Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-01-28 @ 4:23 PM
Study NCT ID:
NCT03638518
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2018-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture vs. Core Stability Training in Women With Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Neither the participants nor their therapists were blind to the treatment allocation. However, the assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomized to a core stability training physiotherapy programme group, an acupuncture treatment group and control group for a 13 week study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2015-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-01', 'studyFirstSubmitDate': '2018-08-14', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from the centre of gravity at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': 'Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Centre of gravity is measured in percentage through posturography study'}, {'measure': 'Change from the monopodal stance test at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': 'Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Monopodal stance test measures static balance in percentage through posturography study.'}, {'measure': 'Change from Berg Balance Scale at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': 'Dynamic balance is the ability to maintain the centre of gravity within the base of support during the performance of functional activities. Berg Balance scale measures dynamic balance through performing multiple tasks and with a score of 0 to 56.'}, {'measure': 'Change from Time Up and Go test at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': 'Time up and Go test measures dynamic balance showed in seconds'}, {'measure': 'Change from 10 meter walk test at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': '10 meter walk test measures walking speed and performance which is related to dynamic balance. The unit use is meter/second.'}, {'measure': 'Change from Health Assessement Questionnaire at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': 'Health Assessement questionnaire measures the functional capacity of a subject. It provides an impairment score of 0 to 3.'}, {'measure': 'Change from physical function item of the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': 'The physical function item of the Spanish Fibromyalgia Impact Questionnaire measures functional capacity with a score of 0 to 3.'}], 'secondaryOutcomes': [{'measure': 'Change from the Spanish Fibromyalgia Impact Questionnaire at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': 'The Spanish Fibromyalgia Impact Questionnaire measures the quality of life and the impact of Fibromyalgia on the life of persons diagnosed with this condition. The maximum score is 100 and the higher the result obtained, the higher the impact of the condition on the person and the less quality of life he/she has.'}, {'measure': 'Change from pain intensity levels measured with the visual analogue scale at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': "The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'."}, {'measure': 'Change from joint stiffness levels measured with the visual analogue scale at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': "The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'."}, {'measure': 'Change from depression level measured with the visual analogue scale at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': "The visual analogue scale is a 100-mm scale, where 0 indicated 'no symptoms' and 100 indicating 'extreme and unbearable symptoms'."}, {'measure': 'Change from perceived difficulty to work measured with the visual analogue scale at 5 weeks and 13 weeks', 'timeFrame': 'Before treatment, after 5 weeks of treatment and after 6 weeks of follow up', 'description': "The visual analogue scale is a 100-mm scale, where 0 indicated 'no difficulty' and 100 indicating 'extreme and unbearable difficulty'."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'balance', 'functional capacity', 'quality of life', 'pain', 'acupuncture'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'This study analyse the effectiveness of a core stability training Physiotherapy programme versus Acupuncture treatment for the management of balance and functional capacity impairments of women with Fibromyalgia.', 'detailedDescription': 'Objective:\n\nThis study investigated the effectiveness of a core stability training Physiotherapy programme versus Acupuncture for the management of balance and functional capacity impairments of women with Fibromyalgia.\n\nDesign:\n\nA single-blind randomized clinical controlled trial.\n\nSetting:\n\nUniversity of Extremadura and Olivenza Fibromyalgia Association, Spain\n\nSubjects:\n\nWomen with Fibromyalgia and balance impairment.\n\nInterventions:\n\n135 Participants were randomized to a core stability training physiotherapy programme group (n=45), an acupuncture treatment group (n=45) and control group (n=45) for 13 weeks.\n\nMain Measures:\n\nMeasures were taken at baseline (week 0), post intervention (week 6) and at follow up (week 13). The primary outcome measures were static balance (posturography) and dynamic balance and functional mobility (Berg Balance Test, Time Up and Go test and 10-metre walk) and functional capacity (Fibromyalgia Health Assessment Questionnaire (FHAQ) and the physical function item from the Spanish Fibromyalgia Impact Questionnaire (SFIQ)).The secondary outcome measure were quality of life (Spanish- Fibromyalgia Impact Questionnaire), pain, joint stiffness, difficulty to work and depression (measured with the visual analogue scale).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'One of the inclusion criteria was to be a woman', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women between 18 and 71 years old,\n* diagnosed with Fibromialgia by a specialized physician,\n* having subjective sensation of balance impairments.\n\nExclusion Criteria:\n\n* The exclusion criteria were to present any medical contraindication for acupuncture and/or physiotherapy, phobia of needles, adverse reactions to medication that could influence in balance, associated pathologies such as alcoholism or severe visual deficit, to have receive acupuncture or core stability based physiotherapy in the two months previous to the intervention and to do physical exercises that train core stability such as Pilates or Yoga'}, 'identificationModule': {'nctId': 'NCT03638518', 'briefTitle': 'Acupuncture vs. Core Stability Training in Women With Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'University of Extremadura'}, 'officialTitle': 'Effectiveness of Acupuncture vs. Core Stability Based Physiotherapy in Balance and Functional Capacity of Women With Fibromyalgia: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '79/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'In the acupuncture experimental group, the technique applied included the use of the following acupuncture points of Traditional Chinesse Medicine: GV20, ST36 and BL60 . One needle insertion was performed in each session and in the case of the last two points the needle insertions were done bilaterally.\n\nPatients laid supine on a treatment table with their legs exposed. The skin on the acupuncture points was prepared with 70% ethyl alcohol. One-time-use disposable sterile stainless steel needles (0,26x50mm) were inserted into acupuncture points.\n\nAfter insertion, acupuncture needles were manually manipulated to obtain the de qi sensation. The needles remained in place for 20 minutes and there were no further manipulations during the retention time.', 'interventionNames': ['Other: Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Physiotherapy', 'description': 'The physiotherapy experimental group received core stability based physiotherapy treatment. Before the beginning of the treatment sessions, the basic principles of core stability exercises were explained to the participants. The exercise programme included 7 exercises. The exercises in the crook lying position were core activation with breathing, single leg lift with knees bent, single leg slides, bridging and knee drop sideways. The exercises completed in side lying included hip external rotation with knees bent and hip abduction with knees straight. After each session gentle stretching of the lower limbs and lumbar spine were performed. The sessions were administered twice a week during 30 minutes with groups of no more than 8 people.', 'interventionNames': ['Other: Physiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'The control group did not receive any intervention. The participants continued with their routine medical treatment.'}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Acupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session)', 'armGroupLabels': ['Acupuncture']}, {'name': 'Physiotherapy', 'type': 'OTHER', 'description': 'Core stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks', 'armGroupLabels': ['Physiotherapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elisa Mª Garrido Ardila, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Extremadura'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Extremadura', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesor of Physiotherapy', 'investigatorFullName': 'Elisa María Garrido Ardila', 'investigatorAffiliation': 'University of Extremadura'}}}}