Treatment of Cervical Syndrome With Physium Therapy
Primary Purpose
Cervical Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy treatment with physium device.
Conventional physiotherapy treatmen
Sponsored by

About this trial
This is an interventional treatment trial for Cervical Syndrome focused on measuring Neck Pain, Physical Therapy Modalities, Massage, Manual Therapy
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes,
- Aged between 20 and 60 years, in an
- Active state of pain and diagnosed with a month of evolution.
Exclusion Criteria:
- Patients who are pregnant, have pacemaker and those Surgically operated cervical spine - - Patients who have been treated with myofascial therapy a month earlier.
Sites / Locations
- Clínica Pastoriza
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EXPERIMENTAL GROUP
CONTROL GROUP
Arm Description
The intervention for this group consisted of 5 massage sessions with the PHYSIUM device for a month.
The multimodal physical therapy program includes 10 sessions of: ultrasound pulsatil therapy (US) for 10 minutes. transcutaneous electric nerve stimulation (TENS) for 20 minutes. massage for 20 minutes.
Outcomes
Primary Outcome Measures
The intensity of cervical pain
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Secondary Outcome Measures
The intensity of cervical pain
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Active cervical range of motion
Measured by goniometer type crom
Pressure pain thresholds in cervical trigger points
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline, Pain TestTM, Wagner Instruments). The clinimetric properties of this instrument have been evaluated previously. The PPT will the point at which pressure elicited pain and will presented as kilograms per square centimeter. All measurements will be conducted by the same well-trained physician.
The multidimensional health related quality of life
Questionnaire SF 12
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
Neck Disability Index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03322683
Brief Title
Treatment of Cervical Syndrome With Physium Therapy
Official Title
Vacuum Myofascial Therapy Device for Non-specific Neck Pain. A Single Blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2018 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
September 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cadiz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aim to investigate the effects of physium therapy for improving pressure pain thresholds (PPTs), range of motion,Neck Disability Index, the multidimensional health related quality of life (SF-12) and the multidimensional health related quality of life and pain in patients with mechanical neck pain (NP).
Detailed Description
Fifty-four participants with NP will randomly allocated to either an physium therapy (five sessions) or a physical therapy (PT) groups (ten sessions) during two weeks. Multimodal PT program included: ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS) and massage. Visual Analogue Scale (VAS), Neck Disability Index ( NDI), range of motion and (CROM), Questionnaire SF-12 and PPTs in sub-occipital and upper trapezius muscles were measured at baseline, at the end of treatment and at 1 month follow-up. T-tests and a repeated-measures multivariate analysis of variance (RM-MANOVA) were used for VAS, CROM and PPTs, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Syndrome
Keywords
Neck Pain, Physical Therapy Modalities, Massage, Manual Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Masking
Investigator
Masking Description
Blind researcher
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPERIMENTAL GROUP
Arm Type
Experimental
Arm Description
The intervention for this group consisted of 5 massage sessions with the PHYSIUM device for a month.
Arm Title
CONTROL GROUP
Arm Type
Experimental
Arm Description
The multimodal physical therapy program includes 10 sessions of:
ultrasound pulsatil therapy (US) for 10 minutes.
transcutaneous electric nerve stimulation (TENS) for 20 minutes.
massage for 20 minutes.
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy treatment with physium device.
Intervention Description
This group will treated five times with the analgesic program of physium therapy. Each maneuver was performed once per session by slow and progressive. The whole procedure lasted no more than 45 minutes.
Intervention Type
Procedure
Intervention Name(s)
Conventional physiotherapy treatmen
Intervention Description
The PT group will treated during two weeks (ten days/week) with ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS) and massage, in this order. Ultrasound will applied in pulse mode at an intensity of 1 megahertz for 10 minutes in the sub-occipital region and the vicinity of the trapezius muscles. TENS will applied with a pulse duration of 250 microseconds at a frequency of 80 Hertz for 20 minutes in the sub-occipital region and the trapezoids. Deep massage was applied at a slow speed for 20 minutes using sliding neutral creams. Massage therapy included gliding and kneading techniques applied over trapezius (upper, lower and middle fibers), splenius capitis and levator scapulae muscles with a therapeutic intention.
Primary Outcome Measure Information:
Title
The intensity of cervical pain
Description
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
The intensity of cervical pain
Description
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of cervical pain, and the worst and lowest level of pain experienced in the preceding week in the cervical area.
Time Frame
Four weeks
Title
Active cervical range of motion
Description
Measured by goniometer type crom
Time Frame
Baseline and four weeks.
Title
Pressure pain thresholds in cervical trigger points
Description
Pressure pain thresholds (PPTs) will be measured with a pressure algometer (Baseline, Pain TestTM, Wagner Instruments). The clinimetric properties of this instrument have been evaluated previously. The PPT will the point at which pressure elicited pain and will presented as kilograms per square centimeter. All measurements will be conducted by the same well-trained physician.
Time Frame
Baseline and four weeks
Title
The multidimensional health related quality of life
Description
Questionnaire SF 12
Time Frame
Baseline and four weeks
Title
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
Description
Neck Disability Index
Time Frame
Baseline and four weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both sexes,
Aged between 20 and 60 years, in an
Active state of pain and diagnosed with a month of evolution.
Exclusion Criteria:
- Patients who are pregnant, have pacemaker and those Surgically operated cervical spine - - Patients who have been treated with myofascial therapy a month earlier.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Rodriguez Huguet
Organizational Affiliation
University of Cadiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica Pastoriza
City
El Puerto De Santa María
State/Province
Cádiz
ZIP/Postal Code
11500
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Treatment of Cervical Syndrome With Physium Therapy
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