Pain SyndromePhase 1/2NCT03402867
Effects of Dry Needling on Neck and Shoulder Pain in Orchestral Musicians: a Prospective Case Series
A Phase 1/2 study testing Deep dry needling in people with Pain Syndrome and Musculoskeletal Pain, run by CEU San Pablo University at 1 site in Spain.
Trial summary
This study evaluates the effectiveness of Deep dry needling of active myofascial trigger points present in muscles of the neck and shoulder region in orchestral musicians. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pain Syndrome, Musculoskeletal Pain, Trigger Point Pain, Myofascial
- 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
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2018to 5 Mar 2018
- Phase
- Phase 1/2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Orchestral musicians
- Chronic neck or shoulder pain
- Presence of active myofascial trigger points
Who cannot join
- Fear of needles
- Coagulation disorders
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Myofascial Trigger Point Dry Needling on Neck Pain in Orchestral Musicians
This study evaluates the effectiveness of Deep dry needling of active myofascial trigger points present in muscles of the neck and shoulder region in orchestral musicians.
- Being tested
- Deep dry needling
- Medical subject headings
- Somatoform Disorders, Musculoskeletal Pain, 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
Insertion of a filiform needle in the active trigger point of musculoskeletal muscle
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Deep dry needling applied on active myofascial trigger points in the shoulder and neck regions Receives: Procedure: Deep dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale for pain
Pain measurement. 100-mm visual analog scale (VAS), horizontal line ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Measured: 2 weeks
Secondary outcomes (3)
Pressure pain threshold
Analogic algometer
Measured: 2 weeks
Neck disability index (NDI)
10-item, 50-point index that assesses different aspects of daily functioning in patients with neck pain. It assesses four items regarding subjective symptoms (pain intensity, headache, concentration, sleeping), four items regarding activities of daily living (lifting, work, driving, recreation), and two items regarding discretionary activities of daily living (personal care, reading). Each item is scored 0 to 5, with the total reported as either a raw score (0-50) or as a percentage score. Higher values represent a worse outcome.
Measured: 2 weeks
Shoulder pain disability index (SPADI)
Self-administered questionnaire, grouping 13 questions, 5 of which measure the severity of pain caused by various arm movements involving the shoulder, the pain being assessed on a numeric pain scale ranging from 0 to 10. Eight additional questions related to functional impairments of the shoulder are assessed with a numeric scale. Higher values represent a worse outcome.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Feb 2018
- Primary completion1 Mar 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Deep dry needling
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aitor Martin-Pintado Zugasti, CEU San Pablo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402867
- Sponsor's protocol ID
- CEU-012
- Status last verified
- Jul 2018
- First submitted
- 10 Jan 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Trigger Point Dry Needling on Neck Pain in Orchestral Musicians
- ClinicalTrials.gov ID
- NCT03402867
- Acronym / sponsor ID
- CEU-012
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 18 Jan 2018 (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.
This study evaluates the effectiveness of Deep dry needling of active myofascial trigger points present in muscles of the neck and shoulder region in orchestral musicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Deep dry needling
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Deep dry needlingDeep dry needling applied on active myofascial trigger points in the shoulder and neck regions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Orchestral musicians
- Chronic neck or shoulder pain
- Presence of active myofascial trigger points
Key exclusion criteria (3 listed)
- Fear of needles
- Coagulation disorders
- Pregnancy
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 needlingInsertion of a filiform needle in the active trigger point of musculoskeletal muscle | Procedure or surgery | Intervention |
Primary outcome
Visual analogue scale for pain
Time frame: 2 weeks
Pain measurement. 100-mm visual analog scale (VAS), horizontal line ranging from 0mm (no pain) to 100mm (worst imaginable pain).
3 secondary outcomes
Pressure pain threshold
Time frame: 2 weeks
Neck disability index (NDI)
Time frame: 2 weeks
Shoulder pain disability index (SPADI)
Time frame: 2 weeks
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 Jul 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Deep dry needling in people with Pain Syndrome and Musculoskeletal Pain, 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 3 inclusion and 3 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 Jul 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Visual analogue scale for pain (time frame: 2 weeks). 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 Jul 2018.