NCT00670917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

May 7, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2010

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

May 1, 2008

Last Update Submit

June 26, 2018

Conditions

Hematopoietic/Lymphoid CancerPain

Keywords

painhematopoietic/lymphoid cancer

Outcome Measures

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

    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

    12 hours

Study Arms (2)

L14 acupoint

ACTIVE COMPARATOR
Other: questionnaire administrationProcedure: acupressure therapyProcedure: biopsyProcedure: bone marrow aspirationProcedure: pain therapy

Sham Point

SHAM COMPARATOR
Other: questionnaire administrationProcedure: acupressure therapyProcedure: biopsyProcedure: bone marrow aspirationProcedure: pain therapy

Interventions

questionnaire administrationOTHER
L14 acupointSham Point
acupressure therapyPROCEDURE
L14 acupointSham Point
biopsyPROCEDURE
L14 acupointSham Point
bone marrow aspirationPROCEDURE
L14 acupointSham Point
pain therapyPROCEDURE
L14 acupointSham Point

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Hematologic NeoplasmsPain

Interventions

AcupressureBiopsyAnalgesia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesAnesthesia and Analgesia

Study Officials

  • Stuart A. Grossman, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2008

First Posted

May 2, 2008

Study Start

May 7, 2008

Primary Completion

January 19, 2010

Study Completion

January 19, 2010

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

US(1)