Not provided
Not provided
Not provided
Not provided
Not provided
Enrollment and study activities were initially suspended due to COVID-19. The investigator has also left Emory and the study will not resume.
Not provided
Not provided
Not provided
Not provided
Not provided
The clinical trial is a randomized control trial to compare the efficacy of a combined lidocaine and corticosteroid (CS) injection versus a corticosteroid injection (CS) alone on pain, range of motion, and patient reported outcomes for the treatment of common upper extremity tendinopathies and nerve entrapments that are often treated with a combination of these injectates.
A tendon is a type of tissue that connects your muscles to your bones. These tissues help control actions such as running, jumping, grasping, and lifting. Without tendons it would be difficult to control the movement of your body. A protective layer known as synovium covers tendons. This sheath produces fluid, which keeps the tendon lubricated and moving properly. Inflammation or swelling of the sheath is known as tendon sheath inflammation or tenosynovitis. This condition is often treated with an injection into or around the sheath. This injection often consists of a corticosteroid with or without lidocaine. Corticosteroid(CS) are drugs that decrease inflammation and are given for a number of orthopaedic conditions to decrease symptoms of the underlying disease. Lidocaine is also a drug that blocks the pain response, although it only blocks it momentarily. The study aims to determine if corticosteroid injection alone is as effective as corticosteroid combined with lidocaine for the relief of tenosynovitis of the upper extremity.
The study plans to enroll 1000 pts with tendinopathies of upper extremities and nerve entrapments and will be followed up in clinic 2 weeks and 6 weeks after the injection. During the clinic visits the Visual Analog Scale for pain (VAS-pain), range of motion (ROM), strength, and patient reported outcome data will be collected and any complications will be noted. Patients will also utilize a pain journal to track VAS-pain over the first 7 post-injection days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group (corticosteroid injection plus lidocaine) | Active Comparator | Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition |
|
| Control Group (corticosteroid alone) | Other | Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment Group: Corticosteroid injection | Drug | Subjects will receive a corticosteroid injection that is 40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone. |
| Measure | Description | Time Frame |
|---|---|---|
| 10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants. | Pre injection, Post injection day, 2 weeks and at 6 weeks |
| Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented. | Post injection day (1-7), 2 weeks and at 6 weeks post intervention |
| Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated [(sum of n responses/n) - 1] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined. | 2 weeks and at 6 weeks post intervention |
| Patient-Rated Wrist Evaluation (PRWE) Score at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | The Patient-Related Wrist Evaluation is a score for the measurement of pain and function after injury to the wrist. The PRWE is a 15-item questionnaire that allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0. Total Score = Sum of pain+ function scores (Best Score = 0, Worst Score = 100). |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles Daly, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic A, Clifton Road Clinic | Atlanta | Georgia | 30322 | United States | ||
| 12 Executive Park Drive |
Not provided
Not provided
Not provided
Not provided
Not provided
62 individuals were consented to participate in the study and 61 individuals of these took part in the study with a total of 74 digits randomized and injected in this study. Patients were assigned to treatment groups by means of randomizing the affected unit(s) they contributed to the study.
Participants were enrolled between May 2019 and January 2020.
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group (Corticosteroid Injection Plus Lidocaine) | Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl). |
| FG001 | Control Group (Corticosteroid Alone) | Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) . |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
62 individuals were consented to participate, and 74 digits were randomized and injected as a part of this study. One individual with one digit withdrew from the study after injection. 61 individuals completed the study, and 73 digits are available for analysis.
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group (Corticosteroid Injection Plus Lidocaine) | Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants. | There was a total of 62 participants enrolled in the study. One patient withdrew after injection and has been excluded from analysis. Only 61 participants contributed data to the summary assessment. 35 in the treatment group and 26 in the control group. The total number of units (digits) analyzed was 73 (digits). 42 digits were analyzed in the treatment group and 31 digits in the control group. Due to time constraints at follow up study visits, data was not collected for 2 and 6 weeks. | Posted | Mean | Standard Deviation | score on a scale | Pre injection, Post injection day, 2 weeks and at 6 weeks | Digits | Digits |
|
Data collected during 6 weeks follow up post intervention (post injection).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group (Corticosteroid Injection Plus Lidocaine) | Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Daly | Emory University | 404-919-6168 | charles.a.daly@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2019 | Jul 27, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013717 | Tenosynovitis |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077555 | Methylprednisolone Acetate |
| D014222 | Triamcinolone Acetonide |
| D035061 | Control Groups |
| D000305 | Adrenal Cortex Hormones |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
Not provided
Not provided
Randomized, unblinded controlled clinical trial
Not provided
Not provided
Not provided
Not provided
|
| Control Group (corticosteroid alone) | Drug | Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) . |
|
|
| Treatment Group: Lidocaine | Drug | Subjects will receive an injection of lidocaine (1% lidocaine HCl). |
|
|
| 2 weeks and at 6 weeks post intervention |
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability) | 2 weeks and at 6 weeks post intervention |
| Short Form Health Survey (SF-12) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state. | 2 weeks and at 6 weeks post intervention |
| Number of Patients With Subsequent Reinjection and Surgical Operation | The number of patients with subsequent reinjection and surgical operation was collected during follow up. | End of follow up (6 weeks post intervention) |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| Emory Healthcare Orthopaedics and Spine Center | Atlanta | Georgia | 30329 | United States |
| BG001 | Control Group (Corticosteroid Alone) | Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) . |
| BG002 | Total | Total of all reporting groups |
| Digits |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 | Participants |
|
| Smoking Status | Count of Participants | Participants | Participants |
|
| Comorbidities | Count of Participants | Participants | Participants |
|
| Quinnell grading system | The Quinnell grading system is used to assess clinical severity of trigger finger (TF). According to this classification, TF fingers are rated as follows: 0, normal movement of the digit; 1, uneven movement; 2, actively correctable locking of the digit; 3, passively correctible locking; and 4, fixed deformity. | Count of Participants | Participants | Participants |
|
| History of Prior Finger Injections | Count of Participants | Participants | Participants |
|
| Finger Injected | Count of Participants | Participants | Participants |
|
| Dominant Hand Injected | Count of Participants | Participants | Participants |
|
| OG000 | Treatment Group (Corticosteroid Injection Plus Lidocaine) | Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition for their upper extremity condition Treatment Group (corticosteroid injection plus lidocaine): Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl). |
| OG001 | Control Group (Corticosteroid Alone) | Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) . |
|
|
| Primary | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented. | 32 participants were seen for a 2-week follow-up and pain journal were collected. Other patients were non compliant with completion of their pain journal or were not seen at 2-weeks. Due to time constraints at follow up study visits, no other data was collected at 2 and 6 weeks post intervention. | Posted | Mean | Standard Deviation | score on a scale | Post injection day (1-7), 2 weeks and at 6 weeks post intervention |
|
|
|
| Primary | Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated [(sum of n responses/n) - 1] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined. | Due to time constraints at study visits, the decision was made to not administer the QuickDASH surveys | Posted | 2 weeks and at 6 weeks post intervention |
|
|
| Primary | Patient-Rated Wrist Evaluation (PRWE) Score at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | The Patient-Related Wrist Evaluation is a score for the measurement of pain and function after injury to the wrist. The PRWE is a 15-item questionnaire that allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0. Total Score = Sum of pain+ function scores (Best Score = 0, Worst Score = 100). | Due to time constraints at study visits, the decision was made to not administer the PRWE questionnaire. | Posted | 2 weeks and at 6 weeks post intervention |
|
|
| Primary | American Shoulder and Elbow Surgeons Shoulder Score (ASES) at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability) | Due to time constraints at study visits, the decision was made to not administer the ASES questionnaire. | Posted | 2 weeks and at 6 weeks post intervention |
|
|
| Primary | Short Form Health Survey (SF-12) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state. | Due to time constraints at study visits, the decision was made to not administer the SF-12 survey. | Posted | 2 weeks and at 6 weeks post intervention |
|
|
| Primary | Number of Patients With Subsequent Reinjection and Surgical Operation | The number of patients with subsequent reinjection and surgical operation was collected during follow up. | Posted | Count of Participants | Participants | End of follow up (6 weeks post intervention) |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control Group (Corticosteroid Alone) | Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition Control Group (corticosteroid alone): Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) . | 0 | 26 | 0 | 26 | 0 | 26 |
Not provided
Not provided
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D014221 | Triamcinolone |
| D013259 | Steroids, Fluorinated |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
|
|
|
|
|
| Post injection day 2 |
|
|
| Post injection day 3 |
|
|
| Post injection day 4 |
|
|
| Post injection day 5 |
|
|
| Post injection day 6 |
|
|
| Post injection day 7 |
|
|
| 2 weeks post intervention |
|
| 6 weeks post intervention |
|