Clinical trial NCT03085355: Evaluation of the Effect of the OMT Exercises Education for Pain in Participants With Cervical Pain
Official title: Evaluation of the Effects of the Association of the Osteopathic Manipulative Treatment to Exercises, Education for Pain in Participants With Cervical Pain - Pragmatic Clinical Trial Randomized
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Pain, Neck
Keywords: neck pain
Lead sponsor: Instituto Brasileiro de Osteopatia
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Design: a randomized single blind controlled pragmatic trial will be conducted trial. Patients (n=40) with non-specific neck pain will be randomized to receive 1) osteopathic manipulative treatment and exercise and and pain neurocience education (n=20) or 2) exercise alone and pain neurocience education (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, global perceived effect, Pain Self-Efficacy Questionnaire and pain catastrophizing scale

Eligibility criteria: Inclusion Criteria:

* 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

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.

Primary outcomes:
measure: Pain intensity
timeFrame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Secondary outcomes:
measure: Functionality and disability
timeFrame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
measure: Range of motion
timeFrame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
measure: Pressure pain threshold
timeFrame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
measure: Global perceived effect
timeFrame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
measure: Self-efficacy
timeFrame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
measure: Catastrophizing
timeFrame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
measure: kinesiophobia
timeFrame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
measure: McGuill
timeFrame: Measured pre and post treatment, 4 weeks after treatment and 8 weeks after treatment
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Sandro Groisman
state: RS
Study officials:
affiliation: UFCSPA Federal University of Health Science of Porto Alegre
name: sandro Groisman
role: PRINCIPAL_INVESTIGATOR
affiliation: UFCSPA Federal University of Health Science of Porto Alegre
name: Geraldo Jotz, Phd
role: STUDY_DIRECTOR
References: