Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-01 @ 11:33 AM
Study NCT ID:
NCT06982456
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-21
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Therapy Techniques for Cervical Pain: Algometric Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009209', 'term': 'Myofascial Pain Syndromes'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052580', 'term': 'Muscle Stretching Exercises'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'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'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking: Double (Participant, Outcomes Assessor) Description: Participants will not be informed about the specific nature of the interventions (e.g., which techniques are expected to be more effective). The assessor conducting the post-intervention measurements will be blinded to group allocation. Therapists cannot be blinded due to the hands-on nature of the treatments.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled trial with three parallel groups. Participants will be randomly assigned to Experimental Group 1, Experimental Group 2, or Control Group. The intervention groups will receive manual therapy techniques (superficial massage, deep massage, and pressure release technique), with or without passive stretching, while the control group will undergo only pressure pain threshold evaluations. Algometric measurements will be performed pre-treatment, post-treatment, and during follow-up at one and two weeks after the intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-05-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPT - Pressure Pain Threshold', 'timeFrame': 'Three weeks', 'description': 'Pressure Pain Threshold (PPT) measured with an algometer (kg/cm²) on the upper trapezius fibers.\n\nMeasurements will be taken pre-treatment, immediately post-treatment, and at one and two weeks post-intervention.'}], 'secondaryOutcomes': [{'measure': 'Brief questionnaire (self-reported).', 'timeFrame': 'Time of assessment: The day after the intervention', 'description': 'Subjective assessment of the discomfort or pain experienced in the treated area the day. post-treatment discomfort report.'}, {'measure': 'Data collection form (demographic questionnaire).', 'timeFrame': 'Prior to the intervention (baseline).', 'description': 'Collection of participant characteristics including age and sex. Do you suffer from neck pain regularly?'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trigger Points', 'Pain Measurement', 'Physical Therapy', 'Passive Stretching'], 'conditions': ['Myofascial Pain Syndromes', 'Massage', 'Stretching']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the effectiveness of different manual therapy techniques in the treatment of cervical pain related to the upper trapezius muscle.\n\nThe intervention will compare the effects of superficial massage, deep massage, and pressure release technique on pain intensity, assessed through algometry.\n\nAdditionally, the study aims to determine whether the application of passive stretching following manual treatment leads to a significantly greater reduction in pain compared to groups that do not receive stretching.\n\nFinally, the persistence of treatment effects will be evaluated one and two weeks after the intervention.', 'detailedDescription': 'Methodological Design:\n\nThis study will be conducted with the participation of undergraduate Physiotherapy students who voluntarily wish to take part in the research.\n\nInclusion Criteria:\n\nBe an undergraduate student in Physiotherapy. Be between 18 and 40 years old. Have experienced cervical pain at least once in their life. Present pain localized in the upper fibers of the trapezius muscle. Voluntarily agree to participate in the study by signing an informed consent form.\n\nExclusion Criteria:\n\nSuffer from migraines. Have any diagnosed neurological disorders. Have suffered a recent injury or trauma in the cervical region. Have scoliosis or any other relevant spinal pathology. Present any musculoskeletal condition that could interfere with the study outcomes.\n\nThe participants will be randomly assigned to three groups: Experimental Group 1, Experimental Group 2, and Control Group.\n\nProcedure:\n\nAll participants in the experimental groups will complete a short survey collecting information such as age, sex, and whether they experienced discomfort in the treated area the following day. Baseline pressure pain thresholds will be assessed using algometry (in Kg/cm²) on the upper fibers of the trapezius muscle prior to the intervention.\n\nThe intervention will consist of superficial massage, deep massage, and the pressure release technique applied to the upper trapezius. Following this, a post-treatment algometric measurement will be taken.\n\nExperimental Group 1: Will receive only the manual treatment. Follow-up algometric measurements will be performed on the upper trapezius one week and two weeks after the intervention.\n\nExperimental Group 2: Will receive the same manual treatment followed by passive stretching of the upper trapezius. An algometric measurement will be conducted immediately after stretching, as well as follow-up assessments one week and two weeks later.\n\nControl Group: Will not receive any intervention but will undergo algometric assessments under the same conditions to enable comparisons with the experimental groups.\n\nStudy Duration:\n\nThe total estimated duration of the study is three weeks.\n\nWeek 1: Intervention and pre-/post-treatment algometric assessments. Week 2: First follow-up algometric measurement. Week 3: Final algometric measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be an undergraduate student in Physiotherapy.\n* Be between 18 and 40 years old.\n* Have experienced cervical pain at least once in their life.\n* Present pain localized in the upper fibers of the trapezius muscle.\n* Voluntarily agree to participate in the study by signing an informed consent form.\n\nExclusion Criteria:\n\n* Suffer from migraines.\n* Have any diagnosed neurological disorders.\n* Have suffered a recent injury or trauma in the cervical region.\n* Have scoliosis or any other relevant spinal pathology.\n* Present any musculoskeletal condition that could interfere with the study outcomes.'}, 'identificationModule': {'nctId': 'NCT06982456', 'briefTitle': 'Manual Therapy Techniques for Cervical Pain: Algometric Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Murcia'}, 'officialTitle': 'Effects of Massage, Pressure Release, and Stretching in the Treatment of Cervical Pain: An Algometric Assessment', 'orgStudyIdInfo': {'id': 'M10/2024/519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group 1', 'description': 'The intervention will consist of superficial massage, deep massage, and the pressure release technique applied to the upper trapezius. Following this, a post-treatment algometric measurement will be taken.\n\nExperimental Group 1: Will receive only the manual treatment. Follow-up algometric measurements will be performed on the upper trapezius one week and two weeks after the intervention.', 'interventionNames': ['Other: Manual Therapy on the Upper Trapezius with or without Passive Stretching']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group 2', 'description': 'The intervention will consist of superficial massage, deep massage, and the pressure release technique applied to the upper trapezius. Following this, a post-treatment algometric measurement will be taken.\n\nExperimental Group 2: Will receive the same manual treatment followed by passive stretching of the upper trapezius. An algometric measurement will be conducted immediately after stretching, as well as follow-up assessments one week and two weeks later.', 'interventionNames': ['Other: Manual Therapy on the Upper Trapezius with or without Passive Stretching']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Control Group: Will not receive any intervention but will undergo algometric assessments under the same conditions to enable comparisons with the experimental groups.', 'interventionNames': ['Other: Manual Therapy on the Upper Trapezius with or without Passive Stretching']}], 'interventions': [{'name': 'Manual Therapy on the Upper Trapezius with or without Passive Stretching', 'type': 'OTHER', 'description': 'The intervention consists of manual therapy techniques applied to the upper fibers of the trapezius muscle, including superficial massage, deep massage, and pressure release technique. In one of the experimental groups, this treatment is followed by passive stretching. The control group receives no intervention. Algometric measurements (pressure pain threshold) are taken before and after the intervention, and at one-week and two-week follow-up points to assess the effectiveness and persistence of the treatment.', 'armGroupLabels': ['Control Group', 'Experimental Group 1', 'Experimental Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Universidad de Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Murcia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Angel Martínez Carrasco', 'investigatorAffiliation': 'Universidad de Murcia'}}}}