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Trial record 82 of 272 for:    Betamethasone

Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

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. Identifier: NCT00685880
Recruitment Status : Terminated (Unable to recruit adequate numbers of patients)
First Posted : May 29, 2008
Results First Posted : August 30, 2012
Last Update Posted : August 30, 2012
Information provided by:
Mayo Clinic

Brief Summary:
Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.

Condition or disease Intervention/treatment Phase
Thumb Carpometacarpal Joint Osteoarthritis Drug: Prolotherapy (10% dextrose solution) Drug: Betamethasone Not Applicable

Detailed Description:
Dextrose prolotherapy has been shown to decrease anterior cruciate ligament (ACL) laxity and decrease knee joint pain. Similar to ACL laxity leading to knee osteoarthritis, laxity of the "beak" ligament can lead to worsening thumb CMC osteoarthritis. We hypothesize that dextrose intra-articular prolotherapy will have similar results in treating the pain and instability related to symptomatic thumb CMC osteoarthritis. This will be a prospective randomized double blind comparison study comparing Celestone to Dextrose intra-articular injections as adjuncts to hand therapy for the treatment of symptomatic thumb CMC osteoarthritis. Twenty patients will be randomized to each treatment arm to provide enough power to show a 20% change in visual analogue scale (VAS) for pain to be significant. We will utilize the ultrasound guided injection protocol described by the co-investigators for both treatment arms to ensure proper placement of the respective solutions. We will measure various grip strengths, and VAS pain scales prior to the first injection, prior to the second injection at 6 weeks and at the final visit at 6 months. A telephone follow-up with pain scale will be administered at 3 months. A Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire measuring upper extremity functional impairment will be obtained at initial and final visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis
Study Start Date : May 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: Prolotherapy group
Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
Drug: Prolotherapy (10% dextrose solution)
Dextrose diluted with sterile water.

Active Comparator: Corticosteroid Group
Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
Drug: Betamethasone
CELESTONE® SOLUSPAN® * (betamethasone injectable suspension) Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. Subjects will receive a 0.25 to 0.5 mL Celestone Soluspan injection.
Other Name: Celestone Soluspan

Primary Outcome Measures :
  1. Number of Participants With a Decreased Pain Score >20% [ Time Frame: baseline, 6 month follow-up ]
    Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age >45
  • Ability to make follow-up visits over the 6 month protocol
  • Ability to give informed consent
  • Eaton grade 2-3 thumb carpo-metacarpal joint osteoarthritis with pain over 3/10 on visual analogue scale with symptoms present greater then 6 months.

Exclusion Criteria:

  • Recent trauma to the hand or wrist or fractures eeen on radiographs
  • Eaton grade 1, or 4 joints affected
  • Metabolic bone disease
  • Recent systemic or localized infection (within last 2 weeks)
  • History of rheumatologic disease
  • Allergies to injected solutions
  • Thumb carpo-metacarpal joint injections in the prior 6 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 identifier (NCT number): NCT00685880

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Michael J. Gruba, M.D. Mayo Clinic Physical Medicine & Rehabilitation Residency

Additional Information:
Hackett, G. (1956). Ligament and Tendon Relaxation Treated by Prolotherapy. Springfield, IL, Charles C Thomas.
Reeves, K. (2000). Prolotherapy: Basic Science, Clinical Studies, and Technique. Pain Procedures in Clinical Practice. T. A. Lennard. Philadelphia, PA, Hanley and Belfus, INC.: 172-90.

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Responsible Party: Michael Joseph Gruba M.D., Mayo Clinic Identifier: NCT00685880     History of Changes
Other Study ID Numbers: 07-006348
First Posted: May 29, 2008    Key Record Dates
Results First Posted: August 30, 2012
Last Update Posted: August 30, 2012
Last Verified: July 2012
Keywords provided by Mayo Clinic:
thumb carpo metacarpal joint osteoarthritis
intra articular steroid
hand therapy
Additional relevant MeSH terms:
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Betamethasone Valerate
Betamethasone benzoate
Betamethasone acetate phosphate
Betamethasone sodium phosphate
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pharmaceutical Solutions
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents