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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

Must not have

Significant visual, motor, or auditory impairment that would interfere with ability to perform study visits-related activities

Presence of a concurrent autoimmune or inflammatory disease that causes pain or any other chronic pain condition with pain greater than sickle pain

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe vision, hearing, or movement problems affecting study activities.

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I have a chronic pain condition more severe than my sickle cell pain.

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I have a blood clotting issue that may make acupuncture unsafe for me.

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I am suspected of or confirmed to have Covid-19.

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I have nerve damage that affects my daily activities.

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I have had vascular surgery on my legs or currently have leg circulation problems.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional brain connectivity characteristics

Somatosensory function

Secondary study objectives

Adult Sickle Cell Quality Measure (ASCQ-ME) Questionnaire

Brain metabolites characteristics

Brief Pain Inventory (BPI) Questionnaire

+8 more

Other study objectives

Blood hemoglobin level

Brain hemodynamic activity

Brain structural characteristics

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Needling Acupuncture - 5 weeksExperimental Treatment1 Intervention

Needling acupuncture treatment will last 30 minutes per session and will be administered two times per week for 5 weeks. Each subject will receive one course of treatment which contains 10 treatment sessions.

Group II: Needling Acupuncture - 12 weeksExperimental Treatment1 Intervention

Needling acupuncture treatment will last 30 minutes per session and will be administered once per week for 12 weeks. Each subject will receive one course of treatment which contains 12 treatment sessions.

Group III: Laser Acupuncture - 5 weeksExperimental Treatment1 Intervention

Laser acupuncture treatment will also last 30 minutes per session and will be administered two times per week for 5 weeks. Each subject will receive one course of laser acupuncture treatment which contains 10 treatment sessions.

Group IV: Laser Acupuncture - 12 weeksExperimental Treatment1 Intervention

Laser acupuncture treatment will also last 30 minutes per session and will be administered once per week for 12 weeks. Each subject will receive one course of laser acupuncture treatment which contains 12 treatment sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

laser acupuncture

2013

Completed Phase 3

~90

0 / 8Eligibility criteria met