FibromyalgiaSCENARNCT03882567
Effectiveness of Electro Neuro Adaptive Regulator in Patients With Fibromyalgia
A study testing Electro Neuro adaptative Regulator in people with Fibromyalgia, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, Evidence shows that different physical therapies could activation situations of chronic pain there is no activation of CPM. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Electro Neuro adaptative Regulator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2018to 31 Oct 2019
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . American College of Rheumatology classification criteria for Fibromyalgia.
- . reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries;
- on stable doses of medications for FM ≥ 4 weeks.
Who cannot join
- Patients will be excluded from enrolment if: (1) they suffer from an inflammatory rheumatic conditions; (2) have a planned elective surgery during the study period; (3) have ongoing unresolved disability claims; (4) experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis; (5) do not speak Spanish fluently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Electro Neuro Adaptive Regulator on Pain, Disability and Central Sensitization in Patients With Fibromyalgia
Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, Evidence shows that different physical therapies could activation situations of chronic pain there is no activation of CPM.
Objectives: The purpose of this study is to measure the CPM response and determine whether Electro Neuro Adaptative Regulator in patients with Fibromyalgia is effective in the improvement of CPM, TS, pain intensity, disability.
Read more
Design: Double-blind, randomized placebo clinical trial. Methods: Patients with fibromyalgia will be randomly allocated into two groups: the Electro Neuro Adaptative Regulator group (SCENAR) or the sham technique (ST) group.
Main outcomes measures: Pain intensity (with visual analogue scale, Conditioned Pain Modulation (CPM), Temporal Summation (TS) and Pressure Pain Thresholds (PPT´s) were the primary outcomes and will be assessed at baseline and at 3-months follow-up. Secondary outcome measures were the Fibromyalgia Impact Questionnaire to measure disability, Pain Catastrophizing Scale and the Pain Anxiety Symptoms Scale, Beck Depression Inventory, Jenkins Sleep Scale. Questionnaire of quality of life SF36.
Participants will be selected if they met the following inclusion criteria: (a) fulfilled the 1990 and 2010 American College of Rheumatology classification criteria for FM; (b) reported an average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale during the previous week to study commencement; (c) were on stable doses of medication for FM ≥ 4 weeks; and (d) were aged between 18 and 65 years.
- Conditions
- Fibromyalgia
- Being tested
- Electro Neuro adaptative Regulator
- Keywords
- visual analogue scale, conditioned pain modulation, disability, pressure pain threshold, temporal summation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro Neuro adaptative RegulatorOther
Also called InterX
The SCENAR device has been previously described and generates high-amplitude, pulsed, damped biphasic sinusoidal current that is delivered to the tissue via a pair of concentric electrodes placed in direct contact with the target area. The intensity of the interactive waveform adjusts in response to changes in skin impedance
| Study group | Role | What they receive |
|---|---|---|
| Electro Neuro adaptative Regulator | Experimental | 8 SCENAR sessions (twice a week) (30 min of duration) following the protocols for treatment several points in the body Receives: Other: Electro Neuro adaptative Regulator |
| Sham Electro Neuro adaptative Regulator | Sham comparator | 8 Sham SCENAR sessions (twice a week) (30 min of duration), following the same protocol tan experimental group but the machine will be turn off 30 seconds after starting on the treatment. Receives: Other: Electro Neuro adaptative Regulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical pain ranting Scale
The patients will be asked to assess the subjective pain intensity of the painful in whole body by to marking the level of pain on the scale. Pain intensity was measured with the NRS of 11 points (interval from 0 to 10), where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable.
Measured: Change from Baseline of pain intensity at 3 months
Fibromyalgia Impact Questionnaire (FIQ)
The FIQ, which is a validated self-reported questionnaire to measure multidimensional function/health-related quality of life, will be used.Scores in the FIQ range from 0 to 100, An improvement greater than 30% in the FIQ total score has been identified in clinical trials as sensitive to identify a positive response to treatment.
