Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-30 @ 11:26 AM
Study NCT ID:
NCT06080334
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Dry Needling of the Gastrocnemius Muscle VS Electrolysis in Subjects With Achilles Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D052256', 'term': 'Tendinopathy'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}, {'id': 'D004572', 'term': 'Electrolysis'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D055664', 'term': 'Electrochemical Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2023-10-06', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity.', 'timeFrame': '5 weeks', 'description': 'Measurement of pain intensity using the VAS scale (0 minimum pain, 10 maximum bearable pain).'}], 'secondaryOutcomes': [{'measure': 'Pressure pain threshold', 'timeFrame': '5 weeks', 'description': 'Pressure pain threshold measured by algometer over the most hyperalgesic point on the Achilles tendon measured in Newtons.'}, {'measure': 'Range of movement', 'timeFrame': '5 weeks', 'description': 'Measurement of ankle dorsiflexion range of motion measured by digital goniometer.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['achilles tendon', 'electrolysis', 'tendinopathy'], 'conditions': ['Achilles Tendinopathy', 'Pain']}, 'referencesModule': {'references': [{'pmid': '34616594', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25133077', 'type': 'RESULT', 'citation': 'Kedia 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.'}, {'pmid': '36292308', 'type': 'RESULT', 'citation': 'Lucena-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.'}, {'pmid': '35210467', 'type': 'RESULT', 'citation': 'Martin-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.'}, {'pmid': '29932797', 'type': 'RESULT', 'citation': 'McDevitt 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.'}, {'pmid': '36583575', 'type': 'RESULT', 'citation': 'Asensio-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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Presence of symptoms (swelling or pain) for at least 3 months.\n* Positive Achilles tendon palpation test.\n* Males and females over 18 years of age.\n* Presence of MMP in the gastrocnemius muscle, meeting at least three of the following criteria diagnostic criteria described by Travell and Simons:\n* Presence of palpable tight band.\n* Local pain on pressure at the nodule of the tense band.\n* Recognition by the patient as his usual pain after mechanical after mechanical stimulation of the sensitive nodule.\n* Limitation of range of motion.\n\nExclusion Criteria:\n\n* Any related acute or chronic musculoskeletal disease that may related chronic musculoskeletal disease, which may affect the results of the study'}, 'identificationModule': {'nctId': 'NCT06080334', 'briefTitle': 'Effectiveness of Dry Needling of the Gastrocnemius Muscle VS Electrolysis in Subjects With Achilles Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica de Ávila'}, 'officialTitle': 'Effectiveness of Dry Needling of the Gastrocnemius Muscle vs. Electrolysis in Subjects With Achilles Tendinopathy: a Randomised Single-blind Clinical Trial', 'orgStudyIdInfo': {'id': '06/10/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dry needling+eccentric exercises', 'description': 'Application of dry needling on the hyperalgesic trigger points of the gastrocnemius muscle and subsequent inclusion of eccentric exercises.', 'interventionNames': ['Device: Dry needling']}, {'type': 'EXPERIMENTAL', 'label': 'Electrolysis+eccentric exercises', 'description': 'Application of electrolysis to the Achilles tendon and subsequent inclusion of eccentric exercises.', 'interventionNames': ['Device: Electrolysis']}], 'interventions': [{'name': 'Dry needling', 'type': 'DEVICE', 'description': 'Dry needling using the Hong technique on the most hyperalgesic trigger point in the gastrocnemius muscle.', 'armGroupLabels': ['Dry needling+eccentric exercises']}, {'name': 'Electrolysis', 'type': 'DEVICE', 'description': 'Electrolysis on the Achilles tendon using ultrasound-guided technique.', 'armGroupLabels': ['Electrolysis+eccentric exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05005', 'city': 'Ávila', 'country': 'Spain', 'facility': 'Jorge Velázquez Saornil', 'geoPoint': {'lat': 40.65724, 'lon': -4.69951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica de Ávila', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'JORGE VELAZQUEZ SAORNIL', 'investigatorAffiliation': 'Universidad Católica de Ávila'}}}}