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Behavioural Intervention

Acupuncture for Pain in Sickle Cell Disease

N/A

Waitlist Available

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Must not have

Subjects with Covid-19 suspicion or confirmation

Concurrent autoimmune or inflammatory diseases that cause 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 aims to study how effective acupuncture is in reducing pain in patients with sickle cell disease, as well as understand the biological reasons behind its pain-relieving effects.

Who is the study for?

This trial is for individuals with sickle cell disease experiencing pain. Specific details about who can join are not provided, but typically participants must meet certain health criteria and may need to agree to undergo various tests like MRI or EEG as part of the study.

What is being tested?

The study is testing the effectiveness of two types of acupuncture—needling and laser—in managing pain in patients with sickle cell disease. It also aims to understand how acupuncture affects brain activity related to pain.

What are the potential side effects?

Acupuncture side effects can include slight bleeding, bruising, or soreness at needle sites for needling acupuncture. Laser acupuncture usually has fewer side effects but might cause skin irritation in some cases.

Eligibility Criteria

Exclusion Criteria

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

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

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I have a chronic pain condition worse than sickle cell pain.

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I have no history of severe head injury, neuropathy, psychiatric illness, or major sensory/motor issues.

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I don't have metal implants or conditions that prevent MRI scans.

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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 / 5Eligibility criteria met