Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT05125705
Status:
UNKNOWN
Last Update Posted:
2021-11-18
First Post:
2021-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PRP Versus Saline in Lateral Epicondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both the patients and the outcome assessor will be blinded in this trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-06', 'studyFirstSubmitDate': '2021-10-23', 'studyFirstSubmitQcDate': '2021-11-06', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm', 'timeFrame': 'baseline', 'description': 'Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst'}, {'measure': 'Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm', 'timeFrame': '6 weeks', 'description': 'Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst'}, {'measure': 'Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm', 'timeFrame': '3 months', 'description': 'Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst'}, {'measure': 'Patient-Related Tennis Elbow Evaluation (PRTEE) pain in affected arm', 'timeFrame': '6 months', 'description': 'Rates pain from 0 (no pain) to 10 (worst imaginable) for at rest, doing task with repeated arm movement, carrying plastic bag of groceries, when pain was least, when pain was worst'}, {'measure': 'Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability', 'timeFrame': 'baseline', 'description': 'Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.'}, {'measure': 'Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability', 'timeFrame': '6 weeks', 'description': 'Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.'}, {'measure': 'Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability', 'timeFrame': '3 months', 'description': 'Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.'}, {'measure': 'Patient-Related Tennis Elbow Evaluation (PRTEE) functional disability', 'timeFrame': '6 months', 'description': 'Rates from 0 (no difficulty) to 10 (unable to do) on specific activities and usual activities. Specific activities include turning doorknob or key, carrying grocery bag or briefcase by handle, lifting full coffee cup or glass of milk to mouth, opening jars, pulling up pants, wringing out washcloths or wet towels. Usual activities include personal activities (dressing, washing), household work (cleaning, maintenance), work (job), recreational or sporting activities.'}, {'measure': 'Visual analog scale (VAS) pain with resisted wrist extension', 'timeFrame': 'baseline', 'description': 'Rated from 0 (no pain) to 5 (extremely pain)'}, {'measure': 'Visual analog scale (VAS) pain with resisted wrist extension', 'timeFrame': '6 weeks', 'description': 'Rated from 0 (no pain) to 5 (extremely pain)'}, {'measure': 'Visual analog scale (VAS) pain with resisted wrist extension', 'timeFrame': '3 months', 'description': 'Rated from 0 (no pain) to 5 (extremely pain)'}, {'measure': 'Visual analog scale (VAS) pain with resisted wrist extension', 'timeFrame': '6 months', 'description': 'Rated from 0 (no pain) to 5 (extremely pain)'}, {'measure': 'Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis', 'timeFrame': 'baseline', 'description': 'Rated from 0 (no pain) to 5 (extremely pain)'}, {'measure': 'Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis', 'timeFrame': '6 weeks', 'description': 'Rated from 0 (no pain) to 5 (extremely pain)'}, {'measure': 'Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis', 'timeFrame': '3 months', 'description': 'Rated from 0 (no pain) to 5 (extremely pain)'}, {'measure': 'Visual analog scale (VAS) pain with contraction of extensor carpi radialis brevis and extensor digitorum communis', 'timeFrame': '6 months', 'description': 'Rated from 0 (no pain) to 5 (extremely pain)'}, {'measure': 'Ultrasound tendon', 'timeFrame': 'baseline', 'description': 'Ultrasonographic changes in tendon thickness and color Doppler activity will be recorded'}, {'measure': 'Ultrasound tendon', 'timeFrame': '6 months', 'description': 'Ultrasonographic changes in tendon thickness and color Doppler activity will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelet rich plasma', 'saline', 'randomised controlled trial'], 'conditions': ['Lateral Epicondylitis, Unspecified Elbow']}, 'descriptionModule': {'briefSummary': 'Lateral epicondylitis (LE), also known as tennis elbow, has an estimated prevalence in the general population of 1% to 3%, peaking at age 45 years to 54 years and affect both men and women equally. A randomised controlled trial published in The Lancet showed that 83% of the patients suffering from LE of more than 6 weeks duration on wait-and-see policy recovered only after 1 year without any therapeutic interventions. The costs associated with LE is substantial as patients not only incur hefty healthcare costs but also lose their productivity owing to their long recovery period.\n\nCurrently, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. This randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.', 'detailedDescription': 'The pathogenesis of LE was initially believed to be a generalised inflammatory process. However, in 1979, the pathology was better understood as invading immature fibroblasts disorganizing the normal collagen architecture of the elbow, associated with immature vascular responses to cellular repair. There is a variety of treatment modalities available for LE, varying from watchful waiting without any therapeutic interventions, pharmaceutical methods such as prescribing non-steroidal anti-inflammatory drugs, physiotherapy such as encouraging bracing and exercise, injections, and surgical modalities once non-surgical options fail.\n\nFor many years, injection with glucocorticoids has remained the mainstay of treatment. However, several studies have proven that the effects of corticosteroid injections do not seem to last in the long-term, amongst which a trial published in The Lancet showed that long-term differences at 52 weeks between injections and physiotherapy was significantly in favour of physiotherapy. Recently, many studies worldwide have demonstrated that platelet-rich-plasma (PRP) stimulates cartilage repair by actively secreting growth factors which activate cell proliferation and differentiation thereby promoting tissue regeneration. It has been postulated that PRP stimulates repair mechanisms within tendons and hence promote tendon healing.\n\nHowever, there is a paucity of evidence worldwide for the efficacy of PRP injections compared to control in LE. Currently, PRP treatment is not formally recognized as a treatment modality for LE in Singapore, with the accepted indications for PRP treatment being limited to non-surgical treatment of acute muscle and ligamentous injuries, and the biological augmentation of acute Achilles tendon repairs.\n\nThis randomised controlled trial aims to compare the efficacy of PRP versus placebo (saline) injections in adults with LE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of age \\>21 years old\n* History of chronic pain on the lateral side of the elbow and pain on lateral epicondyle on direct palpation and resisted dorsiflexion of the wrist for more than 3 months\n* Ability of patients to provide informed consent\n\nExclusion Criteria:\n\n* Previous tennis elbow surgery to affected elbow\n* Previous corticosteroid injections to affected elbow\n* Concurrent complementary and alternative medicine (CAM) treatments e.g. acupuncture\n* Inflammatory diseases / infection / fracture / trauma\n* Neck pain on ipsilateral side\n* Chronic pain syndromes\n* Malignancies\n* Pregnant or lactating females\n* Consistent use of NSAIDs within 48 hours of procedure\n* Systemic use of corticosteroids within 2 weeks\n* History of anemia, any blood disorders, hypothyroidism'}, 'identificationModule': {'nctId': 'NCT05125705', 'briefTitle': 'PRP Versus Saline in Lateral Epicondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Treatment of Lateral Epicondylitis With Platelet-Rich Plasma Versus Saline: A Double-Blinded Randomized Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': 'CIRB1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platelet rich plasma injection', 'description': 'Patients will be treated with a single PRP injection, where 8 mL of whole blood will be collected and 2.5 mL of PRP will be given to the patient. Routine physiotherapy regimens will be implemented, similar to placebo arm.', 'interventionNames': ['Biological: Platelet rich plasma injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline injection', 'description': 'Patients will be treated with 2.5 mL saline 0.9%. Routine physiotherapy regimens will be implemented, similar to intervention arm.', 'interventionNames': ['Other: Saline injection']}], 'interventions': [{'name': 'Platelet rich plasma injection', 'type': 'BIOLOGICAL', 'otherNames': ['PRP'], 'description': "The PRP is prepared by RegenLab's RegenKit-THT, in accordance with operating instructions supplied with the kit. The device allows automated blood collection (8 mL) and blood component separation in closed circuit. After centrifugation at room temperature for 9 minutes at centrifugal force of 1500g, the RegenTHT tube is then inverted several times before re-suspension, allowing 4mL of PRP to be obtained for each tube. 2.5mL will be injected into patients", 'armGroupLabels': ['Platelet rich plasma injection']}, {'name': 'Saline injection', 'type': 'OTHER', 'description': 'Saline injection', 'armGroupLabels': ['Saline injection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kenon Chua', 'role': 'CONTACT', 'email': 'kenonchua@icloud.com', 'phone': '+65 6222 3322'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgery Registrar', 'investigatorFullName': 'Kenon Chua Ser', 'investigatorAffiliation': 'Singapore General Hospital'}}}}