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Completed

NCT Number: NCT02604537

Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

The purpose of this study is to determine if corticosteroid injection modifies the natural course of de Quervain tendinopathy compared to a toradol injection.

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Key information

Conditions

DeQuervain Tendinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

About this study

If steroids are effective for Dequervain tenosynovitis because of their anti-inflammatory properties, then there is a reasonable and rational argument to be made for the local injection of NSAIDS (non-steroidal anti-inflammatory drugs) into the first dorsal extensor compartment. Ketorolac is an NSAID that has been proven efficacious in the treatment of another musculoskeletal condition. Moreover, compared to betamethasone (or other injectable corticosteroids), injection of ketorolac decreases the patient exposure to the potential side-effects of corticosteroids, especially that of elevation of blood sugar levels in diabetics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of DeQuervain tendinopathy
  • Understands the local language and is willing and able to follow the requirements of the protocol
  • Understands the informed consent and signs the institutional review board/independent ethics committee (IRB/IEC) approved informed consent form

Exclusion criteria

  • Patients who have an allergy to lidocaine, celestone, or ketorolac, nonsteroidal anti-inflammatory drugs (NSAIDs), or acetylsalicylic acid (ASA)
  • Patients who have an adverse reaction to lidocaine, celestone, or ketorolac (such as severe elevation of blood sugars in diabetics that caused medical complication)
  • Patients who have received a prior steroid injection within the past three months
  • Patients who have had a prior ipsilateral surgery for DeQuervain Tenosynovitis
  • Patients that have a skin lesion at the location of injection (such as trauma, eczema, rash)
  • Patients who have a current infection at the location of injection
  • Patients who have had iontophoresis within three months
  • Patients who are breast feeding, pregnant, or who plan to become pregnant in the next six months

Treatment and study plan

Betamethasone

Drug

1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone

Other names: Celestone

Ketorolac

Drug

1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac

Other names: Toradol

Primary outcomes

  1. Visual analog scale (VAS) of pain with finklestein test

    Time frame: 6 weeks post injection

    Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)

Secondary outcomes

  1. Visual analog scale (VAS) of pain with tenderness over tendon

    Time frame: pre injection, 2 weeks post injection, 6 weeks post injection

    Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)

  2. Visual analog scale (VAS) of pain on radial side of wrist

    Time frame: pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 month post injection

    Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)

  3. The Disabilities of the Arm, Shoulder, and Hand Score (DASH)

    Time frame: pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection

    Patient-reported evaluation of symptoms as well as ability to perform certain activities. Score is 0-100 (higher scores indicate greater disability). Must answer at least 27/30 questions. Score is 1 to 5 per question. Score is then summed and divided by the number of completed questions. subtract 1 from this number then multiply by 25.

  4. Veterans-Rand 12 (VR-12)

    Time frame: pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection

    Quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health.

  5. Pinch Strength

    Time frame: pre-injection, 2 weeks post injection, 6 weeks post injection

  6. Grip Strength

    Time frame: pre injection, 2 weeks post injection, 6 weeks post injection

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

Betamethason Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2015
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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