Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis

April 5, 2024 updated by: Brent DeGeorge

A Randomized Controlled Trial of Oral Curcumin for the Treatment of Pain of CMC Arthritis

The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis. Turmeric is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for thumb-joint arthritis. The main question[s] it aims to answer are:

  • Is Turmeric more effective than placebo at relieving pain for thumb-joint arthritis? A placebo is a look-alike substance that contains no active drug.
  • Is Turmeric more effective than placebo at improving patient-reported outcomes for CMC arthritis?
  • Is Turmeric safe for participants with thumb-joint arthritis?

Participants will:

  • take 4 weeks of daily Turmeric capsules,
  • take 4 weeks of daily placebo capsules
  • answer daily surveys about how they are feeling and functioning.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial of oral curcumin for the treatment of pain of CMC arthritis will investigate the therapeutic potential of curcumin as an oral treatment for pain of CMC arthritis. Rationale: Curcumin is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for CMC arthritis. Hypothesis: Curcumin is more effective than placebo for relieving pain and improving patient-reported outcomes for CMC arthritis Study Design: The study design will be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 4 weeks of the Curcumin or control and then crossover to the other condition for 4 additional weeks. Patients will take the oral curcumin or control placebo capsule twice daily. Subjects will be advised to observe adverse effects.

The study design will be a double-blind randomized control trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 4 weeks of the case (curcumin) or control capsules and then crossover to the other condition for 4 more weeks with a 2-week washout interval between. Patients will take one oral capsule by mouth twice daily. The subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. If mild to severe adverse events are noticed, the patient's will discontinue the use of the capsules, and appropriate care and observation will be taken. Each condition will last for 4 weeks and then subjects will be contacted by the study coordinator to facilitate crossover into the other condition following a 2-week washout period. To capture any delayed-onset adverse events, subjects will attend a follow-up visit seven days following the last dose of the curcumin capsule.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male or female, aged 18 years or older.

  4. For females, must be willing to use an approved form of birth control during this study. Acceptable forms of birth control:

    • Norplant
    • IUD (intrauterine device)
    • Birth Control Patch
    • Depo-Provera
    • Sterilization

    The following may be used if combined with other birth control methods:

    • Condoms
    • Diaphragm
    • Jellies or foam
    • Cervical cap
    • Sponge

  5. For males, must be willing to not father a baby for the duration of the study and for 90 days after the last dose of study drug, or donate to a sperm back during this time. Must be willing to use an approved form of birth control during this time. Acceptable forms of birth control:

    • Condoms
    • Sterilization
  6. Daily visual analog pain greater than 5 and ≤ 9 out of 10.
  7. Duration of pain for greater than 30 days.
  8. Presence of radiographically confirmed diagnosis of thumb basal joint arthritis

Exclusion Criteria:

  1. Participant does not speak English.
  2. Participant is blind.
  3. Severe cardiac, pulmonary, liver, gastrointestinal and hematological disease (including coagulopathy), and /or renal disease.
  4. Abnormal hematological, coagulation, and/or liver function test results.
  5. Coumadin use at time of screening.
  6. Use of any anticoagulant and antiplatelet medication.
  7. History of mental illness.
  8. Participant who is incarcerated.
  9. History of drug or substance abuse.
  10. Pre-existing curcumin or turmeric product usage within 3 months of the study period.
  11. Participant has had a corticosteroid injection ≤ 60 days prior.
  12. Participant has had prior surgery for osteoarthritis treatment
  13. Participant who has fibromyalgia and post-operative pain.
  14. Females who are pregnant, nursing or planning a pregnancy

  15. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP3A4:

    • Itraconazole,
    • Ketoconazole,
    • Azamulin,
    • Troleandomycin,
    • Verapamil,
    • John's wart,
    • Phenobarbital,

  16. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C19:

    • Nootkatone,
    • Ticlopidine,
    • Rifampin,
    • Omeprazole),

  17. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C8:

    • Montelukast,
    • Quercetin,
    • Phenelzine,
    • Rifampin,
    • Clopidogrel ,

