Neck PainNCT04148469
Dry Needling Effectiveness and Post-punction Pain
A study testing Dry needling and Transcutaneous Nerve Stimulation. in people with Neck Pain, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The purpose of this estudy was to dertermine if the application of Transcutaneous Nerve Stimiulation (TENS) current have an hypoalgesic effect on pattientes suffering from miofascial neck pain, compared with a only dry needling treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry needling and Transcutaneous Nerve Stimulation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to 10 Dec 2013
- 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
- Mechanical Neck pain of at least 6 months.
- VAS 2 or greather.
- Existance of miofascial trigger point in trapezius muscle assesed by an expert PT.
Who cannot join
- Neck pain due secondary to ostheoporosis, metastasis, neoplasias, fractures, infections, cervical stenosis or infexious procces.
- Headache secondary to medular compression presenting one o the following signs: abnormal sensitivity, hiperreflexia, clonus, spread weakness, cervical hernia.
- Neck pain with radiculopathy.
- Whiplash.
- Vertebrobasilar syndrome.
- Dizzyness.
- Pregnancy.
- Having received dry needling treatment before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits and Harms of Dry Needling vs Transcutaneous Nerve Stimulation and Dry Needling in Patients With Chronic Myofascial Neck Pain and Relationship With Psychological Influences
The purpose of this estudy was to dertermine if the application of Transcutaneous Nerve Stimiulation (TENS) current have an hypoalgesic effect on pattientes suffering from miofascial neck pain, compared with a only dry needling treatment. Psicological varaibles were also mesured in order to determine how they change after each treatment.
Read the detailed description
All patients suffered from mechanical neck pain and were randomized into three groups of treatment. A doible blinded control was carryed out. The main outcome messures were Visual Analogue Scale (VAS). The scondary outcome messures were Pressure Pain hreshold (PPT) and Active Range of Movement (ROM). Also psicologicla messures were taken, like Neck Dissability Index, Level of stress and ansiety, Fear Pain and Pain Avoidance Strategies.
- Conditions
- Neck Pain
- Being tested
- Dry needling, Transcutaneous Nerve Stimulation., Placebo needling
- Keywords
- Miofascial pain syndrom., Trigger point., Dry needling., Transcotaneous Nerve Stimuilation., Hipoalgesia
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingProcedure or surgery
Dry needlin is a manual therapy technique used for miofascuial pain syndrom treatment. The patient will be supine, in a confortable position. The therapist localizes the trapezius trigger point number 2 and then performes the needling until 2 REL are obtenined. The patient will remain supine during 15 minutes.
Transcutaneous Nerve Stimulation.Procedure or surgery
Transcutaneous Nerve Stimulation (TENS) is a current used for pain treatment. The needle will be used as the negative pole and a adhesive patch 2 centimeters lateral will be the positive pole. The frecuency selected will have 2 Hz with pulses of 120 microseconds. The currente will be applied for 15 minutes.
Placebo needlingProcedure or surgery
No active technique is performed with the placebo needling. Patient will be supine and a placebo needle willb be performed. The patient will remain supine for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| dry needling and TENS | Experimental | A dry needling treatment was performed on trapezius trigger point number 2, and just after thar, a TENS curretn was applied. Patients will be reassed on fourth day after treatment. Receives: Procedure: Transcutaneous Nerve Stimulation. |
| Placebo | Placebo comparator | A placebo dry needling was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment. Receives: Procedure: Placebo needling |
| dry needling | Experimental | A dry needling treatment was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment. Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual Analogue Scale (VAS) is a subjective evaluation. There are previous studies that demonstrate its reliability and its sensitivity, wich give validity to VAS messures. The messure is made using a two sides 10 centimeters scale. The patient´s face shows an increasing slope that allows the patient to mark his pain level. That mark has his equivalent number on the scale, so 0 is no pain and 10 is maximum pain. A differece of 2 points on the scale means the minimum clinically significant change.
Measured: Patients will be reassed in four days.
Secondary outcomes (2)
Active Cervical Range of Movement
To messure the cervical range of movement, a CROM will be used. The CROM is a special goniometer that allows therapists to messure cervical movements. It conists on trhee pairs of inclinometers that allow reserchers to messure range of flexion-extension, lateral flexion and rotation. The CROM has a porved reliability, providing a inter-meter reliability from 0,7 to 0,9 and an intra-meter reliability from 0,8 to 0,87. The patient will be seated on a cheir, and he´ll perform cervical movements actively, just untill he starts to feel his pain. Each movement will be messure three times, and the average will be taken.
Measured: Patient will be reassed in four days.
Pressure Pain Threshold
Pressure Pain Threshold (PPT) is the minimun pressure needed to araise pain. To messure PPT, an digital algometer will be used. An algometer consists on a 1 square centimeter rubber piece inserted on a pressure gauge. Previous studies have shown the reliability of this method (ICC=0,91) and also inter meter (ICC from 0,82 to 0,97) and intra meter (ICC=0,78). The minimun detectable change on the cervical area goes from 0,44 Kg/cm2 to 1,11 Kg/cm2. We will apply the algometer over trapezius trigger point number 2, and the patient will tell the therapist when he start to feel hgis pain. We´ll do the messure 3 times and the average will be taken.
Measured: Patients will be reassed in four days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study startNov 2012
- Primary completion12 Jun 2013
- Study completion10 Dec 2013
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 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
- Jose Vicente León Hernández, PT, Principal investigator, Universitdad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148469
- Sponsor's protocol ID
- urjc20-13
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- 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
- Benefits and Harms of Dry Needling vs Transcutaneous Nerve Stimulation and Dry Needling in Patients With Chronic Myofascial Neck Pain and Relationship With Psychological Influences
- ClinicalTrials.gov ID
- NCT04148469
- Acronym / sponsor ID
- urjc20-13
- Conditions
- Neck Pain
- Keywords
- Miofascial pain syndrom., Trigger point., Dry needling., Transcotaneous Nerve Stimuilation., Hipoalgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- 12 Jun 2013 (actual)
- Study completion
- 10 Dec 2013 (actual)
- First posted
- 1 Nov 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.
The purpose of this estudy was to dertermine if the application of Transcutaneous Nerve Stimiulation (TENS) current have an hypoalgesic effect on pattientes suffering from miofascial neck pain, compared with a only dry needling treatment. Psicological varaibles were also mesured in order to determine how they change after each treatment.
Detailed description
All patients suffered from mechanical neck pain and were randomized into three groups of treatment. A doible blinded control was carryed out. The main outcome messures were Visual Analogue Scale (VAS). The scondary outcome messures were Pressure Pain hreshold (PPT) and Active Range of Movement (ROM). Also psicologicla messures were taken, like Neck Dissability Index, Level of stress and ansiety, Fear Pain and Pain Avoidance Strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dry needling and TENS | Experimental | Procedure: Transcutaneous Nerve Stimulation.A dry needling treatment was performed on trapezius trigger point number 2, and just after thar, a TENS curretn was applied. Patients will be reassed on fourth day after treatment. |
| Placebo | Placebo comparator | Procedure: Placebo needlingA placebo dry needling was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment. |
| dry needling | Experimental | Procedure: Dry needlingA dry needling treatment was performed on trapezius trigger point number 2. Patients will be reassed on fourth day after treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanical Neck pain of at least 6 months.
- VAS 2 or greather.
- Existance of miofascial trigger point in trapezius muscle assesed by an expert PT.
Key exclusion criteria (8 listed)
- Neck pain due secondary to ostheoporosis, metastasis, neoplasias, fractures, infections, cervical stenosis or infexious procces.
- Headache secondary to medular compression presenting one o the following signs: abnormal sensitivity, hiperreflexia, clonus, spread weakness, cervical hernia.
- Neck pain with radiculopathy.
- Whiplash.
- Vertebrobasilar syndrome.
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 |
|---|---|---|
| Dry needlingDry needlin is a manual therapy technique used for miofascuial pain syndrom treatment. The patient will be supine, in a confortable position. The therapist localizes the trapezius trigger point number 2 and then performes the needling until 2 REL are obtenined. The patient will remain supine during 15 minutes. | Procedure or surgery | dry needling |
| Transcutaneous Nerve Stimulation.Transcutaneous Nerve Stimulation (TENS) is a current used for pain treatment. The needle will be used as the negative pole and a adhesive patch 2 centimeters lateral will be the positive pole. The frecuency selected will have 2 Hz with pulses of 120 microseconds. The currente will be applied for 15 minutes. | Procedure or surgery | dry needling and TENS |
| Placebo needlingNo active technique is performed with the placebo needling. Patient will be supine and a placebo needle willb be performed. The patient will remain supine for 15 minutes. | Procedure or surgery | Placebo |
Primary outcome
Visual Analogue Scale
Time frame: Patients will be reassed in four days.
Visual Analogue Scale (VAS) is a subjective evaluation. There are previous studies that demonstrate its reliability and its sensitivity, wich give validity to VAS messures. The messure is made using a two sides 10 centimeters scale. The patient´s face shows an increasing slope that allows the patient to mark his pain level. That mark has his equivalent number on the scale, so 0 is no pain and 10 is maximum pain. A differece of 2 points on the scale means the minimum clinically significant change.
2 secondary outcomes
Active Cervical Range of Movement
Time frame: Patient will be reassed in four days.
Pressure Pain Threshold
Time frame: Patients will be reassed in four days.
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.
Jose Vicente León Hernández, PT principal investigator
Universitdad 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 Dry needling and Transcutaneous Nerve Stimulation. in people with Neck Pain, 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 8 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?
Visual Analogue Scale (time frame: Patients will be reassed in four days.). 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.