Sacroiliac Joint Pain, Sympathetically Maintained Pain
Conditions
Keywords
sedation, sensitivity, specificity, validity, diagnostic injection
Brief summary
Interventional pain procedures have diagnostic, prognostic and therapeutic value. It is well-documented that the reference standard for identifying a pain generator is a low-volume block performed with local anesthetic, with or without steroid. Many factors may increase the false positive (FP) rate of diagnostic and prognostic nerve blocks; however, the use of sedation is the most controversial and remediable. Proponents of sedation argue that it has little effect on the rate of positive diagnostic blocks, and may even reduce the false-negative rate. The purpose of this study is to determine the effect of intravenous sedation on pain relief and the false-positive rate after diagnostic nerve blocks.
Detailed description
Sixty-eight patients with sacroiliac (SI) joint or sympathetically-maintained pain will be randomized in a crossover fashion to receive diagnostic nerve blocks either with or without intravenous sedation. Among those who obtain some benefit and return for a 2nd block, this 2nd procedure will be done with sedation if the first was done without sedation, and vice versa. Midazolam and fentanyl will be used for intravenous sedation, titrated to anxiolysis and analgesia. Pain scores (0-10 numerical rating scale, or NRS) and an activity log will be recorded over the 8-hours following the blocks via a pain diary. The first follow-up visit will be 4 weeks after the procedure. Patients who obtain some benefit but continue to report significant pain or who might otherwise benefit from a repeat procedure will have this second procedure performed with sedation if no sedation was given for the first procedure, and without sedation if sedation was administered for the first procedure. The post-procedure pain data will be recorded in the same fashion as the initial nerve block. The second follow-up visit will be 4 weeks after the 2nd block.
Interventions
DRUGMidazolam
Used for anxiolysis
DRUGFentanyl
Used for analgesia and as a sedative
Sponsors
Walter Reed National Military Medical Center
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic pain \> 4 weeks but \< 10 years in duration * Suspected SI joint or sympathetically-maintained pain based on history and physical exam * May benefit from a sacroiliac joint or sympathetic block * Pain on 0-10 NRS scale \> 3/10 in intensity
Exclusion criteria
* No previous interventional pain-alleviating injections for the same condition within the past 3 years * Uncontrolled coagulopathy * Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age * Allergy to contrast dye or amide local anesthetics * Unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response * Systemic infection * Age \< 18 or \> 75 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | through 6 hours after injection | pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 1-month | 0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain. |
| Procedure-related Pain Score | 1 day | 0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable |
| Oswestry Disability Index | 1-month | Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability |
| Satisfaction | 1 day | 5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sedation Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure
sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.
Sympathetic block: Sympathetic block with bupivacaine
bupivacaine
corticosteroid | 37 |
| Control Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure | 36 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Sedation | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 1 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 35 Participants | 67 Participants |
| Age, Continuous | 49.7 years STANDARD_DEVIATION 16.1 | 50.3 years STANDARD_DEVIATION 13.8 | 50.0 years STANDARD_DEVIATION 15 |
| Gender Female | 20 Participants | 22 Participants | 42 Participants |
| Gender Male | 17 Participants | 14 Participants | 31 Participants |
| Region of Enrollment United States | 37 participants | 36 participants | 73 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 37 | 6 / 36 |
| serious Total, serious adverse events | 0 / 37 | 0 / 36 |
Outcome results
Primary
Pain Score
pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable
Time frame: through 6 hours after injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation | Pain Score | 2.2 units on a scale | Standard Deviation 2.3 |
| Control | Pain Score | 3.4 units on a scale | Standard Deviation 2.8 |
Secondary
Oswestry Disability Index
Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability
Time frame: 1-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation | Oswestry Disability Index | 34.8 units on a scale | Standard Deviation 14.6 |
| Control | Oswestry Disability Index | 40.6 units on a scale | Standard Deviation 17.9 |
Secondary
Pain Score
0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.
Time frame: 1-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation | Pain Score | 5.1 units on a scale | Standard Deviation 2.9 |
| Control | Pain Score | 5.6 units on a scale | Standard Deviation 2.8 |
Secondary
Procedure-related Pain Score
0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation | Procedure-related Pain Score | 3.1 units on a scale | Standard Deviation 2.8 |
| Control | Procedure-related Pain Score | 5.5 units on a scale | Standard Deviation 2.7 |
Secondary
Satisfaction
5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sedation | Satisfaction | 4.0 units on a scale | Standard Deviation 1.1 |
| Control | Satisfaction | 3.6 units on a scale | Standard Deviation 1.4 |