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Clinical Trials/NCT02956863
NCT02956863CompletedNot Applicable

The Effect of Osteopathic Manipulative Treatment in Pain and Functionality Individuals With Nonspecific Chronic Neck Pain: Randomized Clinical Trial

Instituto Brasileiro de Osteopatia2 sites in 1 country40 target enrollmentStarted: December 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Pain intensity

Study Overview

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

Detailed Description

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 Design: a randomized single blind placebo controlled trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise (n=20) or 2) exercise alone (n=20). Participants will receive 8 treatments during 4 weeks.

Clinical outcomes will be obtained at 1 week, four weeks and 24 weeks after end of treatment.

Methods:

The primary outcome will be pain measured by 11-point numerical pain rating scale.

The secondary outcome will be disability measured by the Neck Disability Index, range of motion measured by Cervical Range of Motion device, Pressure pain threshold measured by electronic algometer.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & Interventions

Exercises

Active Comparator

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

Intervention: Exercises (Procedure)

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)

Intervention: Osteopathic manipulative treatment (Procedure)

Outcomes

Primary Outcomes

Pain intensity

Time Frame: 30 days after end treatment

measured by numeric rating scale

Secondary Outcomes

  • Pressure pain threshold(30 days after end treatment)
  • range of motion(30 days after end treatment)
  • functionality and disability(30 days after end treatment)

Investigators

Sponsor
Instituto Brasileiro de Osteopatia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sandro Groisman, PT, DO, MSc

DO Ms

Instituto Brasileiro de Osteopatia

Study Sites (2)

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