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

NCT ID: NCT00670917

Last Updated: 2018-06-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-07

Study Completion Date

2010-01-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematopoietic/Lymphoid Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Study Groups

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L14 acupoint

Group Type ACTIVE_COMPARATOR

questionnaire administration

Intervention Type OTHER

acupressure therapy

Intervention Type PROCEDURE

biopsy

Intervention Type PROCEDURE

bone marrow aspiration

Intervention Type PROCEDURE

pain therapy

Intervention Type PROCEDURE

Sham Point

Group Type SHAM_COMPARATOR

questionnaire administration

Intervention Type OTHER

acupressure therapy

Intervention Type PROCEDURE

biopsy

Intervention Type PROCEDURE

bone marrow aspiration

Intervention Type PROCEDURE

pain therapy

Intervention Type PROCEDURE

Interventions

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questionnaire administration

Intervention Type OTHER

acupressure therapy

Intervention Type PROCEDURE

biopsy

Intervention Type PROCEDURE

bone marrow aspiration

Intervention Type PROCEDURE

pain therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart A. Grossman, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000594676

Identifier Type: -

Identifier Source: secondary_id

NA_00013389

Identifier Type: OTHER

Identifier Source: secondary_id

J07103

Identifier Type: -

Identifier Source: org_study_id

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