Treatment of Cervical Syndrome With Physium Therapy

NCT ID: NCT03322683

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-13

Study Completion Date

2018-09-15

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.

Conditions

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Cervical Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Investigators
Blind researcher

Study Groups

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EXPERIMENTAL GROUP

The intervention for this group consisted of 5 massage sessions with the PHYSIUM device for a month.

Group Type EXPERIMENTAL

Physiotherapy treatment with physium device.

Intervention Type PROCEDURE

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.

CONTROL GROUP

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.

Group Type EXPERIMENTAL

Conventional physiotherapy treatmen

Intervention Type PROCEDURE

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.

Interventions

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Physiotherapy treatment with physium device.

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

Conventional 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.

Intervention Type PROCEDURE

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Manuel Rodriguez Huguet

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Rodriguez Huguet

Role: PRINCIPAL_INVESTIGATOR

University of Cadiz

Locations

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Clínica Pastoriza

El Puerto de Santa María, Cádiz, Spain

Site Status

Countries

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Spain

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Lopez-Lopez A, Alonso Perez JL, Gonzalez Gutierez JL, La Touche R, Lerma Lara S, Izquierdo H, Fernandez-Carnero J. Mobilization versus manipulations versus sustain apophyseal natural glide techniques and interaction with psychological factors for patients with chronic neck pain: randomized controlled trial. Eur J Phys Rehabil Med. 2015 Apr;51(2):121-32. Epub 2014 Oct 9.

Reference Type BACKGROUND
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Reference Type BACKGROUND

Canadell G. Effectiveness of PHYSIUM Massage in chronic neck pain in patients not responding to the standard physiotherapy. MC Health & Medical Publishing. 2011;1.

Reference Type BACKGROUND

Other Identifiers

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physium therapy

Identifier Type: -

Identifier Source: org_study_id

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