Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-27 @ 2:05 PM
Study NCT ID:
NCT06241404
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2024-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Therapeutic Exercise vs. Treatment of Myofascial Trigger Points.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': 'At the end of Session 10 (each Session is 7 days)', 'description': 'measurement of shoulder range of motion'}, {'measure': 'pain intensity', 'timeFrame': 'At the end of Session 10 (each Session is 7 days)', 'description': 'measured on a VAS scale where 0 is the minimum and 10 is the maximum.'}], 'secondaryOutcomes': [{'measure': 'pressure pain threshold', 'timeFrame': 'At the end of Session 10 (each Session is 7 days)', 'description': 'measured by algometer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shoulder tendinopathy', 'supraspinatus', 'infraspinatus', 'physiotherapy techniques', 'therapeutic exercise', 'trigger points'], 'conditions': ['Shoulder Tendinopathy']}, 'referencesModule': {'references': [{'pmid': '35196648', 'type': 'BACKGROUND', 'citation': 'Yoma M, Herrington L, Mackenzie TA. The Effect of Exercise Therapy Interventions on Shoulder Pain and Musculoskeletal Risk Factors for Shoulder Pain in Competitive Swimmers: A Scoping Review. J Sport Rehabil. 2022 Feb 23;31(5):617-628. doi: 10.1123/jsr.2021-0403. Print 2022 Jul 1.'}, {'pmid': '31256191', 'type': 'BACKGROUND', 'citation': 'Jung KM, Choi JD. The Effects of Active Shoulder Exercise with a Sling Suspension System on Shoulder Subluxation, Proprioception, and Upper Extremity Function in Patients with Acute Stroke. Med Sci Monit. 2019 Jun 30;25:4849-4855. doi: 10.12659/MSM.915277.'}, {'pmid': '35609204', 'type': 'BACKGROUND', 'citation': 'Spanhove V, De Wandele I, Malfait F, Calders P, Cools A. Home-based exercise therapy for treating shoulder instability in patients with hypermobile Ehlers-Danlos syndrome/hypermobility spectrum disorders. A randomized trial. Disabil Rehabil. 2023 Jun;45(11):1811-1821. doi: 10.1080/09638288.2022.2076932. Epub 2022 May 24.'}, {'pmid': '29914494', 'type': 'BACKGROUND', 'citation': 'Richmond H, Lait C, Srikesavan C, Williamson E, Moser J, Newman M, Betteley L, Fordham B, Rees S, Lamb SE, Bruce J; PROSPER Study Group. Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER). BMC Health Serv Res. 2018 Jun 18;18(1):463. doi: 10.1186/s12913-018-3280-x.'}, {'pmid': '28714658', 'type': 'BACKGROUND', 'citation': 'Lin IH, Chang KH, Liou TH, Tsou CM, Huang YC. Progressive shoulder-neck exercise on cervical muscle functions in middle-aged and senior patients with chronic neck pain. Eur J Phys Rehabil Med. 2018 Feb;54(1):13-21. doi: 10.23736/S1973-9087.17.04658-5. Epub 2017 Jul 17.'}, {'pmid': '30777064', 'type': 'RESULT', 'citation': 'Fathollahnejad K, Letafatkar A, Hadadnezhad M. The effect of manual therapy and stabilizing exercises on forward head and rounded shoulder postures: a six-week intervention with a one-month follow-up study. BMC Musculoskelet Disord. 2019 Feb 18;20(1):86. doi: 10.1186/s12891-019-2438-y.'}, {'pmid': '28245853', 'type': 'RESULT', 'citation': 'Eshoj H, Rasmussen S, Frich LH, Hvass I, Christensen R, Jensen SL, Sondergaard J, Sogaard K, Juul-Kristensen B. A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study). Trials. 2017 Feb 28;18(1):90. doi: 10.1186/s13063-017-1830-x.'}, {'pmid': '39430399', 'type': 'DERIVED', 'citation': 'Villa Munoz T, Velazquez Saornil J, Sanchez Mila Z, Romero-Morales C, Almazan Polo J, Baraja Vegas L, Hugo-Villafane J, Abuin-Porras V. Comparative evaluation of the efficacy of therapeutic exercise versus myofascial trigger point therapy in the treatment of shoulder tendinopathies: a randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Oct 16;10(4):e002043. doi: 10.1136/bmjsem-2024-002043. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'Background: Shoulder pain commonly affects the general population, with rotator cuff tendinopathy being the most common cause.\n\nthe most common cause, with rotator cuff tendinopathy diminishing function and quality of life, leading to a major socio-economic impact.\n\nquality of life, leading to a major socio-economic impact. As a result, there are two treatment approaches with potential effectiveness: therapeutic exercise (TE) and myofascial trigger point treatment (TMT).\n\ntrigger point treatment (TTP).\n\nObjective: The main objective of this randomised clinical trial is to determine the efficacy of ET versus treatment of MTPs in shoulder tendinopathies.\n\nMethods: For this study, 20 participants were randomly divided into two groups: a ET group, with which a 10-exercise programme was initiated (n = 10), and a PGM group which was given an intervention protocol (n = 10).\n\nintervention protocol (n = 10). Both received a total of 10 sessions. Pain intensity pain intensity, pressure pain threshold (PPT) and range of motion (ROM) were assessed before starting and after 10 sessions.\n\nand after 10 sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form.\n* Patients diagnosed by an orthopaedic surgeon with shoulder tendinopathy. tendinopathy.\n* Symptoms of shoulder pain lasting more than 3 months.\n* Pain on Jobe, Patte and infraspinatus assessment manoeuvres (highlighting abduction and abduction and external rotation).\n\nExclusion Criteria:\n\n* Previous shoulder surgery.\n* Radiating (non-referred) pain from cervical radiculopathy.\n* Shoulder pain associated with other diagnoses (Examples: retractile capsulitis, subacromial syndrome, tendon rupture, posterosuperior conflict, etc.).\n\nsubacromial syndrome, tendon rupture, posterosuperior conflict, etc).\n\n* Patients with multiple pathologies.\n* Patients with neurological disorders.'}, 'identificationModule': {'nctId': 'NCT06241404', 'briefTitle': 'Efficacy of Therapeutic Exercise vs. Treatment of Myofascial Trigger Points.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica de Ávila'}, 'officialTitle': 'Efficacy of Therapeutic Exercise vs. Treatment of Myofascial Trigger Points in Shoulder Tendinopathies: Randomised Clinical Trial', 'orgStudyIdInfo': {'id': '250124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'therapeutic exercise group', 'description': 'patients who have been treated for shoulder tendinopathy by exercise therapy', 'interventionNames': ['Procedure: Exercise therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'trigger points group', 'description': 'patients who have been treated for shoulder tendinopathy by trigger point therapy', 'interventionNames': ['Procedure: trigger point therapy']}], 'interventions': [{'name': 'trigger point therapy', 'type': 'PROCEDURE', 'description': 'patients who have been treated for shoulder tendinopathy by trigger point therapy', 'armGroupLabels': ['trigger points group']}, {'name': 'Exercise therapy', 'type': 'PROCEDURE', 'description': 'patients who have been treated for shoulder tendinopathy by exercise therapy', 'armGroupLabels': ['therapeutic exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05001', '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'}}}}