Osteoarthritis, Shoulder Pain
Conditions
Brief summary
This study seeks to expand the current literature in demonstrating potentially efficacious, conservative treatments in the management of glenohumeral osteoarthritis (OA) and will compare ultrasound-guided injections of hyaluronic acid vs. platelet-rich plasma. We aim to obtain information measuring potential benefits of these interventions and to observe for any adverse events.
Detailed description
Glenohumeral OA accounts for approximately 2-5% of all chronic shoulder pain and may be classified into primary and secondary forms. Primary glenohumeral OA is caused by degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains growth factors that have been shown to promote tissue regeneration. The aim of this study is to determine whether injections of hyaluronic acid or platelet-rich plasma can be used reliably to decrease pain, restore function, and improve quality of life in patients suffering from glenohumeral OA. Patients will be randomized to receive either an injection of hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via questionnaires for up to 52 weeks post-procedure.
Interventions
BIOLOGICALPRP
DRUGHyaluronic Acid
DEVICEUltrasound
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* English speaking/literate * Age 18-100 years * Visual analog score pain \>= 5 * Greater than or equal to 3 months of pain after onset of symptoms that has failed conservative treatments * Confirmation of glenohumeral OA via routine imaging (MRI and x-ray; must be recent and within the past year) * Transient relief of symptoms after diagnostic intra-articular injection into the glenohumeral joint
Exclusion criteria
* Non-English speaking/illiterate * Painful active, concurrent cervical spine conditions * Current non-steroidal anti-inflammatory drug (NSAID) use * History of taking coumadin or similar anticoagulant, have a known coagulopathy, bleeding dyscrasia, or platelet count \< 150,000/cubic mm * Allergic reaction to poultry or previous viscosupplementation * Involved in workers' compensation or active litigation involving affected shoulder * Inability to refrain from NSAID use for 5 days prior to and 6 weeks after injection * History of corticosteroid injection to affected shoulder within the last 3 months * History of viscosupplementation or platelet-rich plasma to affected shoulder within the last 6 months * Presence of acute fracture * History of shoulder tumor * Known uncontrolled systemic illness (uncontrolled diabetes, human immunodeficiency virus, vasculitis, autoimmune/inflammatory disease) * Psychiatric and somatoform disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain and Disability Index (SPADI) Score | Up to 52 weeks post-procedure | Score ranges from 0-100, with a higher score representing higher disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Function | Up to 52 weeks post-procedure | Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function. |
| Number of Patients Who Were Satisfied After Treatment | Up to 52 weeks post-procedure | Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: The procedure met my expectations; The procedure improved my condition enough so that I would go through it again for the same outcome; The procedure helped me, but I would not go through it again for the same outcome; or I am the same or worse compared to before the procedure. Responses of The procedure met my expectations and The procedure improved my condition enough so that I would go through it again for the same outcome were considered to be satisfied. The other two responses were considered to be not satisfied. |
| Number of Patients With Complication Events After the Procedure | Up to 52 weeks post-procedure | Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platelet-rich Plasma (PRP) Patients will receive an injection of PRP.
PRP
Ultrasound | 34 |
| Hyaluronic Acid Patients will receive an injection of hyaluronic acid.
Hyaluronic Acid
Ultrasound | 36 |
| Total | 70 |
Baseline characteristics
| Characteristic | Platelet-rich Plasma (PRP) | Total | Hyaluronic Acid |
|---|---|---|---|
| Age, Continuous | 69.1 years STANDARD_DEVIATION 11.5 | 68.7 years STANDARD_DEVIATION 11.6 | 68.4 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 68 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 67 Participants | 34 Participants |
| Region of Enrollment United States | 34 participants | 70 participants | 36 participants |
| Severe osteoarthritis | 21 Participants | 44 Participants | 23 Participants |
| Sex: Female, Male Female | 20 Participants | 38 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 32 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 35 |
| other Total, other adverse events | 11 / 34 | 13 / 35 |
| serious Total, serious adverse events | 0 / 34 | 0 / 35 |
Outcome results
Primary
Shoulder Pain and Disability Index (SPADI) Score
Score ranges from 0-100, with a higher score representing higher disability.
Time frame: Up to 52 weeks post-procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Platelet-rich Plasma (PRP) | Shoulder Pain and Disability Index (SPADI) Score | 50.3 score on a scale |
| Hyaluronic Acid | Shoulder Pain and Disability Index (SPADI) Score | 49 score on a scale |
Secondary
Number of Patients Who Were Satisfied After Treatment
Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: The procedure met my expectations; The procedure improved my condition enough so that I would go through it again for the same outcome; The procedure helped me, but I would not go through it again for the same outcome; or I am the same or worse compared to before the procedure. Responses of The procedure met my expectations and The procedure improved my condition enough so that I would go through it again for the same outcome were considered to be satisfied. The other two responses were considered to be not satisfied.
Time frame: Up to 52 weeks post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platelet-rich Plasma (PRP) | Number of Patients Who Were Satisfied After Treatment | 20 Participants |
| Hyaluronic Acid | Number of Patients Who Were Satisfied After Treatment | 20 Participants |
Secondary
Number of Patients With Complication Events After the Procedure
Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100.
Time frame: Up to 52 weeks post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Platelet-rich Plasma (PRP) | Number of Patients With Complication Events After the Procedure | 11 participants |
| Hyaluronic Acid | Number of Patients With Complication Events After the Procedure | 13 participants |
Secondary
Shoulder Function
Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function.
Time frame: Up to 52 weeks post-procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Platelet-rich Plasma (PRP) | Shoulder Function | 57.8 score on a scale |
| Hyaluronic Acid | Shoulder Function | 59 score on a scale |