Adhesive Capsulitis
Conditions
Keywords
Frozen Shoulder, musculoskeletal injuries
Brief summary
The purpose of this study is to compare ActiveMatrix® to standard of care corticosteroid injection in the treatment of adhesive capsulitis of the shoulder (frozen shoulder).
Interventions
DRUGCorticosteroid
Triamcinolone 20 mg (1cc)
OTHERActiveMatrix
1cc ActiveMatrix (Skye Biologics, Inc.)
DRUGLidocaine
Lidocaine 10 mg/mL (5cc)
Sponsors
The University of Texas Health Science Center, Houston
Skye Biologics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Have a clinical diagnosis of adhesive capsulitis, defined as: i. pain along the C5 dermatome; and ii. limitations of passive range of motion of more than 20 degrees in the abduction internal rotation, neutral external rotation, forward elevation and abduction planes when compared to the contralateral shoulder * Have no contraindications or allergies to the treatment administered * Have experienced shoulder pain for more than 6 weeks and less than 1 year (to ensure the patient is in the "freezing" stage of adhesive capsulitis). * Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses.
Exclusion criteria
* Any prior treatment for this episode of shoulder pain, such as prior intra-articular injection or prior physiotherapy * Evidence, based on MRI or plain radiographs, of any pathology within the shoulder other than adhesive capsulitis (e.g., glenohumeral osteoarthritis, full thickness tears of the labrum or rotator cuff, tendinosis, calcific tendonitis) * A history of significant trauma to the shoulder * Poorly controlled diabetes mellitus, as defined by HbA1c \> 7.5 mmol/L and glucose \> 200 mg/dL. For diabetic participants HbA1c and glucose levels will be measured prior to intervention and documented for later analysis. For non-diabetic participants, previous labs will be utilized. All other medical diseases will be documented for later analysis. * History of Cardiovascular Accident (CVA) such as stroke or Transient Ischemic Attack (TIA) * Blood dyscrasias * Use of any NSAIDs besides Tylenol. A letter will be sent to each participant's primary care physician(s) requesting that no additional pain medications be given for the duration of the study * Prior shoulder surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain as Assessed by the Shoulder Pain and Disability Index (SPADI) | Baseline, Week 4 | SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability. The change in score is reported as \[(SPADI at Week 4) - (SPADI at baseline)\] -- a negative value indicates pain and disability decreased over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS) | Baseline, week 4 | Visual Analog Scale (VAS) is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity. The change in pain intensity will be reported as \[(VAS at week 4) - (VAS at baseline)\] - a negative value indicates a decrease in pain intensity. |
| Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score | Baseline, Week 4 | The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as \[(ASES score at week 4) - (ASES score at baseline)\] - a positive value indicates an improvement in shoulder function over time. |
| Change in American Shoulder and Elbow Surgeons (ASES) Score | Baseline, Week 24 | The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as \[(ASES score at week 24) - (ASES score at baseline)\] - a positive value indicates an improvement in shoulder function over time |
| Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation) | Baseline, Week 4 | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion. |
| Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation) | Baseline, Week 4 | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion. |
| Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation) | Baseline, Week 4 | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion. |
| Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction) | Baseline, Week 4 | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion. |
| Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation) | Baseline, Week 4 | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion. |
| Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation) | Baseline, Week 4 | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. Change from baseline will be calculated, with a positive values indicating improved range of motion. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREric F Berkman, MD
The University of Texas Health Science Center, Houston
Participant flow
Pre-assignment details
Of the 56 participants enrolled, 3 were screen failures and 1 participant withdrew prior to randomization; therefore, 52 participants were randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Affected Side Left | 15 Participants |
| Affected Side Right | 9 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 10 |
| American shoulder and elbow surgeons (ASES) score | 39.8 Score on a scale STANDARD_DEVIATION 21.19 |
| Body Mass Index (BMI) | 28.8 kg/m^2 STANDARD_DEVIATION 5.69 |
| Duration of Pain ≥ 1 year | 7 Participants |
| Duration of Pain < 6 months | 14 Participants |
| Duration of Pain 6 months to 1 year | 10 Participants |
| Number of participants who received prior treatment for this episode of shoulder pain No | 23 Participants |
| Number of participants who received prior treatment for this episode of shoulder pain Yes | 4 Participants |
| Number of Participants who Use Tobacco or Vape Products No | 23 Participants |
| Number of Participants who Use Tobacco or Vape Products Yes | 1 Participants |
| Pain Intensity as assessed by the Visual Analog Scale (VAS) | 6.7 mm STANDARD_DEVIATION 2.55 |
| Passive Range of Motion (PROM) - Abduction | 81.8 degrees STANDARD_DEVIATION 20.46 |
| Passive Range of Motion (PROM) - Abduction external rotation | 39.8 degrees STANDARD_DEVIATION 29.13 |
| Passive Range of Motion (PROM) - Abduction Internal Rotation | 23.9 degrees STANDARD_DEVIATION 26.62 |
| Passive range of motion (PROM) - Forward Elevation | 108.5 degrees STANDARD_DEVIATION 33.25 |
| Passive Range of Motion (PROM) - Neutral External Rotation | 30.2 degrees STANDARD_DEVIATION 18.57 |
| Passive Range of Motion (PROM) - Neutral Internal Rotation | 73.0 degrees STANDARD_DEVIATION 28.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 10 Participants |
| Shoulder Pain and Disability Index (SPADI) | 57.4 Score on a scale STANDARD_DEVIATION 21.46 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 1 / 27 | 0 / 25 |
Outcome results
None listed