Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:08 AM
Study NCT ID:
NCT04354194
Status:
UNKNOWN
Last Update Posted:
2020-06-04
First Post:
2020-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2020-04-13', 'studyFirstSubmitQcDate': '2020-04-18', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Change from baseline pain intensity at 3 weeks', 'description': 'pain intensity at rest and activity will measure by VAS'}], 'secondaryOutcomes': [{'measure': 'Disability level', 'timeFrame': 'Change from baseline Neck Disability Index score at 3 weeks', 'description': 'Disability level will measue by Neck Disability Index. Score ranges from 0-100. Higher score indicates worse outcome.'}, {'measure': 'Depression level', 'timeFrame': 'Change from baseline Beck Depression Inventory score at 3 weeks', 'description': 'Depression will measure by Beck Depression Inventory. Scores ranges from 0-63. Higher score indicates worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteopathic Manipulative Treatment', 'Chronic Non-spesific Neck Pain', 'Conventional Therapy'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '18617745', 'type': 'BACKGROUND', 'citation': 'Schwerla F, Bischoff A, Nurnberger A, Genter P, Guillaume JP, Resch KL. Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy. Forsch Komplementmed. 2008 Jun;15(3):138-45. doi: 10.1159/000132397. Epub 2008 Jun 4.'}, {'pmid': '10979164', 'type': 'BACKGROUND', 'citation': 'Jarski RW, Loniewski EG, Williams J, Bahu A, Shafinia S, Gibbs K, Muller M. The effectiveness of osteopathic manipulative treatment as complementary therapy following surgery: a prospective, match-controlled outcome study. Altern Ther Health Med. 2000 Sep;6(5):77-81.'}, {'pmid': '29780605', 'type': 'BACKGROUND', 'citation': 'Edwards DJ, Toutt C. An evaluation of osteopathic treatment on psychological outcomes with patients suffering from chronic pain: A prospective observational cohort study collected through a health and well-being academy. Health Psychol Open. 2018 May 10;5(1):2055102918774684. doi: 10.1177/2055102918774684. eCollection 2018 Jan-Jun.'}, {'pmid': '30219451', 'type': 'RESULT', 'citation': 'Verhaeghe N, Schepers J, van Dun P, Annemans L. Osteopathic care for low back pain and neck pain: A cost-utility analysis. Complement Ther Med. 2018 Oct;40:207-213. doi: 10.1016/j.ctim.2018.06.001. Epub 2018 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of osteopathic manipulative treatment on pain intensity, disability level and psychosocial factors in patients with chronic non-specific neck pain. We hypothesed that osteopathic manipulative treatment is better than conventional physiotherapy in management of pain, disability and depression.', 'detailedDescription': 'This study will conduct between April 2020 and July 2020 at Denizli State Hospital. Participants who were diagnosed as chronic non-specific neck pain by a specialist physician will include the study. They will treated at physical therapy clinic. Inclussion criteria will; participants diagnosed as non-specific neck pain by the physician and Non-spesific neck pain at least 3 months. Exclussion criteria were; participants who have had surgery or are indicated for surgery, participants who have had exercise therapy and / or physical therapy in the last 1 year with a history of trauma to the cervical region, participants who have had neck pain that develop due to a particular cause such as tumor, compression fracture, metastasis and infection. According to power analysis, 102 participant will include the study with 95% coincidence interval and 80% power. Participants will be divided into 2 groups. Randomization method will be closed envelope. Group 1 will receive Conventional Physiotherapy Programme (CP), Group 2 will receive Osteopathin Manipulative Treatment (OMT). Pain Intensity at rest and activity, psychological state( Beck Depression Inventory) and Disability level (Neck Disability Index) will assess at baseline and 3 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants diagnosed as non-specific neck pain by the physician.\n* Non-spesific neck pain at least 3 months.\n\nExclusion Criteria:\n\n* participants who have had surgery or are indicated for surgery\n* participants who have had exercise therapy and / or physical therapy in the last 1 year with a history of trauma to the cervical region\n* participants who have had neck pains that develop due to a particular cause such as tumor, compression fracture, metastasis and infection'}, 'identificationModule': {'nctId': 'NCT04354194', 'briefTitle': 'Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Osteopathic Manipulative Treatment in Chronic Non-specific Neck Pain: A Controlled Study', 'orgStudyIdInfo': {'id': '21.05.2019/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional Physiotherapy Group', 'description': 'This group will receive 15 sessions of conventional physiotherapy programme 5 times per week.', 'interventionNames': ['Procedure: Conventional Physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'Osteopathic Manipulative Treatment Group', 'description': 'This group will receive 9 sessions of Osteopathic Manipulative Treatment programme 3 times per week.', 'interventionNames': ['Procedure: Osteopathic Manupilative Treatment']}], 'interventions': [{'name': 'Conventional Physiotherapy', 'type': 'PROCEDURE', 'description': 'Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in sitting and supported with a pillow under the head, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute. TENS was applied to the cervical region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.', 'armGroupLabels': ['Conventional Physiotherapy Group']}, {'name': 'Osteopathic Manupilative Treatment', 'type': 'PROCEDURE', 'description': 'Osteopathic Manupilative Treatment consist of stretching the fascia to the cervical region, soft tissue mobilization to the surrounding muscles, cervical manual traction, passive joint mobilization to the 7 cervical spine, passive joint mobilization to the 1st costa, passive joint mobilization to the clavicle and passive joint mobilization to the sternum mobilization in supine and prome positions.', 'armGroupLabels': ['Osteopathic Manipulative Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20040', 'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Denizli State Hospital', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'centralContacts': [{'name': 'Şule Şimşek, Phd', 'role': 'CONTACT', 'email': 'sules@pau.edu.tr', 'phone': '+905058099914'}, {'name': 'Merve Bergin Korkmaz, Dr.', 'role': 'CONTACT', 'email': 'mbergina@hotmail.com', 'phone': '+905469114635'}], 'overallOfficials': [{'name': 'Nesrin Yağcı, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Because there is no web site to share my data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Şule', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Şule', 'investigatorAffiliation': 'Pamukkale University'}}}}