Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT06459804
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2024-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Electro Dry Needling Versus Dry Needling in Levator Scapulae Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-13', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric pain rate scale (NPRS)', 'timeFrame': 'upto 3 weeks', 'description': 'The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. the NPRS is anchored by terms describing pain severity extremes.\n\nThe 11-point numeric scale ranges from \'0\' representing one pain extreme (e.g. "no pain") to \'10\' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").'}, {'measure': 'Neck Disability index (NDI)', 'timeFrame': 'upto 3 weeks', 'description': 'The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage.'}, {'measure': 'Universal Goniometer', 'timeFrame': 'upto 3 weeks', 'description': "An instrument called a goniometer is used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer .\n\nRange of motion: Side flexion and Rotation of neck measured with Goniometer."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neck pain', 'disability', 'muscle strength', 'Range of Motion'], 'conditions': ['Neck Syndrome']}, 'referencesModule': {'references': [{'pmid': '32492884', 'type': 'BACKGROUND', 'citation': 'Garcia-de-Miguel S, Pecos-Martin D, Larroca-Sanz T, Sanz-de-Vicente B, Garcia-Montes L, Fernandez-Matias R, Gallego-Izquierdo T. Short-Term Effects of PENS versus Dry Needling in Subjects with Unilateral Mechanical Neck Pain and Active Myofascial Trigger Points in Levator Scapulae Muscle: A Randomized Controlled Trial. J Clin Med. 2020 Jun 1;9(6):1665. doi: 10.3390/jcm9061665.'}, {'pmid': '37664417', 'type': 'BACKGROUND', 'citation': 'Hernandez-Secorun M, Abenia-Benedi H, Borrella-Andres S, Marques-Garcia I, Lucha-Lopez MO, Herrero P, Iguacel I, Tricas-Moreno JM, Hidalgo-Garcia C. Effectiveness of Dry Needling in Improving Pain and Function in Comparison with Other Techniques in Patients with Chronic Neck Pain: A Systematic Review and Meta-Analysis. Pain Res Manag. 2023 Aug 23;2023:1523834. doi: 10.1155/2023/1523834. eCollection 2023.'}, {'type': 'BACKGROUND', 'citation': 'ALchlaihawi A, Tajali SB, Malmir K, Mahdi TS (2023) Effects of Dry Needling and Dry Needling Combined with Electrical Stimulation on Pain and Function in Patients with Subacute Musculoskeletal Neck Pain Following Myofascial Trigger Points. History of Medicine 9(1): 1845-1858. https://doi.org/10.17720/24095834.v9.1.2023.237'}, {'type': 'BACKGROUND', 'citation': 'Song Young-mun, Weon Jong-hyuck, Jung Do-young. Reliability of a New Test of Levator Scapula Muscle Length. J Musculoskelet Sci Technol 2019;3(1):1-6. https://doi.org/10.29273/jmst.2019.3.1.1'}, {'pmid': '28158962', 'type': 'BACKGROUND', 'citation': 'Gattie E, Cleland JA, Snodgrass S. The Effectiveness of Trigger Point Dry Needling for Musculoskeletal Conditions by Physical Therapists: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Mar;47(3):133-149. doi: 10.2519/jospt.2017.7096. Epub 2017 Feb 3.'}, {'pmid': '25576642', 'type': 'BACKGROUND', 'citation': 'Liu L, Huang QM, Liu QG, Ye G, Bo CZ, Chen MJ, Li P. Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2015 May;96(5):944-55. doi: 10.1016/j.apmr.2014.12.015. Epub 2015 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'Mechanical neck pain is posteriorly occurring non-specific pain that originates from the superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by sustained neck postures, neck movements or cervical muscle palpation. The aim of study will be to compare the effects of Electro Dry Needling and Dry Needling on pain, muscle strength, disability and range of motion in patients with Levator Scapulae Syndrome.', 'detailedDescription': 'A Randomized Clinical Trial will be conducted at Shalamar Hospital, (SIHS Physiotherapy Clinic Lahore) through convenience sampling technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will receive Electro Dry Needling along with conventional physiotherapy in which parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated and Group B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes. Standard Physiotherapy will include a Hot pack (10 min), Stretching of levator scapulae (3 times with 30 second hold), and Scapular stabilization exercises (10 times with 5 second hold).There will be 3 sessions per week, Needling in both groups will be for performed 2 times per week for total 3rd week of treatment comprising of 6 sessions, 3rd session will comprise of standard physical therapy. Pre and Post treatment measures will be recorded.Outcome measures will be conducted through pain, \\*muscle strength,\\* disability and range of motion questionnaire. Data will be analyzed during \\*SPSS software version 25.After assessing the normality of data by the Shapiro-Wilk test, it will be decided whether a parametric or non-parametric test will be used within a group or between two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ranges of 18-45 years\n* Both genders, males and females\n* Positive Levator Scapular length Test (7)\n* Positive Simon's criteria for Levator scapulae\n* Neck pain -NPRS \\< 7 (8)\n* Neck and upper back pain for at least 3months.\n* Examination - Increased muscle tone and tenderness at neck and upper back\n* Reduced ROM-Side flexion and Rotation of neck\n* Non traumatic unilateral mechanical neck pain of three or more months of duration, presenting an latent MTrP in the levator scapulae muscle on the painful side\n\nExclusion Criteria:\n\n* Neuropathies\n* Radiated pain towards the arm\n* Vertebral fractures\n* Traumatic neck injury\n* whiplash injury (9)\n* previous surgical procedures in the cervical spine\n* Previous cognitive and functional disorders\n* psychological disorders (mood and psychotic disorders such as schizophrenia, depression,and anxiety disorders),\n* Fibromyalgia"}, 'identificationModule': {'nctId': 'NCT06459804', 'briefTitle': 'Effects of Electro Dry Needling Versus Dry Needling in Levator Scapulae Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Electro Dry Needling Versus Dry Needling on Pain, Muscle Strength, and Range of Motion in Patients With Levator Scapulae Syndrome', 'orgStudyIdInfo': {'id': 'REC/RCRS/1021 Aqsa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Electro Dry Needling', 'description': 'Group A: will receive Electro Dry Needling along with conventional physiotherapy. The parameters for Electro dry needling will be needles of 30×0.25 mm, 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated.', 'interventionNames': ['Procedure: Electro Dry Needling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: Dry Needling', 'description': 'Group B will receive Dry Needling along with conventional Physiotherapy in which parameters will be dry needles will be 30×0.25 and 50×0.25 mm sizes, Frequency 80-100 Hz, Duration 10-20 minutes and intensity as tolerated.', 'interventionNames': ['Procedure: Dry Needling']}], 'interventions': [{'name': 'Electro Dry Needling', 'type': 'PROCEDURE', 'description': 'Standard Physiotherapy:\n\nIt will include Hot pack (10 min), Stretching of levator scapulae (3 times with 30 seconds hold), Scapular stabilization exercises (10 times with 5 seconds hold).\n\nScapular Stabilization exercises will be comprised of four exercise programs. The participants will sit on the knees in 90° flexion position, and a Swiss ball will be propped up between the stomach and chest.', 'armGroupLabels': ['Group A: Electro Dry Needling']}, {'name': 'Dry Needling', 'type': 'PROCEDURE', 'description': 'Dry Needling', 'armGroupLabels': ['Group B: Dry Needling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Aqsa Clinic', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Aqsa Wahid, MSPT*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University,Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}