Dry NeedlingNCT05331430
Effectiveness of Dry Needling and Stretching in People With Fibromyalgia.
A study testing Dry needling on cervical trigger point in people with Dry Needling and Stretch, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Effectiveness of dry needling and stretching on joint range and myofascial pain at the cervical level in people with fibromyalgia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Needling, Stretch, Fibromyalgia
- What is being tested?
- Dry needling on cervical trigger point
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 27 May 2022to 13 Jun 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of fibromyalgia at least six months before the start of the study.
- Be of legal age.
- Report at least one episode of neck pain in the last six months.
Who cannot join
- Surgical interventions or scars at cervical level.
- Dizziness or vertigo.
- Dermatological problems.
- Severe psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dry Needling and Stretching on Joint Range and Myofascial Pain at the Cervical Level in People With Fibromyalgia.
Effectiveness of dry needling and stretching on joint range and myofascial pain at the cervical level in people with fibromyalgia
Read the detailed description
A randomised clinical trial will be conducted in which there will be 3 groups. One control group and 2 experimental groups; one of them will undergo dry needling of the upper trapezius fibres and the other will undergo passive stretching of the upper trapezius fibres. Both groups will have the joint range of cervical lateral tilt, pain measurement by algometer and visual analogue scale (VAS) measured. All these measurements will be taken before and after treatment. The participants of the study will be people who have been diagnosed with fibromyalgia at least 6 months before the start of the study, who are members of the FIBROFAMUR association. Association of Fibromyalgia, Chronic Fatigue, Rheumatic and Musculoskeletal Diseases of Murcia. The data collected will be: socio-demographic data, age, sex, measurement of cervical joint range using a goniometer and measurement of pain using an algometer and visual analogue scale (VAS). As undesirable effects, in exceptional cases, the dry needling technique may produce residual discomfort in the puncture area that may last between 1 and 3 days.
- Conditions
- Dry Needling, Stretch, Fibromyalgia
- Being tested
- Dry needling on cervical trigger point
- Keywords
- Dry needling, Stretch, Fibromyalgia, Physical Therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling on cervical trigger pointOther
Also called Trapezius muscle stretch
One experimental group will receive dry needling treatment on the upper trapezius fibres using the Hong technique and the other experimental group will receive passive muscle stretching treatment on the upper trapezius fibres.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1: Dry needling on cervical trigger point | Experimental | Dry needling of the trigger point of the upper fibres of the trapezius muscle. Using the Hong technique. Receives: Other: Dry needling on cervical trigger point |
| Experimental group 2: Trapezius muscle stretch | Experimental | Manual passive stretching of the upper trapezius muscle fibres. Receives: Other: Dry needling on cervical trigger point |
| Control group: Informative talks | No intervention | Informative talks on breathing techniques, relaxation techniques and posture hygiene. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer measurement
Measurement of the joint range of the contralateral cervical tilt using a goniometer. Measurement of the lateral tilt range in degrees.Values may vary from zero to 45 degrees.
Measured: One month
Measurement of pain with an algometer.
Measurement of cervical myofascial trigger point pain with an algometer. Measurement of pain in kilograms per square centimetre. Values may vary from zero to 10 kilograms.
Measured: One month
Visual analogue scale (VAS)
Measurement of the degree of pain using the visual analogue scale. Measured from zero to ten, zero corresponds to no pain and ten corresponds to worst pain imaginable.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start27 May 2022
- Primary completion31 May 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angel Martínez Carrasco, Universidad de Murcia
- Investigators
- Angel Martínez Carrasco, PhD, Study director, Universidad de MurciaJose Quereda Ruiz, Graduated, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331430
- Sponsor's protocol ID
- JQR-2022-01
- Status last verified
- Jun 2022
- First submitted
- 8 Apr 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling and Stretching on Joint Range and Myofascial Pain at the Cervical Level in People With Fibromyalgia.
- ClinicalTrials.gov ID
- NCT05331430
- Acronym / sponsor ID
- JQR-2022-01
- Conditions
- Dry Needling, Stretch, Fibromyalgia
- Keywords
- Dry needling, Stretch, Fibromyalgia, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 15 Apr 2022 (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.
Effectiveness of dry needling and stretching on joint range and myofascial pain at the cervical level in people with fibromyalgia
Detailed description
A randomised clinical trial will be conducted in which there will be 3 groups. One control group and 2 experimental groups; one of them will undergo dry needling of the upper trapezius fibres and the other will undergo passive stretching of the upper trapezius fibres. Both groups will have the joint range of cervical lateral tilt, pain measurement by algometer and visual analogue scale (VAS) measured. All these measurements will be taken before and after treatment. The participants of the study will be people who have been diagnosed with fibromyalgia at least 6 months before the start of the study, who are members of the FIBROFAMUR association. Association of Fibromyalgia, Chronic Fatigue, Rheumatic and Musculoskeletal Diseases of Murcia. The data collected will be: socio-demographic data, age, sex, measurement of cervical joint range using a goniometer and measurement of pain using an algometer and visual analogue scale (VAS). As undesirable effects, in exceptional cases, the dry needling technique may produce residual discomfort in the puncture area that may last between 1 and 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1: Dry needling on cervical trigger point | Experimental | Other: Dry needling on cervical trigger pointDry needling of the trigger point of the upper fibres of the trapezius muscle. Using the Hong technique. |
| Experimental group 2: Trapezius muscle stretch | Experimental | Other: Dry needling on cervical trigger pointManual passive stretching of the upper trapezius muscle fibres. |
| Control group: Informative talks | No intervention | –Informative talks on breathing techniques, relaxation techniques and posture hygiene. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a diagnosis of fibromyalgia at least six months before the start of the study.
- Be of legal age.
- Report at least one episode of neck pain in the last six months.
Key exclusion criteria (4 listed)
- Surgical interventions or scars at cervical level.
- Dizziness or vertigo.
- Dermatological problems.
- Severe psychiatric disorders.
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 on cervical trigger pointAlso: Trapezius muscle stretchOne experimental group will receive dry needling treatment on the upper trapezius fibres using the Hong technique and the other experimental group will receive passive muscle stretching treatment on the upper trapezius fibres. | Other | Experimental group 1: Dry needling on cervical trigger point, Experimental group 2: Trapezius muscle stretch |
Primary outcome
Goniometer measurement
Time frame: One month
Measurement of the joint range of the contralateral cervical tilt using a goniometer. Measurement of the lateral tilt range in degrees.Values may vary from zero to 45 degrees.
Measurement of pain with an algometer.
Time frame: One month
Measurement of cervical myofascial trigger point pain with an algometer. Measurement of pain in kilograms per square centimetre. Values may vary from zero to 10 kilograms.
Visual analogue scale (VAS)
Time frame: One month
Measurement of the degree of pain using the visual analogue scale. Measured from zero to ten, zero corresponds to no pain and ten corresponds to worst pain imaginable.
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 22 Jun 2022.
- Individual participant dataSharing planned: No
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Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction
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The Immediate Effects of Dry Needling Acupuncture on Pain Intensity and Pressure Pain Threshold in Patients With Myofascial Pain Syndrome of the Upper Trapezius
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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.
Angel Martínez Carrasco, PhD study director
Universidad de Murcia
Jose Quereda Ruiz, Graduated principal investigator
Universidad de Murcia
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 on cervical trigger point in people with Dry Needling and Stretch, run by Universidad de Murcia 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 4 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 22 Jun 2022. 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.
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?
Goniometer measurement (time frame: One month). The study lists 3 primary outcomes in all. 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 22 Jun 2022.