Neck PainNCT03401905
Effects of Low Versus High Frequency Percutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients.
A study testing Low frequency and High frequency in people with Neck Pain and Chronic Pain, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
Comparison between high and low frequency percutaneous electrical nerve stimulation as treatment of myofascial chronic neck pain. The main hypothesis is that low frequency treatment will have more hypoalgesic effects than high frequency, and low frequency effects will last longer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Chronic Pain, Myofascial Pain Syndrome
- What is being tested?
- Low frequency and High frequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 9 Feb 2018to 9 Apr 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neck pain of more than 6 months of evolution.
- Pain level of more than 30 millimeter on the VAS scale.
- Active myofascial frigger points on upper trapezius muscle.
Who cannot join
- Upper limb radiculopathy.
- Recent whiplash.
- Cervicogenic dizziness.
- Migraine.
- Previous cervical surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison and Effects of Low and High Frequency Percutaneous Electrical Nerve Stimulation on Myofascial Chronic Neck Pain Patients.
Comparison between high and low frequency percutaneous electrical nerve stimulation as treatment of myofascial chronic neck pain. The main hypothesis is that low frequency treatment will have more hypoalgesic effects than high frequency, and low frequency effects will last longer.
- Conditions
- Neck Pain, Chronic Pain, Myofascial Pain Syndrome
- Being tested
- Low frequency, High frequency
- Keywords
- Percutaneous electrical nerve stimulation, Myofascial trigger point
- Medical subject headings
- Neck Pain, Chronic Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low frequencyProcedure or surgery
Also called Low frequency group
A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a low frequency TENS is applied, at 2 Hz frequency and 120 microseconds of pulse width.
High frequencyProcedure or surgery
Also called High frequency group
A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a high frequency TENS is applied, at 12o Hz frequency and 200 microseconds of pulse width.
| Study group | Role | What they receive |
|---|---|---|
| Low frequency | Experimental | Percutaneous electrical nerve stimulation with frequency of 2 Hz and 120 microseconds of pulse width will be applied. Receives: Procedure: Low frequency |
| High frequency | Active comparator | Percutaneous electrical nerve stimulation with frequency of 120 Hz and 200 microseconds of pulse width will be applied. Receives: Procedure: High frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Subjective feeling expressed by subjects in the area of discomfort. It will be measured by a Visual Analogue Scale, meaning a score of 0 points/centimiters "no pain" and a score of 10 points/centimiters "unbearable pain".
Measured: Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.
Secondary outcomes (3)
Pressure pain threshold
Minimal amount of pressure that induces pain. An algometer will be used to measure pressure pain threshold. Units will be kilograms per square centimeter. The higher the score is, the less sensitive the area will be.
Measured: Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.
Neck disability index.
Ten items questionnaire designed to asses the level of pain and self-assessment of cervical disability. The NDI (Spanish version) is composed of 10 questions related to daily functional activities. NDI presents an acceptable reliability with an intraclass correlation coeffcient (ICC) ranging from 0.50 to 0.98. It has been proposed that the clinically important difference required for NDI is seven points.
Measured: Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
kinesiofobia
Eleven items questionnaire designed to asses pain-related fear. TSK-11, Spanish version.
Measured: Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start9 Feb 2018
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Double blind randomized control trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Vicente Leon Hernandez, Centro Universitario La Salle
- Investigators
- Jose V León Hernández, PhD, Principal investigator, CSEU La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401905
- Sponsor's protocol ID
- CSEULS-PI-115/2016
- Status last verified
- May 2018
- First submitted
- 21 Dec 2017
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected will be used only for research objective. Once the trial have finished, data will be destroyed.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison and Effects of Low and High Frequency Percutaneous Electrical Nerve Stimulation on Myofascial Chronic Neck Pain Patients.
- ClinicalTrials.gov ID
- NCT03401905
- Acronym / sponsor ID
- CSEULS-PI-115/2016
- Conditions
- Neck Pain, Chronic Pain, Myofascial Pain Syndrome
- Keywords
- Percutaneous electrical nerve stimulation, Myofascial trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 17 Jan 2018 (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.
Comparison between high and low frequency percutaneous electrical nerve stimulation as treatment of myofascial chronic neck pain. The main hypothesis is that low frequency treatment will have more hypoalgesic effects than high frequency, and low frequency effects will last longer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized control trial.
| Arm | Type | Receives |
|---|---|---|
| Low frequency | Experimental | Procedure: Low frequencyPercutaneous electrical nerve stimulation with frequency of 2 Hz and 120 microseconds of pulse width will be applied. |
| High frequency | Active comparator | Procedure: High frequencyPercutaneous electrical nerve stimulation with frequency of 120 Hz and 200 microseconds of pulse width will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neck pain of more than 6 months of evolution.
- Pain level of more than 30 millimeter on the VAS scale.
- Active myofascial frigger points on upper trapezius muscle.
Key exclusion criteria (5 listed)
- Upper limb radiculopathy.
- Recent whiplash.
- Cervicogenic dizziness.
- Migraine.
- Previous cervical surgery.
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 |
|---|---|---|
| Low frequencyAlso: Low frequency groupA dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a low frequency TENS is applied, at 2 Hz frequency and 120 microseconds of pulse width. | Procedure or surgery | Low frequency |
| High frequencyAlso: High frequency groupA dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a high frequency TENS is applied, at 12o Hz frequency and 200 microseconds of pulse width. | Procedure or surgery | High frequency |
Primary outcome
Pain
Time frame: Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.
Subjective feeling expressed by subjects in the area of discomfort. It will be measured by a Visual Analogue Scale, meaning a score of 0 points/centimiters "no pain" and a score of 10 points/centimiters "unbearable pain".
3 secondary outcomes
Pressure pain threshold
Time frame: Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.
Neck disability index.
Time frame: Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
kinesiofobia
Time frame: Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
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 9 May 2018.
- Individual participant dataSharing planned: No. Data collected will be used only for research objective. Once the trial have finished, data will be destroyed.
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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.
Jose V León Hernández, PhD principal investigator
CSEU La Salle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low frequency and High frequency in people with Neck Pain and Chronic Pain, run by Centro Universitario La Salle 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 5 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 9 May 2018. 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. 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?
Pain (time frame: Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.). 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 9 May 2018.