Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094874
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2004-10-27
Brief Title:
Acupuncture for the Treatment of Interstitial Cystitis IC Symptoms
Sponsor:
The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust
Organization:
The Mary Elizabeth Groff Surgical Medical Research and Education Charitable Trust
Study Overview
Official Title:
A Double-Blind Randomized Study of Puncturing Versus Non-Puncturing Acupuncture for the Treatment of Interstitial Cystitis Symptoms
Status:
UNKNOWN
Status Verified Date:
2004-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acupuncture is a form of Chinese medicine that has been in existence for more than a thousand years This clinical trial performs two types of acupuncture on traditional bladder points to determine if one type demonstrates improvement over the other In the first type needles stimulate acupuncture points on the skin and in the second type the needles penetrate through the skin similar to how acupuncture is usually performed The technique is done through shields so that people will not know what type of acupuncture they receive
Patients must have at least moderately severe disease as determined by a urologist They must be willing not to change their medical regimen for the duration of the trial Patients will receive twelve treatments over six to twelve weeks They will be asked to fill out symptom questionnaires and bladder diaries at regular intervals to monitor change All treatment is free of charge and patients who complete the trial will receive a small stipend
Patients must have at least moderately severe disease as determined by a urologist They must be willing not to change their medical regimen for the duration of the trial Patients will receive twelve treatments over six to twelve weeks They will be asked to fill out symptom questionnaires and bladder diaries at regular intervals to monitor change All treatment is free of charge and patients who complete the trial will receive a small stipend
Detailed Description:
Patients eligible for enrollment include
Age 18-65 years
Symptomatic IC for at least six months
Urinary frequency of at least eleven voids in a 24 hour period
A self-rated global discomfort score of 4 or greater on a 0-10 scale
Patients may not be enrolled who have a history of chronic bladder disease or pelvic disease including cancer calculi infection or complications of nervous system disease or diabetes They must be on no blood thinning agents or have had any recent medication changes or bladder procedures
After screening physical examination and history-taking patients will be asked to fill out standard symptom questionnaires They will be given a bladder diary to fill out for the 24 hours prior to their first acupuncture treatment which will be scheduled within a week
Patients will be asked to return from once- to twice-weekly for a total of twelve treatments Patients will complete a bladder diary before each treatment and a questionnaire form before every other visit The same questionnaire will be used at the exit interview after the last treatment and a final time four weeks after the last treatment This is because we are interested in the duration of potential benefit from acupuncture treatment
Patients will be randomly assigned to one of two groups All acupuncture will be performed through plastic shields so that the patient does not know which group he or she has been assigned to In the first type of acupuncture retractable needles are used such that the patient feels a pin sensation but there is no penetration of the epidermis In the second type non-retractable needles penetrate the acupuncture points into deeper tissue It is not known whether deeper penetration is required for acupuncture to work or if acupuncture is of benefit at all for this condition
Age 18-65 years
Symptomatic IC for at least six months
Urinary frequency of at least eleven voids in a 24 hour period
A self-rated global discomfort score of 4 or greater on a 0-10 scale
Patients may not be enrolled who have a history of chronic bladder disease or pelvic disease including cancer calculi infection or complications of nervous system disease or diabetes They must be on no blood thinning agents or have had any recent medication changes or bladder procedures
After screening physical examination and history-taking patients will be asked to fill out standard symptom questionnaires They will be given a bladder diary to fill out for the 24 hours prior to their first acupuncture treatment which will be scheduled within a week
Patients will be asked to return from once- to twice-weekly for a total of twelve treatments Patients will complete a bladder diary before each treatment and a questionnaire form before every other visit The same questionnaire will be used at the exit interview after the last treatment and a final time four weeks after the last treatment This is because we are interested in the duration of potential benefit from acupuncture treatment
Patients will be randomly assigned to one of two groups All acupuncture will be performed through plastic shields so that the patient does not know which group he or she has been assigned to In the first type of acupuncture retractable needles are used such that the patient feels a pin sensation but there is no penetration of the epidermis In the second type non-retractable needles penetrate the acupuncture points into deeper tissue It is not known whether deeper penetration is required for acupuncture to work or if acupuncture is of benefit at all for this condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None