Radiotherapy Compared to Corticosteroid Injection for Treatment of Hand Osteoarthritis

Purpose

The purpose of this research is to compare low-dose radiotherapy to corticosteroid injection for treatment of hand/wrist osteoarthritis.

Conditions

  • Osteoarthritis Hand
  • Osteoarthritis Wrist

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient at Mayo Clinic, Rochester, MN - Age 50 years or older - Mild, moderate, or severe hand OA (Kellgren and Lawrence classification grade 2, 3, or 4) on hand radiographs within the last 24 months - Hand OA pain with a minimum VAS score relating to hand pain of ≥40 (on a 100-point scale) when using the affected hand - Ability to complete study questionnaires

Exclusion Criteria

  • History of previous surgery to the affected hand(s) - Autoimmune joint disease such as rheumatoid arthritis or psoriatic arthritis - Active confounding hand condition such as stenosing tenosynovitis or Dupuytren's contracture - Recent injury (within last 1 month) to the affected hand causing current pain - History of crystalline arthritis (gout or pseudogout) flare in the affected hand(s) - Active use of opioid pain medication(s) or oral steroids within the last 3 months - Fibromyalgia or central sensitization syndrome - Hand CSI or other hand injection within the past 3 months - History of hand LDRT within the past 3 months - Poorly controlled diabetes (HbA1c > 10%) - Active infection - Current pregnancy

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low-dose radiotherapy (LDRT) 		Subjects will receive a total of six (6) low-dose radiotherapy (LDRT) treatments for hand osteoarthritis.
  • Radiation: Low-dose radiotherapy (LDRT)
    Subjects will be treated with low-dose radiotherapy of 300cGy in 6 fractions, 2-3 times per week on non-consecutive days. Non-responders to the initial LDRT treatment will receive a second treatment course of 300cGy in 6 fractions to be given 2-3 times per week on non-consecutive days.
Active Comparator
Corticosteroid injection (CSI) 		Subjects will receive standard of care corticosteroid injection (CSI) therapy for hand osteoarthritis.
  • Drug: Corticosteroid injection (CSI)
    A maximum of 3 joints will be treated with standard a standard combination of methylprednisolone and lidocaine: - 1st Carpometacarpal (CMC) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine* - Radiocarpal (RC) joint - 40 mg methylprednisolone/1 mL 1% lidocaine* - Scaphotrapeziotrapezoidal (STT) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine* - Metacarpophalangeal (MCP) joint - 20 mg methylprednisolone/0.5 mL 1% lidocaine - Interphalangeal (IP) joint - 10 mg methylprednisolone/0.25 mL 1% lidocaine
    Other names:
    • Methylprednisolone
    • Lidocaine

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Tochukwu Iyke-Nzeocha
(507) 422-3201
iyke-nzeocha.tochukwu@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Tochukwu Iyke-Nzeocha
(507) 422-3201
Iyke-Nzeocha.Tochukwu@mayo.edu