Neck PainNCT02190890
Dry Needling Dosage in the Treatment of Myofascial Neck Pain
A study testing Dry needling in people with Neck Pain, run by Universidad Rey Juan Carlos.
Trial summary
The purpose of this study are (1) to determine the effectiveness of different dry needling dosages in the treatment of myofascial trigger points in the upper trapezius muscle in patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and (3) evaluate the influence of psychological… Read more about this study
- Who is it for?
- Ages 18 to 53 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 2015
- 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 53 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of an active myofascial trigger point. Neck pain: Superior to 3 cm in VAS
Who cannot join
- Neck area: Fracture, radiculopathy, previous surgery, previous needling treatment in the last 6 months, previous analgesic medication (24 hours), psychiatric disease
About this study
Official title: Effects of Different Deep Dry Needling Dosages on Pain and Postneedling Soreness in the Treatment of Patients With Cervical Myofascial Pain
The purpose of this study are (1) to determine the effectiveness of different dry needling dosages in the treatment of myofascial trigger points in the upper trapezius muscle in patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and (3) evaluate the influence of psychological factors on the perception of postneedling soreness.
- Conditions
- Neck Pain
- Being tested
- Dry needling, Control
- 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
ControlProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Dry needling: 4 local twitch responses | Experimental | Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 4 local twitch responses were elicited. Receives: Procedure: Dry needling |
| Dry needling: 6 local twitch responses | Experimental | Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 6 local twitch responses were elicited. Receives: Procedure: Dry needling |
| Dry needling: Until no more local twitch responses elicited | Experimental | Deep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until no more local twitch responses were elicited. Receives: Procedure: Dry needling |
| Control | Active comparator | The needle was inserted 1.5 cm away from the trigger point in the trapezius muscle and withdrawn without any consecutive insertion. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Measured: 1 week
Postneedling soreness
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Measured: 1 week
Secondary outcomes (8)
Pressure pain threshold
Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
Measured: 1 week
Cervical range of motion
The subjects sat in a chair and a CROM goniometer was placed over the head. They were asked to perform active neck movements to the fullest extent of their mobility. Each movement was recorded three times and the average value was calculated.
Measured: 1 week
Neck disability
Neck Disability Index questionnarie was completed.
Measured: 1 week
Pain in cervical range of motion
Pain in a numerical pain rating scale during all cervical movements was recorded.
Measured: 1 week
Psychological factors
State Trait Anxiety Inventory (STAI-T)
Measured: Pre-intervention
Psychological factors
Beck Depression Inventory (BDI-II)
Measured: Pre-intervention
Psychological factors
Tampa Scale for Kinesiophobia
Measured: Pre-intervention
Psychological factors
Pain Catastrophizing Scale
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionDec 2015
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
- 94 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190890
- Sponsor's protocol ID
- 16/2013
- Status last verified
- Dec 2017
- First submitted
- 4 Jul 2014
- Last updated
- 6 Dec 2017
- Results posted
- No
Publications
Martin-Pintado-Zugasti A, Fernandez-Carnero J, Leon-Hernandez JV, Calvo-Lobo C, Beltran-Alacreu H, Alguacil-Diego I, Gallego-Izquierdo T, Pecos-Martin D. Postneedling Soreness and Tenderness After Different Dosages of Dry Needling of an Active Myofascial Trigger Point in Patients With Neck Pain: A Randomized Controlled Trial. PM R. 2018 Dec;10(12):1311-1320. doi: 10.1016/j.pmrj.2018.05.015. Epub 2018 May 29.
PubMed 29857165
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Deep Dry Needling Dosages on Pain and Postneedling Soreness in the Treatment of Patients With Cervical Myofascial Pain
- ClinicalTrials.gov ID
- NCT02190890
- Acronym / sponsor ID
- 16/2013
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jul 2014 (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 purpose of this study are (1) to determine the effectiveness of different dry needling dosages in the treatment of myofascial trigger points in the upper trapezius muscle in patients with myofascial neck pain, (2) to assess postneedling soreness and tenderness and (3) evaluate the influence of psychological factors on the perception of postneedling soreness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dry needling: 4 local twitch responses | Experimental | Procedure: Dry needlingDeep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 4 local twitch responses were elicited. |
| Dry needling: 6 local twitch responses | Experimental | Procedure: Dry needlingDeep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until 6 local twitch responses were elicited. |
| Dry needling: Until no more local twitch responses elicited | Experimental | Procedure: Dry needlingDeep dry needling in the active myofascial trigger point in the upper trapezius muscle. The muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the MTrP until no more local twitch responses were elicited. |
| Control | Active comparator | Procedure: ControlThe needle was inserted 1.5 cm away from the trigger point in the trapezius muscle and withdrawn without any consecutive insertion. |
Who may qualify
- Ages
- 18 to 53 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of an active myofascial trigger point. Neck pain: Superior to 3 cm in VAS
Key exclusion criteria (1 listed)
- Neck area: Fracture, radiculopathy, previous surgery, previous needling treatment in the last 6 months, previous analgesic medication (24 hours), psychiatric disease
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 needling | Procedure or surgery | Dry needling: 4 local twitch responses, Dry needling: 6 local twitch responses, Dry needling: Until no more local twitch responses elicited |
| Control | Procedure or surgery | Control |
Primary outcome
Pain
Time frame: 1 week
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Postneedling soreness
Time frame: 1 week
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
8 secondary outcomes
Pressure pain threshold
Time frame: 1 week
Cervical range of motion
Time frame: 1 week
Neck disability
Time frame: 1 week
Pain in cervical range of motion
Time frame: 1 week
Psychological factors
Time frame: Pre-intervention
Psychological factors
Time frame: Pre-intervention
Psychological factors
Time frame: Pre-intervention
Psychological factors
Time frame: Pre-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 6 Dec 2017.
- Derived from this study: PubMed 29857165Martin-Pintado-Zugasti A, Fernandez-Carnero J, Leon-Hernandez JV, Calvo-Lobo C, Beltran-Alacreu H, Alguacil-Diego I, Gallego-Izquierdo T, Pecos-Martin D. Postneedling Soreness and Tenderness After Different Dosages of Dry Needling of an Active Myofascial Trigger Point in Patients With Neck Pain: A Randomized Controlled Trial. PM R. 2018 Dec;10(12):1311-1320. doi: 10.1016/j.pmrj.2018.05.015. Epub 2018 May 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling 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 6 Dec 2017. 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. 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: 1 week). 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?
On the ClinicalTrials.gov record for NCT02190890, 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 6 Dec 2017.