NCT00066079

Brief Summary

The purpose of this study is to compare the effects of in-home, family-administered massage and in-home relaxation training on measures of physical status and health care utilization in a sample of African American adolescents age 15 years and older and adults with chronic pain associated with sickle cell disease who have been randomly assigned to six sessions of either family-administered massage or progressive muscle relaxation training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2003

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2003

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

August 6, 2008

Status Verified

August 1, 2008

Enrollment Period

3.3 years

First QC Date

August 1, 2003

Last Update Submit

August 4, 2008

Conditions

Sickle Cell Disease

Keywords

Sickle Cell PainSickle Cell DiseaseChronic PainAlternative Medicine/TherapyComplementary MedicineMassage TherapyRelaxation TechniqueHome-based Therapy

Interventions

massagePROCEDURE
relaxationBEHAVIORAL

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medically diagnosed with sickle cell disease, including hemoglobin SS disease, hemoglobin SD disease, hemoglobin SC disease, or sickle-thalassemia
  • Self-report of having experienced chronic pain related to sickle cell disease during the past 30 days.
  • Availability of a family member or friend who agrees to be trained to administer massages if the participant is randomized to the massage arm of the study.

You may not qualify if:

  • Sickle cell trait instead of sickle cell disease diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Los Angeles Orthopaedic Hospital - Vascular Medicine Program

Los Angeles, California, 90007, United States

Location

Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (14)

  • Shapiro BS, Dinges DF, Orne EC, Bauer N, Reilly LB, Whitehouse WG, Ohene-Frempong K, Orne MT. Home management of sickle cell-related pain in children and adolescents: natural history and impact on school attendance. Pain. 1995 Apr;61(1):139-144. doi: 10.1016/0304-3959(94)00164-A.

    PMID: 7644237BACKGROUND

  • Elander J, Midence K. A review of evidence about factors affecting quality of pain management in sickle cell disease. Clin J Pain. 1996 Sep;12(3):180-93. doi: 10.1097/00002508-199609000-00006.

    PMID: 8866159BACKGROUND

  • Zeltzer L, Dash J, Holland JP. Hypnotically induced pain control in sickle cell anemia. Pediatrics. 1979 Oct;64(4):533-6.

    PMID: 492819BACKGROUND

  • Co LL, Schmitz TH, Havdala H, Reyes A, Westerman MP. Acupuncture: an evaluation in the painful crises of sickle cell anaemia. Pain. 1979 Oct;7(2):181-185. doi: 10.1016/0304-3959(79)90009-5.

    PMID: 523174BACKGROUND

  • Thomas JE, Koshy M, Patterson L, Dorn L, Thomas K. Management of pain in sickle cell disease using biofeedback therapy: a preliminary study. Biofeedback Self Regul. 1984 Dec;9(4):413-20. doi: 10.1007/BF01000558.

    PMID: 6399460BACKGROUND

  • Cozzi L, Tryon WW, Sedlacek K. The effectiveness of biofeedback-assisted relaxation in modifying sickle cell crises. Biofeedback Self Regul. 1987 Mar;12(1):51-61. doi: 10.1007/BF01000078.

    PMID: 3663738BACKGROUND

  • Wang WC, George SL, Wilimas JA. Transcutaneous electrical nerve stimulation treatment of sickle cell pain crises. Acta Haematol. 1988;80(2):99-102. doi: 10.1159/000205612.

    PMID: 3138879BACKGROUND

  • Gil KM, Wilson JJ, Edens JL, Webster DA, Abrams MA, Orringer E, Grant M, Clark WC, Janal MN. Effects of cognitive coping skills training on coping strategies and experimental pain sensitivity in African American adults with sickle cell disease. Health Psychol. 1996 Jan;15(1):3-10. doi: 10.1037//0278-6133.15.1.3.

    PMID: 8788535BACKGROUND

  • Gil KM, Carson JW, Sedway JA, Porter LS, Schaeffer JJ, Orringer E. Follow-up of coping skills training in adults with sickle cell disease: analysis of daily pain and coping practice diaries. Health Psychol. 2000 Jan;19(1):85-90. doi: 10.1037//0278-6133.19.1.85.

    PMID: 10711591BACKGROUND

  • Dinges DF, Whitehouse WG, Orne EC, Bloom PB, Carlin MM, Bauer NK, Gillen KA, Shapiro BS, Ohene-Frempong K, Dampier C, Orne MT. Self-hypnosis training as an adjunctive treatment in the management of pain associated with sickle cell disease. Int J Clin Exp Hypn. 1997 Oct;45(4):417-32. doi: 10.1080/00207149708416141.

    PMID: 9308268BACKGROUND

  • Jacobson E. 1974. Progressive muscle relaxation. Chicago: University of Chicago Press, Midway Reprint.

    BACKGROUND

  • Field TM. Massage therapy effects. Am Psychol. 1998 Dec;53(12):1270-81. doi: 10.1037//0003-066x.53.12.1270.

    PMID: 9872050BACKGROUND

  • Myers CD, Robinson ME, Guthrie TH, Jr, Lamp SP, Lottenberg R. Adjunctive approaches for sickle cell chronic pain. Alternative Health Practitioner 1999;5:203-212.36.

    BACKGROUND

  • Benjamin LJ, Dampier CD, Jacox AK, Odesina V, Phoenix D, Shapiro B, Strafford M, Treadwell M. Guideline for the management of acute and chronic pain in sickle-cell disease. APS Clinical Practice Guidelines Series, No. 1. 1999. Glenview, IL: American Pain Society.

    BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle CellChronic Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Cynthia D. Myers, PhD, LMT

    The Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

August 1, 2003

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

August 6, 2008

Record last verified: 2008-08

Locations

US(2)