Study of Sulfasalazine in Treating Painful Neuropathy
- Registration Number
- NCT01667029
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The investigators hypothesize that sulfasalazine, an FDA-approved medication for rheumatoid arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. In this study, the investigators will evaluate whether sulfasalazine improves pain due to painful peripheral neuropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- Painful neuropathy
- Michigan Neuropathy Screening Instrument score of 3 or greater
- no obvious alternative explanation for neuropathy
- average baseline pain > 4/10
- other severe pain
- anticipated difficulty weaning off medications
- past or current psychiatric disorder as determined by Mini International Neuropsychiatric Interview
- medical contraindication to sulfasalazine
- not proficient in English (due to heavy use of questionaires)
- pregnant or breast feeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description placebo placebo oral placebo pill twice daily for two weeks. sulfasalazine Sulfasalazine 1 g oral twice daily for 2 weeks
- Primary Outcome Measures
Name Time Method Pain Score (First Treatment Period) second week of two week treatment period Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine).
- Secondary Outcome Measures
Name Time Method Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study) Assessed at end of two week treatment period Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during baseline and the second week of each of the two week treatment periods. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine). Percent pain reduction will be calculated from BL to end of treatment period 1 (2 weeks) and from end of treatment period 1 to end of treatment period 2 (2 weeks), based on average pain scores at each time point.
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) Assessed at end of two week treatment period The BPI interference items are general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. The seven items are rated from 0 (pain does not interfere) to 10 (pain completely interferes).
Emotional Functioning (First Treatment Period Only) Assessed at end of two week treatment period Will be assessed by the Beck Depression Inventory (BDI) total score. The BDI has 21 items, each scored 0-3. Higher values are worse. The total score is the sum of the 21 items and ranges from 0-63.
Overall Improvement (First Treatment Period Only) Will be assessed at end of two week treatment period The Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Item 1 is as follows: Since beginning treatment at this clinic, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition? (tick ONE box) (1=No change (or condition has gotten worse), 2=Almost the same, hardly any change at all, 3=A little better, but no noticeable change, 4=Somewhat better, but the change has not made any real difference, 5=Moderately better, and a slight but noticeable change, 6=Better, and a definite improvement that has made a real and worthwhile difference, 7=A great deal better, and a considerable improvement that has made all the difference). Item 2 is as follows: In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic (0-10 scale): 0= Much better, 5= No change, 10= Much worse.
Missed Medication Dose (First Treatment Period Only) Assessed during two week treatment period Number of missed medication doses
Pain Score (Using the Crossover Comparison Structure of the Study) Assessed at end of two week treatment period Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine).
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) Assessed at end of two week treatment period The BPI interference items are general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. The seven items are rated from 0 (pain does not interfere) to 10 (pain completely interferes).
Categorical Rating of Pain Intensity (First Treatment Period Only) Assessed at end of two week treatment period Assessed using number of days rated as none, mild, moderate, or severe in pain diary
Breakthrough Treatment (Using the Crossover Comparison Structure of the Study) Assessed during two week treatment period Number of days breakthrough pain medication was taken
Missed Medication Doses (Using the Crossover Comparison Structure of the Study) Assessed during two week treatment period Number of missed medication doses
Number of Patients With >=50% Pain Reduction (First Treatment Period) second week of two week treatment period Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary at baseline and during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine). Percent pain reduction will be calculated from BL to end of treatment period 1 (2 weeks), based on average pain scores at each time point.
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) Assessed at end of two week treatment period The EQ-5D physical functioning items are mobility self-care, and usual activities. These three items are rated from 1 (no problems) to 5 (unable).
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) Assessed at end of two week treatment period The EQ-5D physical functioning items are mobility self-care, and usual activities. These three items are rated from 1 (no problems) to 5 (unable).
Overall Improvement (Using the Crossover Comparison Structure of the Study) Will be assessed at end of two week treatment period The Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Item 1 is as follows: Since beginning treatment at this clinic, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition? (tick ONE box) (1=No change (or condition has gotten worse), 2=Almost the same, hardly any change at all, 3=A little better, but no noticeable change, 4=Somewhat better, but the change has not made any real difference, 5=Moderately better, and a slight but noticeable change, 6=Better, and a definite improvement that has made a real and worthwhile difference, 7=A great deal better, and a considerable improvement that has made all the difference). Item 2 is as follows: In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic (0-10 scale): 0= Much better, 5= No change, 10= Much worse.
Emotional Functioning (Using the Crossover Comparison Structure of the Study) Assessed at end of two week treatment period Will be assessed by the Beck Depression Inventory (BDI) total score. The BDI has 21 items, each scored 0-3. Higher values are worse. The total score is the sum of the 21 items and ranges from 0-63.
Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) Assessed at end of two week treatment period Assessed using number of days rated as none, mild, moderate, or severe in pain diary
Breakthrough Treatment (First Treatment Period Only) Assessed during two week treatment period Number of days breakthrough pain medication was taken
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States