Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-01 @ 7:51 PM
Study NCT ID:
NCT02532595
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2015-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TDN, Manual Therapy and Exercise For the Management of Achilles Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2015-08-14', 'studyFirstSubmitQcDate': '2015-08-21', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure', 'timeFrame': '4 weeks'}, {'measure': 'Change in Functional Activity Level from baseline with the Functional Ankle Ability Measure', 'timeFrame': '3 months'}, {'measure': 'Change in Pain from Baseline with the Numeric Pain Rating Scale', 'timeFrame': '4 weeks'}, {'measure': 'Change in Pain from Baseline with the Numeric Pain Rating Scale', 'timeFrame': '3 months'}, {'measure': 'Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia', 'timeFrame': '4 weeks'}, {'measure': 'Change in Fear of Activity from baseline with the Tampa Scale of Kinesiophobia', 'timeFrame': '3 months'}, {'measure': 'Change in Pain from baseline with the Global Rating of Change', 'timeFrame': '4 weeks'}, {'measure': 'Change in Pain from baseline with the Global Rating of Change', 'timeFrame': '3 months'}, {'measure': 'Change in Pain from baseline with the Pain Pressure Threshold Measure', 'timeFrame': '4 weeks', 'description': 'Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.'}, {'measure': 'Change in Pain from baseline with the Pain Pressure Threshold Measure', 'timeFrame': '3 months', 'description': 'Primary site of pain on the Achilles tendon. All measurements taken with the Wagner FPK 20 Algometer.'}, {'measure': 'Change in strength from baseline with the Muscle Endurance Test for single leg heel raise', 'timeFrame': '4 weeks'}, {'measure': 'Change in strength from baseline with the Muscle Endurance Test for single leg heel raise', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'baseline', 'description': 'Demographic information -'}, {'measure': 'Height', 'timeFrame': 'baseline', 'description': 'Demographic information'}, {'measure': 'Weight', 'timeFrame': 'baseline', 'description': 'Demographic information'}, {'measure': 'Gender', 'timeFrame': 'baseline', 'description': 'Demographic information'}, {'measure': 'Duration of Pain', 'timeFrame': 'baseline', 'description': 'Demographic information'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Achilles Tendon Injury']}, 'referencesModule': {'references': [{'pmid': '20805627', 'type': 'BACKGROUND', 'citation': 'Carcia CR, Martin RL, Houck J, Wukich DK; Orthopaedic Section of the American Physical Therapy Association. Achilles pain, stiffness, and muscle power deficits: achilles tendinitis. J Orthop Sports Phys Ther. 2010 Sep;40(9):A1-26. doi: 10.2519/jospt.2010.0305. No abstract available.'}, {'pmid': '17718644', 'type': 'BACKGROUND', 'citation': 'Ga H, Choi JH, Park CH, Yoon HJ. Dry needling of trigger points with and without paraspinal needling in myofascial pain syndromes in elderly patients. J Altern Complement Med. 2007 Jul-Aug;13(6):617-24. doi: 10.1089/acm.2006.6371.'}, {'pmid': '20213036', 'type': 'BACKGROUND', 'citation': 'Fernandez-Carnero J, La Touche R, Ortega-Santiago R, Galan-del-Rio F, Pesquera J, Ge HY, Fernandez-de-Las-Penas C. Short-term effects of dry needling of active myofascial trigger points in the masseter muscle in patients with temporomandibular disorders. J Orofac Pain. 2010 Winter;24(1):106-12.'}, {'pmid': '22018577', 'type': 'BACKGROUND', 'citation': 'Gonzalez-Iglesias J, Cleland JA, del Rosario Gutierrez-Vega M, Fernandez-de-las-Penas C. Multimodal management of lateral epicondylalgia in rock climbers: a prospective case series. J Manipulative Physiol Ther. 2011 Nov;34(9):635-42. doi: 10.1016/j.jmpt.2011.09.003. Epub 2011 Oct 21.'}, {'pmid': '23138883', 'type': 'BACKGROUND', 'citation': 'Tekin L, Akarsu S, Durmus O, Cakar E, Dincer U, Kiralp MZ. The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013 Mar;32(3):309-15. doi: 10.1007/s10067-012-2112-3. Epub 2012 Nov 9.'}, {'pmid': '24700136', 'type': 'BACKGROUND', 'citation': 'Cotchett MP, Munteanu SE, Landorf KB. Effectiveness of trigger point dry needling for plantar heel pain: a randomized controlled trial. Phys Ther. 2014 Aug;94(8):1083-94. doi: 10.2522/ptj.20130255. Epub 2014 Apr 3.'}, {'pmid': '25269764', 'type': 'BACKGROUND', 'citation': 'Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30.'}, {'pmid': '20351377', 'type': 'BACKGROUND', 'citation': 'Osborne NJ, Gatt IT. Management of shoulder injuries using dry needling in elite volleyball players. Acupunct Med. 2010 Mar;28(1):42-5. doi: 10.1136/aim.2009.001560.'}, {'pmid': '24261928', 'type': 'BACKGROUND', 'citation': 'Jayaseelan DJ, Moats N, Ricardo CR. Rehabilitation of proximal hamstring tendinopathy utilizing eccentric training, lumbopelvic stabilization, and trigger point dry needling: 2 case reports. J Orthop Sports Phys Ther. 2014 Mar;44(3):198-205. doi: 10.2519/jospt.2014.4905. Epub 2013 Nov 21.'