Painful Neuropathy
Conditions
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.
Interventions
DRUGSulfasalazine
DRUGplacebo
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Painful neuropathy * Michigan Neuropathy Screening Instrument score of 3 or greater * no obvious alternative explanation for neuropathy * average baseline pain \> 4/10
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 (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). |
| 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 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). |
| 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). |
| 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. |
| 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. |
| 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). |
| 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. |
| 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 |
| 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 |
| 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 Dose (First Treatment Period Only) | Assessed during two week treatment period | Number of missed medication doses |
| Missed Medication Doses (Using the Crossover Comparison Structure of the Study) | Assessed during two week treatment period | Number of missed medication doses |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants who were randomized to either Group A or Group B:
Group A: Placebo daily for two weeks, washout period of one week, sulfasalazine for 2 week period Group B: Sulfasalazine daily for two weeks, washout period of one week, placebo for 2 week period. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 5.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Pain Score (First 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).
Time frame: second week of two week treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulfasalazine | Pain Score (First Treatment Period) | 5.60 units on a scale | Standard Deviation 1.35 |
| Placebo | Pain Score (First Treatment Period) | 4.20 units on a scale | Standard Deviation 0.91 |
Secondary
Breakthrough Treatment (First Treatment Period Only)
Number of days breakthrough pain medication was taken
Time frame: Assessed during two week treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulfasalazine | Breakthrough Treatment (First Treatment Period Only) | 0.75 days | Standard Deviation 0.96 |
| Placebo | Breakthrough Treatment (First Treatment Period Only) | 2.00 days | Standard Deviation 2.83 |
Secondary
Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)
Number of days breakthrough pain medication was taken
Time frame: Assessed during two week treatment period
Population: 8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulfasalazine | Breakthrough Treatment (Using the Crossover Comparison Structure of the Study) | 1.29 days | Standard Deviation 2.21 |
| Placebo | Breakthrough Treatment (Using the Crossover Comparison Structure of the Study) | 1.14 days | Standard Deviation 2.27 |
Secondary
Categorical Rating of Pain Intensity (First Treatment Period Only)
Assessed using number of days rated as none, mild, moderate, or severe in pain diary
Time frame: Assessed at end of two week treatment period
Population: One participant in the sulfasalazine arm did not complete the categorical pain data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sulfasalazine | Categorical Rating of Pain Intensity (First Treatment Period Only) | None rating | 0 days | Standard Deviation 0 |
| Sulfasalazine | Categorical Rating of Pain Intensity (First Treatment Period Only) | Mild rating | 1.67 days | Standard Deviation 2.89 |
| Sulfasalazine | Categorical Rating of Pain Intensity (First Treatment Period Only) | Moderate rating | 4.33 days | Standard Deviation 2.52 |
| Sulfasalazine | Categorical Rating of Pain Intensity (First Treatment Period Only) | Severe rating | 1.00 days | Standard Deviation 1.73 |
| Placebo | Categorical Rating of Pain Intensity (First Treatment Period Only) | Severe rating | 0 days | Standard Deviation 0 |
| Placebo | Categorical Rating of Pain Intensity (First Treatment Period Only) | None rating | 0 days | Standard Deviation 0 |
| Placebo | Categorical Rating of Pain Intensity (First Treatment Period Only) | Moderate rating | 5.25 days | Standard Deviation 3.5 |
| Placebo | Categorical Rating of Pain Intensity (First Treatment Period Only) | Mild rating | 1.75 days | Standard Deviation 3.5 |
Secondary
Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)
Assessed using number of days rated as none, mild, moderate, or severe in pain diary
Time frame: Assessed at end of two week treatment period
Population: 8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1. One participant did not complete the categorical pain data in either period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sulfasalazine | Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) | Mild rating | 2.00 days | Standard Deviation 3.16 |
| Sulfasalazine | Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) | None rating | 0 days | Standard Deviation 0 |
| Sulfasalazine | Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) | Severe rating | 0.67 days | Standard Deviation 1.21 |
| Sulfasalazine | Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) | Moderate rating | 4.33 days | Standard Deviation 2.88 |
| Placebo | Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) | Severe rating | 0.17 days | Standard Deviation 0.41 |
| Placebo | Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) | None rating | 1.17 days | Standard Deviation 2.86 |
| Placebo | Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) | Moderate rating | 3.83 days | Standard Deviation 3.54 |
| Placebo | Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study) | Mild rating | 1.83 days | Standard Deviation 2.99 |
Secondary
Emotional Functioning (First Treatment Period Only)
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.
Time frame: Assessed at end of two week treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulfasalazine | Emotional Functioning (First Treatment Period Only) | 8.25 units on a scale | Standard Deviation 5.12 |
| Placebo | Emotional Functioning (First Treatment Period Only) | 10.50 units on a scale | Standard Deviation 6.61 |
Secondary
Emotional Functioning (Using the Crossover Comparison Structure of the Study)
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.
Time frame: Assessed at end of two week treatment period
Population: 8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulfasalazine | Emotional Functioning (Using the Crossover Comparison Structure of the Study) | 7.29 units on a scale | Standard Deviation 5.91 |
| Placebo | Emotional Functioning (Using the Crossover Comparison Structure of the Study) | 8.29 units on a scale | Standard Deviation 6.29 |
Secondary
Missed Medication Dose (First Treatment Period Only)
Number of missed medication doses
Time frame: Assessed during two week treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulfasalazine | Missed Medication Dose (First Treatment Period Only) | 0 dose | Standard Deviation 0 |
| Placebo | Missed Medication Dose (First Treatment Period Only) | 0 dose | Standard Deviation 0 |
Secondary
Missed Medication Doses (Using the Crossover Comparison Structure of the Study)
Number of missed medication doses
Time frame: Assessed during two week treatment period
Population: 8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulfasalazine | Missed Medication Doses (Using the Crossover Comparison Structure of the Study) | 0.43 doses | Standard Deviation 1.13 |
| Placebo | Missed Medication Doses (Using the Crossover Comparison Structure of the Study) | 0 doses | Standard Deviation 0 |
Secondary
Number of Patients With >=50% Pain Reduction (First 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.
Time frame: second week of two week treatment period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sulfasalazine | Number of Patients With >=50% Pain Reduction (First Treatment Period) | 0 Participants |
| Placebo | Number of Patients With >=50% Pain Reduction (First Treatment Period) | 0 Participants |
Secondary
Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)
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.
Time frame: Assessed at end of two week treatment period
Population: 8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sulfasalazine | Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study) | 0 Participants |
| Placebo | Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study) | 1 Participants |
Secondary
Overall Improvement (First Treatment Period Only)
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.
Time frame: Will be assessed at end of two week treatment period
Population: 2 participants in the sulfasalazine group are missing PGIC information.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sulfasalazine | Overall Improvement (First Treatment Period Only) | PGIC Item 1 | 1.50 units on a scale | Standard Deviation 0.71 |
| Sulfasalazine | Overall Improvement (First Treatment Period Only) | PGIC Item 2 | 5.00 units on a scale | Standard Deviation 0 |
| Placebo | Overall Improvement (First Treatment Period Only) | PGIC Item 1 | 1.75 units on a scale | Standard Deviation 0.96 |
| Placebo | Overall Improvement (First Treatment Period Only) | PGIC Item 2 | 4.50 units on a scale | Standard Deviation 1 |
Secondary
Overall Improvement (Using the Crossover Comparison Structure of the Study)
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.
Time frame: Will be assessed at end of two week treatment period
Population: 8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1. 2 of the sulfasalzine participants are missing PGIC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sulfasalazine | Overall Improvement (Using the Crossover Comparison Structure of the Study) | PGIC item 1 | 2.80 units on a scale | Standard Deviation 2.39 |
| Sulfasalazine | Overall Improvement (Using the Crossover Comparison Structure of the Study) | PGIC item 2 | 4.00 units on a scale | Standard Deviation 1.73 |
| Placebo | Overall Improvement (Using the Crossover Comparison Structure of the Study) | PGIC item 1 | 3.00 units on a scale | Standard Deviation 2.08 |
| Placebo | Overall Improvement (Using the Crossover Comparison Structure of the Study) | PGIC item 2 | 3.56 units on a scale | Standard Deviation 1.81 |
Secondary
Pain Score (Using the Crossover Comparison Structure of the Study)
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).
Time frame: Assessed at end of two week treatment period
Population: 8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sulfasalazine | Pain Score (Using the Crossover Comparison Structure of the Study) | 4.91 units on a scale | Standard Deviation 1.38 |
| Placebo | Pain Score (Using the Crossover Comparison Structure of the Study) | 3.93 units on a scale | Standard Deviation 2.08 |
Secondary
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)
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).
Time frame: Assessed at end of two week treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Walking ability | 4.50 units on a scale | Standard Deviation 3.87 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Relations with other people | 1.25 units on a scale | Standard Deviation 2.5 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Mood | 3.75 units on a scale | Standard Deviation 3.86 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Sleep | 5.00 units on a scale | Standard Deviation 3.56 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Normal work | 5.25 units on a scale | Standard Deviation 4.03 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Enjoyment of life | 5.75 units on a scale | Standard Deviation 4.65 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | General activity | 5.25 units on a scale | Standard Deviation 2.75 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Enjoyment of life | 4.75 units on a scale | Standard Deviation 2.5 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | General activity | 4.00 units on a scale | Standard Deviation 1.41 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Mood | 5.00 units on a scale | Standard Deviation 2.16 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Walking ability | 5.50 units on a scale | Standard Deviation 2.08 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Normal work | 4.75 units on a scale | Standard Deviation 2.5 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Relations with other people | 3.75 units on a scale | Standard Deviation 1.71 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only) | Sleep | 5.25 units on a scale | Standard Deviation 2.22 |
Secondary
Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)
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).
Time frame: Assessed at end of two week treatment period
Population: 8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Walking ability | 3.57 units on a scale | Standard Deviation 3.21 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Relations with other people | 1.43 units on a scale | Standard Deviation 2.15 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Mood | 3.57 units on a scale | Standard Deviation 3.1 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Sleep | 4.86 units on a scale | Standard Deviation 3.24 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Normal work | 4.14 units on a scale | Standard Deviation 3.48 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Enjoyment of life | 4.57 units on a scale | Standard Deviation 4.39 |
| Sulfasalazine | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | General activity | 4.00 units on a scale | Standard Deviation 2.77 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Enjoyment of life | 4.00 units on a scale | Standard Deviation 3.61 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | General activity | 3.71 units on a scale | Standard Deviation 2.06 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Mood | 4.00 units on a scale | Standard Deviation 2.94 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Walking ability | 4.57 units on a scale | Standard Deviation 2.57 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Normal work | 4.14 units on a scale | Standard Deviation 2.61 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Relations with other people | 2.57 units on a scale | Standard Deviation 1.99 |
| Placebo | Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study) | Sleep | 4.43 units on a scale | Standard Deviation 2.76 |
Secondary
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)
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).
Time frame: Assessed at end of two week treatment period
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 5 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 4 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 2 | 1 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 5 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 1 | 3 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 1 | 2 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 4 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 2 | 1 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 2 | 1 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 3 | 1 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 3 | 2 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 4 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 3 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 5 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 1 | 1 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 5 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 1 | 1 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 2 | 2 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 3 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 4 | 1 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D mobility | 5 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 1 | 4 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 2 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 3 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 4 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D self-care | 5 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 1 | 1 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 2 | 1 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 3 | 2 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only) | EQ-5D usual activities | 4 | 0 Participants |
Secondary
Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)
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).
Time frame: Assessed at end of two week treatment period
Population: 8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 1 | 4 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 1 | 4 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 2 | 1 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 3 | 2 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 4 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 5 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 1 | 5 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 2 | 2 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 3 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 4 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 5 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 2 | 2 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 3 | 1 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 4 | 0 Participants |
| Sulfasalazine | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 5 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 2 | 2 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 1 | 2 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 3 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 4 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 2 | 3 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 4 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 3 | 1 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 3 | 3 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 4 | 1 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 5 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D mobility | 5 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 1 | 2 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 1 | 7 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D usual activities | 5 | 0 Participants |
| Placebo | Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study) | EQ-5D self-care | 2 | 0 Participants |