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

January 18, 2024 updated by: Maria Wilcke, Karolinska Institutet
Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, S-11883
        • Department of Hand Surgery Södersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Arthritis in the thumb base.
  • Radiological Eaton Littler class 1-3.
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PRP
Intra-articular injection PRP
Other: PRP
Platelet rich plasma
Placebo Comparator: Saline
Intra-articular injection Saline
Other: Placebo
Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient-rated pain on load
Time Frame: 3 and 6 months after injection.
Numerical rating scale 0-10p (10=worst possible pain).
3 and 6 months after injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Nelson Thumb score
Time Frame: 3 and 6 months after injection.
Patient Rated Outcome Measure, 0-100p, lower score= more disability
3 and 6 months after injection.
Change in EQ-5D
Time Frame: 3 and 6 months after injection.
Weight mean value: 0=dead, 1= healthy
3 and 6 months after injection.
Change in Patient-rated Wrist and Hand Evaluation (PRWHE)
Time Frame: 3 and 6 months after injection.
Patient Rated Outcome Measure 0-100p, higher score=more disability
3 and 6 months after injection.
Change in Disability of the Hand, Arm and Shoulder (DASH) score
Time Frame: 3 and 6 months after injection.
Patient Rated Outcome Measure, 0-100p higher score=more disability
3 and 6 months after injection.
Change in Hospital Anxiety and Depression Score (HADS),
Time Frame: 3 and 6 months after injection.
2 subscores for anxiety (0-21p) and depression (0-21p), higher score = worse
3 and 6 months after injection.
Change in Pain Catastrophizing Score (PCS).
Time Frame: 3 and 6 months after injection.
0-52p, higher score = more pain catastrophizing
3 and 6 months after injection.
Change in thumb range of motion
Time Frame: 3 and 6 months after injection.
Radial and palmar abduction of the first metacarpal (degrees)
3 and 6 months after injection.
Change in thumb strength
Time Frame: 3 and 6 months after injection.
Key pinch and pinch strength (Kg)
3 and 6 months after injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Maria Wilcke, MD PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP vs placebo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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