Achilles TendinopathyNCT06080334
Effectiveness of Dry Needling of the Gastrocnemius Muscle VS Electrolysis in Subjects With Achilles Tendinopathy
A study testing Dry needling and Electrolysis in people with Achilles Tendinopathy and Pain, run by Universidad Católica de Ávila at 1 site in Spain.
Trial summary
Achilles tendinopathy is the injury that primarily occurs in athletes and people who engage in repetitive activities that involve the calf muscles, such as running, jumping, and sudden acceleration and deceleration movements. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Achilles Tendinopathy, Pain
- What is being tested?
- Dry needling and Electrolysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 1 Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing of informed consent both to participate in the study and to undergo invasive in the study, as well as to undergo invasive physiotherapy techniques. physiotherapy techniques.
- Presence of symptoms (swelling or pain) for at least 3 months.
- Positive Achilles tendon palpation test.
- Males and females over 18 years of age.
- Presence of MMP in the gastrocnemius muscle, meeting at least three of the following criteria diagnostic criteria described by Travell and Simons:
- Presence of palpable tight band.
Show all 9Show fewer
- Local pain on pressure at the nodule of the tense band.
- Recognition by the patient as his usual pain after mechanical after mechanical stimulation of the sensitive nodule.
- Limitation of range of motion.
Who cannot join
- Any related acute or chronic musculoskeletal disease that may related chronic musculoskeletal disease, which may affect the results of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dry Needling of the Gastrocnemius Muscle vs. Electrolysis in Subjects With Achilles Tendinopathy: a Randomised Single-blind Clinical Trial
Achilles tendinopathy is the injury that primarily occurs in athletes and people who engage in repetitive activities that involve the calf muscles, such as running, jumping, and sudden acceleration and deceleration movements. To observe the effectiveness of dry needling in the PGM of the gastrocnemius muscle, in the short and medium term, on the intensity of pain in gastrocnemius muscle, in the short and medium term, on pain intensity in patients with patients with Achilles tendinopathy, compared to the application of ultrasound-guided percutaneous electrolysis on the tendon.
- Conditions
- Achilles Tendinopathy, Pain
- Being tested
- Dry needling, Electrolysis
- Keywords
- achilles tendon, electrolysis, tendinopathy
- Medical subject headings
- Pain, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingDevice
Dry needling using the Hong technique on the most hyperalgesic trigger point in the gastrocnemius muscle.
ElectrolysisDevice
Electrolysis on the Achilles tendon using ultrasound-guided technique.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling+eccentric exercises | Experimental | Application of dry needling on the hyperalgesic trigger points of the gastrocnemius muscle and subsequent inclusion of eccentric exercises. Receives: Device: Dry needling |
| Electrolysis+eccentric exercises | Experimental | Application of electrolysis to the Achilles tendon and subsequent inclusion of eccentric exercises. Receives: Device: Electrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity.
Measurement of pain intensity using the VAS scale (0 minimum pain, 10 maximum bearable pain).
Measured: 5 weeks
Secondary outcomes (2)
Pressure pain threshold
Pressure pain threshold measured by algometer over the most hyperalgesic point on the Achilles tendon measured in Newtons.
Measured: 5 weeks
Range of movement
Measurement of ankle dorsiflexion range of motion measured by digital goniometer.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Dec 2023
- Primary completion30 Apr 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Achilles TendinopathyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Ávila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JORGE VELAZQUEZ SAORNIL, Universidad Católica de Ávila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080334
- Sponsor's protocol ID
- 06/10/2023
- Status last verified
- Sep 2024
- First submitted
- 6 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zunko H, Vauhnik R. Reliability of the weight-bearing ankle dorsiflexion range of motion measurement using a smartphone goniometer application. PeerJ. 2021 Sep 22;9:e11977. doi: 10.7717/peerj.11977. eCollection 2021.
PubMed 34616594Kedia M, Williams M, Jain L, Barron M, Bird N, Blackwell B, Richardson DR, Ishikawa S, Murphy GA. The effects of conventional physical therapy and eccentric strengthening for insertional achilles tendinopathy. Int J Sports Phys Ther. 2014 Aug;9(4):488-97.
PubMed 25133077Lucena-Anton D, Luque-Moreno C, Valencia-Medero J, Garcia-Munoz C, Moral-Munoz JA. Effectiveness of Dry Needling of Myofascial Trigger Points in the Triceps Surae Muscles: Systematic Review. Healthcare (Basel). 2022 Sep 24;10(10):1862. doi: 10.3390/healthcare10101862.
PubMed 36292308Martin-Sacristan L, Calvo-Lobo C, Pecos-Martin D, Fernandez-Carnero J, Alonso-Perez JL. Dry needling in active or latent trigger point in patients with neck pain: a randomized clinical trial. Sci Rep. 2022 Feb 24;12(1):3188. doi: 10.1038/s41598-022-07063-0.
PubMed 35210467McDevitt AW, Snodgrass SJ, Cleland JA, Leibold MBR, Krause LA, Mintken PE. Treatment of individuals with chronic bicipital tendinopathy using dry needling, eccentric-concentric exercise and stretching; a case series. Physiother Theory Pract. 2020 Mar;36(3):397-407. doi: 10.1080/09593985.2018.1488023. Epub 2018 Jun 22.
