Back to resultsInterferential Current and Therapeutic Exercise Program in Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Interferential Current and Therapeutic Exercise Program
Therapeutic Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Chronic Neck Pain, Interferential Current Electrotherapy, Therapeutic Exercise, Physical Therapy
Eligibility Criteria
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
Sites / Locations
- University of Sevilla
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IFC and Therapeutic Exercise Program
Therapeutic Exercise Program
Arm Description
Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour. Participants will receive treatment with Interferential current therapy plus a program of therapeutic exercise focused on the neck region
Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour.This group will only receive the same therapeutic exercise program.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03979287
Brief Title
Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain
Official Title
Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2019 (Actual)
Primary Completion Date
October 25, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Chronic Neck Pain, Interferential Current Electrotherapy, Therapeutic Exercise, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IFC and Therapeutic Exercise Program
Arm Type
Experimental
Arm Description
Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour. Participants will receive treatment with Interferential current therapy plus a program of therapeutic exercise focused on the neck region
Arm Title
Therapeutic Exercise Program
Arm Type
Active Comparator
Arm Description
Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour.This group will only receive the same therapeutic exercise program.
Intervention Type
Other
Intervention Name(s)
Interferential Current and Therapeutic Exercise Program
Intervention Description
The Interferential Current Program will be based on a bipolar application using the Sonopuls 692 device (Enraf Nonius, Rotterdam, The Netherlands). The current parameters will be: a) 4000Hz carrier frequency; and b) 60 Hz AMF with a modulation frequency of 90 Hz. The intensity of the current will be adapted to the sensitivity of each patient.
The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:
Ergonomic advices on reducing repetitive movements and/or maintained positions
A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise Program
Intervention Description
The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:
Ergonomic advices on reducing repetitive movements and/or maintained positions
A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises
Primary Outcome Measure Information:
Title
Neck pain intensity
Description
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.
Time Frame
From baseline to immediately after treatment
Title
Disability
Description
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.
Time Frame
From baseline to immediately after treatment
Secondary Outcome Measure Information:
Title
Range of movement (ROM)
Description
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
Time Frame
From baseline to immediately after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Heredia-Rizo, PhD
Organizational Affiliation
Physiotherapy Department, University of Seville, spain
Official's Role
Study Director
Facility Information:
Facility Name
University of Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain
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