Treatment of Chronic Thoracic and Neck and Upper Extremity Pain

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pain Management Center of Paducah
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Lidocaine

Criteria

Inclusion Criteria:

• Subjects of at least 18 years of age

• Subjects with a history of chronic, function-limiting thoracic or cervical pain with or without upper extremity pain of at least 6 months in duration

• Subjects who are able to give voluntary, written informed consent to participate in this investigation

• Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups

• Subjects have not had recent surgical procedures within the last 3 months.

Exclusion Criteria:

• Compressive radiculopathy

• Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent

• Uncontrolled major depression or uncontrolled psychiatric disorders

• Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease

• Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function

• Women who are pregnant or lactating

• Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment

• Patients with multiple complaints involving concomitant shoulder osteoarthritis, due to the overlap of pain complaints

• Inability to achieve appropriate positioning and inability to understand informed consent and protocol

• History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers.