Osteoarthritis of the ShoulderPhase 3PRPNCT05160441
Comparing Platelet Rich Plasma and Corticosteroid for Military & Civilian Patients With Glenohumeral Osteoarthritis
A Phase 3 study testing Platelet Rich Plasma Injection, Corticosteroid Injection and Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure in people with Osteoarthritis of the Shoulder and Corticosteroid, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
Shoulder arthroplasty provides successful improvement in pain and function for the treatment of end stage osteoarthritis (OA) of the shoulder in the older patient population (Sanchez 2008, Sampson 2010, Kon 2012, Fitzpatrick 2017). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteoarthritis of the Shoulder, Corticosteroid, PRP
- What is being tested?
- Platelet Rich Plasma Injection, Corticosteroid Injection and Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to 8 May 2025
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DEERS eligible
- Male or female, aged 18 to 70 years (inclusive)
- Presenting symptoms of shoulder pain caused by mild to moderate Shoulder OA as defined by Samilson Prieto criteria on a standard anterior-posterior (AP) Xray series
- BMI < 40
- Willing and able to give voluntary informed consent to participate in this investigation
- Glenohumeral joint osteoarthritis that has been refractory to standard care treatments
Who cannot join
- Patients who have received shoulder intraarticular or subacromial injection(s) in the last 3 months
- Patients who have undergone arthroscopic surgery on the study shoulder within the past year
- Patients who have undergone arthroplasty on the study shoulder
- Diabetes (Type 1 or II)
- Inflammatory arthropathies
- Fibromyalgia or chronic fatigue syndrome
Show all 11Show fewer
- Female patient who is pregnant or nursing
- Patients taking narcotics
- Patients with planned deployment or separation from the military within 12 months
- Any other serious medical condition(s) that might preclude optimal outcome and/or interfere with participation such as intra-articular sepsis, bacteremia, fracture, joint instability, rheumatoid arthritis, osteoporosis, cancer, and coagulopathy
- Patients who have had an adverse reaction to a previous corticosteroid or PRP injection either documented in the medical record or shared by the patient during screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: A Prospective, Single-blind, Randomized, Multi-Center Study Comparing Platelet Rich Plasma and Corticosteroid for Patients With Glenohumeral Osteoarthritis in the Military and Civilian Population
Shoulder arthroplasty provides successful improvement in pain and function for the treatment of end stage osteoarthritis (OA) of the shoulder in the older patient population (Sanchez 2008, Sampson 2010, Kon 2012, Fitzpatrick 2017). However, the optimal non-operative treatment for shoulder OA in the young active duty and civilian populations has yet to be determined. Although corticosteroid injections (CSI) are a viable option with diagnostic and short-term therapeutic benefit in glenohumeral OA, steroid does little to address the underlying pathology and confers risk of adjacent tendon failure (Kon 2009, Gosens 2011, Monto 2014, Tietze 2014). Platelet-rich plasma (PRP) derived from autologous blood, however, has the potential to enhance soft tissue healing as previously observed in muscles and tendons (Sanchez 2005, Randelli 2008, Hall 2009). PRP contains growth factors purported to safely facilitate local tissue regeneration as corroborated in multiple clinical studies investigating tendinopathy (Virchenko 2006, Kesikburun 2013, Fitzpatrick 2017, Schwitzguebel 2019). PRP is a promising concept to bridge the gap between conventional non-operative measures and surgical arthroscopy or arthroplasty options in a high functioning patient population with refractory disease. However, clinical literature elucidating the effects of intra-articular leukocyte-poor PRP (LP-PRP) injections in large joint degenerative OA has been slower to emerge, lacking substantiated data due to small sample sizes and treatment variability. Therefore, high level evidence-based studies remain critical in ascertaining the therapeutic value and clinical efficacy of LP-PRP in glenohumeral OA in order to establish standard of care protocols and guide systematic implementation.
Read the detailed description
Shoulder arthroplasty provides successful improvement in pain and function for the treatment of end stage osteoarthritis (OA) of the shoulder in the older patient population (Sanchez 2008, Sampson 2010, Kon 2012, Fitzpatrick 2017). However, the optimal non-operative treatment for shoulder OA in the young active duty and civilian populations has yet to be determined. Although corticosteroid injections (CSI) are a viable option with diagnostic and short-term therapeutic benefit in glenohumeral OA, steroid does little to address the underlying pathology and confers risk of adjacent tendon failure (Kon 2009, Gosens 2011, Monto 2014, Tietze 2014). Platelet-rich plasma (PRP) derived from autologous blood, however, has the potential to enhance soft tissue healing as previously observed in muscles and tendons (Sanchez 2005, Randelli 2008, Hall 2009). PRP contains growth factors purported to safely facilitate local tissue regeneration as corroborated in multiple clinical studies investigating tendinopathy (Virchenko 2006, Kesikburun 2013, Fitzpatrick 2017, Schwitzguebel 2019). PRP is a promising concept to bridge the gap between conventional non-operative measures and surgical arthroscopy or arthroplasty options in a high functioning patient population with refractory disease. However, clinical literature elucidating the effects of intra-articular leukocyte-poor PRP (LP-PRP) injections in large joint degenerative OA has been slower to emerge, lacking substantiated data due to small sample sizes and treatment variability. Therefore, high level evidence-based studies remain critical in ascertaining the therapeutic value and clinical efficacy of LP-PRP in glenohumeral OA in order to establish standard of care protocols and guide systematic implementation.
Although commonly used corticosteroid injections have shown some clinical benefit, there are known deleterious effects from steroid use, which include accelerated osteoarthritis progression, cartilage toxicity, and increased risk of septic arthritis. In addition to this, multiple studies demonstrate corticosteroids confers risk of adjacent tendon failure (Kon 2009, Gosens 2011, Monto 2014, Tietze 2014). There is also a concern that multiple corticosteroid injections increase the risk of fat atrophy, skin pigment changes, and tissue thinning if placed incorrectly in the more superficial tissue of the shoulder. These negative findings associated with corticosteroid injections have prompted ongoing research into alternative orthobiologic treatments that provide short to medium duration benefit for patients with osteoarthritis.
Conversely, Leukocyte-Poor Platelet-Rich Plasma (LP-PRP), derived from autologous blood, has demonstrated safety and efficacy in multiple pre-clinical, randomized controlled clinical trials, and meta-analysis studies in the other large joints, causing slow acceptance in the medical community to utilize this as a treatment option, despite its increased cost compared to corticosteroid injection (Campbell 2015, Cavallo 2014, Lai 2015, Laudy 2015, Patel 2013, Smith 2016, Tietze 2014, Piuzzi 2019). However, clinical literature elucidating the effects of intraarticular leukocyte-poor PRP (LP-PRP) injections in shoulder joint degenerative OA has been slower to emerge, lacking substantiated data due to small sample sizes and treatment variability. Therefore, high level evidence-based studies remain critical in ascertaining the therapeutic value and clinical efficacy of LP-PRP in glenohumeral OA in order to establish standard of care protocols and guide systematic implementation. PRP is a promising concept to bridge the gap between conventional non-operative measures and surgical arthroscopy or arthroplasty options in a high functioning patient population with refractory disease.
- Conditions
- Osteoarthritis of the Shoulder, Corticosteroid, PRP, Pain
- Being tested
- Platelet Rich Plasma Injection, Corticosteroid Injection, Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma InjectionBiological
Minimum 2cc Leukocyte Poor Platelet Rich Plasma
The PRP will be prepared by drawing 60cc blood from the participant through venipuncture, spinning the blood sample in a centrifuge and then injecting the platelet rich plasma (approximately 2-5cc or max collected) into the study shoulder using ultrasound guidance. This sample will be prepared by the study provider (physician assistant or physician). Any leftover blood will be safely discarded per standard protocols.
Corticosteroid InjectionBiological
5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog)
Delayed Platelet Rich Plasma Injection After Corticosteroid Injection FailureBiological
Participants randomized to the corticosteroid injection (CSI) group who report no improvement in their pain level at the 6 week post-CSI visit will be unblinded to their study injection (CSI) and will be offered the option to stay in the study and receive Platelet Rich Plasma injection.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma Injection Group | Experimental | Minimum 2cc Leukocyte Poor Platelet Rich Plasma Receives: Biological: Platelet Rich Plasma Injection |
| Corticosteroid Injection Group | Active comparator | 5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog) Receives: Biological: Corticosteroid Injection |
| Delayed Platelet Rich Plasma Injection Group upon Corticosteroid Injection Failure | Experimental | If a participant does not have any benefit from the corticosteroid injection by the six-week follow-up time point, then that participant will be eligible for a platelet rich plasma injection. Receives: Biological: Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Single Assessment Numeric Evaluation (SANE) from before injection to after injection
The SANE score is a validated patient reported outcome measure. It is a single question score that asks, "how would you rate your condition today as a percentage of normal (0% to 100% scale with 100% being normal)?" The SANE score is collected as standard of care.
Measured: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before injection to after injection
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points
Measured: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Change in the Visual Analogue Scale (VAS) from before injection to after injection
A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Measured: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Change in the Veterans RAND 12-Item Health Survey (VR-12) from before injection to after injection
The VR-12 comprises 12 questions that correspond to eight domains of health, including general health perceptions, physical functioning, role limitations because of physical problems, role limitations because of emotional problems, bodily pain, vitality, social functioning, and mental health.
Measured: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Change in the Western Ontario Osteoarthritis Shoulder Index (WOOS) from before injection to after injection
The WOOS is a patient-administrated, disease-specific questionnaire for measurement of the quality-of-life of patients with osteoarthritis.7 It provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life, whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life.
Measured: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
Change in range of motion (ROM) from before injection to after injection
Testing the range of motion (ROM) of the shoulder in different directions. If movement in a specific direction is painful or limited, this may signify that pathology is present in a specific structure of the shoulder. Common ROM tests include: forward flexion, abduction, cross-body adduction, external rotation, extension, internal rotation, scapular motion
Measured: Pre-injection (baseline) and then post-injection at 6 weeks, 3 months, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start26 Sep 2022
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the ShoulderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Naval Medical Center, San Diego, Brooke Army Medical Center, Uniformed Services University of the Health Sciences
- Responsible party
- Principal investigator, Sean Slaven, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160441
- Sponsor's protocol ID
- WRNMMC-2021-0345
- Acronym
- PRP
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2021
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual level data will not be shared with anyone. Only aggregate results will be shared publicly.
Publications
Centeno CJ, Al-Sayegh H, Bashir J, Goodyear S, Freeman MD. A prospective multi-site registry study of a specific protocol of autologous bone marrow concentrate for the treatment of shoulder rotator cuff tears and osteoarthritis. J Pain Res. 2015 Jun 5;8:269-76. doi: 10.2147/JPR.S80872. eCollection 2015.
PubMed 26089699Fitzpatrick J, Bulsara M, Zheng MH. The Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Clinical Trials. Am J Sports Med. 2017 Jan;45(1):226-233. doi: 10.1177/0363546516643716. Epub 2016 Jul 21.
PubMed 27268111Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.
PubMed 21422467Hak A, Rajaratnam K, Ayeni OR, Moro J, Peterson D, Sprague S, Bhandari M. A Double-Blinded Placebo Randomized Controlled Trial Evaluating Short-term Efficacy of Platelet-Rich Plasma in Reducing Postoperative Pain After Arthroscopic Rotator Cuff Repair: A Pilot Study. Sports Health. 2015 Jan;7(1):58-66. doi: 10.1177/1941738114548413.
PubMed 25553214Hall MP, Band PA, Meislin RJ, Jazrawi LM, Cardone DA. Platelet-rich plasma: current concepts and application in sports medicine. J Am Acad Orthop Surg. 2009 Oct;17(10):602-8. doi: 10.5435/00124635-200910000-00002.
PubMed 19794217Kesikburun S, Tan AK, Yilmaz B, Yasar E, Yazicioglu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26.
PubMed 23893418Kon E, Filardo G, Delcogliano M, Presti ML, Russo A, Bondi A, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma: new clinical application: a pilot study for treatment of jumper's knee. Injury. 2009 Jun;40(6):598-603. doi: 10.1016/j.injury.2008.11.026. Epub 2009 Apr 19.
PubMed 19380129Kon E, Filardo G, Drobnic M, Madry H, Jelic M, van Dijk N, Della Villa S. Non-surgical management of early knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2012 Mar;20(3):436-49. doi: 10.1007/s00167-011-1713-8. Epub 2011 Oct 25.
PubMed 22037809Randelli PS, Arrigoni P, Cabitza P, Volpi P, Maffulli N. Autologous platelet rich plasma for arthroscopic rotator cuff repair. A pilot study. Disabil Rehabil. 2008;30(20-22):1584-9. doi: 10.1080/09638280801906081.
PubMed 18608363Monto RR. Platelet-rich plasma efficacy versus corticosteroid injection treatment for chronic severe plantar fasciitis. Foot Ankle Int. 2014 Apr;35(4):313-8. doi: 10.1177/1071100713519778. Epub 2014 Jan 13.
PubMed 24419823Sampson S, Reed M, Silvers H, Meng M, Mandelbaum B. Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. Am J Phys Med Rehabil. 2010 Dec;89(12):961-9. doi: 10.1097/PHM.0b013e3181fc7edf.
PubMed 21403592Sanchez, M., Anitua, E., & Andia, I. (2005, May). Application of autologous growth factors on skeletal muscle healing. In 2nd World Congress on Regenerative Medicine. Podium Presentation.
Sanchez M, Anitua E, Orive G, Mujika I, Andia I. Platelet-rich therapies in the treatment of orthopaedic sport injuries. Sports Med. 2009;39(5):345-54. doi: 10.2165/00007256-200939050-00002.
PubMed 19402740Schwitzguebel AJ, Kolo FC, Tirefort J, Kourhani A, Nowak A, Gremeaux V, Saffarini M, Ladermann A. Efficacy of Platelet-Rich Plasma for the Treatment of Interstitial Supraspinatus Tears: A Double-Blinded, Randomized Controlled Trial. Am J Sports Med. 2019 Jul;47(8):1885-1892. doi: 10.1177/0363546519851097. Epub 2019 Jun 4.
PubMed 31161947Sanchez M, Anitua E, Azofra J, Aguirre JJ, Andia I. Intra-articular injection of an autologous preparation rich in growth factors for the treatment of knee OA: a retrospective cohort study. Clin Exp Rheumatol. 2008 Sep-Oct;26(5):910-3.
PubMed 19032827
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-blind, Randomized, Multi-Center Study Comparing Platelet Rich Plasma and Corticosteroid for Patients With Glenohumeral Osteoarthritis in the Military and Civilian Population
- ClinicalTrials.gov ID
- NCT05160441
- Acronym / sponsor ID
- PRP / WRNMMC-2021-0345
- Conditions
- Osteoarthritis of the Shoulder, Corticosteroid, PRP, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Collaborators
- United States Naval Medical Center, San Diego, Brooke Army Medical Center, Uniformed Services University of the Health Sciences
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 16 Dec 2021 (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.
Shoulder arthroplasty provides successful improvement in pain and function for the treatment of end stage osteoarthritis (OA) of the shoulder in the older patient population (Sanchez 2008, Sampson 2010, Kon 2012, Fitzpatrick 2017). However, the optimal non-operative treatment for shoulder OA in the young active duty and civilian populations has yet to be determined. Although corticosteroid injections (CSI) are a viable option with diagnostic and short-term therapeutic benefit in glenohumeral OA, steroid does little to address the underlying pathology and confers risk of adjacent tendon failure (Kon 2009, Gosens 2011, Monto 2014, Tietze 2014). Platelet-rich plasma (PRP) derived from autologous blood, however, has the potential to enhance soft tissue healing as previously observed in muscles and tendons (Sanchez 2005, Randelli 2008, Hall 2009). PRP contains growth factors purported to safely facilitate local tissue regeneration as corroborated in multiple clinical studies investigating tendinopathy (Virchenko 2006, Kesikburun 2013, Fitzpatrick 2017, Schwitzguebel 2019). PRP is a promising concept to bridge the gap between conventional non-operative measures and surgical arthroscopy or arthroplasty options in a high functioning patient population with refractory disease. However, clinical literature elucidating the effects of intra-articular leukocyte-poor PRP (LP-PRP) injections in large joint degenerative OA has been slower to emerge, lacking substantiated data due to small sample sizes and treatment variability. Therefore, high level evidence-based studies remain critical in ascertaining the therapeutic value and clinical efficacy of LP-PRP in glenohumeral OA in order to establish standard of care protocols and guide systematic implementation.
Detailed description
Shoulder arthroplasty provides successful improvement in pain and function for the treatment of end stage osteoarthritis (OA) of the shoulder in the older patient population (Sanchez 2008, Sampson 2010, Kon 2012, Fitzpatrick 2017). However, the optimal non-operative treatment for shoulder OA in the young active duty and civilian populations has yet to be determined. Although corticosteroid injections (CSI) are a viable option with diagnostic and short-term therapeutic benefit in glenohumeral OA, steroid does little to address the underlying pathology and confers risk of adjacent tendon failure (Kon 2009, Gosens 2011, Monto 2014, Tietze 2014). Platelet-rich plasma (PRP) derived from autologous blood, however, has the potential to enhance soft tissue healing as previously observed in muscles and tendons (Sanchez 2005, Randelli 2008, Hall 2009). PRP contains growth factors purported to safely facilitate local tissue regeneration as corroborated in multiple clinical studies investigating tendinopathy (Virchenko 2006, Kesikburun 2013, Fitzpatrick 2017, Schwitzguebel 2019). PRP is a promising concept to bridge the gap between conventional non-operative measures and surgical arthroscopy or arthroplasty options in a high functioning patient population with refractory disease. However, clinical literature elucidating the effects of intra-articular leukocyte-poor PRP (LP-PRP) injections in large joint degenerative OA has been slower to emerge, lacking substantiated data due to small sample sizes and treatment variability. Therefore, high level evidence-based studies remain critical in ascertaining the therapeutic value and clinical efficacy of LP-PRP in glenohumeral OA in order to establish standard of care protocols and guide systematic implementation.
Although commonly used corticosteroid injections have shown some clinical benefit, there are known deleterious effects from steroid use, which include accelerated osteoarthritis progression, cartilage toxicity, and increased risk of septic arthritis. In addition to this, multiple studies demonstrate corticosteroids confers risk of adjacent tendon failure (Kon 2009, Gosens 2011, Monto 2014, Tietze 2014). There is also a concern that multiple corticosteroid injections increase the risk of fat atrophy, skin pigment changes, and tissue thinning if placed incorrectly in the more superficial tissue of the shoulder. These negative findings associated with corticosteroid injections have prompted ongoing research into alternative orthobiologic treatments that provide short to medium duration benefit for patients with osteoarthritis.
Conversely, Leukocyte-Poor Platelet-Rich Plasma (LP-PRP), derived from autologous blood, has demonstrated safety and efficacy in multiple pre-clinical, randomized controlled clinical trials, and meta-analysis studies in the other large joints, causing slow acceptance in the medical community to utilize this as a treatment option, despite its increased cost compared to corticosteroid injection (Campbell 2015, Cavallo 2014, Lai 2015, Laudy 2015, Patel 2013, Smith 2016, Tietze 2014, Piuzzi 2019). However, clinical literature elucidating the effects of intraarticular leukocyte-poor PRP (LP-PRP) injections in shoulder joint degenerative OA has been slower to emerge, lacking substantiated data due to small sample sizes and treatment variability. Therefore, high level evidence-based studies remain critical in ascertaining the therapeutic value and clinical efficacy of LP-PRP in glenohumeral OA in order to establish standard of care protocols and guide systematic implementation. PRP is a promising concept to bridge the gap between conventional non-operative measures and surgical arthroscopy or arthroplasty options in a high functioning patient population with refractory disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma Injection Group | Experimental | Biological: Platelet Rich Plasma InjectionMinimum 2cc Leukocyte Poor Platelet Rich Plasma |
| Corticosteroid Injection Group | Active comparator | Biological: Corticosteroid Injection5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog) |
| Delayed Platelet Rich Plasma Injection Group upon Corticosteroid Injection Failure | Experimental | Biological: Delayed Platelet Rich Plasma Injection After Corticosteroid Injection FailureIf a participant does not have any benefit from the corticosteroid injection by the six-week follow-up time point, then that participant will be eligible for a platelet rich plasma injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DEERS eligible
- Male or female, aged 18 to 70 years (inclusive)
- Presenting symptoms of shoulder pain caused by mild to moderate Shoulder OA as defined by Samilson Prieto criteria on a standard anterior-posterior (AP) Xray series
- BMI < 40
- Willing and able to give voluntary informed consent to participate in this investigation
Key exclusion criteria (11 listed)
- Patients who have received shoulder intraarticular or subacromial injection(s) in the last 3 months
- Patients who have undergone arthroscopic surgery on the study shoulder within the past year
- Patients who have undergone arthroplasty on the study shoulder
- Diabetes (Type 1 or II)
- Inflammatory 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 |
|---|---|---|
| Platelet Rich Plasma InjectionMinimum 2cc Leukocyte Poor Platelet Rich Plasma The PRP will be prepared by drawing 60cc blood from the participant through venipuncture, spinning the blood sample in a centrifuge and then injecting the platelet rich plasma (approximately 2-5cc or max collected) into the study shoulder using ultrasound guidance. This sample will be prepared by the study provider (physician assistant or physician). Any leftover blood will be safely discarded per standard protocols. | Biological | Platelet Rich Plasma Injection Group |
| Corticosteroid Injection5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog) | Biological | Corticosteroid Injection Group |
| Delayed Platelet Rich Plasma Injection After Corticosteroid Injection FailureParticipants randomized to the corticosteroid injection (CSI) group who report no improvement in their pain level at the 6 week post-CSI visit will be unblinded to their study injection (CSI) and will be offered the option to stay in the study and receive Platelet Rich Plasma injection. | Biological | Delayed Platelet Rich Plasma Injection Group upon Corticosteroid Injection Failure |
Primary outcome
Change in the Single Assessment Numeric Evaluation (SANE) from before injection to after injection
Time frame: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
The SANE score is a validated patient reported outcome measure. It is a single question score that asks, "how would you rate your condition today as a percentage of normal (0% to 100% scale with 100% being normal)?" The SANE score is collected as standard of care.
Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before injection to after injection
Time frame: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points
Change in the Visual Analogue Scale (VAS) from before injection to after injection
Time frame: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable.
Change in the Veterans RAND 12-Item Health Survey (VR-12) from before injection to after injection
Time frame: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
The VR-12 comprises 12 questions that correspond to eight domains of health, including general health perceptions, physical functioning, role limitations because of physical problems, role limitations because of emotional problems, bodily pain, vitality, social functioning, and mental health.
Change in the Western Ontario Osteoarthritis Shoulder Index (WOOS) from before injection to after injection
Time frame: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months
The WOOS is a patient-administrated, disease-specific questionnaire for measurement of the quality-of-life of patients with osteoarthritis.7 It provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life, whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life.
Change in range of motion (ROM) from before injection to after injection
Time frame: Pre-injection (baseline) and then post-injection at 6 weeks, 3 months, 6 months, 12 months, and 24 months
Testing the range of motion (ROM) of the shoulder in different directions. If movement in a specific direction is painful or limited, this may signify that pathology is present in a specific structure of the shoulder. Common ROM tests include: forward flexion, abduction, cross-body adduction, external rotation, extension, internal rotation, scapular motion
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 23 Sep 2025.
- Background: PubMed 26089699Centeno CJ, Al-Sayegh H, Bashir J, Goodyear S, Freeman MD. A prospective multi-site registry study of a specific protocol of autologous bone marrow concentrate for the treatment of shoulder rotator cuff tears and osteoarthritis. J Pain Res. 2015 Jun 5;8:269-76. doi: 10.2147/JPR.S80872. eCollection 2015.
