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Trial record 53 of 272 for:    Betamethasone

Celestone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosyovitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02604537
Recruitment Status : Unknown
Verified July 2017 by OrthoCarolina Research Institute, Inc..
Recruitment status was:  Recruiting
First Posted : November 13, 2015
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

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

Condition or disease Intervention/treatment Phase
DeQuervain Tendinopathy Drug: Celestone Drug: Ketorolac Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Celestone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosyovitis
Actual Study Start Date : November 11, 2015
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : November 2017


Arm Intervention/treatment
Active Comparator: Celestone
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml Celestone OR
Drug: Celestone
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml celestone OR

Experimental: Ketorolac
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of Ketoraloc
Drug: Ketorolac
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac




Primary Outcome Measures :
  1. Visual analog scale of pain with finklestein test [ Time Frame: 6 weeks post injection ]

Secondary Outcome Measures :
  1. Visual analog scale of pain with tenderness over tendon [ Time Frame: pre injection, 2 weeks post injection, 6 weeks post injection ]
  2. Visual analog scale 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 ]
  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 ]
  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 ]
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, NSAIDS, or 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 steriod injection within the past three months
  • Patients who have had a prior ipsilateral surgery for De!uervains Tenosyovitis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604537


Contacts
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Contact: Susan Odum, PhD 704.323.2265 Susan.Odum@OrthoCarolina.com

Locations
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United States, North Carolina
OrthoCarolina Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Susan M Odum, PhD    704-323-2265    Susan.Odum@OrthoCarolina.com   
Principal Investigator: Christopher Chadderdon, MD         
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
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Principal Investigator: Christopher Chadderdon, MD OrthoCarolina Research Institute, Inc.

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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02604537     History of Changes
Other Study ID Numbers: 15060
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Ketorolac
Ketorolac Tromethamine
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents