NCT02956863

Brief Summary

The purpose of this study is to determine whether manipulative osteopathic treatment associated exercises improves pain and function in individuals with chronic non-specific neck pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

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

November 3, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

7 months

First QC Date

November 3, 2016

Last Update Submit

February 20, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    measured by numeric rating scale

    30 days after end treatment

Secondary Outcomes (3)

  • range of motion

    30 days after end treatment

  • Pressure pain threshold

    30 days after end treatment

  • functionality and disability

    30 days after end treatment

Study Arms (2)

Exercises

ACTIVE COMPARATOR

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

Procedure: Exercises

Osteopathic manipulative treatment

EXPERIMENTAL

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

Procedure: Osteopathic manipulative treatment

Interventions

Osteopathic manipulative treatment delivered on pragmatic way.

Osteopathic manipulative treatment
ExercisesPROCEDURE

Exercise for stretching and strength for neck muscles

Exercises

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptoms of chronic neck pain does not specify that persists for more than 3 months

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

Manipulation, OsteopathicExercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sandro Groisman, MS

    IBO Brazilian Osteopathic Institute

    PRINCIPAL INVESTIGATOR

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
DO Ms

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 7, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations