Tenosynovitis
Conditions
Keywords
orthopedic disorders, corticosteroids(CS), Lidocaine, Injections
Brief summary
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.
Detailed description
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.
Interventions
DRUGTreatment Group: Corticosteroid injection
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.
DRUGControl Group (corticosteroid alone)
Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
DRUGTreatment Group: Lidocaine
Subjects will receive an injection of lidocaine (1% lidocaine HCl).
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, unblinded controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* All adult clinical patients of Emory upper extremity surgeons undergoing injection for treatment of the following who are willing to participate in the study will be included in the study: Tenosynovitis of the upper extremity, including but not limited to, the shoulder, biceps, elbow, wrist, thumb, carpometacarpal, midcarpal, elbow, and small joints of the hand. * Between the ages of 18 years and 95 years. * For trigger finger: patients with a diagnosis of stenosing tenosynovitis based on a history of triggering and the presence of tenderness over the A1 pulley upon clinical examination. All patients, based on the Quinnell grading of trigger finger will be included.
Exclusion criteria
* Patients who are minors, vulnerable subjects, or who are not willing to consent to participate in the study. * Allergies to glucocorticoids, current daily use of glucocorticoids or strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, and meperidine), severe diabetic neuropathy of the hand influencing pain perception, rheumatoid arthritis, and neurological or psychiatric diseases, potentially influencing pain perception. * Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pre injection, Post injection day, 2 weeks and at 6 weeks | 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. |
| Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day (1-7), 2 weeks and at 6 weeks post intervention | 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. |
| 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 | 2 weeks and at 6 weeks post intervention | 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. |
| Patient-Rated Wrist Evaluation (PRWE) Score at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | 2 weeks and at 6 weeks post intervention | 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). |
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | 2 weeks and at 6 weeks post intervention | 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) |
| Short Form Health Survey (SF-12) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group | 2 weeks and at 6 weeks post intervention | 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. |
| Number of Patients With Subsequent Reinjection and Surgical Operation | End of follow up (6 weeks post intervention) | The number of patients with subsequent reinjection and surgical operation was collected during follow up. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between May 2019 and January 2020.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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). | 35 |
| 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). | 42 |
| 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) . | 26 |
| 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) . | 31 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment Group (Corticosteroid Injection Plus Lidocaine) | Control Group (Corticosteroid Alone) | Total |
|---|---|---|---|
| Age, Continuous | 63.00 years STANDARD_DEVIATION 13 | 68 years STANDARD_DEVIATION 11 | 65 years STANDARD_DEVIATION 12 |
| Body Mass Index (BMI) | 29 kg/m^2 STANDARD_DEVIATION 5 | 32 kg/m^2 STANDARD_DEVIATION 9 | 30.6 kg/m^2 STANDARD_DEVIATION 7.1 |
| Comorbidities Diabetes | 6 Participants | 5 Participants | 11 Participants |
| Comorbidities Inflammatory Arthritis | 0 Participants | 1 Participants | 1 Participants |
| Comorbidities Osteoarthritis | 7 Participants | 5 Participants | 12 Participants |
| Comorbidities Psychological Diagnoses (Anxiety, Depression, PTSD, Bipolar Disorder) | 5 Participants | 5 Participants | 10 Participants |
| Dominant Hand Injected | 25 Participants | 20 Participants | 45 Participants |
| Finger Injected Index | 7 Participants | 2 Participants | 9 Participants |
| Finger Injected Little | 4 Participants | 2 Participants | 6 Participants |
| Finger Injected Middle | 9 Participants | 13 Participants | 22 Participants |
| Finger Injected Ring | 5 Participants | 4 Participants | 9 Participants |
| Finger Injected Thumb | 10 Participants | 5 Participants | 15 Participants |
| History of Prior Finger Injections Left | 13 Participants | 5 Participants | 18 Participants |
| History of Prior Finger Injections Right | 22 Participants | 21 Participants | 43 Participants |
| Quinnell grading system 0 | 2 Participants | 2 Participants | 4 Participants |
| Quinnell grading system 1 | 11 Participants | 9 Participants | 20 Participants |
| Quinnell grading system 2 | 13 Participants | 9 Participants | 22 Participants |
| Quinnell grading system 3 | 2 Participants | 1 Participants | 3 Participants |
| Quinnell grading system 4 | 1 Participants | 1 Participants | 2 Participants |
| Quinnell grading system Not recorded | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 6 Participants | 16 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 | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 24 Participants | 20 Participants | 44 Participants |
| Region of Enrollment United States | 35 participants | 26 participants | 61 participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 19 Participants | 12 Participants | 31 Participants |
| Smoking Status Current smoker | 0 Participants | 1 Participants | 1 Participants |
| Smoking Status Never a smoker | 27 Participants | 20 Participants | 47 Participants |
| Smoking Status Quit > 3 months prior | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 26 |
| other Total, other adverse events | 0 / 35 | 0 / 26 |
| serious Total, serious adverse events | 0 / 35 | 0 / 26 |
Outcome results
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.
Time frame: Pre injection, Post injection day, 2 weeks and at 6 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | 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 | Pre-Injection: How painful do you think the injection will be? | 5.9 score on a scale | Standard Deviation 2.3 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | 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 | Pre-Injection: How painful do you think it will be 1-minute after the injection? | 4.4 score on a scale | Standard Deviation 2.6 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | 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 | Pre-Injection: How nervous are you about the injection? | 4.0 score on a scale | Standard Deviation 3.5 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | 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 | Post-Injection: Actual pain of the needle | 4.3 score on a scale | Standard Deviation 3.1 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | 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 | Post-Injection: Actual pain of the medication | 4.7 score on a scale | Standard Deviation 3.2 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | 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 | Post-Injection: Actual pain 1-minute after the injection | 1.7 score on a scale | Standard Deviation 2.2 |
| Control Group (Corticosteroid Alone) | 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 | Post-Injection: Actual pain of the medication | 4.3 score on a scale | Standard Deviation 2.8 |
| Control Group (Corticosteroid Alone) | 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 | Pre-Injection: How painful do you think the injection will be? | 5.4 score on a scale | Standard Deviation 2.6 |
| Control Group (Corticosteroid Alone) | 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 | Post-Injection: Actual pain of the needle | 4.2 score on a scale | Standard Deviation 2.9 |
| Control Group (Corticosteroid Alone) | 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 | Pre-Injection: How painful do you think it will be 1-minute after the injection? | 3.2 score on a scale | Standard Deviation 2.7 |
| Control Group (Corticosteroid Alone) | 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 | Post-Injection: Actual pain 1-minute after the injection | 1.7 score on a scale | Standard Deviation 2.2 |
| Control Group (Corticosteroid Alone) | 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 | Pre-Injection: How nervous are you about the injection? | 3.5 score on a scale | Standard Deviation 3.3 |
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)
Time frame: 2 weeks and at 6 weeks post intervention
Population: Due to time constraints at study visits, the decision was made to not administer the ASES questionnaire.
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.
Time frame: End of follow up (6 weeks post intervention)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | Number of Patients With Subsequent Reinjection and Surgical Operation | 0 Participants |
| Control Group (Corticosteroid Alone) | Number of Patients With Subsequent Reinjection and Surgical Operation | 0 Participants |
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).
Time frame: 2 weeks and at 6 weeks post intervention
Population: Due to time constraints at study visits, the decision was made to not administer the PRWE questionnaire.
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.
Time frame: 2 weeks and at 6 weeks post intervention
Population: Due to time constraints at study visits, the decision was made to not administer the QuickDASH surveys
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.
Time frame: 2 weeks and at 6 weeks post intervention
Population: Due to time constraints at study visits, the decision was made to not administer the SF-12 survey.
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.
Time frame: Post injection day (1-7), 2 weeks and at 6 weeks post intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 3 | 1.7 score on a scale | Standard Deviation 1.9 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 5 | 1.0 score on a scale | Standard Deviation 1.4 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 2 | 2.2 score on a scale | Standard Deviation 2 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 6 | 0.69 score on a scale | Standard Deviation 1.1 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 4 | 1.1 score on a scale | Standard Deviation 1.5 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 7 | 0.58 score on a scale | Standard Deviation 0.95 |
| Treatment Group (Corticosteroid Injection Plus Lidocaine) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 1 | 3.7 score on a scale | Standard Deviation 2.2 |
| Control Group (Corticosteroid Alone) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 7 | 1.6 score on a scale | Standard Deviation 1.9 |
| Control Group (Corticosteroid Alone) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 1 | 3.7 score on a scale | Standard Deviation 3 |
| Control Group (Corticosteroid Alone) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 2 | 3.0 score on a scale | Standard Deviation 2.9 |
| Control Group (Corticosteroid Alone) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 3 | 2.6 score on a scale | Standard Deviation 2.6 |
| Control Group (Corticosteroid Alone) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 4 | 2.2 score on a scale | Standard Deviation 2 |
| Control Group (Corticosteroid Alone) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 5 | 2.0 score on a scale | Standard Deviation 2.2 |
| Control Group (Corticosteroid Alone) | Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7 | Post injection day 6 | 1.5 score on a scale | Standard Deviation 1.8 |