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Clinical Trials/NCT04218591
NCT04218591CompletedNot Applicable

A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base

Karolinska Institutet2 sites in 1 country90 target enrollmentStarted: February 24, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Locations
2
Primary Endpoint
Change in patient-rated pain on load
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Arthritis in the thumb base.
  • •Radiological Eaton Littler class 1-
  • •Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.

Exclusion Criteria

  • •Rheumatoid arthritis.
  • •Ongoing infection in the hand or wrist.
  • •History of gout or pseudo gout.
  • •Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
  • •Intra-articular injection in the affected joint within 6 months.
  • •Eaton Littler class 4 (STT joint involved).

Outcomes

Primary Outcomes

Change in patient-rated pain on load

Time Frame: 3 and 6 months after injection.

Numerical rating scale 0-10p (10=worst possible pain).

Secondary Outcomes

  • Change in Nelson Thumb score(3 and 6 months after injection.)
  • Change in Patient-rated Wrist and Hand Evaluation (PRWHE)(3 and 6 months after injection.)
  • Change in Disability of the Hand, Arm and Shoulder (DASH) score(3 and 6 months after injection.)
  • Change in Pain Catastrophizing Score (PCS).(3 and 6 months after injection.)
  • Change in thumb strength(3 and 6 months after injection.)
  • Change in Hospital Anxiety and Depression Score (HADS),(3 and 6 months after injection.)
  • Change in thumb range of motion(3 and 6 months after injection.)
  • Change in EQ-5D(3 and 6 months after injection.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maria Wilcke

Principal Investigator

Karolinska Institutet

Study Sites (2)

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