NCT02353195

Brief Summary

The aim of this study was to evaluate the potential clinical benefits of Monopolar Capacitive Resistive Radio-frequency (448 kHz) (MCRR)F for the treatment of myofascial chronic neck pain.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

January 27, 2015

Last Update Submit

September 27, 2016

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (VAS).

    Pain intensity was measured using a 100-mm visual analogue scale (VAS). This scale consists of a 100-mm horizontal line with pain descriptors ranging from "no pain" marked on the left side to "the worst pain imaginable" on the right side. The perceived pain level of the patients was measured at rest, by marking the VAS with a perpendicular line. This is a valid method to measure pain level, and psychometric properties of the VAS have been reported widely. The minimal important difference of the VAS is based on detecting an 8.6-mm difference (based on a previous study for a score \< 40 mm with a pain onset of greater than 12 weeks) immediately after treatment The VAS has been documented in previous studies as having good reliability and validity.

    1 month

Secondary Outcomes (2)

  • Neck disability

    1 month

  • Cervical Range of Motion

    1 month

Study Arms (2)

Radio-frequency group

EXPERIMENTAL

The equipment used, (INDIBA® activ 902, (448kHz)). The electricity was administered in the following manner: cream was applied to the site with the severe rest pain and its adjacent area, and the electrical output was increased by moving the movable electrode within the patient´s tolerance level, while monitoring the skin temperature tolerable to the patient. Therapy was conducted for 12 minutes, two times per week over four weeks (eight sessions in total)

Other: Radiofrequency

Placebo group

PLACEBO COMPARATOR

All patients were treated with the same device in a nonfunctional application (no energy source) and the therapy was conducted for 12 minutes, two times per week over four weeks (eight sessions in total).

Other: Radiofrequency

Interventions

RadiofrequencyOTHER

The equipment used, 35-mm diameter CAP and 30-mm diameter RES movable electrode was used on the affected site, and a planar electrode was used as a return electrode on the abdomen. The electricity was administered in the following manner: cream was applied to the site with the severest pain and its adjacent area, and the electrical output was increased by moving the movable electrode within the patient´s tolerance level, while monitoring the skin temperature tolerable to the patient.

Placebo groupRadio-frequency group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged between 18 and 60 years with myofascial chronic neck pain. The area of neck pain was defined as the cervical region, possibly with referred or radiating pain into the occiput, nuchal muscles, shoulders and upper limbs. Symptoms had to have been present for at least six months before. At least one active MTrP in one upper trapezius muscle had to be present. For bilateral neck pain, the most painful side was designated for treatment.

You may not qualify if:

  • Severe disorders of the cervical spine, such as spinal stenosis, disk prolapse, postoperative conditions of the neck and shoulder areas, history of severe trauma, whiplash, spasmodic torticollis, instability, migraine, peripheral nerve entrapment, fibromyalgia, shoulder diseases, inflammatory rheumatic diseases, severe psychiatric illness and pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Diego IMA, Fernandez-Carnero J, Val SL, Cano-de-la-Cuerda R, Calvo-Lobo C, Piedrola RM, Oliva LCL, Rueda FM. Analgesic effects of a capacitive-resistive monopolar radiofrequency in patients with myofascial chronic neck pain: a pilot randomized controlled trial. Rev Assoc Med Bras (1992). 2019 Feb;65(2):156-164. doi: 10.1590/1806-9282.65.2.156.

    PMID: 30892438DERIVED

Related Links

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Josué Fernández-Carnero, PhD

    Universidad Rey Juan Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 27, 2015

First Posted

February 2, 2015

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

September 28, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share