Integrative Training for Sickle Cell Disease Pain

(I-STRONG SCD Trial)

Recruiting at 3 trial locations

Overseen By Soumitri Sil, PhD, ABPP

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Disease-modifying treatments

Disqualifiers: Rheumatologic disorders, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

155 Participants Needed

Trial Summary

What is the purpose of this trial?

This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms? The program will be tailored to address challenges related to frequent or chronic sickle cell pain and may improve participants' physical and emotional health. The program, called I-STRONG for SCD (Integrative Strong Body and Mind Training for Sickle Cell Disease), may help improve everyday functioning and pain symptoms in teens with chronic pain related to SCD. The research team aims to determine how participants (teens and parents) respond to this program.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that adolescents should be on stable disease-modifying treatments, meaning no new or significantly increased dosages in the past 3 months.

What data supports the effectiveness of the treatment I-STRONG for Sickle Cell Disease pain?

Research suggests that integrative approaches like yoga and mindfulness can help manage chronic pain in sickle cell disease. These methods are considered safe and may reduce pain intensity and hospital visits, making them promising components of the I-STRONG treatment. ^{1 2 3 4 5}

Is Integrative Training for Sickle Cell Disease Pain safe for humans?

There is limited information on the safety of Integrative Training for Sickle Cell Disease Pain specifically, but exercise and integrative medicine approaches are generally considered safe for managing sickle cell disease-related pain, with careful monitoring and appropriate guidelines. ^{2 6 7 8 9}

How is the I-STRONG treatment for sickle cell disease pain different from other treatments?

I-STRONG is unique because it combines physical and cognitive-behavioral activities to manage pain, unlike traditional treatments that mainly rely on medications with side effects. It focuses on integrative approaches, which are less common in sickle cell disease pain management. ^{2 3 4 7 10}

Research Team

Soumitri Sil, PhD, ABPP

Principal Investigator

Emory University

Eligibility Criteria

This trial is for teenagers with chronic pain due to sickle cell disease (SCD). It's designed to help them manage their condition better. To join, participants must have SCD and experience frequent or long-lasting pain from it.

Inclusion Criteria

Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

Speak and read English

Adolescent scores at least 3 on the Pediatric Pain Screening Tool

Exclusion Criteria

I am currently in a non-drug treatment program like physical therapy.

I have received genetic or stem cell therapy.

Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the I-STRONG for SCD intervention, consisting of 16 group-based telehealth sessions over 8 weeks

8 weeks

16 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Enhanced Usual Care

Participants continue with standard care and optimal management of their SCD and chronic pain

8 months

Treatment Details

Interventions

• I-STRONG for SCD

Trial Overview The study tests a group training program called I-STRONG, which aims to strengthen both mind and body in teens with SCD. The effectiveness of this program will be compared against Enhanced Usual Care (EUC) in improving daily function and reducing pain symptoms.

Participant Groups

Group I: I-STRONG - Early Start Experimental Treatment 1 Intervention

Youth and caregivers will receive the I-STRONG for SCD intervention in addition to standard care.

Group II: Enhanced Usual Care (EUC) Experimental Treatment 1 Intervention

Participants randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months. After completing the 6-month follow-up assessment, participants will have the opportunity to start the I-STRONG SCD intervention.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Adolescents with sickle cell disease (SCD) and chronic pain generally have a positive attitude towards yoga, indicating potential acceptability for a yoga program as a complementary therapy.

Despite the positive opinions, the study faced significant challenges in recruitment and retention, with only 60% of surveyed participants moving to the yoga intervention, and very low attendance at the sessions, highlighting feasibility issues for in-person group yoga interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the acceptability, feasibility and safety of yoga for chronic pain in sickle cell disease. Bakshi, N., Cooley, A., Ross, D., et al.[2021]

Providers at a large urban children's hospital generally have a positive attitude towards using integrative medicine (IM) for managing pain in children with sickle cell disease (SCD), but they do not optimally utilize these therapies due to barriers like lack of integration processes and transient resources.

To enhance the use of IM for SCD-related pain, there is a need for better education for providers about the efficacy of IM and the development of protocols to incorporate these therapies into patient management plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider Perspective on Integrative Medicine for Pediatric Sickle Cell Disease-related Pain. Neri, CM., Beeson, T., Mead, H., et al.[2020]

In a study involving 37 children and adolescents with sickle cell disease, cognitive-behavioral and physical pain management activities were reported to be used alongside analgesics on 77% of pain days, indicating a common practice of combining these methods for pain relief.

