## Protocol Section
### Identification Module
**NCT ID:** NCT00066079

**Brief Title:** Home Based Massage and Relaxation for Sickle Cell Pain

**Official Title:** Home Based Massage and Relaxation for Sickle Cell Pain

#### Organization Study ID Info
**ID:** R21AT001078-01A1
**Link:** https://reporter.nih.gov/quickSearch/R21AT001078-01A1
**Type:** NIH
#### Organization
**Class:** NIH
**Full Name:** National Center for Complementary and Integrative Health (NCCIH)
### Status Module
#### Completion Date
**Date:** 2006-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-08-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-08-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2006-11

**Type:** ACTUAL

#### Start Date
**Date:** 2003-08

**Status Verified Date:** 2008-08

#### Study First Post Date
**Date:** 2003-08-05
**Type:** ESTIMATED
**Study First Submit Date:** 2003-08-01
**Study First Submit QC Date:** 2003-08-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Center for Complementary and Integrative Health (NCCIH)

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** massage

**Type:** PROCEDURE

#### Intervention 2

**Name:** relaxation

**Type:** BEHAVIORAL

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

* 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.

Exclusion Criteria:

* 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)

**Maximum Age:** 65 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** Los Angeles Orthopaedic Hospital - Vascular Medicine Program

**State:** California

**Zip:** 90007

**Location 2:**

**City:** Tampa

**Country:** United States

**Facility:** Moffitt Cancer Center and Research Institute

**State:** Florida

**Zip:** 33612

#### Overall Officials

**Official 1:**

**Affiliation:** The Moffitt Cancer Center

**Name:** Cynthia D. Myers, PhD, LMT

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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:** 7644237

**Citation:** 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:** 8866159

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

**PMID:** 492819

**Citation:** 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:** 523174

**Citation:** 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:** 6399460

**Citation:** 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:** 3663738

**Citation:** 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:** 3138879

**Citation:** 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:** 8788535

**Citation:** 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:** 10711591

**Citation:** 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:** 9308268

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

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

**PMID:** 9872050

**Citation:** 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.

**Citation:** 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.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000000745

- Term: Anemia, Hemolytic, Congenital

- ID: D000000743

- Term: Anemia, Hemolytic

- ID: D000000740

- Term: Anemia

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006453

- Term: Hemoglobinopathies

- ID: D000030342

- Term: Genetic Diseases, Inborn

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29442

- Name: Chronic Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4085

- Name: Anemia, Sickle Cell

- Relevance: HIGH

- As Found: Sickle Cell Disease

- ID: M4070

- Name: Anemia

- Relevance: LOW

- As Found: Unknown

- ID: M9547

- Name: Hemolysis

- Relevance: LOW

- As Found: Unknown

- ID: M4073

- Name: Anemia, Hemolytic

- Relevance: LOW

- As Found: Unknown

- ID: M4075

- Name: Anemia, Hemolytic, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9539

- Name: Hemoglobinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T5229

- Name: Sickle Cell Anemia

- Relevance: HIGH

- As Found: Sickle Cell Disease

### Condition Browse Module - Meshes

- ID: D000000755

- Term: Anemia, Sickle Cell

### Misc Info Module

- Version Holder: 2024-05-24
