Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

Thumb Carpometacarpal Joint Osteoarthritis Clinical Trial

Official title:

Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00685880
• Other study ID #: 07-006348
• Status: Terminated
• Phase: N/A
• First received: May 26, 2008
• Last updated: July 27, 2012
• Start date: May 2008
• Est. completion date: July 2010

Study information

• Verified date: July 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Carpometacarpal Joint Osteoarthritis

Intervention

Drug:
• Prolotherapy (10% dextrose solution)
Dextrose diluted with sterile water.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (28)

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Reeves KD, Hassanein KM. Long-term effects of dextrose prolotherapy for anterior cruciate ligament laxity. Altern Ther Health Med. 2003 May-Jun;9(3):58-62. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

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

External Links

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