The findings suggest that as pain intensity increases, patients, particularly females, are more likely to engage in various pain management activities, highlighting the need for additional training and support for families in using these non-pharmacologic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and cognitive-behavioral activities used in the home management of sickle pain: a daily diary study in children and adolescents. Dampier, C., Ely, E., Eggleston, B., et al.[2022]

This study aims to evaluate the acceptability and preliminary efficacy of a telephonic mindfulness-based intervention (MBI) for managing chronic pain in 60 adults with sickle cell disease (SCD).

Participants will be randomized into an MBI group or a wait-listed control group, with the MBI consisting of six 60-minute sessions, and outcomes will be assessed through questionnaires and interviews to measure pain catastrophizing and overall intervention acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial. Williams, H., Silva, S., Simmons, LA., et al.[2018]

In a study of 156 adults with sickle cell disease, somatization was found to significantly predict pain severity and intensity, indicating that those who focus excessively on their health may experience more pain.

Somatization also correlated with negative psychological outcomes such as depression and anxiety, suggesting that mental health is closely linked to pain perception in patients with sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatization in the conceptualization of sickle cell disease. Wellington, C., Edwards, CL., McNeil, J., et al.[2022]

There is a need for clear exercise guidelines for individuals with sickle cell trait (SCT) and sickle cell anemia (SCA) due to concerns about the risks of high-intensity exercise, which may lead to complications like pain and collapse.

Understanding the distinct issues and mechanisms that affect exercise-related risks in SCT and SCA is crucial for developing safe and effective exercise prescriptions, highlighting the importance of balancing the benefits of exercise against potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balancing exercise risk and benefits: lessons learned from sickle cell trait and sickle cell anemia. Liem, RI.[2019]

The Balance Program, a four-week telemedicine intervention for youth with sickle cell disease (SCD), was found to be feasible and highly acceptable, with 90% of participants completing all sessions and positive feedback from both youth and caregivers.

Approximately 44% of youth and 47% of caregivers reported significant improvements in pain interference after the intervention, indicating that behavioral approaches can effectively complement traditional pharmacological treatments for managing pain in SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of the Balance Program to reduce pain-related disability in pediatric sickle cell disease. Connolly, ME., Forman, S., Sharkey, CM., et al.[2023]

Adults with sickle cell disease (SCD) showed significantly lower levels of cardiorespiratory endurance and muscle strength compared to healthy controls, indicating potential fitness challenges associated with the condition.

A positive correlation was found between muscular strength and cardiorespiratory endurance in adults with SCD, suggesting that improving muscle strength may benefit overall cardiopulmonary health in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of cardiopulmonary endurance and muscular strength in adults living with sickle cell disease. Ogunsile, FJ., Stewart, KJ., Kanter, J., et al.[2022]

Inspiratory muscle training (IMT) significantly improved respiratory muscle strength, lung function, and exercise tolerance in adults with sickle cell anemia, regardless of whether they received true or sham training, indicating a potential benefit of IMT for this patient group.

After 18 weeks of home-based IMT, both groups experienced reductions in dyspnea during daily activities and improvements in fatigue impact, suggesting that IMT can enhance quality of life for individuals with sickle cell anemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home-based inspiratory muscle training on sickle cell disease (SCD) patients. Galvão, F., Zanoni, CT., Moreira, MM., et al.[2021]

The American Society of Hematology developed 18 evidence-based recommendations for managing acute and chronic pain in individuals with sickle cell disease, emphasizing a comprehensive approach that includes both pharmacological and nonpharmacological interventions.

Most recommendations are conditional due to low-certainty evidence, highlighting the need for patient preferences in clinical decisions and the necessity for further research, including randomized controlled trials, to improve pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Brandow, AM., Carroll, CP., Creary, S., et al.[2021]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

A pilot study of the acceptability, feasibility and safety of yoga for chronic pain in sickle cell disease. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Provider Perspective on Integrative Medicine for Pediatric Sickle Cell Disease-related Pain. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Physical and cognitive-behavioral activities used in the home management of sickle pain: a daily diary study in children and adolescents. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Somatization in the conceptualization of sickle cell disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Balancing exercise risk and benefits: lessons learned from sickle cell trait and sickle cell anemia. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of the Balance Program to reduce pain-related disability in pediatric sickle cell disease. [2023]

8. England pubmed.ncbi.nlm.nih.gov

An evaluation of cardiopulmonary endurance and muscular strength in adults living with sickle cell disease. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

Effects of home-based inspiratory muscle training on sickle cell disease (SCD) patients. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. [2021]