Expired Study
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Baltimore, Maryland 21231


Purpose:

RATIONALE: Acupressure may help relieve pain in cancer patients undergoing bone marrow aspiration and biopsy. It is not yet known whether magnetic acupressure is more effective than sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy. PURPOSE: This randomized clinical trial is studying magnetic acupressure to see how well it works compared with sham acupressure in reducing pain in cancer patients undergoing bone marrow aspiration and biopsy.


Study summary:

OBJECTIVES: Primary - To compare pain rating in cancer patients undergoing bone marrow aspiration and biopsy (BMAB) treated with magnetic acupressure at bilateral large intestine 4 (LI 4) points vs sham acupressure at bilateral proximal fourth interosseus space of the hand. Secondary - To compare the duration of BMAB, patient's rating of the procedure, and patient's willingness to receive acupressure during subsequent BMABs. OUTLINE: Patients are stratified according to the number of prior bone marrow aspirations and biopsies (BMAB) (0-1 vs ≥ 2) and type of procedure (bone marrow aspiration alone vs BMAB). Patients are randomized to one of two treatment arms. - Arm I (acupressure): Patients receive acupressure at bilateral large intestine 4 (LI 4) points using Haci Magnetic Acupressure Suction Cups (MASC) during BMAB. - Arm II (sham acupressure): Patients receive acupressure at bilateral proximal fourth interosseus space of the hand using the same size MASC as in arm I during BMAB. Patients in both arms also receive analgesic and anxiolytic medications as determined by the acupressure operator and physician. Patients complete a questionnaire before and after BMAB to assess pain experienced before and during BMAB and their attitude towards the procedure.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of cancer - Scheduled to undergo a routine bone marrow aspiration with or without biopsy - No requirement for conscious sedation during the procedure PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior acupuncture or acupressure - No prior participation in this study


Study is Available At:


Original ID:

J07103


NCT ID:

NCT00670917


Secondary ID:

P30CA006973


Study Acronym:


Brief Title:

Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy


Official Title:

A Randomized Controlled Trial Assessing the Effect of Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Oversight Authority:

Unspecified


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

83


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stuart A. Grossman, MD
Principal Investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Dates

Start Date:May 7, 2008
Completion Date:January 19, 2010
Completion Type:Actual
Primary Completion Date:January 19, 2010
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 26, 2018
First Received Date:May 1, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Clinical benefit response as measured by duration of BMAB, patient's rating of the procedure, and patient's willingness to receive acupressure during subsequent BMAB
Time Frame:12 hours
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pain scores before and during bone marrow aspiration and biopsy (BMAB) as measured by a patient-reported 11-point visual analogue pain scale
Time Frame:12 hours
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:questionnaire administration
Arm Name:L14 acupoint
Intervention Type:Procedure
Name:acupressure therapy
Arm Name:L14 acupoint
Intervention Type:Procedure
Name:biopsy
Arm Name:L14 acupoint
Intervention Type:Procedure
Name:bone marrow aspiration
Arm Name:L14 acupoint
Intervention Type:Procedure
Name:pain therapy
Arm Name:L14 acupoint

Study Arms

Study Arm Type:Active Comparator
Arm Name:L14 acupoint
Study Arm Type:Sham Comparator
Arm Name:Sham Point

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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