Pelvic Pain
Conditions
Keywords
chronic pain, pelvic pain, nicotine patch
Brief summary
The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.
Detailed description
Potential subjects are female non-smokers presenting to their physicians for treatment of chronic pelvic pain. When consented, the subjects fill out a questionnaire on demographic information and pain experience. The trial is conducted at home over three days. Each subject uses three different levels of nicotine (0mg, 5mg, and 10mg) administered in a random order; the study is double-blinded and patients act as their own controls. Subjects apply the placebo or nicotine patches in the morning and remove them in the evening when they fill out a pain diary for the day. During the study, patients will continue their typical course of pain medication and report pain medication use in the pain diary.
Interventions
DRUGPlacebo
Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
DRUGNicotine (5 mg)
Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
DRUGNicotine (10 mg)
Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Chronic pelvic pain * Aged 18-60 years * Female
Exclusion criteria
* Uncontrolled hypertension * Cardiovascular disease * Current analgesic abuse * Pregnancy * Current usage of nicotine patch or gum * Allergy to adhesive tape
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 1 day | Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Self-assessment of Psychological Distress | 1 day | Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90. |
| Number of Participants Who Reported an Increase in Daily Pain Medication Regime | 1 day | Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime. |
| Nausea | 1 day | Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea. |
Countries
United States
Participant flow
Recruitment details
This double-blind prospective study was approved by the Institutional Review Board of Columbia University Medical Center. Written consent was obtained from all subjects. Women presenting with chronic pelvic pain to a gynecologist or to the pain clinic at New York Presbyterian Hospital were eligible for inclusion.
Pre-assignment details
Twenty-six women were recruited for the study. Six women declined to participate after consenting but before commencing treatment; these women are not included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Pain Score
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
Time frame: 1 day
Population: This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pain Score | 7.1 Units on a scale | Standard Deviation 3.1 |
| Nicotine 5 mg | Pain Score | 6.4 Units on a scale | Standard Deviation 3 |
| Nicotine 10 mg | Pain Score | 6.9 Units on a scale | Standard Deviation 3.2 |
Secondary
Nausea
Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.
Time frame: 1 day
Population: This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Nausea | 2.3 Units on a scale | Standard Deviation 1.8 |
| Nicotine 5 mg | Nausea | 2.3 Units on a scale | Standard Deviation 2.1 |
| Nicotine 10 mg | Nausea | 2.3 Units on a scale | Standard Deviation 2.1 |
Secondary
Number of Participants Who Reported an Increase in Daily Pain Medication Regime
Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.
Time frame: 1 day
Population: This analysis was per protocol. Only data from those patients who returned the pain diaries with the above information to the research staff by mail were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Reported an Increase in Daily Pain Medication Regime | 2 Participants |
| Nicotine 5 mg | Number of Participants Who Reported an Increase in Daily Pain Medication Regime | 3 Participants |
| Nicotine 10 mg | Number of Participants Who Reported an Increase in Daily Pain Medication Regime | 2 Participants |
Secondary
Patient Self-assessment of Psychological Distress
Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.
Time frame: 1 day
Population: This analysis was per protocol. One patient dropped out of the study before the third intervention period. This patient does not have data for the 10 mg nicotine patch.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient Self-assessment of Psychological Distress | 40.2 Units on a scale | Standard Deviation 18.3 |
| Nicotine 5 mg | Patient Self-assessment of Psychological Distress | 36.7 Units on a scale | Standard Deviation 18.6 |
| Nicotine 10 mg | Patient Self-assessment of Psychological Distress | 37.5 Units on a scale | Standard Deviation 18.2 |