Myofascial Pain SyndromeNCT03345238

Neurophysiological Effects of Dry Needling in Patients With Neck Pain

A study testing Deep Dry Needling in people with Myofascial Pain Syndrome, run by Universidad Rey Juan Carlos at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present study aims to evaluate the differences that may be experienced in pain and cervical disability, before, during and just after the intervention of the Deep Dry Needling in the upper trapezius muscle in active, passive myofascial trigger points (MTP) or non-MTP in Patients with neck pain, assessing, in turn… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Myofascial Pain Syndrome
What is being tested?: Deep Dry Needling
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteSpain
Study dates: 13 Mar 2017to 10 Aug 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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Non-specific neck pain, unilateral or bilateral.
Neck pain ≥ 3 months of duration.
Presence of active and latent MTP in the upper, left, right or bilateral trapezius muscle, in relation to the patient's neck pain.
Clinical criteria recommended to identify active and latent MTP:
Tensile band palpable.
Exquisite local pain at the pressure of a taut band node.
Recognition by the patient of their usual pain when pressing on the sensitive nodule (to identify an active MTP).
Painful limitation of range of mobility to complete stretching. It is considered positive when 3 of the 4 clinical criteria are found.

Who cannot join

Unsurpassed fear of needles.
Coagulation disorders.
Specific alterations of the cervical region in the clinical history.
Infiltration of corticosteroids or local anesthetics during a year before the study.
Surgical intervention of the cervical region or previous shoulder.
Skin lesions in the area, as well as infection or inflammation.

Show all 9Show fewer

Taking analgesic, anti-inflammatory or anticoagulant medication the week before the study.
Treatment of MTP or Deep Dry Needling in the neck region in the 6 months prior to the intervention.
Cognitive deficit in the medical history.

Trial locations and contacts

1 site in 1 country.

Spain1 site

universidad de Alcalá de Henares
Alcalá de Henares, Madrid

Other trials in Spain

About this study

Hypothesis: Deep Dry Needling of active myofascial trigger points produces a greater decrease of pain and cervical disability index and increase of pressure pain threshold; Than the Deep Dry Needling of Myofascial Trigger Points latent or out of Myofascial Trigger Points in patients with chronic neck pain.

Objective: To determine the efficacy of Deep Dry Needling applied on Active Myofascial Triggers (MTP) vs. latent MTP versus MTP, on pain reduction and cervical disability, in patients with chronic neck pain attributable to Myofascial Pain Syndrome.

Conditions: Myofascial Pain Syndrome
Being tested: Deep Dry Needling
Keywords: Dry Needling, Myofascial Pain Syndrome, Neurophysiological effects, Autonomic Nervous System
Medical subject headings: Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deep Dry NeedlingProcedure or surgery
Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.

Study groups in NCT03345238
Study group	Role	What they receive
Active MTP	Experimental	Not described Receives: Procedure: Deep Dry Needling
Latent MTP	Experimental	Not described Receives: Procedure: Deep Dry Needling
Out of MTP	Experimental	Not described Receives: Procedure: Deep Dry Needling

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of Deep Dry Needling applied on Active Myofascial Trigger Points (MTP) vs. latent MTP versus outside MTP, on pain reduction in patients with chronic neck pain.
Checkin the Intensity of pain with the Visual Analogic Scale.
It is a 100 mm line that measures the intensity of pain.The left end of the line represents the absence of pain, while the far right represents the worst pain imaginable. The numerical scale of intensity of pain adds a numerical ranking where 1 is no pain and 10 the worst pain imaginable.
Measured: Baseline, during intervention, immediately after intervention, 1, 6, 12, 24, 48 and 72 hours after intervention, a week after intervention and one month after the intervention

Secondary outcomes (7)

Threshold of pain to pressure
Using a Digital algometer in the pain points of the patient.
Measured: Baseline and immediately after intervention
Cervical pain and dysfunction
Using the questionnaire: Neck Disability Index
It is the scale that has been used in more different populations and the one that has been more times validated against multiple measures of function, pain and clinical signs and symptoms. The NDI is a self-completed questionnaire with 10 sections. Each of the sections (cervical pain intensity, personal care, weight lifting, reading, headache, ability to concentrate, work capacity, driving, sleep and leisure activities) offers 6 possible answers that represent 6 levels progressive functional capacity, and scored from 0 to 5 (0 = no disability, 5 = total disability). The total score is expressed in percentage terms with respect to the maximum possible.
Measured: Baseline, a week after intervention and one month after the intervention
Cervical pain and dysfunction
Using the questionnaire: Catastrophic Scale of Pain
It is a self-administered scale of 13 items and one of the most used to assess the construct "catastrophization in the face of pain".
It comprises 3 dimensions: a) rumination; b) magnification, and c) hopelessness.
The theoretical range of the instrument is between 13 and 62, indicating low scores, little catastrophization, and high values, high catastrophization.
Measured: Baseline
Cervical pain and dysfunction
Using the questionnaire: Chronic pain gradation scale
It is a scale that serves as a valid, reliable and useful instrument to measure chronic pain early in clinical practice. The first factor formed by 4 items, can be called "disability related to pain"; the second, "the intensity of pain", is made up of 3 items. The version of the scale in Spanish consists of 8 items and the final score is obtained with the sum of items 2 to 8, which results in a range of 0 to 70.
Measured: Baseline, a week after intervention and one month after the intervention
Changes related to the Autonomic Nervous System
Checking heart rate measuring the beats per minute.
Measured: Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
Changes related to the Autonomic Nervous System
Checking changes of the skin temperature measuring the surface temperature of the skin in ºC.
Measured: Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
Changes related to the Autonomic Nervous System
Checking changes on skin conductance measuring the conductance of the skin in microsiemens.
Measured: Baseline, during intervention and after intervention (1 and 10 minutes after intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 201710 Aug 2019

First posted17 Nov 2017
Study start13 Mar 2017
Primary completion29 Dec 2017
Study completion10 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Myofascial Pain SyndromeStudies 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: Factorial
Model description: Randomized controlled trial with double-blind
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03345238
Sponsor's protocol ID: 31/8/2017
Status last verified: Nov 2019
First submitted: 31 Aug 2017
Last updated: 12 Nov 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myofascial Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurophysiological Effects of Dry Needling in Patients With Neck Pain
ClinicalTrials.gov ID: NCT03345238
Acronym / sponsor ID: 31/8/2017
Conditions: Myofascial Pain Syndrome
Keywords: Dry Needling, Myofascial Pain Syndrome, Neurophysiological effects, Autonomic Nervous System
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Universidad Rey Juan CarlosUniversity, hospital or other
Collaborators: Luis Martín Sacristán
Study start: 13 Mar 2017 (actual)
Primary completion: 29 Dec 2017 (actual)
Study completion: 10 Aug 2019 (actual)
First posted: 17 Nov 2017 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: Randomized controlled trial with double-blind

Arm	Type	Receives
Active MTP	Experimental	Procedure: Deep Dry Needling
Latent MTP	Experimental	Procedure: Deep Dry Needling
Out of MTP	Experimental	Procedure: Deep Dry Needling

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Non-specific neck pain, unilateral or bilateral.
Neck pain ≥ 3 months of duration.
Presence of active and latent MTP in the upper, left, right or bilateral trapezius muscle, in relation to the patient's neck pain.
Clinical criteria recommended to identify active and latent MTP:

Key exclusion criteria (9 listed)

Unsurpassed fear of needles.
Coagulation disorders.
Specific alterations of the cervical region in the clinical history.
Infiltration of corticosteroids or local anesthetics during a year before the study.
Surgical intervention of the cervical region or previous shoulder.

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
Deep Dry NeedlingDeep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.	Procedure or surgery	Active MTP, Latent MTP, Out of MTP

Primary outcome

Efficacy of Deep Dry Needling applied on Active Myofascial Trigger Points (MTP) vs. latent MTP versus outside MTP, on pain reduction in patients with chronic neck pain.
Time frame: Baseline, during intervention, immediately after intervention, 1, 6, 12, 24, 48 and 72 hours after intervention, a week after intervention and one month after the intervention
Checkin the Intensity of pain with the Visual Analogic Scale. It is a 100 mm line that measures the intensity of pain.The left end of the line represents the absence of pain, while the far right represents the worst pain imaginable. The numerical scale of intensity of pain adds a numerical ranking where 1 is no pain and 10 the worst pain imaginable.

7 secondary outcomes

Threshold of pain to pressure
Time frame: Baseline and immediately after intervention
Cervical pain and dysfunction
Time frame: Baseline, a week after intervention and one month after the intervention
Cervical pain and dysfunction
Time frame: Baseline
Cervical pain and dysfunction
Time frame: Baseline, a week after intervention and one month after the intervention
Changes related to the Autonomic Nervous System
Time frame: Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
Changes related to the Autonomic Nervous System
Time frame: Baseline, during intervention and after intervention (1 and 10 minutes after intervention)
Changes related to the Autonomic Nervous System
Time frame: Baseline, during intervention and after intervention (1 and 10 minutes after intervention)

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 12 Nov 2019.
Individual participant dataSharing planned: No

Related trials for Myofascial Pain Syndrome

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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Recruiting
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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.

Luis Martín Sacristán, MSc principal investigator

University of Alcala

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Deep Dry Needling in people with Myofascial Pain Syndrome, 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 8 inclusion and 9 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 12 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. 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?

Efficacy of Deep Dry Needling applied on Active Myofascial Trigger Points (MTP) vs. latent MTP versus outside MTP, on pain reduction in patients with chronic neck pain. (time frame: Baseline, during intervention, immediately after intervention, 1, 6, 12, 24, 48 and 72 hours after intervention, a week after intervention and one month after the intervention). 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 NCT03345238.

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 12 Nov 2019.