Neck PainNCT02353195
Effects of Radio-frequency in Patients With Myofascial Chronic Neck Pain
A study testing Radiofrequency in people with Neck Pain, run by Universidad Rey Juan Carlos.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Radiofrequency
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -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.
Who cannot join
- 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.
About this study
Official title: "Analgesic Effects of Capacitive Resistive Monopolar Radio-frequency (448 kHz) in Patients With Myofascial Chronic Neck Pain: A Pilot Randomized Controlled Trial."
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.
Read the detailed description
A randomized, double-blind, placebo-controlled trial. Setting: University community.
Patients with myofascial chronic neck pain with active MTrP in one upper trapezius muscle were involved. The patients were randomly divided into two groups: a radiofrequency group (RFG), who (14 patients) received 8 sessions of a monopolar capacitive resistive radiofrequency (MCRRF) application over the upper trapezius muscle and ten patients received 8 sessions of placebo radiofrequency (PG) over the same muscle. Main outcome measures: Visual analog scale (VAS), neck disability index (NDI) and cervical range of motion (pre-treatment, immediately post-first session treatment and post-treatment.
- Conditions
- Neck Pain
- Being tested
- Radiofrequency
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Other: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
Neck disability
The Neck Disability Index (NDI) was used. NDI is a self-reporting questionnaire used to determine how neck pain affects a patient's daily life. It consists of ten questions in the following domains: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation. Each question contains six response options, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale (0 being the best possible score and 50 the worst). The NDI has good construct validity. The NDI is seen as a valid tool to measure neck pain and disabilities in patients with neck pain due to acute or chronic conditions, as well as in patients suffering from musculoskeletal dysfunctions.
Measured: 1 month
Cervical Range of Motion
Cervical range of movement was measured with adevice (Performance Attainment Associates, Roseville, MN) .The device was placed on the subject's head, and a magnetic collar, also part of the device, was placed on the shoulders to take into account any rotation of the trunk.a chair was used on which the subjects were sitting to kept in the same position for all data collection. The initial position of the head was set to neutral at the zero mark of the inclinometer for flexion, extensión both side flexion and rotation. Three trials were executed consecutively in each direction, and the average of the three trials was computed.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Josué Fernández-Carnero, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353195
- Sponsor's protocol ID
- 15/2013
- Status last verified
- Sep 2016
- First submitted
- 27 Jan 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30892438
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Analgesic Effects of Capacitive Resistive Monopolar Radio-frequency (448 kHz) in Patients With Myofascial Chronic Neck Pain: A Pilot Randomized Controlled Trial."
- ClinicalTrials.gov ID
- NCT02353195
- Acronym / sponsor ID
- 15/2013
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized, double-blind, placebo-controlled trial. Setting: University community.
Patients with myofascial chronic neck pain with active MTrP in one upper trapezius muscle were involved. The patients were randomly divided into two groups: a radiofrequency group (RFG), who (14 patients) received 8 sessions of a monopolar capacitive resistive radiofrequency (MCRRF) application over the upper trapezius muscle and ten patients received 8 sessions of placebo radiofrequency (PG) over the same muscle. Main outcome measures: Visual analog scale (VAS), neck disability index (NDI) and cervical range of motion (pre-treatment, immediately post-first session treatment and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radio-frequency group | Experimental | Other: RadiofrequencyThe 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) |
| Placebo group | Placebo comparator | Other: RadiofrequencyAll 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiofrequencyThe 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. | Other | Placebo group, Radio-frequency group |
Primary outcome
Visual analogue scale (VAS).
Time frame: 1 month
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.
2 secondary outcomes
Neck disability
Time frame: 1 month
Cervical Range of Motion
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Derived from this study: PubMed 30892438Diego 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.
- web site of the UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josué Fernández-Carnero, PhD principal investigator
Universidad Rey Juan Carlos
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency in people with Neck Pain, run by Universidad Rey Juan Carlos.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS). (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353195, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.