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Treatment of Cervical Syndrome With Physium Therapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03322683
Enrollment
38
Registered
2017-10-26
Start date
2018-07-13
Completion date
2018-09-15
Last updated
2020-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Syndrome

Keywords

Neck Pain, Physical Therapy Modalities, Massage, Manual Therapy

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.

Interventions

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.

PROCEDUREConventional physiotherapy treatmen

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.

Sponsors

University of Cadiz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Blind researcher

Intervention model description

RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The intensity of cervical painBaselineA 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

MeasureTime frameDescription
The intensity of cervical painFour weeksA 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 motionBaseline and four weeks.Measured by goniometer type crom
Pressure pain thresholds in cervical trigger pointsBaseline and four weeksPressure 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 lifeBaseline and four weeksQuestionnaire 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.Baseline and four weeks.Neck Disability Index

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026