Pain After Dry NeedlingPhase 2NCT01608633
Effects of Spray and Stretch on Postneedling Soreness and Sensitivity After Dry Needling of a Latent Myofascial Trigger Point.
A Phase 2 study testing Spray and stretch in people with Pain After Dry Needling, run by CEU San Pablo University at 1 site in Spain.
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 spray and stretch technique is evaluated as a method to reduce this soreness. 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?
- Spray and stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Apr 2013
- Phase
- Phase 2
- 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
Who may be able to join
- Subjects presenting latent trigger points in the trapezius muscle
Who cannot join
- Subjects with active trigger points or absence of trigger points.
Trial locations and contacts
1 site in 1 country.
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 spray and stretch technique is evaluated as a method to reduce this soreness. As well, the characteristics and the different factors that influence in this pain will be described.
- Conditions
- Pain After Dry Needling
- Being tested
- Spray and stretch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spray and stretchOther
Physiotherapeutic technique which consist in stretching the muscle while a cold spray is applied on the skin.
| Study group | Role | What they receive |
|---|---|---|
| Spray and stretch | Experimental | Not described Receives: Other: Spray and stretch |
| Control | No intervention | Not described |
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 (2)
Pain
Pressure pain threshold
Measured: 48 hours
Psychological factors
Symptom check list revised. SCL-90-r
Measured: 72 hours after needling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2013
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 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
- NCT01608633
- Sponsor's protocol ID
- CEU-001
- Status last verified
- Sep 2013
- First submitted
- 27 May 2012
- Last updated
- 4 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spray and Stretch on Postneedling Soreness and Sensitivity After Dry Needling of a Latent Myofascial Trigger Point.
- ClinicalTrials.gov ID
- NCT01608633
- Acronym / sponsor ID
- CEU-001
- Conditions
- Pain After Dry Needling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- First posted
- 31 May 2012 (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 spray and stretch technique is evaluated as a method to reduce this soreness. As well, the characteristics and the different factors that influence in this pain will be described.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spray and stretch | Experimental | Other: Spray and stretch |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects presenting latent trigger points in the trapezius muscle
Key exclusion criteria (1 listed)
- Subjects with active trigger points or absence of trigger points.
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 |
|---|---|---|
| Spray and stretchPhysiotherapeutic technique which consist in stretching the muscle while a cold spray is applied on the skin. | Other | Spray and stretch |
Primary outcome
Pain
Time frame: 72 hours
Visual analogue scale
2 secondary outcomes
Pain
Time frame: 48 hours
Psychological factors
Time frame: 72 hours after needling
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 4 Sep 2013.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spray and stretch in people with Pain After Dry Needling, run by CEU San Pablo University 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 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 4 Sep 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 4 Sep 2013; AzTrials last refreshed its copy on 6 Nov 2026.