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Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

This study has been terminated.
(Unable to recruit adequate numbers of patients)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00685880
First received: May 26, 2008
Last updated: July 27, 2012
Last verified: July 2012

May 26, 2008
July 27, 2012
May 2008
July 2010   (final data collection date for primary outcome measure)
Number of Participants With a Decreased Pain Score >20% [ Time Frame: baseline, 6 month follow-up ] [ Designated as safety issue: No ]
Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.
Decreased pain score >20%. [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00685880 on ClinicalTrials.gov Archive Site
Not Provided
Analgesic use, grip strength and functional assessment of upper extremities use. Side effects will be recorded if any. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis
Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Thumb Carpometacarpal Joint Osteoarthritis
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00685880
07-006348
No
Michael Joseph Gruba M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Michael J. Gruba, M.D. Mayo Clinic Physical Medicine & Rehabilitation Residency
Mayo Clinic
July 2012

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