Pain Expectations in Subjects With Osteoarthritis

NCT02155257 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00028525
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to test whether or not researchers can alter or change expectations on pain. The researchers will test whether there is an effect on the size of the pupil and responses to thermal heat temperatures in subjects with osteoarthritis of the knee or hip or healthy subjects for comparison. One of 3 possible treatment groups will be administered to qualifying subjects: (1) gabapentin, a medication that is commonly used to treat nerve pain, (2) modafinil, a medication that is commonly used to treat people with narcolepsy (a disorder that causes people to fall asleep) and (3) a placebo, which is an inactive substance, like a sugar pill, that is not thought to have any effect on your disease or condition

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Knee pain; Hip pain; Total Knee Replacement Surgery

Outcome Measures

Primary Outcomes (3)

• Resting Pupil Diameter

  Resting pupil diameter will be measured using an infrared camera to obtain baseline measurements 2 hours after dosing subject pupil diameter measurements will be repeated

  Baseline and 2 hours

• Pain Intensity Rating

  Pain is reported verbally after each stimulus by the subject on a scale of 0 (no pain) to 10 (worst imagineable pain). For each individual the value used is the average of all presentations of the 50 degree stimulus.

  Reported 5 seconds after each stimulus

• Cognitive Style

  Cognitive style determined for each individual by subtracting the score in the Pain Catastrophizing Scale (CATS) questionnaire (with a score range of 0-52 with higher score showing more catastrophizing) from the Life Orientation Test Revised (LOT-R) questionnaire (score range of 0-24, with a higher score denoting a better outcome). Thus, the total score could range from ranges from -52 to 24, with lower scores indicating worse cognitive style related to pain reporting and higher scores indicating better cognitive style related to pain reporting. There are no subscales here.

  baseline

Study Arms (3)

Modafinil

ACTIVE COMPARATOR

Modafinil 200 mg will be administered orally one time

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

A placebo will be administered orally one time

Drug: Placebo

Gabapentin

ACTIVE COMPARATOR

Gabapentin 900 mg will be administered orally one time

Drug: Gabapentin

Interventions

Modafinil DRUG

Also known as: Provigil

Modafinil

Gabapentin DRUG

Also known as: Neurontin

Gabapentin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis of the knee or hip
• Adult (ages 18-80)
• Moderate pain (verbal score of ≥ 4 ≤ 7 on 0-10 scale for average pain intensity with normal activity)
• American Society of Anesthesiologists physical status 1-3
• Healthy subjects without pain

You may not qualify if:

• Pregnancy;
• Currently taking gabapentin
• Currently taking a narcotic prescription medication that is \> 50 mg morphine equivalents/day
• Advanced or unstable cardiac, pulmonary, renal or hepatic dysfunction
• History of previous eye surgery
• Psychotic disorder or a recent psychiatric hospitalization

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Modafinil; Gabapentin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. James Eisenach
• Organization: Wake Forest University Health Sciences

eisenach@wakehealth.edu

3367164182

Study Officials

• James C Eisenach, M.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: March 7, 2019
• Results First Posted: March 7, 2019

Record last verified: 2019-02

Locations

US (1)