Musculoskeletal Diseases Clinical Trial
Official title:
Effects of Adding Platelet-Rich Plasma (PRP) Therapy to Extracorporeal Shock Wave Therapy (ESWT) in Patients With Lateral Epicondylitis: Double-Blind Randomized Sham-Controlled Study
Verified date | January 2024 |
Source | Afyonkarahisar Health Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to determine the effectiveness of adding PRP or Sham PRP injection to ESWT treatment in patients with lateral epicondylitis on pain, muscle strength, functional activities, quality of life and work activities, and to determine the superiority of the treatments over each other.
Status | Completed |
Enrollment | 91 |
Est. completion date | January 10, 2024 |
Est. primary completion date | December 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Diagnosed with lateral epicondylitis after physical examination 2. No other pathology detected on direct radiography 3. Complaints persisting for more than 3 months despite the application of other conservative treatment methods 4. Patients accepting to give blood for PRP or sham injection and can tolerate elbow injection and extracorporeal shock wave therapy (ESWT) Exclusion Criteria: 1. Not being able to fully cooperate with the study and inability to read and write, 2. Injection (corticosteroid, PRP, etc.) treatment applied to the elbow area within three months, 3. Previous surgery or ESWT treatment in the area to be treated, 4. Pregnant women, 5. Arthritis (rheumatoid arthritis, spondyloarthritis, crystal arthropathies), 6. Those who have a history of direct trauma to the elbow and a history of fracture, 7. Those with a history of malignancy, 8. Bleeding diathesis, 9. Complex regional pain syndrome, 10. Presence of acute systemic infection, 11. Presence of local infection at the injection site, 12. Peripheral vasculopathy, 13. Cervical radiculopathy, 14. Patients with contraindications to ESWT application (pregnancy, cancer, coagulation disorders, inflammatory disease, pacemaker, metal implant in the area to be applied) were excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Afyonkarahisar Health Sciences University | Afyonkarahisar |
Lead Sponsor | Collaborator |
---|---|
Afyonkarahisar Health Sciences University |
Turkey,
Alessio-Mazzola M, Repetto I, Biti B, Trentini R, Formica M, Felli L. Autologous US-guided PRP injection versus US-guided focal extracorporeal shock wave therapy for chronic lateral epicondylitis: A minimum of 2-year follow-up retrospective comparative study. J Orthop Surg (Hong Kong). 2018 Jan-Apr;26(1):2309499017749986. doi: 10.1177/2309499017749986. — View Citation
Arirachakaran A, Sukthuayat A, Sisayanarane T, Laoratanavoraphong S, Kanchanatawan W, Kongtharvonskul J. Platelet-rich plasma versus autologous blood versus steroid injection in lateral epicondylitis: systematic review and network meta-analysis. J Orthop Traumatol. 2016 Jun;17(2):101-12. doi: 10.1007/s10195-015-0376-5. Epub 2015 Sep 11. — View Citation
Gunduz R, Malas FU, Borman P, Kocaoglu S, Ozcakar L. Physical therapy, corticosteroid injection, and extracorporeal shock wave treatment in lateral epicondylitis. Clinical and ultrasonographical comparison. Clin Rheumatol. 2012 May;31(5):807-12. doi: 10.1007/s10067-012-1939-y. Epub 2012 Jan 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline visual analog scale (VAS) elbow pain at 4th and 12th week | Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity. The patient will be asked to score rest, movement, and nighttime pain. | baseline and 12th week | |
Secondary | Change from baseline Handgrip strength at 4th and 12th week | Measuring hand grip strength is an objective method for evaluating response to treatment and functional recovery. Grip strength will be evaluated with the Jamar hydraulic hand dynamometer. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg. Higher scores means better grip strength. | baseline and 12th week | |
Secondary | Change from baseline Quick Disabilities of the Arm, Shoulder and Hand Score (Quick DASH) at 4th and 12th week | Quick DASH is a questionnaire that can be used to evaluate disability, activity restriction and work participation restriction caused by musculoskeletal problems involving the upper extremity. The QuickDASH tool uses a 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not able to do at all) from which the patient can mark an appropriate number corresponding to his/her severity/function level. According to the results of the Quick DASH questionnaire, a score between 0-100 is obtained from each section and a higher score indicates greater disability. | baseline and 12th week | |
Secondary | Change from baseline quality of life (Short Form 36 (SF-36)) at 4th and 12th weeks | This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health. Total score was between 0 (disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health. | baseline and 12th week | |
Secondary | Change from baseline Ultrasonographic examination at 4th and 12th weeks | Ultrasonographic examination will be made using the Esaote My Lab 70 XVision 6-18 Mhz linear probe. Before the treatment, patients will be evaluated for tendinosis of the common extensor tendon (extensor carpi radialis brevis, extensor carpi ulnaris, extensor digitorum, extensor digiti minimini tendons) by a physician experienced in the field of ultrasound, as gray scale and color Doppler activity. | baseline and 12th week | |
Secondary | Change from baseline upper extremity muscle strength with isokinetic device at 4th and 12th weeks | Isokinetic systems are complex systems used for both rehabilitation and patient evaluation. Isokinetic contraction; It is defined as contraction at a constant rate throughout the entire range of motion and at an equal rate at all angles of motion. Wrist extensor strength isokinetic strength assessment will be performed by a physiotherapist who is trained in using the isokinetic device (IsoMed 2000, isokinetic dynamometer, Germany) and has at least 5 years of experience. | baseline and 12th week |
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