thrust manipulation (NTM)	Non-thrust manipulation (NTM)	The patients allocated to the NTM group will receive TM aimed at the L4-L5 intervertebral segments. All the patients will be positioned in a standardized position (right side-lying) and will receive 30 oscilations of a grade III rotational NTM. A single treatment will be provided

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