Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
40 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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We propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment protocol, using either true or placebo needles at sham acupuncture points, for a period of four weeks (eight treatments).
The primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck Depression Score. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
true acupuncture
acupuncture
2 treatments/week for 4 weeks
2
placebo/sham acupuncture
placebo/sham acupuncture
2 treatments/week for 4 weeks
Interventions
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acupuncture
2 treatments/week for 4 weeks
placebo/sham acupuncture
2 treatments/week for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Age 18 years and older
* Scheduled for lower single limb amputation (above or below knee)
* Ability to comply with study protocol
Exclusion Criteria
* Patients displaying symptoms of overt Axis-1 psychopathology such as Schizophrenia or Substance Abuse
* Inability to comply with the study protocol
* Previous experience with acupuncture treatment; current use of complementary or alternative medical treatments.
18 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Shaare Zedek Medical Center
Principal Investigators
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Noah Samuels, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shaare Zedek Medical Center, Jerusalem, Israel
Locations
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Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Other Identifiers
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ACP.PLP.10.06
Identifier Type: -
Identifier Source: org_study_id
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