}, {'pmid': '32048918', 'type': 'DERIVED', 'citation': 'Koszalinski A, Flynn T, Hellman M, Cleland JA. Trigger point dry needling, manual therapy and exercise versus manual therapy and exercise for the management of Achilles tendinopathy: a feasibility study. J Man Manip Ther. 2020 Sep;28(4):212-221. doi: 10.1080/10669817.2020.1719299. Epub 2020 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'Conflicting evidence exists regarding the recommendations from the Orthopaedic section of the American Physical Therapy Association for treatment of Achilles tendinitis. Trigger point dry needling is effective in reducing pain in several body regions, but no published (TDN) studies are found reporting the effect on Achilles tendinopathy. The purpose of this study is to investigate whether a treatment program performed including TDN, manual therapy and exercise will result in a significant improvement in pain, strength and function compared to a treatment program including manual therapy and exercise for Achilles tendinopathy. Subjects with Achilles tendinopathy that receive treatment including TDN, manual therapy and exercise will demonstrate a significant improvement in pain, strength and functional outcomes compared to the group that receives manual therapy and exercise.', 'detailedDescription': 'This study is a randomized controlled trial, pretest-posttest control group design comparing the effect of TDN, manual therapy and exercise to manual therapy and exercise on human subjects with Achilles tendinopathy following eight treatments in four weeks and a follow up examination at three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. pain onset greater than 4 weeks\n2. primary region of pain 2-6 cm proximal to the insertion on the calcaneus\n3. read and write in english\n\nExclusion Criteria:\n\n1. Fear of needles or unwilling to have needling performed due to fear or personal beliefs.\n2. Vascular or sensory disturbances in the lower leg which include but is not limited to injury to the nerve root or peripheral nerve in the affected lower leg, inflammatory diseases, bleeding or clotting disorders, lymphedema, peripheral vascular or peripheral arterial disease. Diabetes is included in this group due to the progressive changes to the sensation and circulation in the lower extremities.\n3. Recent infection.\n4. Previous surgery to the foot/ankle.\n5. Steroid by injection or transdermal delivery to the posterior heel within three months.\n6. Full rupture of the Achilles tendon.\n7. Pregnant or may be pregnant.\n8. Participants with a work related injury insured by the bureau of worker's compensation or involved in litigation related to injury of the lower leg, foot or ankle."}, 'identificationModule': {'nctId': 'NCT02532595', 'briefTitle': 'TDN, Manual Therapy and Exercise For the Management of Achilles Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Nova Southeastern University'}, 'officialTitle': 'Trigger Point Dry Needling, Manual Therapy and Exercise vs Manual Therapy and Exercise For the Management of Achilles Tendinopathy', 'orgStudyIdInfo': {'id': '03261504F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 manual therapy and exercise', 'description': 'manual therapy with soft tissue mobilization to trigger points in the gastrocnemius, soleus, and tibialis posterior; exercise including stretching, concentric and eccentric exercises to the hip, triceps surae, tibialis posterior and foot intrinsics.', 'interventionNames': ['Procedure: manual therapy and exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 TDN, manual therapy and exercise', 'description': 'trigger point dry needling (TDN) to trigger points in the gastrocnemius, soleus and tibialis posterior; manual therapy with soft tissue mobilization to trigger points in the gastrocnemius, soleus, and tibialis posterior; exercise including stretching, concentric and eccentric exercises to the hip, triceps surae, tibialis posterior and foot intrinsics.', 'interventionNames': ['Procedure: manual therapy and exercise', 'Procedure: trigger point dry needling']}], 'interventions': [{'name': 'manual therapy and exercise', 'type': 'PROCEDURE', 'description': 'soft tissue mobilization, stretches, concentric and eccentric strengthening', 'armGroupLabels': ['Group 1 manual therapy and exercise', 'Group 2 TDN, manual therapy and exercise']}, {'name': 'trigger point dry needling', 'type': 'PROCEDURE', 'description': 'trigger point dry needling to trigger points located in the gastrocnemius, soleus and tibialis posterior', 'armGroupLabels': ['Group 2 TDN, manual therapy and exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28311', 'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Breakthrough Physical Therapy', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}], 'overallOfficials': [{'name': 'Josh Cleland, DPT, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nova Southeastern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Southeastern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}