NCT03085355

Brief Summary

The purpose of this randomized pragmatic clinical trial is to assess the effectiveness of the association of the osteopathic manipulative treatment in individuals with chronic non-specific neck pain who receive a exercice program and pain neurocience education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

March 19, 2017

Last Update Submit

November 2, 2019

Conditions

Neck PainPain, Neck

Keywords

neck pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    measured by numeric rating scale

    Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment

Secondary Outcomes (8)

  • Functionality and disability

    Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment

  • Range of motion

    Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment

  • Pressure pain threshold

    Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment

  • Global perceived effect

    Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment

  • Self-efficacy

    Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment

  • +3 more secondary outcomes

Study Arms (2)

Exercises and PNE

ACTIVE COMPARATOR

Individuals with neck pain will receive a exercises program and pain neuroscience education. Participants will receive treatments during 4 weeks, 1 treatment per week

Procedure: Exercises and PNE

Osteopathic manipulative treatment

EXPERIMENTAL

Individuals with neck pain in this group will also receive a exercises program and pain neuroscience education and the participants will receive treatments during 4 weeks, 1 treatment per week associated with Osteopathic Manipulative Treatment (OMT)

Procedure: Osteopathic manipulative treatment

Interventions

Exercises and PNEPROCEDURE

Exercise for stretching and strength for neck muscles and pain neuroscience education

Exercises and PNE
Osteopathic manipulative treatmentPROCEDURE

Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education

Osteopathic manipulative treatment

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms of chronic neck pain does not specify that persists for more than 3 months
  • Pain at least 3 points on 0-10 numeric pain rating and at least 14% disability on Neck Disability Index

You may not qualify if:

  • individuals who report inflammatory previous surgery, spondylolisthesis, spinal stenosis, herniated disc, radiculopathy, fracture and musculoskeletal degenerative diseases. , Cancer, neurological diseases, pregnancy. They will be excluded participants who received some form of manipulative treatment in the last three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandro Groisman

Porto Alegre, Rio Grande do Sul, 90130061, Brazil

Location

MeSH Terms

Conditions

Neck Pain

Interventions

ExerciseManipulation, Osteopathic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • sandro Groisman

    UFCSPA Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Geraldo Jotz, Phd

    UFCSPA Federal University of Health Science of Porto Alegre

    STUDY DIRECTOR

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
Master

Study Record Dates

First Submitted

March 19, 2017

First Posted

March 21, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)