Sickle Cell DiseasePhase 2NCT00066079
Home Based Massage and Relaxation for Sickle Cell Pain
A Phase 2 study testing massage and relaxation in people with Sickle Cell Disease, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- massage and relaxation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2003to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Sickle cell trait instead of sickle cell disease diagnosis.
- Diagnosis of disease in addition to sickle cell disease which requires regular use of pain medication. (Please note, regular use of pain medication for sickle cell pain is NOT an exclusion)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles Orthopaedic Hospital - Vascular Medicine Program
Los Angeles, California, 90007
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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.
- Conditions
- Sickle Cell Disease
- Being tested
- massage, relaxation
- Keywords
- Sickle Cell Pain, Sickle Cell Disease, Chronic Pain, Alternative Medicine/Therapy, Complementary Medicine, Massage Therapy, Relaxation Technique, Home-based Therapy
- Medical subject headings
- Anemia, Sickle Cell, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageProcedure or surgery
relaxationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startAug 2003
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Cynthia D. Myers, PhD, LMT, Principal investigator, The Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066079
- Sponsor's protocol ID
- R21AT001078-01A1
- Status last verified
- Aug 2008
- First submitted
- 1 Aug 2003
- Last updated
- 6 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 7644237Elander 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.
PubMed 8866159Zeltzer L, Dash J, Holland JP. Hypnotically induced pain control in sickle cell anemia. Pediatrics. 1979 Oct;64(4):533-6.
PubMed 492819Co 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.
PubMed 523174Thomas 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.
PubMed 6399460Cozzi 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.
PubMed 3663738Wang 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.
PubMed 3138879Gil 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.
PubMed 8788535Gil 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.
PubMed 10711591Dinges 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.
PubMed 9308268Jacobson E. 1974. Progressive muscle relaxation. Chicago: University of Chicago Press, Midway Reprint.
Field TM. Massage therapy effects. Am Psychol. 1998 Dec;53(12):1270-81. doi: 10.1037//0003-066x.53.12.1270.
PubMed 9872050Myers 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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Based Massage and Relaxation for Sickle Cell Pain
- ClinicalTrials.gov ID
- NCT00066079
- Acronym / sponsor ID
- R21AT001078-01A1
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Pain, Sickle Cell Disease, Chronic Pain, Alternative Medicine/Therapy, Complementary Medicine, Massage Therapy, Relaxation Technique, Home-based Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Aug 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 5 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Sickle cell trait instead of sickle cell disease diagnosis.
- Diagnosis of disease in addition to sickle cell disease which requires regular use of pain medication. (Please note, regular use of pain medication for sickle cell pain is NOT an exclusion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massage | Procedure or surgery | – |
| relaxation | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2008.
- Background: PubMed 7644237Shapiro 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.
- Background: PubMed 8866159Elander 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.
- Background: PubMed 492819Zeltzer L, Dash J, Holland JP. Hypnotically induced pain control in sickle cell anemia. Pediatrics. 1979 Oct;64(4):533-6.
- Background: PubMed 523174Co 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.
- Background: PubMed 6399460Thomas 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.
- Background: PubMed 3663738Cozzi 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.
- Background: PubMed 3138879Wang 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.
- Background: PubMed 8788535Gil 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.
- Background: PubMed 10711591Gil 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.
- Background: PubMed 9308268Dinges 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.
- BackgroundJacobson E. 1974. Progressive muscle relaxation. Chicago: University of Chicago Press, Midway Reprint.
- Background: PubMed 9872050Field TM. Massage therapy effects. Am Psychol. 1998 Dec;53(12):1270-81. doi: 10.1037//0003-066x.53.12.1270.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia D. Myers, PhD, LMT principal investigator
The Moffitt Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing massage and relaxation in people with Sickle Cell Disease, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066079, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2008.