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OpenTrials
Completed

NCT Number: NCT00670917

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

acupressure therapy

Procedure

Biopsy

Procedure

Bone Marrow Aspiration

Procedure

pain therapy

Procedure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 2, 2008
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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