Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain

The Effects of Thrust Versus Non-thrust Manipulation on Pain, Trunk Proprioception and Postural Stability in Subjects With Chronic Low Back Pain

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.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain; Mechanical Low Back Pain; Backache
• Intervention / Treatment: Other: Thrust Manipulation; Other: Non-thrust manipulation (NTM)

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do sul
    • Porto Alegre, Rio Grande do sul, Brazil, 90050-170
      • Federal University of Health Sciences of Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Manual Therapy; Spinal manipulation; Lumbar manipulation; Lumbar thrust; 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: Manual therapy; Joint mobilization; Mobilization; lumbar mobilization; Maitland

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot contact area	Foot contact area will be measured by a digital baropodometer (FootWork Pro)	Up to 10 minutes after intervention

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Investigators: Study Chair: Marcelo F Silva, PhD, Adjunct Professor

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Low back pain; Spinal manipulation; proprioception; Postural stability; Joint mobilization; Baropodometry; Thrust manipulation; Non-thrust manipulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 19051513.5.0000.5345