Treatment of Cervical Syndrome With Myofascial Therapies (MRH)

April 12, 2019 updated by: Manuel Rodriguez Huguet, University of Cadiz
This study aimed to investigate the effects of myofascial release therapy (MRT) for improving pressure pain thresholds (PPTs), range of motion and pain in patients with mechanical neck pain (NP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fifty-four participants with NP were randomly allocated to either an MRT (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), range of motion and (CROM) 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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cádiz
      • Cadiz, Cádiz, Spain, 11008
        • Policlínica Santa María

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both sexes, aged between 20 and 60 years, in an active state of pain and diagnosed with muscle breakdown

Exclusion Criteria:

- Patients who are pregnant, have pacemakers and surgically operated in the area to be treated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERIMENTAL GROUP

Patients who are pregnant, have pacemaker and those surgically operated cervical spine patients who have been treated with myofascial therapy a month earlier.

Multimodal physical therapy program includes:

Myofascial syndrome cervical therapy treatment.
Procedure: Physiotherapy treatment

The MRT group was treated five times with several maneuvers. Each maneuver was performed once per session by slow and progressive application of a light force. The whole procedure lasted no more than 45 minutes. The treatment included four basic maneuvers.

  • Suboccipital induction
  • Posterior elongation of the cervical fascia in Supine position
  • Assisted cervical fascia
  • Myofascial induction of sternocleidomastoid
Procedure: Physiotherapy treatment
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.
Experimental: CONTROL GROUP

Multimodal physical therapy program includes:

  • ultrasound therapy (US),
  • transcutaneous electric nerve stimulation (TENS)
  • massage.
Procedure: Physiotherapy treatment

The MRT group was treated five times with several maneuvers. Each maneuver was performed once per session by slow and progressive application of a light force. The whole procedure lasted no more than 45 minutes. The treatment included four basic maneuvers.

  • Suboccipital induction
  • Posterior elongation of the cervical fascia in Supine position
  • Assisted cervical fascia
  • Myofascial induction of sternocleidomastoid
Procedure: Physiotherapy treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of cervical pain
Time Frame: Baseline
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
Time Frame: Four weeks
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
The intensity of cervical pain
Time Frame: Eight weeks
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.
Eight weeks
Active cervical range of motion
Time Frame: Baseline, four weeks and eight weeks
Measured by goniometer type crom
Baseline, four weeks and eight weeks
Pressure pain thresholds in cervical trigger points
Time Frame: Baseline, four weeks and eight weeks
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, four weeks and eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cadiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

December 20, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

May 18, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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