  18. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C9:

    • Sulfaphenazole,
    • Tienilic acid,
    • Carbamazepine,
    • Apoflutamide ,
    • Fluconazole,
    • Celecoxib,

  19. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP1A2:

    • alpha-Naphthoflavone,
    • Furafylline,
    • Phenytoin,
    • Rifampin,
    • Ritonavir,
    • smoking,
    • Teriflunomide,
    • Ciprofloxacin,
    • oral contraceptives,
    • Allopurinol

  20. Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2B6 :

    • Sertraline,
    • Phencyclidine,
    • Thiotepa,
    • Ticlopidine,
    • Carbamazepine,
    • Efavirenz,
    • Rifampin,
    • Bupropion)

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral curcumin
Oral curcumin 500 mg capsules taken twice each day for 4 weeks.
Drug: Curcumin
500 mg capsule twice daily
Other Names:
  • Turmeric
  • Nature Made, PharmaVite LLC
Placebo Comparator: Placebo
Oral placebo capsules taken twice each day for 4 weeks.
Drug: Placebo
capsule twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score
Time Frame: Baseline and Week 4, Week 6
The Visual Analog Pain (VAS) Score is a validated, self-reported subjective measure for measuring acute and chronic pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week (4 or 6) Score - Baseline Score).a validated, self-report
Baseline and Week 4, Week 6
Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover condition
Time Frame: Baseline and Week 10, Week 12
The Visual Analog Pain (VAS) Score is a validated, self-reported subjective measure for measuring acute and chronic pain. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change = (Week Change = (Week (10 or 12) Score - Baseline Score).
Baseline and Week 10, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score
Time Frame: Baseline and Week 4, Week 6
The SANE Score is a self-reported subjective measure for measuring percentage of normal function. Possible scores range from 0 (most abnormal) to 100 (normal). Change = (Week (4 or 6) Score - Baseline Score)
Baseline and Week 4, Week 6
Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition
Time Frame: Baseline and Week 10, Week 12
The SANE Score is a self-reported subjective measure for measuring percentage of normal function. Possible scores range from 0 (most abnormal) to 100 (normal). Change = (Week 10, Week 12 Score - Baseline Score)
Baseline and Week 10, Week 12
Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score
Time Frame: Baseline and Week 4, Week 6
The PROMIS Global Health-10 is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (most severe impairment) to 20 (best health). Change = (Week (4 or 6) Score - Baseline Score)
Baseline and Week 4, Week 6
Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - crossover condition
Time Frame: Baseline and Week 10, Week 12
The PROMIS Global Health-10 is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (most severe impairment) to 20 (best health). Change = (Week (10 or 12) Score - Baseline Score)
Baseline and Week 10, Week 12
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
Time Frame: Baseline and Week 4, Week 6
The PROMIS Pain Interference is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (does not interfere) to 10 (completely interferes). Change = (Week (4, 6) Score - Baseline Score)
Baseline and Week 4, Week 6
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover condition
Time Frame: Baseline and Week 10, Week 12
The PROMIS Pain Interference is a validated, self-reported subjective measure for measuring generic health related quality of life. Possible scores range from 0 (does not interfere) to 10 (completely interferes). Change = (Week (10, 12) Score - Baseline Score)
Baseline and Week 10, Week 12
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score
Time Frame: Baseline and Week 4, Week 6
The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (4, 6) Score - Baseline Score)
Baseline and Week 4, Week 6
Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score
Time Frame: Baseline and Week 10, Week 12
The PROMIS UE computer adaptive test is a validated computer adaptive test to assess upper extremity functional status. Change = (Week (10, 12) Score - Baseline Score)
Baseline and Week 10, Week 12
Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index
Time Frame: Baseline and Week 4, Week 6
The AUSCAN Index is a 15-item scale measuring pain (5 items), stiffness (1 item) and function (9 items) during the preceding 48 hours. Possible scores range from 0 (none) to 4 (extreme). Change = (Week (4, 6) Score - Baseline Score)
Baseline and Week 4, Week 6
Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index
Time Frame: Baseline and Week 10, Week 12
The AUSCAN Index is a 15-item scale measuring pain (5 items), stiffness (1 item) and function (9 items) during the preceding 48 hours. Possible scores range from 0 (none) to 4 (extreme). Change = (Week (10, 12) Score - Baseline Score)
