Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT03121859
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Current Therapies for Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline VAS (Visual analog scale) at 6th and 12th weeks', 'timeFrame': 'Up to12 weeks', 'description': 'The patients were asked to make an assessment of their pain between 0 (no pain) and 10 (severe pain).'}], 'secondaryOutcomes': [{'measure': 'Change from baseline quality of life (short form- 36) at 6th and 12th weeks', 'timeFrame': 'Up to 12 weeks', 'description': 'This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health.'}, {'measure': 'Change from baseline Beck depression inventory (BDI) at 6th and 12th weeks', 'timeFrame': 'Up to 12 weeks', 'description': 'The Beck Depression Inventory (BDI); was used to assess the depression levels of the patients. The BDI evaluates 21 symptoms of depression. These symptoms deal with emotions, behavioral changes, and somatic symptoms. Each symptom is rated on a 4-point intensity scale. Higher scores indicate more severe depression'}, {'measure': 'Change from baseline Neck Pain and Disability Index at 6th and 12th weeks', 'timeFrame': 'Up to 12 weeks', 'description': 'The questionnaire consists of 20 items and measures neck movements, pain intensity, effect of neck pain on emotion factors, and interference with daily life activities. Each section is scored on a 0-5 rating scale and total score ranges from 0 to 100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TENS', 'interferential current therapy', 'Chronic neck pain'], 'conditions': ['Chronic Neck Pain']}, 'descriptionModule': {'briefSummary': 'Does the use of analgesic current therapies increase the effectiveness of neck stabilization exercises for improving pain, disability, mood, and quality of life in chronic neck pain? a randomized, controlled, single-blind study', 'detailedDescription': "Analgesic therapies; such as interferential current (IFC) and transcutaneous electrical nerve stimulation (TENS) have been applied solo or combined with exercise for management of neck pain (NP), however, the efficacy of these combinations are unclear. In this study, our objective were to determine if TENS or IFC increase the effectiveness of neck stabilization exercises on pain, disability, mood, and quality of life for chronic NP. 81 patients with chronic NP were included in the study. Patients were randomly assigned into 3 groups; Group I: neck stabilization exercise, Group II: TENS+ neck stabilization exercise and Group III: IFC+ neck stabilization exercise. Patients' pain levels (visual analogue scale (VAS)), quality of life (short form- 36), mood (Beck depression inventory (BDI)), levels of disability (Neck Pain and Disability Index) and the need for analgesics were evaluated prior to treatment, at 6th and 12th week follow-up. All participants had group exercise accompanied by a physiotherapist for 3 weeks and an additional 3 weeks of home exercise program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders between 20-50 years, had chronic neck pain\n\nExclusion Criteria: Having disc hernia that causes neurological deficit\n\n* Having malignity,\n* Having neck pain secondary neurological or vascular disease.\n* Pregnancy\n* Having psychiatric disease\n* Having arthritic disease\n* Having any contraindication for electrotherapy'}, 'identificationModule': {'nctId': 'NCT03121859', 'briefTitle': 'Analgesic Current Therapies for Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Does The Use Of Analgesic Current Therapies Increase The Effectiveness Of Neck Stabilization Exercises For Improving Pain, Disability, Mood, And Quality Of Life In Chronic Neck Pain? A Randomized, Controlled, Single-Blind Study', 'orgStudyIdInfo': {'id': '2017-SHHY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neck stabilization exercise', 'description': 'The patients who had only neck stabilization exercise', 'interventionNames': ['Other: Neck stabilization exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TENS+ neck stabilization exercise', 'description': 'The patients who had both TENS and neck stabilization exercise', 'interventionNames': ['Other: Neck stabilization exercise', 'Other: TENS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IFC+ neck stabilization exercise', 'description': 'The patients who had both interferential current therapy and neck stabilization exercise', 'interventionNames': ['Other: Neck stabilization exercise', 'Other: IFC']}], 'interventions': [{'name': 'Neck stabilization exercise', 'type': 'OTHER', 'description': 'Exercise', 'armGroupLabels': ['IFC+ neck stabilization exercise', 'Neck stabilization exercise', 'TENS+ neck stabilization exercise']}, {'name': 'TENS', 'type': 'OTHER', 'description': 'Transcutaneous electrical nerve stimulation (TENS)', 'armGroupLabels': ['TENS+ neck stabilization exercise']}, {'name': 'IFC', 'type': 'OTHER', 'description': 'Interferential current therapy(IFC)', 'armGroupLabels': ['IFC+ neck stabilization exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0300', 'city': 'Afyonkarahisar', 'state': 'Eyalet/Yerleşke', 'country': 'Turkey (Türkiye)', 'facility': 'Hilal Yesil', 'geoPoint': {'lat': 38.75667, 'lon': 30.54333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hilal Yeşil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assist Prof', 'investigatorFullName': 'Hilal Yeşil', 'investigatorAffiliation': 'Ege University'}}}}