Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:21 PM
Study NCT ID:
NCT05568394
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2022-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Manual Therapy Combined With Therapeutic Exercise on Brain Biomarkers in Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single-blinded design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2022-10-04', 'studyFirstSubmitQcDate': '2022-10-04', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortical gray matter: volume and thickness', 'timeFrame': 'At baseline and post-intervention', 'description': 'Cortical gray matter (volume and thickness) will be measured in pain-related areas (thalamus, prefrontal cortex (PFC), primary somatosensory cortex (S1), primary motor cortex (M1), insula, cingulate cortex, precuneus, temporal lobe and periaqueductal gray matter) using a Magnetic resonance imaging (MRI) machine'}], 'secondaryOutcomes': [{'measure': 'Neurochemical biomarkers: N-acetylaspartate (NAA), creatine (Cr), glutamic acid/glutamine (Glu/Gln), myoinositol (mI), and choline (cho)', 'timeFrame': 'At baseline and post-intervention', 'description': 'Neurochemistry biomarkers will be measured using single-voxel proton magnetic resonance spectroscopy (1H-MRS) in dorsolateral prefrontal cortex (DLPFC), primary somatosensory cortex (S1), anterior cingulate (ACC), insula and thalamus.'}, {'measure': 'Neck pain intensity', 'timeFrame': 'At baseline and post-intervention', 'description': 'The average intensity of neck pain will be assessed by using a 0-10 cm visual analogue scale (VAS), with 0 indicating no pain and 10 indicating worst imaginable pain.'}, {'measure': 'Neck pain and disability', 'timeFrame': 'At baseline and post-intervention', 'description': "Neck Disability Index (NDI) will be used to assess how neck pain affects a patient's daily life and to assess the self-rated disability. A total score is 50, which a higher score indicates a higher disability."}, {'measure': 'Anxiety and depression', 'timeFrame': 'At baseline and post-intervention', 'description': 'The symptoms of anxiety and depression will be assessed using Hospital Anxiety and Depression Scale (HADS). It includes two subscales: anxiety (HADS-A) and depression (HADS-D). A total score for each subscale ranges from 0 to 21, with higher scores indicating worse symptoms.'}, {'measure': 'Cervical range of motion', 'timeFrame': 'At baseline and post-intervention', 'description': 'Cervical range of motion (degrees) will be measured in flexion, extension, left-right lateral flexion and left-right rotation.'}, {'measure': 'Cervical muscle strength', 'timeFrame': 'At baseline and post-intervention', 'description': 'Cervical muscle strength will be measured in a craniocervical flexion action, using a handheld dynamometer (Newtons).'}, {'measure': 'White matter integrity: fractional anisotropy (FA) and mean diffusivity (MD)', 'timeFrame': 'At baseline and post-intervention', 'description': 'White matter in the brain will be quantified using diffusion tensor imaging (DTI) technique.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neck pain', 'Manual therapy', 'Exercise', 'Magnetic resonance imaging', 'Magnetic resonance spectroscopy'], 'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "Jull G, Falla D, Treleaven J, O'Leary S. Management of neck pain disorders: a research informed approach. Edinburgh: Elseiver Limited; 2019."}, {'pmid': '25306220', 'type': 'BACKGROUND', 'citation': "Johnston V, O'Leary S, Comans T, Straker L, Melloh M, Khan A, Sjogaard G. A workplace exercise versus health promotion intervention to prevent and reduce the economic and personal burden of non-specific neck pain in office personnel: protocol of a cluster-randomised controlled trial. J Physiother. 2014 Dec;60(4):233; discussion 233. doi: 10.1016/j.jphys.2014.08.007. Epub 2014 Oct 11."}, {'pmid': '29433500', 'type': 'BACKGROUND', 'citation': 'Sremakaew M, Jull G, Treleaven J, Barbero M, Falla D, Uthaikhup S. Effects of local treatment with and without sensorimotor and balance exercise in individuals with neck pain: protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2018 Feb 13;19(1):48. doi: 10.1186/s12891-018-1964-3.'}, {'type': 'BACKGROUND', 'citation': 'Maitland GD, Hengeveld E, Banks K, Anglaise K. Vertebral manipulation. 7th ed. Oxford: Butterworth-Heinemann: Elsevier; 2005.'}, {'pmid': '35210851', 'type': 'BACKGROUND', 'citation': 'de Zoete RMJ, Stanwell P, Weber KA, Snodgrass SJ. Differences in Structural Brain Characteristics Between Individuals with Chronic Nonspecific Neck Pain and Asymptomatic Controls: A Case-Control Study. J Pain Res. 2022 Feb 18;15:521-531. doi: 10.2147/JPR.S345365. eCollection 2022.'}, {'pmid': '29327392', 'type': 'BACKGROUND', 'citation': 'Coppieters I, De Pauw R, Caeyenberghs K, Lenoir D, DeBlaere K, Genbrugge E, Meeus M, Cagnie B. Differences in white matter structure and cortical thickness between patients with traumatic and idiopathic chronic neck pain: Associations with cognition and pain modulation? Hum Brain Mapp. 2018 Apr;39(4):1721-1742. doi: 10.1002/hbm.23947. Epub 2018 Jan 11.'