Baseline and Week 10, Week 12
Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH).
Time Frame: Baseline and Week 4
The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 4 Score - Baseline Score)
Baseline and Week 4
Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition
Time Frame: Baseline and Week 10
The QuickDASH is a validated, self-reported 11-item scale measuring disability. Possible scores range from 0 (no disability) to 100 (most severe disability. Change = (Week 10 Score - Baseline Score)
Baseline and Week 10
Change from Baseline in perseverance on the Brief Resilience Index (BRI)
Time Frame: Baseline and Week 4, Week 6
The BRI is a validated, self-reported 6-item validated tool to assess for resilience. Possible scores range from 1 (low resilience) to 5 (high resilience). Change = (Week (4, 6) Score - Baseline Score)
Baseline and Week 4, Week 6
Change from Baseline in perseverance on the Brief Resilience Index (BRI) - crossover condition
Time Frame: Baseline and Week 10, Week 12
The BRI is a validated, self-reported 6-item validated tool to assess for resilience. Possible scores range from 1 (low resilience) to 5 (high resilience). Change = (Week (10, 12) Score - Baseline Score)
Baseline and Week 10, Week 12
Number of Participants With Treatment-Related Adverse Events
Time Frame: Through study completion, an average of 12 weeks
Treatment-related adverse events will be reported throughout the study by self-report and clinician-driven questions at each visit
Through study completion, an average of 12 weeks
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
Time Frame: Baseline and Week 4
Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up
Baseline and Week 4
Change from Baseline in heart rate
Time Frame: Baseline and Week 4
Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up
Baseline and Week 4
Change from Baseline in the Mean Seated Trough Cuff Systolic Blood Pressure
Time Frame: Week 4 and Week 6
Blood pressure (SBP and DBP) in mmHg using Sphygmomanometer will be assessed by the researchers at baseline and follow-up
Week 4 and Week 6
Change from Baseline in heart rate
Time Frame: Week 4 and Week 6
Heartbeats per minute (BPM) will be assessed by the researchers at baseline and follow-up
Week 4 and Week 6
Change from baseline in serum liver panel parameters: Alanine transaminase (ALT), Alkaline phosphatase (ALP) and Aspartate aminotransferase (AST)
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum liver panel parameters: ALT, ALP and AST (International units per liter) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, blood urea nitrogen (BUN), Creatinine, Calcium
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: glucose, BUN, Creatinine, Calcium (mg/dL) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: estimated glomerular filtration rate (eGFR)
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: eGFR (mL/min/1.73m2) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Bilirubin (umol/L) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Sodium, Potassium, Chloride, Carbon Dioxide (meq/L) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Protein, Albumin (g/dL) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT-INR)
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum comprehensive metabolic panel (CMP) parameters: Prothrombin time- International normalized ratio (PT (seconds)-INR) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Red Blood Cells (CBC), White Blood Cells (WBC), Platelets
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: RBC, WBC, Platelets (uL) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hemoglobin (g.dL) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hematocrit
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Hematocrit (percentage) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV)
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: Mean Corpuscular Volume (MCV) (pg) at baseline and follow up
Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH)
Time Frame: Through study completion, an average of 12 weeks
Change from baseline in serum complete blood count (CBC) parameters: the amount of hemoglobin per red blood cell.(MCH) (pg) at baseline and follow up
Through study completion, an average of 12 weeks

Collaborators and Investigators

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

Sponsor

Brent DeGeorge

Investigators

  • Principal Investigator: Brent DeGeorge, MD, PhD, University of Virginia Department of Plastic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR230544

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

Yes

Studies a U.S. FDA-regulated device product

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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