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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656942
• Other study ID #: 2003P 000110
• Secondary ID: MGH Fund # 1200-
• Status: Completed
• Start date: July 2006
• Est. completion date: December 2018

Study information

• Verified date: July 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The study consists of one visit, in which an interview, physical exam, lab work (urine test) and sensory testing will be done. The testing (Quantitative Sensory Testing) is noninvasive (no needles) and involves heat and cold stimulation. Compensation and some parking reimbursement provided.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: December 2018
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

a. Inclusion/exclusion criteria

Inclusion Criteria for the group with chronic pain on chronic treatment with opioids:

1. 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.

2. Subject is age 18 to 65 years.

Inclusion Criteria for the group with chronic pain on chronic treatment with non-opioids (currently not recruiting):

1. Subject has pain and is on stable chronic non-opioid treatment for chronic pain for at least one month.

2. Subject is age 18 to 65 years.

Inclusion Criteria for the group of opioid-naive healthy volunteers without chronic pain (currently not recruiting):

1. 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

2. Subject does not have pain

3. Subject is age 18 to 65 years.

Exclusion Criteria for all groups:

1. Subject has lost tactile sensation in the sites for QST testing (upper extremities)

2. Subject has scar tissue or acute injury in the skin areas for QST testing (upper extremities)

3. Subject has neurological disease or a medical condition causing peripheral polyneuropathy and sensory changes (including but not limited to diabetes, alcoholism, AIDS, thyroid disease, liver or kidney disorders). It is the presence of neuropathy, not the causative disease itself, that is the exclusion criteria.

4. 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.

5. Subject has litigation pending relative to their chronic pain.

6. 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.

7. Subject has used illicit drugs within past 6 months.

8. Subject is pregnant

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Quantitative Sensory Testing (QST)
QST consists of a series of heat and cold stimulation tests.

Locations

Country	Name	City	State
United States	MGH Center for Translational Pain Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to warm/cold temperature	Responses to warm/cold temperatures will be recorded by the Quantitative Sensory Testing device (QST).	2 hours