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Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

Sponsor
Mayo Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT00685880
Collaborator
(none)
2
Enrollment
1
Location
2
Arms
26
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
N/A

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 Design

Study Type:
Interventional
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 1, 2008
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

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 Names:
  • Celestone Soluspan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With a Decreased Pain Score >20% [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00685880
    Other Study ID Numbers:
    • 07-006348
    First Posted:
    May 29, 2008
    Last Update Posted:
    Aug 30, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by , ,
    thumb carpo metacarpal joint osteoarthritis
    prolotherapy
    intra articular steroid
    hand therapy
    Additional relevant MeSH terms:
    Osteoarthritis
    Betamethasone
    Betamethasone acetate phosphate

    Study Results

    Participant Flow

    Recruitment Details Subjects were recruited from the pool of referrals to the Mayo Hand Clinic who are interested in receiving an injection for their pain, agree to comply with the standardized hand therapy program, meet the inclusion/exclusion criteria and are able to make the scheduled follow-up visits from Mayo 2008 to July 2010.
    Pre-assignment Detail
    Arm/Group Title Prolotherapy Group Corticosteroid Group
    Arm/Group Description Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
    Period Title: Overall Study
    STARTED 0 2
    COMPLETED 0 2
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Prolotherapy Group Corticosteroid Group Total
    Arm/Group Description Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint. Total of all reporting groups
    Overall Participants 0 2 2
    Age (participants) [Number]
    <=18 years
    0
    NaN
    0
    0%
    Between 18 and 65 years
    0
    NaN
    0
    0%
    >=65 years
    2
    Infinity
    2
    100%
    Gender (participants) [Number]
    Female
    2
    Infinity
    2
    100%
    Male
    0
    NaN
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    2
    Infinity
    2
    100%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Prolotherapy Group Corticosteroid Group
    Arm/Group Description Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
    Measure Participants 0 0

    Adverse Events

    Time Frame Subjects will be followed for adverse events for six months following the intervention.
    Adverse Event Reporting Description
    Arm/Group Title Prolotherapy Group Corticosteroid Group
    Arm/Group Description Subjects randomized to this arm will receive injection(s) of 10% dextrose solution in the affected thumb joint. Subjects randomized to this arm will receive injection(s) of betamethasone solution in the affected thumb joint.
    All Cause Mortality
    Prolotherapy Group Corticosteroid Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Prolotherapy Group Corticosteroid Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/2 (0%)
    Other (Not Including Serious) Adverse Events
    Prolotherapy Group Corticosteroid Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/2 (0%)

    Limitations/Caveats

    Early termination due to low enrollment; no subject data was analyzed.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Jeffrey S. Brault
    Organization Mayo Clinic
    Phone 507-284-1643
    Email brault.jeffrey@mayo.edu
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00685880
    Other Study ID Numbers:
    • 07-006348
    First Posted:
    May 29, 2008
    Last Update Posted:
    Aug 30, 2012
    Last Verified:
    Jul 1, 2012