Trial Outcomes & Findings for Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial (NCT NCT02232282)
NCT ID: NCT02232282
Last Updated: 2022-04-14
Results Overview
Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
0 weeks, 6 weeks
Results posted on
2022-04-14
Participant Flow
Participant milestones
| Measure |
Minimal Acupuncture
This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.
|
Standard Acupuncture Treatment
This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Minimal Acupuncture
n=10 Participants
This arm received sham/minimal acupuncture with low level electrical stimulation. This intervention used superficial needle insertion at body locations not recognized as true acupoints.
|
Standard Acupuncture Treatment
n=11 Participants
This arm received standard acupuncture treatment: A standardized acupuncture treatment followed a standardized protocol on classical acupuncture points, with or without mild electrical stimulation Standard acupuncture treatment protocol will include 4 gates plus GV 20. Subsequent visits included administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation was applied.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 14.7 • n=99 Participants
|
50.6 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
49.9 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Prefers not to answer
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Marital status
Married
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Marital status
Not married
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Education
Completed 4 years of college or more
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Education
Completed fewer than 4 years of college
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Body mass index
|
26.2 kg/m^2
n=99 Participants
|
24.0 kg/m^2
n=107 Participants
|
25.0 kg/m^2
n=206 Participants
|
|
Menstrual status
Pre-menopausal
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Menstrual status
Post-menopausal
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Menstrual status
Not sure
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Vaginal parity
Nulliparous
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Vaginal parity
At least primiparous
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Number of Pain comorbidities
0
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Number of Pain comorbidities
1
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Number of Pain comorbidities
2
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Number of Pain comorbidities
3
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Number of Pain comorbidities
4
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
First line treatment
First-line treatment
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
First line treatment
No first-line treatment
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Second-line treatment
Second-line treatment
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Second-line treatment
No second-line treatment
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Third-line treatment
Third-line treatment
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Third-line treatment
No third-line treatment
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0 weeks, 6 weeksPopulation: All participants were included.
Change in worst pain as measured by the Brief Pain Inventory-Short Form. Scores range from 0 to 10 and higher scores indicate more pain. Change is calculated as the 6 weeks score minus the baseline score.
Outcome measures
| Measure |
Minimal Acupuncture
n=10 Participants
Control Sham/Minimal Acupuncture: Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treat
|
Standard Acupuncture Treatment
n=11 Participants
Standard acupuncture treatment: protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.
|
|---|---|---|
|
Efficacy of Acupuncture to Reduce Pain in Women With Interstitial Cystitis/Painful Bladder Syndrome
|
-2.08 score on a scale
Standard Error 0.68
|
-2.91 score on a scale
Standard Error 0.59
|
SECONDARY outcome
Timeframe: 0 weeks, 6 weeksPopulation: All participants were included.
The total number of acupuncture sessions stopped due to poor tolerability of acupuncture
Outcome measures
| Measure |
Minimal Acupuncture
n=10 Participants
Control Sham/Minimal Acupuncture: Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treat
|
Standard Acupuncture Treatment
n=11 Participants
Standard acupuncture treatment: protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.
|
|---|---|---|
|
Tolerability of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrom
|
0 total number of sessions
|
0 total number of sessions
|
SECONDARY outcome
Timeframe: 0 weeks, 12 weeksPopulation: All participants were included.
The total number of adverse events experienced by women receiving acupuncture
Outcome measures
| Measure |
Minimal Acupuncture
n=10 Participants
Control Sham/Minimal Acupuncture: Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including "minimal acupuncture", therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treat
|
Standard Acupuncture Treatment
n=11 Participants
Standard acupuncture treatment: protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.
|
|---|---|---|
|
Safety of Acupuncture in Women With Interstitial Cystitis/Painful Bladder Syndrome
|
0 total number of adverse events
|
0 total number of adverse events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 weeks, 6 weeksA change in the urinary microbiome may be detected for responders to acupuncture compared with nonresponders.
Outcome measures
Outcome data not reported
Adverse Events
Minimal Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Acupuncture Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place