Clinical trial NCT03322683: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Syndrome
Keywords: Neck Pain
Physical Therapy Modalities
Massage
Manual Therapy
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMIZED CLINICAL TRIAL WITH BLIND EVALUATION BY THIRD PARTIES, LONGITUDINAL AND PROSPECTIVE.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The intensity of cervical pain
timeFrame: Baseline
Secondary outcomes:
measure: The intensity of cervical pain
timeFrame: Four weeks
measure: Active cervical range of motion
timeFrame: Baseline and four weeks.
measure: Pressure pain thresholds in cervical trigger points
timeFrame: Baseline and four weeks
measure: The multidimensional health related quality of life
timeFrame: Baseline and four weeks
measure: This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life.
timeFrame: Baseline and four weeks.
Other outcomes:
Locations:
city: El Puerto De Santa María
country: Spain
facility: Clínica Pastoriza
state: Cádiz
Study officials:
affiliation: University of Cadiz
name: Manuel Rodriguez Huguet
role: PRINCIPAL_INVESTIGATOR
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