Clinical trial NCT00670917: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic/Lymphoid Cancer
Pain
Keywords: pain
hematopoietic/lymphoid cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-05-02
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Pain scores before and during bone marrow aspiration and biopsy (BMAB) as measured by a patient-reported 11-point visual analogue pain scale
timeFrame: 12 hours
Secondary outcomes:
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
timeFrame: 12 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Stuart A. Grossman, MD
role: PRINCIPAL_INVESTIGATOR
References: