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Trial record 4 of 4 for:    "Trigger thumb"

Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture

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ClinicalTrials.gov Identifier: NCT02421419
Recruitment Status : Terminated (Study closed; recruitment problems)
First Posted : April 20, 2015
Results First Posted : January 23, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Kenneth Taylor, M.D., Milton S. Hershey Medical Center

Brief Summary:
This research is being done to compare pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Condition or disease Intervention/treatment Phase
Trigger Finger Disorder Drug: Dexamethasone Sodium Phosphate Drug: Xylocaine Drug: Sodium Chloride Phase 4

Detailed Description:
This is a prospective, randomized study comparing pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture
Study Start Date : June 2015
Actual Primary Completion Date : January 25, 2017
Actual Study Completion Date : January 25, 2017


Arm Intervention/treatment
Active Comparator: Corticosteroid alone (CS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Drug: Dexamethasone Sodium Phosphate
adreno-cortical steroid anti-inflammatory drug
Other Name: Decadron phosphate

Active Comparator: Corticosteroid/Lidocaine (CSL) Group
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Drug: Dexamethasone Sodium Phosphate
adreno-cortical steroid anti-inflammatory drug
Other Name: Decadron phosphate

Drug: Xylocaine
a local anesthetic agent
Other Name: Lidocaine HCL

Active Comparator: Corticosteroid/Saline (CSS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Drug: Dexamethasone Sodium Phosphate
adreno-cortical steroid anti-inflammatory drug
Other Name: Decadron phosphate

Drug: Sodium Chloride
Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
Other Name: Saline




Primary Outcome Measures :
  1. VAS [ Time Frame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection ]
    Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).


Secondary Outcome Measures :
  1. Presence of Triggering [ Time Frame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection ]
    Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected.

  2. Degree of Triggering [ Time Frame: Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey ]
    A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint.

  3. Number of Participants With Adverse Effects [ Time Frame: Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection. ]
    Incidence of adverse effects



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-90
  • Male or female (non-pregnant)
  • Clinically diagnosed trigger digit
  • Subject is able to provide voluntary, written informed consent
  • Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.

Exclusion Criteria:

  • Age <18 or >90
  • Pregnant or lactating women
  • Non-English speaking individuals
  • Medication contradictions to lidocaine, corticosteroids and/or saline
  • Prior injection or surgery on the affected finger
  • Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome (CRPS)
  • Open wound

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): NCT02421419


Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Kenneth Taylor, M.D.
Investigators
Principal Investigator: Kenneth Taylor, MD Milton S. Hershey Medical Center
  Study Documents (Full-Text)

Documents provided by Kenneth Taylor, M.D., Milton S. Hershey Medical Center:
Informed Consent Form  [PDF] May 20, 2015


Publications:
Responsible Party: Kenneth Taylor, M.D., Associate Professor, Orthopaedics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02421419     History of Changes
Other Study ID Numbers: IRB - 001858
First Posted: April 20, 2015    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: April 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kenneth Taylor, M.D., Milton S. Hershey Medical Center:
flexor tendon entrapment
snapping finger
trigger digits
trigger thumb

Additional relevant MeSH terms:
Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lidocaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers