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Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

Primary Purpose

Low Back Pain, Mechanical Low Back Pain, Backache

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Thrust Manipulation
Non-thrust manipulation (NTM)
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Thrust manipulation, Spinal manipulation, Joint mobilization, Non-thrust manipulation, proprioception, Postural stability, Baropodometry

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Health Sciences of Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thrust manipulation (TM)

Non-thrust manipulation (NTM)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2014
Last Updated
February 14, 2017
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02276794
Brief Title
Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain
Official Title
The Effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Time and funding constraints
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical Low Back Pain, Backache
Keywords
Low back pain, Thrust manipulation, Spinal manipulation, Joint mobilization, Non-thrust manipulation, proprioception, Postural stability, Baropodometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thrust manipulation (TM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-thrust manipulation (NTM)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Thrust Manipulation
Other Intervention Name(s)
Spinal manipulation, Lumbar manipulation, Lumbar thrust, Manual Therapy, Manipulative therapy
Intervention Description
After positioning patients in right side-lying, a rotational TM technique will be addressed at the L4-L5 lumbar segments. The treating therapist will have up to two attempts to apply the TM.
Intervention Type
Other
Intervention Name(s)
Non-thrust manipulation (NTM)
Other Intervention Name(s)
Mobilization, Joint mobilization, lumbar mobilization, Manual therapy, Maitland
Intervention Description
A grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed.
Primary Outcome Measure Information:
Title
Pain
Description
Pain will me measured Up to 10 minutes after intervention by an 11 point (0-11) Numeric Pain Rating Scale (NPRS)
Time Frame
Up to 10 minutes after intervention
Secondary Outcome Measure Information:
Title
Global Perceived Effect
Description
Global Perceived effect will be measured by an 11 point (-5-+5) Global Perceived Effect (GPE)
Time Frame
Up to 10 minutes after intervention
Title
Lumbar joint position sense
Description
Lumbar joint position sense will be measured by a isokinetic dynamometer (BIODEX System 4 Pro™, Shirley, NY)
Time Frame
Up to 10 minutes after intervention
Title
Peak plantar pressure
Description
Peak plantar pressure will be measured by a digital baropodometer (FootWork Pro)
Time Frame
Up to 10 minutes after intervention
Title
Center of Pressure displacement
Description
CoP displacement will be measured by a digital baropodometer (FootWork Pro) by means of stabilometry
Time Frame
Up to 10 minutes after intervention
Other Pre-specified Outcome Measures:
Title
Foot contact area
Description
Foot contact area will be measured by a digital baropodometer (FootWork Pro)
Time Frame
Up to 10 minutes after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo F Silva, PhD
Organizational Affiliation
Adjunct professor
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do sul
ZIP/Postal Code
90050-170
Country
Brazil

12. IPD Sharing Statement

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Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

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