Neck Pain Clinical Trial
Official title:
Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With Chronic Neck Pain
Verified date | February 2020 |
Source | University of Seville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objectives: To analyze the number of sessions needed to achieve a positive impact after
combining interferential current therapy and therapeutic exercise, compared with therapeutic
exercise alone, on self-reported pain, disability and range of motion in subjects with
chronic neck pain.
Design: A randomized, single-blind, controlled trial. Subjects: Patients between 18 and 65
years old, with idiopathic chronic neck pain.
Methods: The experimental group who will perform a combined treatment using Interferential
current therapy and therapeutic exercise for two weeks. The control group will receive the
same program of therapeutic exercise during the same period of time.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 15, 2019 |
Est. primary completion date | October 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Nonspecific mechanical neck pain (chronic neck pain diagnosed by a physician) - Age between 18 and 65 years old - Both males and females - Non apprehension to electrotherapy (determined by the Personal Psychological Apprehension scale- EAPP) - Self-reported pain higher than 2 in the 11-point Numeric Pain Rating Scale Exclusion Criteria: - Metallic implants in the vertebral column - Apprehension to electrotherapy (a score >45 points in EAPP) - Cervicogenic headache - Cervicogenic Dizziness - Neck pain associated with neurological deficits - Unexplained fever - Cervical surgery associated to persistent pain - Specific diagnostics (cervical myelopathy, cervical stenosis, osteomyopathy) - Other diagnostics such as visceral pain referred to the neck or non-cervical cause. - Involvement in litigation - Manual treatment for the neck-shoulder area in the last month before data collection |
Country | Name | City | State |
---|---|---|---|
Spain | University of Sevilla | Sevilla |
Lead Sponsor | Collaborator |
---|---|
University of Seville |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neck pain intensity | Participants will rate the intensity of their neck pain at rest on an 11-point numeric pain rating scale, where 0 is no pain and 11 maximum pain. The subjects will be ask to indicate the pain levels that they experienced before treatment and after treatment. | From baseline to immediately after treatment | |
Primary | Disability | The Neck Disability Index (NDI) will be used in the Spanish version to measure level of disability of the neck area during the daily life activities. where under 9 denotes No Disability; from 10 to 29 denotes Slight Disability; from 30 to 49 denotes Moderate Disability; from 50 to 69 denotes Severe Disability and more tan 70 denote Complete Disability. |
From baseline to immediately after treatment | |
Secondary | Range of movement (ROM) | The secondary outcome measure will be the active cervical range of motion assessed with the CROM device (Performance Attainment Associates, Lindstrom, MN). The measurements will be made separately for each direction and in a standard sequence: flexion, extension, right lateral flexion, left lateral flexion, right rotation and left rotation. Two measurements will be recorded for each movement and the average of the two measurements will be used in the analysis of results | From baseline to immediately after treatment |
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