PubMed 29932797Asensio-Olea L, Leiros-Rodriguez R, Marques-Sanchez MP, de Carvalho FO, Maciel LYS. Efficacy of percutaneous electrolysis for the treatment of tendinopathies: A systematic review and meta-analysis. Clin Rehabil. 2023 Jun;37(6):747-759. doi: 10.1177/02692155221144272. Epub 2022 Dec 30.
PubMed 36583575
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling of the Gastrocnemius Muscle vs. Electrolysis in Subjects With Achilles Tendinopathy: a Randomised Single-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06080334
- Acronym / sponsor ID
- 06/10/2023
- Conditions
- Achilles Tendinopathy, Pain
- Keywords
- achilles tendon, electrolysis, tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universidad Católica de ÁvilaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 12 Oct 2023 (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.
Achilles tendinopathy is the injury that primarily occurs in athletes and people who engage in repetitive activities that involve the calf muscles, such as running, jumping, and sudden acceleration and deceleration movements. To observe the effectiveness of dry needling in the PGM of the gastrocnemius muscle, in the short and medium term, on the intensity of pain in gastrocnemius muscle, in the short and medium term, on pain intensity in patients with patients with Achilles tendinopathy, compared to the application of ultrasound-guided percutaneous electrolysis on the tendon.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling+eccentric exercises | Experimental | Device: Dry needlingApplication of dry needling on the hyperalgesic trigger points of the gastrocnemius muscle and subsequent inclusion of eccentric exercises. |
| Electrolysis+eccentric exercises | Experimental | Device: ElectrolysisApplication of electrolysis to the Achilles tendon and subsequent inclusion of eccentric exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signing of informed consent both to participate in the study and to undergo invasive in the study, as well as to undergo invasive physiotherapy techniques. physiotherapy techniques.
- Presence of symptoms (swelling or pain) for at least 3 months.
- Positive Achilles tendon palpation test.
- Males and females over 18 years of age.
- Presence of MMP in the gastrocnemius muscle, meeting at least three of the following criteria diagnostic criteria described by Travell and Simons:
Key exclusion criteria (1 listed)
- Any related acute or chronic musculoskeletal disease that may related chronic musculoskeletal disease, which may affect the results of the study
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 needlingDry needling using the Hong technique on the most hyperalgesic trigger point in the gastrocnemius muscle. | Device | Dry needling+eccentric exercises |
| ElectrolysisElectrolysis on the Achilles tendon using ultrasound-guided technique. | Device | Electrolysis+eccentric exercises |
Primary outcome
Pain intensity.
Time frame: 5 weeks
Measurement of pain intensity using the VAS scale (0 minimum pain, 10 maximum bearable pain).
2 secondary outcomes
Pressure pain threshold
Time frame: 5 weeks
Range of movement
Time frame: 5 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 19 Sep 2024.
- Background: PubMed 34616594Zunko H, Vauhnik R. Reliability of the weight-bearing ankle dorsiflexion range of motion measurement using a smartphone goniometer application. PeerJ. 2021 Sep 22;9:e11977. doi: 10.7717/peerj.11977. eCollection 2021.
- Results publication: PubMed 25133077Kedia M, Williams M, Jain L, Barron M, Bird N, Blackwell B, Richardson DR, Ishikawa S, Murphy GA. The effects of conventional physical therapy and eccentric strengthening for insertional achilles tendinopathy. Int J Sports Phys Ther. 2014 Aug;9(4):488-97.
- Results publication: PubMed 36292308Lucena-Anton D, Luque-Moreno C, Valencia-Medero J, Garcia-Munoz C, Moral-Munoz JA. Effectiveness of Dry Needling of Myofascial Trigger Points in the Triceps Surae Muscles: Systematic Review. Healthcare (Basel). 2022 Sep 24;10(10):1862. doi: 10.3390/healthcare10101862.
- Results publication: PubMed 35210467Martin-Sacristan L, Calvo-Lobo C, Pecos-Martin D, Fernandez-Carnero J, Alonso-Perez JL. Dry needling in active or latent trigger point in patients with neck pain: a randomized clinical trial. Sci Rep. 2022 Feb 24;12(1):3188. doi: 10.1038/s41598-022-07063-0.
- Results publication: PubMed 29932797McDevitt AW, Snodgrass SJ, Cleland JA, Leibold MBR, Krause LA, Mintken PE. Treatment of individuals with chronic bicipital tendinopathy using dry needling, eccentric-concentric exercise and stretching; a case series. Physiother Theory Pract. 2020 Mar;36(3):397-407. doi: 10.1080/09593985.2018.1488023. Epub 2018 Jun 22.
- Results publication: PubMed 36583575Asensio-Olea L, Leiros-Rodriguez R, Marques-Sanchez MP, de Carvalho FO, Maciel LYS. Efficacy of percutaneous electrolysis for the treatment of tendinopathies: A systematic review and meta-analysis. Clin Rehabil. 2023 Jun;37(6):747-759. doi: 10.1177/02692155221144272. Epub 2022 Dec 30.
- Individual participant dataSharing planned: Undecided
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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 Electrolysis in people with Achilles Tendinopathy and Pain, run by Universidad Católica de Ávila 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 9 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 19 Sep 2024. 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?
Pain intensity. (time frame: 5 weeks). 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 NCT06080334, which also lists 6 linked publications.
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 19 Sep 2024.