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
  Purpose

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 Intervention
Thumb Carpometacarpal Joint Osteoarthritis
Drug: Prolotherapy (10% dextrose solution)
Drug: Betamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: May 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685880

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

Additional Information:
Publications:
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.

Responsible Party: Michael Joseph Gruba M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00685880     History of Changes
Other Study ID Numbers: 07-006348
Study First Received: May 26, 2008
Results First Received: July 27, 2012
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
thumb carpo metacarpal joint osteoarthritis
prolotherapy
intra articular steroid
hand therapy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Pharmaceutical Solutions
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014