Corticosteroid(CS) + Lido or Corticosteroid(CS) Alone

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• Tenosynovitis 43

Keywords

• orthopedic disorders
• corticosteroids(CS)
• Lidocaine
• Injections

Study arms

• Active comparator
  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

  Drug: Treatment Group: Corticosteroid injection · Drug: Treatment Group: Lidocaine

• Other
  Control Group (corticosteroid alone)

  Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition

  Drug: Control Group (corticosteroid alone)

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.

  Also known as: depo-medrol, kenalog

• 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) .

  Also known as: Methylprednisolone acetate injectable suspension

• DrugTreatment Group: Lidocaine

  Subjects will receive an injection of lidocaine (1% lidocaine HCl).

  Also known as: Xylocaine

Primary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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)

Baseline characteristics

3 further baseline measures are reported on the registry.

Study documents

• Protocol and statistical analysis plan · Jul 9, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No