- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03218644
Effectiveness of Proprioceptive Exercise in Neck Pain (PropNeckPain)
Effectiveness of a Propioceptive Exercise Program in Subjects With Inespecific Neck Pain
Introduction: Neck pain is among the most common and costly for industrialized societies. It is difficult to know the exact structure causing the pain so most are considered as non-specific neck pain. There is a correlation between the alteration of craneocervical proprioception and neck pain. The evidence for treatment with proprioceptive exercises is very limited.
Objective: To know the efficacy of a proprioceptive exercise program for neck pain and to compare its effects with a cervical mobility program.
Materials and Methods: Subjects between 18-65 years old with non-traumatic neck pain are included. They will be randomized into two groups of exercises: proprioception or mobility, which will be developed over a period of two weeks, every day, with a total of 10 sessions per patient.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Valencia, Spain, 46010
- Gemma Victoria Espí-López
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Neck pain (NAD I-II) of recent onset (0-3 months)
Exclusion Criteria:
- Cognitive difficulties
- Lack of commitment to attend sessions
- Subjects with pacemakers or defibrillators
- Being receiving another physiotherapeutic treatment
- Other pathologies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Control group
Follow the usual treatment and perform the exercises of cervical mobility before a mirror.
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Usual treatment and exercises of cervical mobility before a mirror.
|
|
EXPERIMENTAL: Experimental group
The same procedure is followed by substituting proprioceptive exercises for craniocervical sensorimotor control with a laser instrument located on the patient's head and a target.
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proprioceptive exercises for craniocervical sensorimotor control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensity of Pain
Time Frame: four weeks
|
Visual Analogue Scale (VAS) was used to register the pain.
The VAS is a 10-point rating scale.
|
four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Head Repositioning Test
Time Frame: four weeks
|
The cervical position is reevaluated with a laser pointer.
|
four weeks
|
|
Cervical movement range (CROM)
Time Frame: four weeks
|
Evaluated with cervical goniometer.
|
four weeks
|
|
Pain points
Time Frame: four weeks
|
Algometer
|
four weeks
|
|
Neck Disability
Time Frame: four weeks
|
Neck Disability Index
|
four weeks
|
|
Health status
Time Frame: four weeks
|
Evaluated with questionnaire of Quality of life
|
four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gemma Victoria Espí-López, fisiotherapy
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID0017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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