NCT02276794

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

October 22, 2014

Last Update Submit

February 14, 2017

Conditions

Low Back PainMechanical Low Back PainBackache

Keywords

Low back painThrust manipulationSpinal manipulationJoint mobilizationNon-thrust manipulationproprioceptionPostural stabilityBaropodometry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Global Perceived Effect

    Up to 10 minutes after intervention

  • Lumbar joint position sense

    Up to 10 minutes after intervention

  • Peak plantar pressure

    Up to 10 minutes after intervention

  • Center of Pressure displacement

    Up to 10 minutes after intervention

Other Outcomes (1)

  • Foot contact area

    Up to 10 minutes after intervention

Study Arms (2)

Thrust manipulation (TM)

EXPERIMENTAL

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

Non-thrust manipulation (NTM)

EXPERIMENTAL

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)

Interventions

Thrust ManipulationOTHER

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.

Also known as: Spinal manipulation, Lumbar manipulation, Lumbar thrust, Manual Therapy, Manipulative therapy
Thrust manipulation (TM)
Non-thrust manipulation (NTM)OTHER

A grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed.

Also known as: Mobilization, Joint mobilization, lumbar mobilization, Manual therapy, Maitland
Non-thrust manipulation (NTM)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Conditions

Low Back PainBack Pain

Interventions

Manipulation, SpinalMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitationComplementary Therapies

Study Officials

  • Marcelo F Silva, PhD

    Adjunct professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

February 16, 2017

Record last verified: 2017-02

Locations

BR(1)