Treatment of Cervical Syndrome With Physium Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vacuum Myofascial Therapy Device for Non-specific Neck Pain. A Single Blind Randomized Clinical Trial

Conditions
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Cervical Syndrome

Intervention / Treatment
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* Procedure: Physiotherapy treatment with physium device.
* Procedure: Conventional physiotherapy treatmen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPERIMENTAL GROUP<br>The intervention for this group consisted of 5 massage sessions with the PHYSIUM device for a month. | Procedure: Physiotherapy treatment with physium device.<br>* 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.<br>|
| Experimental: CONTROL GROUP<br>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. | Procedure: Conventional physiotherapy treatmen<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Four weeks | 
| Active cervical range of motion | Measured by goniometer type crom | Baseline and four weeks. | 
| 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. | Baseline and four weeks | 
| The multidimensional health related quality of life | Questionnaire SF 12 | Baseline and four weeks | 
| 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 | Baseline and four weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, Neck Pain, Physical Therapy Modalities, Manual Therapy