Trigger Point Pain, MyofascialDN-TSNCT03273985
Effectiveness of Dry Needling in Shortened Triceps Surae Muscle
A study testing Dry needling and Ischemic compression in people with Trigger Point Pain, Myofascial and Myofascial Pain Syndrome, run by Universidad de León at 1 site in Spain.
Trial summary
To date, there are not studies about the effectiveness of dry needling versus ischemic compression in the triceps surae trigger points. A randomized clinical trial is carried out. A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic compression (n = 15). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Point Pain, Myofascial, Myofascial Pain Syndrome
- What is being tested?
- Dry needling and Ischemic compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2017to 6 Dec 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Myofascial pain syndrome in the triceps surae muscle, limitation of ankle dorsal flexion range of motion.
Who cannot join
- Neurologic disorders, pharmacologic treatment (within the previous 3 months), cognitive impairment, prosthesis in the lower limb, systemic or infectious diseases, autoimmune diseases, fibromyalgia, hypothyroidism, anticoagulants or antiplatelet agents, and fear of needles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Deep Dry Needling in Subjects With Shortened Triceps Surae Originated by Myofascial Pain Syndrome
To date, there are not studies about the effectiveness of dry needling versus ischemic compression in the triceps surae trigger points. A randomized clinical trial is carried out. A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic compression (n = 15). Outcome measurements such as dorsal flexion range of motion, plantar pressures, temperature, superficial muscle activity and trigger points pressure pain threshold are measured immediately before and after treatment.
- Being tested
- Dry needling, Ischemic compression
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
Trigger point deep dry needling
Ischemic compressionOther
Trigger point ischemic compression
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Not described Receives: Other: Dry needling |
| Ischemic compression | Experimental | Not described Receives: Other: Ischemic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Ankle dorsal flexion by means of the goniometer
Measured: Change from Baseline Range of motion at 25 minutes
Secondary outcomes (4)
Plantar pressures
Plantar pressures platform
Measured: Change from Baseline Plantar pressures at 25 minutes
Temperature
Thermal imaging
Measured: Change from Baseline Temperature at 25 minutes
Superficial muscle activity
Electromyography
Measured: Change from Baseline Superficial muscle activity at 25 minutes
Pressure pain threshold
Algometer
Measured: Change from Baseline Pressure pain threshold at 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start15 Sep 2017
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
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 Trigger Point Pain, MyofascialStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273985
- Sponsor's protocol ID
- DN-TS-UCM
- Acronym
- DN-TS
- Status last verified
- Dec 2017
- First submitted
- 1 Sep 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benito-de-Pedro M, Becerro-de-Bengoa-Vallejo R, Elena Losa-Iglesias M, Rodriguez-Sanz D, Lopez-Lopez D, Palomo-Lopez P, Mazoteras-Pardo V, Calvo-Lobo AC. Effectiveness of Deep Dry Needling vs Ischemic Compression in the Latent Myofascial Trigger Points of the Shortened Triceps Surae from Triathletes on Ankle Dorsiflexion, Dynamic, and Static Plantar Pressure Distribution: A Clinical Trial. Pain Med. 2020 Feb 1;21(2):e172-e181. doi: 10.1093/pm/pnz222.
PubMed 31502640
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Deep Dry Needling in Subjects With Shortened Triceps Surae Originated by Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT03273985
- Acronym / sponsor ID
- DN-TS / DN-TS-UCM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 6 Sep 2017 (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.
To date, there are not studies about the effectiveness of dry needling versus ischemic compression in the triceps surae trigger points. A randomized clinical trial is carried out. A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic compression (n = 15). Outcome measurements such as dorsal flexion range of motion, plantar pressures, temperature, superficial muscle activity and trigger points pressure pain threshold are measured immediately before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needling |
| Ischemic compression | Experimental | Other: Ischemic compression |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Myofascial pain syndrome in the triceps surae muscle, limitation of ankle dorsal flexion range of motion.
Key exclusion criteria (1 listed)
- Neurologic disorders, pharmacologic treatment (within the previous 3 months), cognitive impairment, prosthesis in the lower limb, systemic or infectious diseases, autoimmune diseases, fibromyalgia, hypothyroidism, anticoagulants or antiplatelet agents, and fear of needles.
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 needlingTrigger point deep dry needling | Other | Dry needling |
| Ischemic compressionTrigger point ischemic compression | Other | Ischemic compression |
Primary outcome
Range of motion
Time frame: Change from Baseline Range of motion at 25 minutes
Ankle dorsal flexion by means of the goniometer
4 secondary outcomes
Plantar pressures
Time frame: Change from Baseline Plantar pressures at 25 minutes
Temperature
Time frame: Change from Baseline Temperature at 25 minutes
Superficial muscle activity
Time frame: Change from Baseline Superficial muscle activity at 25 minutes
Pressure pain threshold
Time frame: Change from Baseline Pressure pain threshold at 25 minutes
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 8 Dec 2017.
- Derived from this study: PubMed 31502640Benito-de-Pedro M, Becerro-de-Bengoa-Vallejo R, Elena Losa-Iglesias M, Rodriguez-Sanz D, Lopez-Lopez D, Palomo-Lopez P, Mazoteras-Pardo V, Calvo-Lobo AC. Effectiveness of Deep Dry Needling vs Ischemic Compression in the Latent Myofascial Trigger Points of the Shortened Triceps Surae from Triathletes on Ankle Dorsiflexion, Dynamic, and Static Plantar Pressure Distribution: A Clinical Trial. Pain Med. 2020 Feb 1;21(2):e172-e181. doi: 10.1093/pm/pnz222.
- Individual participant dataSharing planned: No
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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 study testing Dry needling and Ischemic compression in people with Trigger Point Pain, Myofascial and Myofascial Pain Syndrome, run by Universidad de León 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 8 Dec 2017. 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?
Range of motion (time frame: Change from Baseline Range of motion at 25 minutes). 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 NCT03273985, 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 8 Dec 2017.