}, {'pmid': '31773541', 'type': 'BACKGROUND', 'citation': 'Didehdar D, Kamali F, Yoosefinejad AK, Lotfi M. The effect of spinal manipulation on brain neurometabolites in chronic nonspecific low back pain patients: a randomized clinical trial. Ir J Med Sci. 2020 May;189(2):543-550. doi: 10.1007/s11845-019-02140-2. Epub 2019 Nov 26.'}, {'pmid': '37094892', 'type': 'DERIVED', 'citation': 'Chaikla R, Sremakaew M, Kothan S, Saekho S, Wantanajittikul K, Uthaikhup S. Effects of manual therapy combined with therapeutic exercise versus routine physical therapy on brain biomarkers in patients with chronic non-specific neck pain in Thailand: a study protocol for a single-blinded randomised controlled trial. BMJ Open. 2023 Apr 24;13(4):e072624. doi: 10.1136/bmjopen-2023-072624.'}]}, 'descriptionModule': {'briefSummary': 'Structural brain alterations in pain-related areas have been demonstrated in patients with nonspecific neck pain. While manual therapy combined with therapeutic exercise is an effective management for neck pain, its underlying mechanisms are poorly understood. The primary objective of this trial is to investigate the effects of manual therapy combined with therapeutic exercise on brain imaging biomarkers in patients with chronic nonspecific neck pain. The secondary objectives are to assess neurochemical biomarkers, clinical features of neck pain, cervical range of motion and cervical muscle strength.', 'detailedDescription': 'This study is a single-blinded, randomized controlled trial. Forty-eight participants with chronic nonspecific neck pain will be recruited into the study. Participants will be randomly allocated to either an intervention or control group (1:1 ratio). Participants in the intervention group will receive manual therapy combined with therapeutic exercise for 10 weeks (2 visits per week). The control group will receive routine physical therapy. Primary outcomes are brain imaging biomarkers (cortical gray matter: volume, thickness and area, and white matter: fractional anisotropy and mean diffusivity) in pain-related areas. Secondary outcomes are neurochemical biomarkers (N-acetylaspartate, NAA; creatine, Cr; glutamic acid/glutamine, Glu/Gln; myoinositol, mI; and choline, cho), clinical features (neck pain intensity, duration, neck disability and psychological symptoms), cervical range of motion and cervical muscle strength.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a history of nonspecific neck pain for ≥ 3 months\n* an average pain intensity over the past week ≥ 35 mm. on a visual analogue scale (VAS)\n\nExclusion Criteria:\n\n* a history of head and neck injury or surgery\n* known or suspected vestibular pathology or dizziness caused by underlying pathology in the ear, brain and sensory nerve pathways (e.g. benign paroxysmal positional vertigo) and/or vascular disorders\n* any neurological or musculoskeletal condition that could affect the outcomes (e.g., scoliosis, torticollis, myofascial pain syndrome, fibromyalgia and rheumatoid arthritis)\n* metabolic conditions (e.g., diabetes, obesity (BMI \\> 30 kg/m2) and hypertension)\n* psychological symptoms (e.g., anxiety, depression and schizophrenia)\n* contraindications to MRI (e.g., pregnancy/breastfeeding, claustrophobia and ferromagnetic implants)\n* receiving physiotherapy treatment for their neck conditions in the past 12 months.'}, 'identificationModule': {'nctId': 'NCT05568394', 'briefTitle': 'Effects of Manual Therapy Combined With Therapeutic Exercise on Brain Biomarkers in Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Effects of Manual Therapy Combined With Therapeutic Exercise on Brain Biomarkers in Patients With Chronic Nonspecific Neck Pain: Study Protocol for a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'FF-65 2301484'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Manual therapy and therapeutic exercise', 'interventionNames': ['Other: Manual therapy combinded with therapeutic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Routine physical therapy', 'interventionNames': ['Other: Routine physical therapy']}], 'interventions': [{'name': 'Manual therapy combinded with therapeutic exercise', 'type': 'OTHER', 'description': 'The treatment includes cervical mobilization and specific therapeutic exercises: craniocervical and cervical flexors and extensors, axioscapular muscles, and postural correction (30-40 minutes).\n\nThe participants will attend 20 individual treatment sessions (2 visits per week for 10 weeks).', 'armGroupLabels': ['Intervention group']}, {'name': 'Routine physical therapy', 'type': 'OTHER', 'description': 'The treatment includes routine physical therapy (e.g., modalities, range of motion and/or gentle stretching exercise) (30-40 minutes).\n\nThe participants will attend 20 individual treatment sessions (2 visits per week for 10 weeks).', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50202', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of Physical Therapy, Faculty of Associated Medical Sciences', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Sureeporn Uthaikhup, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of physical therapy, Chiang Mai university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sureeporn Uthaikhup', 'investigatorAffiliation': 'Chiang Mai University'}}}}