Pain Responses in Patients on Long-Term Opioid Therapy for Chronic Pain

NCT00656942 | Completed DMC

• 2 other identifiers: 2003P 000110MGH Fund # 1200-204727
• Study Type: observational
• Target: 419
• Locations: 1 country
• Sites: 1

Brief Summary

The MGH Center for Translational Pain Research is seeking patients with chronic pain for a research study. The study is looking at the effect of opioid (narcotic) pain medicines on pain sensation, threshold and tolerance.

Conditions

Chronic Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• Response to warm/cold temperature

  Responses to warm/cold temperatures will be recorded by the Quantitative Sensory Testing device (QST).

  2 hours

Study Arms (3)

Healthy

* subjects with no pain and no opioid treatment for at least six months * subjects receive quantitative sensory testing (QST)

Device: Quantitative Sensory Testing (QST)

Pain, no opioid

* subjects have chronic pain but have not taken any opioid medication for at least 3 months * subjects receive QST

Device: Quantitative Sensory Testing (QST)

Pain, opioid

* subjects have chronic pain and have been taking opioid medication for at least 3 months * subjects receive QST

Device: Quantitative Sensory Testing (QST)

Interventions

Quantitative Sensory Testing (QST) DEVICE

QST consists of a series of heat and cold stimulation tests.

Healthy; Pain, no opioid; Pain, opioid

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The groups of subjects on chronic opioid and non-opioid treatment for chronic pain will be recruited from the MGH Pain Center's patients. We want to emphasize that our MGH Pain Center patient population comprehends a significant number of patients on stable dose of non-opioid and opioid pain medication for chronic pain. The investigators and study staff will search daily the MGH Pain Center clinic list and will approach the patients who might qualify for the study. The group of opioid naive subjects will be recruited by advertising in local newspapers and by using e-mail announcements through Partners HealthCare system.

You may not qualify if:

• Subject has chronic pain and is on stable chronic opioid treatment (morphine, fentanyl, oxycodone, methadone, hydromorphone, hydrocodone) for chronic pain for at least one month. We consider stable treatment if no change in the type and amount of daily opioid treatment for one month. Only patients with minimal daily opioid dose of at least 30 mg morphine equianalgesic dose will be included.
• Subject is age 18 to 65 years.
• Subject has pain and is on stable chronic non-opioid treatment for chronic pain for at least one month.
• Subject is age 18 to 65 years.
• Subject is opioid naive meaning he/she did not receive chronic opioid treatment in the past or present, and did not receive acute treatment with opioids in the last 1 month
• Subject does not have pain
• Subject is age 18 to 65 years.
• Subject has lost tactile sensation in the sites for QST testing (upper extremities)
• Subject has scar tissue or acute injury in the skin areas for QST testing (upper extremities)
• Subject had recent therapy that may influence QST results, e.g., neuroablative procedure involving upper extremities within six-months; peripheral neurolytic block within two-months; injection therapy for pain within four-weeks; sympathetic block within six months.
• Subject has litigation pending relative to their chronic pain.
• Subject has major psychiatric disorder (major depression disorder; bipolar disorder; schizophrenia; anxiety disorder; psychotic disorders; eating disorders; alcohol or drug dependence; attention deficit hyperactivity disorder); any known history of these conditions will exclude participation.
• Subject has used illicit drugs within past 6 months.
• Subject is pregnant

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Center for Translational Pain Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jianren Mao, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 14, 2008
• Study Start: July 1, 2006
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2018
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

US (1)