Pain After Dry NeedlingNCT02158104
Soreness After Deep Dry Needling of One Latent Myofascial Trigger Point
An observational study of Pain After Dry Needling, run by CEU San Pablo University.
Trial summary
Pain after dry needling or injection in the muscle is a frequent secondary effect in the treatment of myofascial pain syndrome. In this trial pain and sensitivity will be assessed during a 72 hours follow up period. Factors that may contribute to higher levels of pain or sensitivity will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain After Dry Needling
- What is being tested?
- Deep dry needling
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Feb 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjetct. Community sample from university.
Who may be able to join
- The latent MTrP diagnosis was based upon the following criteria:10
- presence of a palpable taut band in the muscle
- presence of a hypersensitive tender spot in the taut band
- palpable or visible local twitch response with snapping palpation of the tout band
- referred pain elicitation in response to compression.
Who cannot join
- presence of coagulation disorders
- neck or facial pain
- previous application of a dry needling technique
- MTrP therapy in head or neck within the previous 3 months
- fibromyalgia
- an insurmountable fear of needles as a reason of refusing the treatment
- history of surgery in the head or neck area.
About this study
Pain after dry needling or injection in the muscle is a frequent secondary effect in the treatment of myofascial pain syndrome. In this trial pain and sensitivity will be assessed during a 72 hours follow up period. Factors that may contribute to higher levels of pain or sensitivity will be evaluated.
- Conditions
- Pain After Dry Needling
- Being tested
- Deep dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep dry needlingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Latent trigger point in the upper trapezius muscle | Not described Receives: Procedure: Deep dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual analogue scale
Measured: 72 hours
Secondary outcomes (1)
Sensitivity
Pressure pain threshold
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After Dry NeedlingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158104
- Sponsor's protocol ID
- CEU-004
- Status last verified
- Jan 2014
- First submitted
- 5 Jun 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soreness After Deep Dry Needling of One Latent Myofascial Trigger Point
- ClinicalTrials.gov ID
- NCT02158104
- Acronym / sponsor ID
- CEU-004
- Conditions
- Pain After Dry Needling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 6 Jun 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.
Pain after dry needling or injection in the muscle is a frequent secondary effect in the treatment of myofascial pain syndrome. In this trial pain and sensitivity will be assessed during a 72 hours follow up period. Factors that may contribute to higher levels of pain or sensitivity will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latent trigger point in the upper trapezius muscle | – | Procedure: Deep dry needling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjetct. Community sample from university.
Key inclusion criteria (5 listed)
- The latent MTrP diagnosis was based upon the following criteria:10
- presence of a palpable taut band in the muscle
- presence of a hypersensitive tender spot in the taut band
- palpable or visible local twitch response with snapping palpation of the tout band
- referred pain elicitation in response to compression.
Key exclusion criteria (7 listed)
- presence of coagulation disorders
- neck or facial pain
- previous application of a dry needling technique
- MTrP therapy in head or neck within the previous 3 months
- fibromyalgia
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 needling | Procedure or surgery | Latent trigger point in the upper trapezius muscle |
Primary outcome
Pain
Time frame: 72 hours
Visual analogue scale
1 secondary outcome
Sensitivity
Time frame: 72 hours
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 Jun 2014.
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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?
An observational study of Pain After Dry Needling, run by CEU San Pablo University.
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 5 inclusion and 7 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 Jun 2014. 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: 72 hours). 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 6 Jun 2014.