Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07196267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shockwave and Cryoflow for Shoulder Pain After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074059', 'term': 'Extracorporeal Shockwave Therapy'}, {'id': 'D016474', 'term': 'Weight-Bearing'}], 'ancestors': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to either the Control Group (traditional PT + placebo) or the Experimental Group (traditional PT + real ESWT and Cryoflow). Both groups receive treatment concurrently over 8 weeks, with outcomes compared at baseline and post-intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Shoulder Muscle Tone (Spasticity)', 'timeFrame': 'Baseline and after 8 weeks of treatment (24 sessions)', 'description': 'Measured using the Modified Ashworth Scale (MAS) for shoulder adductors. MAS is a 6-point ordinal scale (0 = no increase in muscle tone, 5 = affected part rigid) to assess resistance during passive movement. Lower scores indicate reduced spasticity.'}], 'secondaryOutcomes': [{'measure': 'Change in Shoulder Range of Motion', 'timeFrame': 'Baseline and after 8 weeks of treatment (24 sessions)', 'description': 'Measured using a digital goniometer for active shoulder abduction and adduction. Range of motion recorded in degrees.'}, {'measure': 'Change in Supraspinatus Muscle Strength', 'timeFrame': 'Baseline and after 8 weeks of treatment (24 sessions)', 'description': 'Measured using a tensiometer (Lafayette, U.S.A.) to quantify isometric strength of the supraspinatus muscle. Force recorded in kilograms or Newtons.'}, {'measure': 'Change in Hand Dexterity and Fine Motor Function', 'timeFrame': 'Baseline and after 8 weeks of treatment (24 sessions)', 'description': 'Measured using surface electromyography (Neuropac apparatus) to record amplitude of motor unit action potentials (MUAP) of the supraspinatus muscle during standardized contractions. Reflects neuromuscular activation.'}, {'measure': 'Change in Supraspinatus Muscle Electromyographic Activity', 'timeFrame': 'Baseline and after 8 weeks of treatment (24 sessions)', 'description': 'Measured using surface electromyography (Neuropac apparatus) to record amplitude of motor unit action potentials (MUAP) of the supraspinatus muscle during standardized contractions. Reflects neuromuscular activation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracorporeal Shockwave Therapy', 'Cryoflow Therapy', 'Stroke Rehabilitation', 'Modified Ashworth Scale', 'Electromyography', 'Purdue Pegboard', 'Physical Therapy'], 'conditions': ['Post-stroke Shoulder Pain,Rotator Cuff Tendonitis,Shoulder Spasticity']}, 'descriptionModule': {'briefSummary': 'This study aims to find out whether combining two physical therapy treatments - Extracorporeal Shockwave Therapy and Cryoflow Therapy - can help reduce shoulder pain and improve function in patients who have developed rotator cuff tendonitis after a stroke. Participants will be divided into groups to receive either one therapy alone or both therapies together. Researchers will measure pain levels, shoulder movement, and daily function before and after treatment to see which approach works best. The goal is to find a more effective, non-drug way to manage shoulder pain in stroke survivors and help them regain better use of their arm.', 'detailedDescription': 'This study will test whether combining Extracorporeal Shockwave Therapy (ESWT) and Cryoflow Therapy with traditional physical therapy is more effective than traditional therapy alone for reducing shoulder pain and improving arm function in stroke patients with rotator cuff tendonitis. Thirty stroke patients (ages 50-70) with moderate-to-severe shoulder spasticity (MAS grade 3) will be randomly assigned to one of two groups:\n\nGroup 1 (Control): Receives traditional physical therapy (stretching, strengthening, PNF, hand function training) + placebo ESWT/Cryoflow.\n\nGroup 2 (Experimental): Receives the same traditional therapy + real ESWT (7Hz, 15 min) and Cryoflow (14°C, 15 min).\n\nAll patients will be treated 3 times per week for 8 weeks. Before and after treatment, researchers will measure: shoulder muscle tone (Modified Ashworth Scale), range of motion (digital goniometer), muscle strength (tensiometer), hand dexterity (Purdue Pegboard), and muscle activity (electromyography). The goal is to find a better, non-drug way to relieve shoulder pain and restore function after stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stroke confirmed by neurologist via physical examination and MRI. Age between 50 and 70 years. Moderate to severe shoulder spasticity, graded as Stage 3 on the Modified Ashworth Scale (MAS) for shoulder adductors.\n\nMedically stable (vital signs within normal limits). Conscious, cooperative, and able to follow instructions. No orthopedic conditions, surgeries, or injuries affecting the shoulder or upper limb.\n\nNo sensory impairments (visual, auditory, proprioceptive) that would interfere with assessment or treatment.\n\nAble to provide informed consent.\n\nExclusion Criteria:\n\n* History of shoulder surgery or fracture. Presence of shoulder subluxation or dislocation. Severe cognitive impairment or inability to communicate. Uncontrolled hypertension, cardiac disease, or other unstable medical conditions.\n\nSkin lesions, open wounds, or infection over the shoulder region. Diagnosis of frozen shoulder (adhesive capsulitis), rheumatoid arthritis, or other inflammatory joint diseases.\n\nPrevious treatment with ESWT or cryotherapy for shoulder within the last 6 months.\n\nUse of botulinum toxin injections in the upper limb within the last 3 months'}, 'identificationModule': {'nctId': 'NCT07196267', 'acronym': 'SW-CF-STROKE', 'briefTitle': 'Shockwave and Cryoflow for Shoulder Pain After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'MTI University'}, 'officialTitle': 'Combination Effect of Extracorporeal Shockwave and Cryoflow Therapy on Rotator Cuff Tendonitis in Stroke Patients', 'orgStudyIdInfo': {'id': 'PT. BU. EC. Y'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control: Traditional PT + Placebo', 'description': 'Participants receive a traditional physical therapy program including stretching, strengthening, PNF, weight-bearing, and hand function training (Purdue Pegboard) for 40 minutes per session, 3 times per week for 8 weeks. Placebo extracorporeal shockwave and cryoflow therapy (device turned off or mimicked without active energy delivery) are applied to maintain blinding where possible.', 'interventionNames': ['Behavioral: Traditional Physical Therapy Program', 'Device: Placebo ESWT and Cryoflow']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Traditional PT + ESWT + Cryoflow', 'description': 'Participants receive the same traditional physical therapy program as the control group, plus active Extracorporeal Shockwave Therapy (7 Hz, 2.5-3 bar, 15 min) and Cryoflow Therapy (14°C, 15 min) applied sequentially before PT. Treatments are administered 3 times per week for 8 weeks.', 'interventionNames': ['Device: Extracorporeal Shockwave Therapy', 'Device: Cryoflow Therapy', 'Behavioral: Traditional Physical Therapy Program']}], 'interventions': [{'name': 'Extracorporeal Shockwave Therapy', 'type': 'DEVICE', 'otherNames': ['ESWT'], 'description': 'Delivered using Shock Master (Master Plus MP200, STORZ Medical AG, Switzerland). Applied at 7 Hz frequency, 2.5-3 bar pressure, for 15 minutes per session, 3 times per week for 8 weeks. Target: supraspinatus tendon region. Applied after Cryoflow therapy in experimental group.', 'armGroupLabels': ['Experimental: Traditional PT + ESWT + Cryoflow']}, {'name': 'Cryoflow Therapy', 'type': 'DEVICE', 'otherNames': ['Cryoflow 1000IR'], 'description': 'Delivered using Cryoflow 1000IR (Model ICE-CT, EC). Applied at 14°C for 15 minutes per session, 3 times per week for 8 weeks. Applied directly over rotator cuff tendon region before ESWT in experimental group.', 'armGroupLabels': ['Experimental: Traditional PT + ESWT + Cryoflow']}, {'name': 'Traditional Physical Therapy Program', 'type': 'BEHAVIORAL', 'otherNames': ['Stretching, Strengthening, PNF, Weight-bearing, Hand Function Training'], 'description': 'tretching of shoulder flexors/adductors/internal rotators Strengthening of shoulder extensors/external rotators Weight-bearing exercises (sitting \\& quadruped) Neuromuscular Facilitation (PNF) for upper limb Hand dexterity training using Purdue Pegboard', 'armGroupLabels': ['Control: Traditional PT + Placebo', 'Experimental: Traditional PT + ESWT + Cryoflow']}, {'name': 'Placebo ESWT and Cryoflow', 'type': 'DEVICE', 'otherNames': ['Sham Shockwave ,Sham Cryoflow'], 'description': 'Identical device setup as active ESWT and Cryoflow, but with energy delivery disabled (no acoustic pulses, no cold air output). Applied for 15 min each, mimicking active treatment to maintain blinding where possible. Used in control group alongside traditional PT.', 'armGroupLabels': ['Control: Traditional PT + Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Reda kotb Abdelrazik, Ph.D.', 'role': 'CONTACT', 'email': 'dr_reda_kotb@yahoo.com', 'phone': '+966 53 247 6201'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MTI University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Physical Therapy for musculoskeletal disorders and its surgery, Faculty of Physical Therapy, Benha University', 'investigatorFullName': 'reda abd elrazik', 'investigatorAffiliation': 'MTI University'}}}}