- Background: PubMed 27268111Fitzpatrick J, Bulsara M, Zheng MH. The Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Clinical Trials. Am J Sports Med. 2017 Jan;45(1):226-233. doi: 10.1177/0363546516643716. Epub 2016 Jul 21.
- Background: PubMed 21422467Gosens T, Peerbooms JC, van Laar W, den Oudsten BL. Ongoing positive effect of platelet-rich plasma versus corticosteroid injection in lateral epicondylitis: a double-blind randomized controlled trial with 2-year follow-up. Am J Sports Med. 2011 Jun;39(6):1200-8. doi: 10.1177/0363546510397173. Epub 2011 Mar 21.
- Background: PubMed 25553214Hak A, Rajaratnam K, Ayeni OR, Moro J, Peterson D, Sprague S, Bhandari M. A Double-Blinded Placebo Randomized Controlled Trial Evaluating Short-term Efficacy of Platelet-Rich Plasma in Reducing Postoperative Pain After Arthroscopic Rotator Cuff Repair: A Pilot Study. Sports Health. 2015 Jan;7(1):58-66. doi: 10.1177/1941738114548413.
- Background: PubMed 19794217Hall MP, Band PA, Meislin RJ, Jazrawi LM, Cardone DA. Platelet-rich plasma: current concepts and application in sports medicine. J Am Acad Orthop Surg. 2009 Oct;17(10):602-8. doi: 10.5435/00124635-200910000-00002.
- Background: PubMed 23893418Kesikburun S, Tan AK, Yilmaz B, Yasar E, Yazicioglu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013 Nov;41(11):2609-16. doi: 10.1177/0363546513496542. Epub 2013 Jul 26.
- Background: PubMed 19380129Kon E, Filardo G, Delcogliano M, Presti ML, Russo A, Bondi A, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma: new clinical application: a pilot study for treatment of jumper's knee. Injury. 2009 Jun;40(6):598-603. doi: 10.1016/j.injury.2008.11.026. Epub 2009 Apr 19.
- Background: PubMed 22037809Kon E, Filardo G, Drobnic M, Madry H, Jelic M, van Dijk N, Della Villa S. Non-surgical management of early knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2012 Mar;20(3):436-49. doi: 10.1007/s00167-011-1713-8. Epub 2011 Oct 25.
- Background: PubMed 18608363Randelli PS, Arrigoni P, Cabitza P, Volpi P, Maffulli N. Autologous platelet rich plasma for arthroscopic rotator cuff repair. A pilot study. Disabil Rehabil. 2008;30(20-22):1584-9. doi: 10.1080/09638280801906081.
- Background: PubMed 24419823Monto RR. Platelet-rich plasma efficacy versus corticosteroid injection treatment for chronic severe plantar fasciitis. Foot Ankle Int. 2014 Apr;35(4):313-8. doi: 10.1177/1071100713519778. Epub 2014 Jan 13.
- Background: PubMed 21403592Sampson S, Reed M, Silvers H, Meng M, Mandelbaum B. Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. Am J Phys Med Rehabil. 2010 Dec;89(12):961-9. doi: 10.1097/PHM.0b013e3181fc7edf.
- BackgroundSanchez, M., Anitua, E., & Andia, I. (2005, May). Application of autologous growth factors on skeletal muscle healing. In 2nd World Congress on Regenerative Medicine. Podium Presentation.
- Individual participant dataSharing planned: No. Individual level data will not be shared with anyone. Only aggregate results will be shared publicly.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet Rich Plasma Injection, Corticosteroid Injection and Delayed Platelet Rich Plasma Injection After Corticosteroid Injection Failure in people with Osteoarthritis of the Shoulder and Corticosteroid, run by Walter Reed National Military Medical Center at 1 site in United States.
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 6 inclusion and 11 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 23 Sep 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in the Single Assessment Numeric Evaluation (SANE) from before injection to after injection (time frame: Pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months). The study lists 6 primary outcomes in all. 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 NCT05160441, which also lists 18 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 23 Sep 2025.