Musculoskeletal DiseasesNCT05602571
The Effectiveness of the Combination of PRP and ESWT in Lateral Epicondylitis
A study testing ESWT+Exercise and PRP+ESWT+Exercise in people with Musculoskeletal Diseases and Elbow Tendinitis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Diseases, Elbow Tendinitis, Lateral Epicondylitis
- What is being tested?
- ESWT+Exercise and PRP+ESWT+Exercise
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with lateral epicondylitis after physical examination
- No other pathology detected on direct radiography
- Complaints persisting for more than 3 months despite the application of other conservative treatment methods
- Patients accepting to give blood for PRP or sham injection and can tolerate elbow injection and extracorporeal shock wave therapy (ESWT)
Who cannot join
- Not being able to fully cooperate with the study and inability to read and write,
- Injection (corticosteroid, PRP, etc.) treatment applied to the elbow area within three months,
- Previous surgery or ESWT treatment in the area to be treated,
- Pregnant women,
- Arthritis (rheumatoid arthritis, spondyloarthritis, crystal arthropathies),
- Those who have a history of direct trauma to the elbow and a history of fracture,
Show all 14Show fewer
- Those with a history of malignancy,
- Bleeding diathesis,
- Complex regional pain syndrome,
- Presence of acute systemic infection,
- Presence of local infection at the injection site,
- Peripheral vasculopathy,
- Cervical radiculopathy,
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200
About this study
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
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.
Read the detailed description
Lateral epicondylitis (LE) is one of the most common elbow problems. It is characterized by pain in the lateral epicondyle of the humerus and on the surface of the extensor muscles of the forearm. It is seen in those who perform activities involving repetitive forced wrist extension and can lead to chronic pain syndrome.
Various treatment methods are used in the treatment of LE in order to reduce the patient's pain and increase his/her functional capacity. There are more than 40 treatment methods in the literature such as oral and local non-steroidal anti-inflammatory drugs (NSAID), cold application, deep friction massage, stretching and strengthening exercises, ultrasound, laser, ESWT, corticosteroid/botulinum toxin/glucosamine/autologous blood/platelet rich plasma (PRP) injections, prolotherapy, acupuncture, manipulation, and surgery.
Extracorporeal shock wave therapy (ESWT) is a method that aims to provide treatment by focusing high amplitude sound waves on the area of the body to be applied.
PRP is an autologous concentration of human platelets in a small volume of plasma produced by centrifuging a patient's own blood.
This study was designed as a double-blind, prospective, placebo-controlled, randomized study. Participants were randomized into 3 groups: ESWT + therapeutic exercise, ESWT + Sham PRP injection + therapeutic exercise, ESWT + PRP injection + therapeutic exercise.
Visual Pain Scale (VAS), Patient Rated Tennis Elbow Evaluation (PRTEE), Quick Disabilities of the Arm, Shoulder and Hand Score (Quick DASH), SF (Short form) -36 Quality of Life Scale, Handgrip strength with Jamar hydraulic hand dynamometer, Common extensor tendon thicknesses, peritendinous fluid, bone irregularities, calcifications, and diffuse tendon heterogeneity with ultrasound, upper extremity muscle strength with Isomed 2000 isokinetic device will be evaluated.
It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the 4th week and at the 12th week controls.
- Conditions
- Musculoskeletal Diseases, Elbow Tendinitis, Lateral Epicondylitis, Platelet-Rich Plasma (PRP)
- Being tested
- ESWT+Exercise, PRP+ESWT+Exercise, Sham PRP+ESWT+Exercise
- Keywords
- Lateral Epicondylitis, Extracorporeal Shockwave Therapy (ESWT), Platelet-Rich Plasma (PRP)
- Medical subject headings
- Musculoskeletal Diseases, Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWT+ExerciseOther
Radial ESWT treatment will be applied to patients for 3 weeks, once a week for a total of 3 sessions. Radial shock waves will be applied in circular motions by applying gel on the epicondylar area where the most pain and sensitivity is. In each session, 8 Hz, 2.0 bar, 2000 beats will be applied.
Therapeutic Exercise:
All patients will be taught a home exercise program including stretching and eccentric strengthening exercises by an experienced physiotherapist. The eccentric exercises consisted of the following: three sets of 10 repetitions for wrist and elbow flexion; two sets of 10 repetitions for wrist extension strengthening, starting with 50% of maximum strength and density and increasing the resistance each week; and finally, two sets of 10 repetitions for the wrist flexor and extensor muscle groups comprising 20s of stretching and 10s of relaxing using the unaffected hand. Exercise program will be done twice a day for 3 months.
PRP+ESWT+ExerciseProcedure or surgery
Radial ESWT treatment will be applied to patients for 3 weeks, once a week for a total of 3 sessions. Radial shock waves will be applied in circular motions by applying gel on the epicondylar area where the most pain and sensitivity is. In each session, 8 Hz, 2.0 bar, 2000 beats will be applied.
Therapeutic Exercise:
All patients will be taught aforementioned home exercise program. Exercise program will be done twice a day for 3 months.
Procedure:
10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged. Approximately 3 cc of the PRP obtained will be applied to the tendinosis area under USG guidance. All injections will be performed with long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).
Sham PRP+ESWT+ExerciseProcedure or surgery
Radial ESWT treatment will be applied to patients for 3 weeks, once a week for a total of 3 sessions. Radial shock waves will be applied in circular motions by applying gel on the epicondylar area where the most pain and sensitivity is. In each session, 8 Hz, 2.0 bar, 2000 beats will be applied.
Therapeutic Exercise:
All patients will be taught aforementioned home exercise program. Exercise program will be done twice a day for 3 months.
Procedure:
In Sham-PRP group,10 ml of venous blood will be taken and after the same waiting time 3 cc of 0.9% saline will be injected to the tendinosis area under USG guidance. All injections will be performed with long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe).
| Study group | Role | What they receive |
|---|---|---|
| ESWT+Exercise | Experimental | Home exercise program including stretching and eccentric strengthening exercises twice a day for 3 months + 3 sessions of ESWT once a week for 3 weeks. Receives: Other: ESWT+Exercise |
| PRP+ESWT+Exercise | Active comparator | Home exercise program including stretching and eccentric strengthening exercises twice a day for 3 months + 3 sessions of ESWT once a week for 3 weeks + PRP injection Receives: Procedure: PRP+ESWT+Exercise |
| Sham PRP+ESWT+Exercise | Sham comparator | Home exercise program including stretching and eccentric strengthening exercises twice a day for 3 months + 3 sessions of ESWT once a week for 3 weeks + Sham PRP injection Receives: Procedure: Sham PRP+ESWT+Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 12th week
Secondary outcomes (5)
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.
Measured: baseline and 12th week
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.
Measured: baseline and 12th week
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.
Measured: baseline and 12th week
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.
Measured: baseline and 12th week
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.
Measured: baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start15 Oct 2022
- Primary completion20 Dec 2023
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali İzzet Akçin, Afyonkarahisar Health Sciences University
- Investigators
- Nuran EYVAZ, MD, Principal investigator, Afyonkarahisar Health Sciences UniversityAli İzzet AKÇİN, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602571
- Sponsor's protocol ID
- LEPRPESWT22
- Status last verified
- Jan 2025
- First submitted
- 27 Oct 2022
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22278162Alessio-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.
PubMed 29320964Arirachakaran 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.
PubMed 26362783Akcin AI, Eyvaz N, Dundar U, Toktas H, Yesil H, Eroglu S, Adar S. The Clinical Efficacy of Extracorporeal Shock Wave Therapy Combined With Platelet-Rich Plasma and Exercise for Lateral Epicondylitis: Prospective Randomized Sham-Controlled Ultrasonographic Study. Arch Phys Med Rehabil. 2025 Aug;106(8):1173-1182. doi: 10.1016/j.apmr.2025.01.420. Epub 2025 Jan 20.
PubMed 39842562
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05602571
- Acronym / sponsor ID
- LEPRPESWT22
- Conditions
- Musculoskeletal Diseases, Elbow Tendinitis, Lateral Epicondylitis, Platelet-Rich Plasma (PRP)
- Keywords
- Lateral Epicondylitis, Extracorporeal Shockwave Therapy (ESWT), Platelet-Rich Plasma (PRP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lateral epicondylitis (LE) is one of the most common elbow problems. It is characterized by pain in the lateral epicondyle of the humerus and on the surface of the extensor muscles of the forearm. It is seen in those who perform activities involving repetitive forced wrist extension and can lead to chronic pain syndrome.
Various treatment methods are used in the treatment of LE in order to reduce the patient's pain and increase his/her functional capacity. There are more than 40 treatment methods in the literature such as oral and local non-steroidal anti-inflammatory drugs (NSAID), cold application, deep friction massage, stretching and strengthening exercises, ultrasound, laser, ESWT, corticosteroid/botulinum toxin/glucosamine/autologous blood/platelet rich plasma (PRP) injections, prolotherapy, acupuncture, manipulation, and surgery.
Extracorporeal shock wave therapy (ESWT) is a method that aims to provide treatment by focusing high amplitude sound waves on the area of the body to be applied.
PRP is an autologous concentration of human platelets in a small volume of plasma produced by centrifuging a patient's own blood.
This study was designed as a double-blind, prospective, placebo-controlled, randomized study. Participants were randomized into 3 groups: ESWT + therapeutic exercise, ESWT + Sham PRP injection + therapeutic exercise, ESWT + PRP injection + therapeutic exercise.
Visual Pain Scale (VAS), Patient Rated Tennis Elbow Evaluation (PRTEE), Quick Disabilities of the Arm, Shoulder and Hand Score (Quick DASH), SF (Short form) -36 Quality of Life Scale, Handgrip strength with Jamar hydraulic hand dynamometer, Common extensor tendon thicknesses, peritendinous fluid, bone irregularities, calcifications, and diffuse tendon heterogeneity with ultrasound, upper extremity muscle strength with Isomed 2000 isokinetic device will be evaluated.
It was planned that the evaluations were made and recorded by a blinded physician to the groups at the beginning of the treatment, at the 4th week and at the 12th week controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESWT+Exercise | Experimental | Other: ESWT+ExerciseHome exercise program including stretching and eccentric strengthening exercises twice a day for 3 months + 3 sessions of ESWT once a week for 3 weeks. |
| PRP+ESWT+Exercise | Active comparator | Procedure: PRP+ESWT+ExerciseHome exercise program including stretching and eccentric strengthening exercises twice a day for 3 months + 3 sessions of ESWT once a week for 3 weeks + PRP injection |
| Sham PRP+ESWT+Exercise | Sham comparator | Procedure: Sham PRP+ESWT+ExerciseHome exercise program including stretching and eccentric strengthening exercises twice a day for 3 months + 3 sessions of ESWT once a week for 3 weeks + Sham PRP injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with lateral epicondylitis after physical examination
- No other pathology detected on direct radiography
- Complaints persisting for more than 3 months despite the application of other conservative treatment methods
- Patients accepting to give blood for PRP or sham injection and can tolerate elbow injection and extracorporeal shock wave therapy (ESWT)
Key exclusion criteria (14 listed)
- Not being able to fully cooperate with the study and inability to read and write,
- Injection (corticosteroid, PRP, etc.) treatment applied to the elbow area within three months,
- Previous surgery or ESWT treatment in the area to be treated,
- Pregnant women,
- Arthritis (rheumatoid arthritis, spondyloarthritis, crystal arthropathies),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESWT+ExerciseRadial ESWT treatment will be applied to patients for 3 weeks, once a week for a total of 3 sessions. Radial shock waves will be applied in circular motions by applying gel on the epicondylar area where the most pain and sensitivity is. In each session, 8 Hz, 2.0 bar, 2000 beats will be applied. Therapeutic Exercise: All patients will be taught a home exercise program including stretching and eccentric strengthening exercises by an experienced physiotherapist. The eccentric exercises consisted of the following: three sets of 10 repetitions for wrist and elbow flexion; two sets of 10 repetitions for wrist extension strengthening, starting with 50% of maximum strength and density and increasing the resistance each week; and finally, two sets of 10 repetitions for the wrist flexor and extensor muscle groups comprising 20s of stretching and 10s of relaxing using the unaffected hand. Exercise program will be done twice a day for 3 months. | Other | ESWT+Exercise |
| PRP+ESWT+ExerciseRadial ESWT treatment will be applied to patients for 3 weeks, once a week for a total of 3 sessions. Radial shock waves will be applied in circular motions by applying gel on the epicondylar area where the most pain and sensitivity is. In each session, 8 Hz, 2.0 bar, 2000 beats will be applied. Therapeutic Exercise: All patients will be taught aforementioned home exercise program. Exercise program will be done twice a day for 3 months. Procedure: 10 ml of venous blood taken from the patients will be put into the T-LAB® PRP kit (T-Biotechnology Laboratory, İstanbul, Turkey) and will then be centrifuged. Approximately 3 cc of the PRP obtained will be applied to the tendinosis area under USG guidance. All injections will be performed with long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe). | Procedure or surgery | PRP+ESWT+Exercise |
| Sham PRP+ESWT+ExerciseRadial ESWT treatment will be applied to patients for 3 weeks, once a week for a total of 3 sessions. Radial shock waves will be applied in circular motions by applying gel on the epicondylar area where the most pain and sensitivity is. In each session, 8 Hz, 2.0 bar, 2000 beats will be applied. Therapeutic Exercise: All patients will be taught aforementioned home exercise program. Exercise program will be done twice a day for 3 months. Procedure: In Sham-PRP group,10 ml of venous blood will be taken and after the same waiting time 3 cc of 0.9% saline will be injected to the tendinosis area under USG guidance. All injections will be performed with long axis in-plane technique, using the ultrasound device (Esaote My Lab 70 XVision 6-18 Mhz linear probe). | Procedure or surgery | Sham PRP+ESWT+Exercise |
Primary outcome
Change from baseline visual analog scale (VAS) elbow pain at 4th and 12th week
Time frame: baseline 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.
5 secondary outcomes
Change from baseline Handgrip strength at 4th and 12th week
Time frame: baseline and 12th week
Change from baseline Quick Disabilities of the Arm, Shoulder and Hand Score (Quick DASH) at 4th and 12th week
Time frame: baseline and 12th week
Change from baseline quality of life (Short Form 36 (SF-36)) at 4th and 12th weeks
Time frame: baseline and 12th week
Change from baseline Ultrasonographic examination at 4th and 12th weeks
Time frame: baseline and 12th week
Change from baseline upper extremity muscle strength with isokinetic device at 4th and 12th weeks
Time frame: baseline and 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 22278162Gunduz 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.
- Background: PubMed 29320964Alessio-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.
- Background: PubMed 26362783Arirachakaran 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.
- Derived from this study: PubMed 39842562Akcin AI, Eyvaz N, Dundar U, Toktas H, Yesil H, Eroglu S, Adar S. The Clinical Efficacy of Extracorporeal Shock Wave Therapy Combined With Platelet-Rich Plasma and Exercise for Lateral Epicondylitis: Prospective Randomized Sham-Controlled Ultrasonographic Study. Arch Phys Med Rehabil. 2025 Aug;106(8):1173-1182. doi: 10.1016/j.apmr.2025.01.420. Epub 2025 Jan 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuran EYVAZ, MD principal investigator
Afyonkarahisar Health Sciences University
Ali İzzet AKÇİN, MD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT+Exercise and PRP+ESWT+Exercise in people with Musculoskeletal Diseases and Elbow Tendinitis, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline visual analog scale (VAS) elbow pain at 4th and 12th week (time frame: baseline and 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05602571, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.