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Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE May 26, 2008
First Posted Date  ICMJE May 29, 2008
Results First Submitted Date  ICMJE July 27, 2012
Results First Posted Date  ICMJE August 30, 2012
Last Update Posted Date August 30, 2012
Study Start Date  ICMJE May 2008
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2008)
Decreased pain score >20%. [ Time Frame: 6 month follow-up ]
Change History Complete list of historical versions of study NCT00685880 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2008)
Analgesic use, grip strength and functional assessment of upper extremities use. Side effects will be recorded if any. [ Time Frame: 6 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
Official Title  ICMJE Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Thumb Carpometacarpal Joint Osteoarthritis
Intervention  ICMJE
  • Drug: Prolotherapy (10% dextrose solution)
    Dextrose diluted with sterile water.
  • 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
Study Arms  ICMJE
  • Experimental: Prolotherapy group
    Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint.
    Intervention: Drug: Prolotherapy (10% dextrose solution)
  • Active Comparator: Corticosteroid Group
    Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
    Intervention: Drug: Betamethasone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 4, 2010)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2008)
40
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00685880
Other Study ID Numbers  ICMJE 07-006348
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Joseph Gruba M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael J. Gruba, M.D. Mayo Clinic Physical Medicine & Rehabilitation Residency
PRS Account Mayo Clinic
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP