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Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276794
Recruitment Status : Terminated (Time and funding constraints)
First Posted : October 28, 2014
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Giovanni Esteves Ferreira, 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Mechanical Low Back Pain Backache Other: Thrust Manipulation Other: Non-thrust manipulation (NTM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thrust manipulation (TM)

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.

Other: Thrust Manipulation
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.
Other Names:
  • Spinal manipulation
  • Lumbar manipulation
  • Lumbar thrust
  • Manual Therapy
  • Manipulative therapy

Experimental: 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

Other: Non-thrust manipulation (NTM)
A grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed.
Other Names:
  • Mobilization
  • Joint mobilization
  • lumbar mobilization
  • Manual therapy
  • Maitland




Primary Outcome Measures :
  1. Pain [ Time Frame: 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 :
  1. Global Perceived Effect [ Time Frame: Up to 10 minutes after intervention ]
    Global Perceived effect will be measured by an 11 point (-5-+5) Global Perceived Effect (GPE)

  2. Lumbar joint position sense [ Time Frame: Up to 10 minutes after intervention ]
    Lumbar joint position sense will be measured by a isokinetic dynamometer (BIODEX System 4 Pro™, Shirley, NY)

  3. Peak plantar pressure [ Time Frame: Up to 10 minutes after intervention ]
    Peak plantar pressure will be measured by a digital baropodometer (FootWork Pro)

  4. Center of Pressure displacement [ Time Frame: Up to 10 minutes after intervention ]
    CoP displacement will be measured by a digital baropodometer (FootWork Pro) by means of stabilometry


Other Outcome Measures:
  1. Foot contact area [ Time Frame: Up to 10 minutes after intervention ]
    Foot contact area will be measured by a digital baropodometer (FootWork Pro)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276794


Locations
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Brazil
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do sul, Brazil, 90050-170
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Investigators
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Study Chair: Marcelo F Silva, PhD Adjunct professor
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Responsible Party: Giovanni Esteves Ferreira, PT, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT02276794    
Other Study ID Numbers: 19051513.5.0000.5345
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Keywords provided by Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre:
Low back pain
Thrust manipulation
Spinal manipulation
Joint mobilization
Non-thrust manipulation
proprioception
Postural stability
Baropodometry
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations