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Acupuncture for Sickle Cell Disease Pain Management

N/A

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age range: 14-17 (Adolescents) and 18-80 (Adults)

Diagnosed with SCD (includes but not limited to SS, SC or other type) and experiencing chronic pain in the past 6 months or vaso-occlusive crisis (VOC) in the past 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit.

Awards & highlights

Study Summary

This trial will test if acupuncture can help relieve pain for patients with sickle cell disease, and if so, try to understand how it works.

Who is the study for?

This trial is for right-handed individuals aged 14-80 with sickle cell disease (SCD), experiencing chronic pain or vaso-occlusive crises. Participants must be fluent in English, able to travel for study visits, and willing to limit new pain treatments during the trial. Pregnant/nursing individuals, those with coagulation issues, recent acupuncture treatment, certain chronic conditions or severe psychiatric illnesses are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of acupuncture as a pain management method in SCD patients against a sham procedure (placebo). It involves scheduled visits for questionnaires and various tests like MRI and EEG over five weeks with up to two acupuncture sessions weekly.See study design

What are the potential side effects?

While not specified here, common side effects of acupuncture may include soreness, minor bleeding or bruising at needle sites. The risk of serious side effects is low but could involve injury if needles touch organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 14 and 80 years old.

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I have sickle cell disease and have had chronic pain or a pain crisis in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes of pain-related quality of life scores from baseline to post-treatment time point (approximately 5 weeks interval), as well as monthly follow-up visits till the 12th month of last in-person visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain metabolites characteristics

Functional brain connectivity characteristics

Somatosensory function

Secondary outcome measures

Adult Sickle Cell Quality Measure (ASCQ-ME) Questionnaire

Brief Pain Inventory (BPI) Questionnaire

Hospital Anxiety and Depression Scale (HADS) Questionnaire

+7 more

Other outcome measures

Blood hemoglobin level

Brain hemodynamic activity

Brain structural characteristics

+5 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TreatmentActive Control1 Intervention

Group II: ShamPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH

832 Previous Clinical Trials

668,853 Total Patients Enrolled

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,156 Total Patients Enrolled

Media Library

Acupuncture (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05045820 — N/A

Sickle Cell Disease Research Study Groups: Treatment, Sham

Sickle Cell Disease Clinical Trial 2023: Acupuncture Highlights & Side Effects. Trial Name: NCT05045820 — N/A

Acupuncture (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05045820 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals aged 80 or above be admitted in this trial?

"As per the terms of this medical trial, hopeful participants must fall within a 14 - 80 year old age bracket."

Answered by AI

What is the numerical scope of enrollees participating in this research?

"Affirmative. According to clinicaltrials.gov, this medical experiment is recruiting participants as of now; it was initially posted on June 29th 2021 and last updated on February 4th 2022. They are looking for 120 individuals across 1 research centre."

Answered by AI

Are there any specific prerequisites to be part of this medical investigation?

"This clinical trial is in search of 120 participants aged between 14 and 80 who have received acupuncture. Other criteria to be met include being right-handed, having previously been prescribed analgesic medication or hydroxyurea by a primary hematologist/physician, willingness to limit the introduction of any new medications for pain symptom control during study visits, primarily African American/Black individuals with SCD (though other ethnicities are acceptable), outpatient or inpatient status changing ability, any gender allowed, diagnosed with SCD and experiencing chronic pain within past 6 months or VOC within last 12 months."

Answered by AI

Is there any availability remaining in this research trial?

"Affirmative. Clinicaltrials.gov supports that this research trail, which was initially posted on June 29th 2021, is actively recruiting new participants. Approximately 120 people must be sourced from a solitary medical centre."

Answered by AI

What can we anticipate to be the ultimate conclusions of this investigation?

"This clinical trial is assessing somatosensory function over a five-week period. The primary objectives are evaluated using the Multidimensional Fatigue Inventory (MFI) Questionnaire, which measures General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity on a scale of 4 to 20; the Brief Pain Inventory (BPI) Questionnaire that scores pain severity from 0 to 10; and the Pittsburgh Sleep Quality Index (PSQI), with a range of 0 to 21 indicating worse sleep quality."

Answered by AI

Recent research and studies

Translational ResearchJournal

Alteration of Grey Matter Volume Is Associated with Pain and Quality of Life in Children with Sickle Cell Disease

Wang, Ying, Steven J. Hardy, Eric Ichesco, Pengyue Zhang, Richard E. Harris, and Deepika S. Darbari. 2022. “Alteration of Grey Matter Volume Is Associated with Pain and Quality of Life in Children with Sickle Cell Disease”. Translational Research. Elsevier BV. doi:10.1016/j.trsl.2021.08.004.

Translational ResearchJournal

Alteration of Grey Matter Volume Is Associated with Pain and Quality of Life in Children with Sickle Cell Disease

clinicaltrials.govStudy

Integrative Medicine in Pain Management in Sickle Cell Disease

Ying Wang 2021. "Integrative Medicine in Pain Management in Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05045820.

All > Sickle Cell Disease > Pain