Measured: Change from Baseline of Fibromyalgia impact questionnaire at 3 months
Secondary outcomes (9)
Conditioned pain modulation
After an interval of 5 minutes CPM was assessed by replicating the TS assessment associated with a conditioning stimulus for eliciting CPM. The conditioning stimulus was an occlusion cuff at the left arm inflated, at a rate of 20 mmHg/s until the subject reports "the first sensation of pain". Acquired pressure at this point remained for 30 seconds. The subject described the intensity of pain, because of occlusion in the arm, on a verbal numerical rating scale (0 = no pain and 10 = worst possible pain). Then cuff inflation was increased or decreased until the intensity of pain will be 3/10 in verbal rating scale
Measured: Change from Baseline of CPM at 3 months
Mechanical Hyperalgesia
Pressure Pain Thresholds (PPTs) were assessed using algometry in the thumb (dorsal aspect of the distal phalanx). The PPT is defined as the lowest pressure that, using standardized testing conditions, needs to be applied to cause the slightest sensation of pain. It is a reliable and widely used measure
Measured: Change from Baseline of PPT at 3 months
Temporal Summation
The degree of TS or wind-up will be evaluated in response to 10 applications (pulses) of the algometer, with an approximate rate of pressure increase of 2 Kg/s, at the previously defined PPT at the dorsal surface of the right-hand middle finger midway between the first and second distal joints, and at the middle of the right-hand side upper trapezius belly. Participants were asked to rate the intensity and unpleasantness of the pain intuitively of the first, fifth, and tenth pulse on a numeric pain rating scale.
Measured: Change from Baseline of TS at 3 months
Pain Catastrophizing
The Spanish version of the Pain Catastrophizing Scale (PCS) was used to assess catastrophic thoughts about pain, which has shown appropriate psychometric properties.
Measured: Change from Baseline of pain catastrophizing at 3 months
State Trait Anxiety Inventory
All participants will complete the Spanish version of the trait subscale of the State Trait Anxiety Inventory (STAI-T). The STAI-T has been found to possess adequate reliability (alpha coefficients of 0.93, test-retest reliability of 0.80) and validity.
Measured: Change from Baseline of Anxiety at 3 months
Beck Depression Inventory (BDI)
The level of depressive symptomatology was measured by the Spanish version of the Beck Depression Inventory (BDI-II); a self-report measure that assesses affective, cognitive and somatic symptoms of depression.
Measured: Change from Baseline of Depression symptoms at 3 months
Tampa Scale for Kinesiophobia
Developed by Miller, will be used to assess fear of movement and injury. We'll use the original 17-item version, which has shown good psychometric guarantees
Measured: Change from Baseline of kinesiophobia at 3 months
Jenkins Sleep Scale
The Jenkins Sleep Scale (JSS) is a 4-item self-report questionnaire designed to measure how often a subject has experienced sleep problems in the past month and has been studied in FM patients and found to be valid, reliable, and able to detect change after treatment.
Measured: Change from Baseline of sleep scale at 3 months
SF-36. Short Form-36 Health Survey
The Health related of quality of life will be selected primary outcome. It is a multipurpose, form health survey that includes 36 items taken directly from eight scale scores (physical functioning [PF], role-physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role-emotional [RE], and mental health [MH]).
Measured: Change from Baseline of quality of life at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start30 Jun 2018
- Primary completion29 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 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
- Josue Fernández-Carnero, PhD, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882567
- Sponsor's protocol ID
- 03/2015
- Acronym
- SCENAR
- Status last verified
- Oct 2019
- First submitted
- 4 Sep 2018
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electro Neuro Adaptive Regulator on Pain, Disability and Central Sensitization in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03882567
- Acronym / sponsor ID
- SCENAR / 03/2015
- Conditions
- Fibromyalgia
- Keywords
- visual analogue scale, conditioned pain modulation, disability, pressure pain threshold, temporal summation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 20 Mar 2019 (actual)
- 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.
Background: There is evidence linking conditioned pain modulation (CPM) deficiency with musculoskeletal pain syndromes such as fibromyalgia, Evidence shows that different physical therapies could activation situations of chronic pain there is no activation of CPM.
Objectives: The purpose of this study is to measure the CPM response and determine whether Electro Neuro Adaptative Regulator in patients with Fibromyalgia is effective in the improvement of CPM, TS, pain intensity, disability.
