Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:55 PM
Study NCT ID:
NCT07456735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Dry Needling Versus the Combination of Dry Needling and Local Anesthetic Injection in Myofascial Pain Syndrome of the Upper Trapezius Muscle: A Sham-Controlled, Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079245', 'term': 'Dry Needling'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain Rating Scale (NRS)', 'timeFrame': 'It is the change from the baseline (pre-treatment) NRS (Numeric Pain Rating Scale) score to the NRS score at the 3rd month.', 'description': 'Numeric Pain Rating Scale (NRS): Participants will be asked to rate their pain on a scale from 0 (no pain) to 10 (the most severe pain) based on their own perception; the measurement will be conducted verbally by a qualified researcher in a calm environment'}], 'secondaryOutcomes': [{'measure': 'Neck Pain and Disability Scale (NPADS', 'timeFrame': '3 months', 'description': "Neck Pain and Disability Scale (NPADS): The 20-item short form of the NPADS will be used; the researcher will ask each item using a standardized questionnaire form and record the participant's responses."}, {'measure': 'QuickDASH', 'timeFrame': '3 months', 'description': 'QuickDASH: The 11-item Turkish QuickDASH form will be used to assess upper extremity function and quality of life; the participant will complete the form themselves, and the researcher will provide clarification if needed.'}, {'measure': 'Pressure Pain Threshold (PPT)', 'timeFrame': '3 months', 'description': 'Pressure Pain Threshold (PPT): Using a digital algometer (e.g., Wagner FDX Digital Force Gauge), the pressure tolerance threshold applied to the trigger point will be recorded in kg/cm² while the patient is seated in a passive position. Each measurement will be repeated three times, and the average value will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myofascial pain syndrome,trigger points,dry needling'], 'conditions': ['Myofascial Pain of Upper Trapezius Muscle']}, 'descriptionModule': {'briefSummary': 'This study was designed to compare the effectiveness of three different treatment protocols in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle. A total of 90 volunteers aged between 18 and 65 years, with active trigger points identified in the upper trapezius muscle, will be included in the study. Participants will be randomly assigned to three groups:\n\n* Group 1: Dry needling and stretching exercises\n* Group 2: Dry needling following local anesthetic injection with 1% lidocaine and stretching exercises\n* Group 3 (Control): Sham dry needling following local anesthetic injection with 1% lidocaine and stretching exercises\n\nIn all groups, treatment sessions will be administered at weeks 0, 1, 2, and 3; and participants will undergo clinical assessments at baseline (pre-treatment), at the end of treatment, one month after treatment completion, and three months after treatment completion. The primary outcome will be pain severity, measured using the Numeric Pain Rating Scale (NRS); secondary outcomes will include functional status evaluated with the Neck Pain and Disability Scale (NPADS) and QuickDASH, and muscle tenderness assessed by pressure pain threshold (PPT) measurement. The findings are expected to contribute scientifically to clinical practice by identifying the most effective treatment combination for managing upper trapezius myofascial pain syndrome.', 'detailedDescription': 'Myofascial pain syndrome (MPS) is one of the most common causes of chronic pain among musculoskeletal disorders, leading to both individual workforce loss and a decrease in quality of life. The pathophysiological basis of MPS consists of hyperalgesic areas within the muscle tissue, known as "trigger points. These trigger points usually arise due to repetitive microtrauma, poor posture, or static muscle use, with the upper trapezius muscle being one of the most frequently affected muscle groups .\n\nDry needling (DN) induces local microtrauma within the muscle by directly and invasively stimulating the trigger points, thereby initiating local inflammation and achieving an analgesic effect. DN is thought to work by reducing muscle spasm, increasing oxygenation, and providing segmental pain inhibition \\\\\\[1, 5\\]. On the other hand, local anesthetic injection (LAI), particularly with agents such as lidocaine, provides rapid analgesia by temporarily blocking nerve conduction when applied directly around the trigger point .\n\nAlthough the combined use of DN and LAI has gained attention in recent years, comparative clinical data regarding their efficacy remain limited. Some studies in the literature have shown that LAI is more effective than DN in reducing pain , yet systematic data on the advantages of combined protocols are insufficient. Additionally, some randomized controlled trials have reported that DN provides functional improvement, while achieving similar pain scores compared to LAI.\n\nThe use of sham procedures is critically important for evaluating the true biological effect of treatment. Especially in invasive techniques like dry needling, the absence of placebo control increases the risk of misinterpreting the analgesic effect. Therefore, there is a need for methodologically robust study designs.\n\nThe present study aims to demonstrate the clinical superiority of combining DN with LAI, compared to DN alone and sham groups, in terms of both pain reduction and functional improvement. The combined approach may result in more lasting outcomes on muscle tension and function. Moreover, thanks to the comparison group with sham procedures, the true clinical efficacy of the interventions can be evaluated more objectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between 18 and 65 years of age\n\n * Having a diagnosis of myofascial pain syndrome with at least one active trigger point in the upper trapezius muscle according to the criteria of Travell and Simons\n * Having signed the informed consent form regarding the study\n * Having a history of muscle pain with VAS \\>3 persisting for at least four weeks in the same area (upper trapezius muscle)\n\nExclusion Criteria:\n\n* Having a diagnosis of cervical disc herniation, cervical radiculopathy, or myelopathy\n\n * A history of central or peripheral nervous system disease (e.g., multiple sclerosis, stroke, peripheral neuropathy)\n * Diagnosis of a major psychiatric disorder (major depression, anxiety disorder, bipolar disorder, schizophrenia) or receiving active psychiatric treatment\n * Having bleeding diathesis, thrombocytopenia, or using anticoagulant/antiplatelet therapy for any reason (e.g., warfarin, clopidogrel)\n * Presence of local infection at the injection site, dermatological lesions disrupting skin integrity, or signs of systemic infection\n * Being pregnant or breastfeeding\n * Having undergone injection, prolotherapy, or similar interventional treatment in the upper trapezius region within the last 6 months\n * Having received dry needling treatment in any region previously\n * A history of orthopedic or neurosurgical surgery involving the cervical spine, shoulder, or upper trapezius muscle region within the last year\n * Having a diagnosis of uncontrolled diabetes mellitus or advanced-stage chronic disease (e.g., congestive heart failure, renal failure)\n * Having a diagnosis of malignancy or systemic rheumatologic disease (e.g., rheumatoid arthritis, fibromyalgia syndrome, lupus)\n * Having communication difficulties, cognitive impairment, or severe visual/hearing loss that could prevent participation in the study\n * Having social/logistical barriers (e.g., transportation difficulties) that would prevent regular participation in the study process'}, 'identificationModule': {'nctId': 'NCT07456735', 'briefTitle': 'Comparison of the Effectiveness of Dry Needling Versus the Combination of Dry Needling and Local Anesthetic Injection in Myofascial Pain Syndrome of the Upper Trapezius Muscle: A Sham-Controlled, Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}, 'officialTitle': 'Comparison of the Effectivenes of Combined Dry Needling and Local Anesthetic Injection in Myofascial Pain Syndrome in Upper Trapezius Muscle', 'orgStudyIdInfo': {'id': 'SultanAbdülhamidftr2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Local Anesthetic Injection + Sham Dry Needling Group', 'description': 'Patients will recieve %1 Lidocaine injection to the upper trapezius muscles trigger points. They will also recieve a sham dry needling, where the needle will not penetrate to the skin but the tube of the needle will be contacted to the skin.', 'interventionNames': ['Procedure: Sham Dry Needling', 'Procedure: Local Anesthehetic Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dry Needling Group', 'description': 'This group will get 3 sessions of dry needling to the trigger points on upper trapezius muscle.', 'interventionNames': ['Procedure: Dry Needling']}, {'type': 'EXPERIMENTAL', 'label': 'Local Aensthetic injection + Dry Needling Group', 'description': 'This group will get trigger point local anesthetic injection and 3 sessions of dry needling terapy to the trigger points on upper trapezius muscle', 'interventionNames': ['Procedure: Dry Needling', 'Procedure: Local Anesthehetic Injection']}], 'interventions': [{'name': 'Dry Needling', 'type': 'PROCEDURE', 'description': 'Dry needling is a procedure where an acupuncture needle is penetrated to the active myofascial trigger point in a muscle, until a twitch response is gained. Patients will be lied supine and an examiner with 10 years of experience will palpate the upper trapezius muscle. Identified active myofascial trigger points will be penetrated with acupuncture needles until the twitch response is obtained.', 'armGroupLabels': ['Dry Needling Group', 'Local Aensthetic injection + Dry Needling Group']}, {'name': 'Sham Dry Needling', 'type': 'PROCEDURE', 'description': 'Sham dry needling is a procedure where the needle does not penetrate to the skin or the muscle, but the tube of the needle will be contacted to the skin.', 'armGroupLabels': ['Local Anesthetic Injection + Sham Dry Needling Group']}, {'name': 'Local Anesthehetic Injection', 'type': 'PROCEDURE', 'description': 'Local anesthetic injection is a procedure where the %1 lidocaine ( 4 cc) is injected to the myofascial trigger points. Patient will be lying supine and the examiner with 10 years of experience will palpate the trapezius muscles upper part. Identified trigger points will be penetrated by a needle and will be injected lidocaine.', 'armGroupLabels': ['Local Aensthetic injection + Dry Needling Group', 'Local Anesthetic Injection + Sham Dry Needling Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34674', 'city': 'Istanbul', 'state': 'ÜSKÜDAR', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'EMRE A ATA, Associate Professor, MD', 'role': 'CONTACT', 'email': 'mgorgelitf@gmail.com', 'phone': '+905462388649'}], 'facility': 'Sultan Abdulhamid Han Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'muhammed G GÖRGEL, Resident Doctor', 'role': 'CONTACT', 'email': 'mgorgelitf@gmail.com', 'phone': '+905462388649'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emre Ata, Assoc Prof', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD', 'investigatorFullName': 'Emre Ata, Assoc Prof', 'investigatorAffiliation': 'Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey'}}}}