A Randomized Controlled Trial Assessing the Effect of Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Pain, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific
Both
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Pain, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Randomized Controlled Trial Assessing the Effect of Magnetic Acupressure in Reducing Pain in Cancer Patients Undergoing Bone Marrow Aspiration and Biopsy
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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
Safety Issue:
No
Principal Investigator
Stuart A. Grossman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
Unspecified
Study ID:
CDR0000594676
NCT ID:
NCT00670917
Start Date:
April 2008
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Lymphoproliferative Disorder
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
- Pain
- Precancerous Condition
- Unspecified Adult Solid Tumor, Protocol Specific
- pain
- unspecified adult solid tumor, protocol specific
- accelerated phase chronic myelogenous leukemia
- acute undifferentiated leukemia
- adult acute lymphoblastic leukemia in remission
- adult acute myeloid leukemia in remission
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- atypical chronic myeloid leukemia, BCR-ABL negative
- blastic phase chronic myelogenous leukemia
- chronic myelomonocytic leukemia
- chronic phase chronic myelogenous leukemia
- mast cell leukemia
- meningeal chronic myelogenous leukemia
- progressive hairy cell leukemia, initial treatment
- prolymphocytic leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult T-cell leukemia/lymphoma
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- stage 0 chronic lymphocytic leukemia
- stage I adult T-cell leukemia/lymphoma
- stage I chronic lymphocytic leukemia
- stage II adult T-cell leukemia/lymphoma
- stage II chronic lymphocytic leukemia
- stage III adult T-cell leukemia/lymphoma
- stage III chronic lymphocytic leukemia
- stage IV adult T-cell leukemia/lymphoma
- stage IV chronic lymphocytic leukemia
- T-cell large granular lymphocyte leukemia
- untreated adult acute lymphoblastic leukemia
- untreated adult acute myeloid leukemia
- untreated hairy cell leukemia
- recurrent adult Hodgkin lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma
- cutaneous B-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- adult grade III lymphomatoid granulomatosis
- adult nasal type extranodal NK/T-cell lymphoma
- Waldenstrom macroglobulinemia
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II marginal zone lymphoma
- stage I adult Burkitt lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I mantle cell lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- intraocular lymphoma
- primary central nervous system non-Hodgkin lymphoma
- primary central nervous system Hodgkin lymphoma
- post-transplant lymphoproliferative disorder
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- primary myelofibrosis
- essential thrombocythemia
- polycythemia vera
- extramedullary plasmacytoma
- isolated plasmacytoma of bone
- monoclonal gammopathy of undetermined significance
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- primary systemic amyloidosis
- refractory multiple myeloma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoproliferative Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Nervous System Neoplasms
- Precancerous Conditions
- Lymphoma, Large-Cell, Immunoblastic
- Central Nervous System Neoplasms
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