Design: Double-blind, randomized placebo clinical trial. Methods: Patients with fibromyalgia will be randomly allocated into two groups: the Electro Neuro Adaptative Regulator group (SCENAR) or the sham technique (ST) group.
Main outcomes measures: Pain intensity (with visual analogue scale, Conditioned Pain Modulation (CPM), Temporal Summation (TS) and Pressure Pain Thresholds (PPT´s) were the primary outcomes and will be assessed at baseline and at 3-months follow-up. Secondary outcome measures were the Fibromyalgia Impact Questionnaire to measure disability, Pain Catastrophizing Scale and the Pain Anxiety Symptoms Scale, Beck Depression Inventory, Jenkins Sleep Scale. Questionnaire of quality of life SF36.
Participants will be selected if they met the following inclusion criteria: (a) fulfilled the 1990 and 2010 American College of Rheumatology classification criteria for FM; (b) reported an average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale during the previous week to study commencement; (c) were on stable doses of medication for FM ≥ 4 weeks; and (d) were aged between 18 and 65 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electro Neuro adaptative Regulator | Experimental | Other: Electro Neuro adaptative Regulator8 SCENAR sessions (twice a week) (30 min of duration) following the protocols for treatment several points in the body |
| Sham Electro Neuro adaptative Regulator | Sham comparator | Other: Electro Neuro adaptative Regulator8 Sham SCENAR sessions (twice a week) (30 min of duration), following the same protocol tan experimental group but the machine will be turn off 30 seconds after starting on the treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- . American College of Rheumatology classification criteria for Fibromyalgia.
- . reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries;
- on stable doses of medications for FM ≥ 4 weeks.
Key exclusion criteria (1 listed)
- Patients will be excluded from enrolment if: (1) they suffer from an inflammatory rheumatic conditions; (2) have a planned elective surgery during the study period; (3) have ongoing unresolved disability claims; (4) experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis; (5) do not speak Spanish fluently.
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 |
|---|---|---|
| Electro Neuro adaptative RegulatorAlso: InterXThe SCENAR device has been previously described and generates high-amplitude, pulsed, damped biphasic sinusoidal current that is delivered to the tissue via a pair of concentric electrodes placed in direct contact with the target area. The intensity of the interactive waveform adjusts in response to changes in skin impedance | Other | Electro Neuro adaptative Regulator, Sham Electro Neuro adaptative Regulator |
Primary outcome
Numerical pain ranting Scale
Time frame: Change from Baseline of pain intensity at 3 months
The patients will be asked to assess the subjective pain intensity of the painful in whole body by to marking the level of pain on the scale. Pain intensity was measured with the NRS of 11 points (interval from 0 to 10), where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable.
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Change from Baseline of Fibromyalgia impact questionnaire at 3 months
The FIQ, which is a validated self-reported questionnaire to measure multidimensional function/health-related quality of life, will be used.Scores in the FIQ range from 0 to 100, An improvement greater than 30% in the FIQ total score has been identified in clinical trials as sensitive to identify a positive response to treatment.
9 secondary outcomes
Conditioned pain modulation
Time frame: Change from Baseline of CPM at 3 months
Mechanical Hyperalgesia
Time frame: Change from Baseline of PPT at 3 months
Temporal Summation
Time frame: Change from Baseline of TS at 3 months
Pain Catastrophizing
Time frame: Change from Baseline of pain catastrophizing at 3 months
State Trait Anxiety Inventory
Time frame: Change from Baseline of Anxiety at 3 months
Beck Depression Inventory (BDI)
Time frame: Change from Baseline of Depression symptoms at 3 months
Tampa Scale for Kinesiophobia
Time frame: Change from Baseline of kinesiophobia at 3 months
Jenkins Sleep Scale
Time frame: Change from Baseline of sleep scale at 3 months
SF-36. Short Form-36 Health Survey
Time frame: Change from Baseline of quality of life at 3 months
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 1 Nov 2019.
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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.
Josue Fernández-Carnero, PhD study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro Neuro adaptative Regulator in people with Fibromyalgia, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 3 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Numerical pain ranting Scale (time frame: Change from Baseline of pain intensity at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2019.