Alteration of grey matter volume is associated with pain and quality of life in children with sickle cell disease.
Ying Wang, Steven J Hardy, Eric Ichesco...
https://pubmed.ncbi.nlm.nih.gov/34418575Actively Recruiting
Phase Not Applicable
Age: 14Years - 80Years
All Genders
ID06725550
Integrative Medicine in Pain Management in Sickle Cell Disease: Assessing the Clinical Efficacy and Neurobiological Impact With Acupuncture, 2.0
Led by Indiana University · Updated on 2025-10-20
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness and neurobiological mechanisms of acupuncture as a non-opioid pain management option in patients with sickle cell disease. The study aims to find out if acupuncture can help relieve pain and understand how it affects the brain and sensory functions in this population. This randomized trial involves participants aged 14 to 80 years who experience chronic pain or vaso-occlusive crisis related to sickle cell disease. Participants will be randomly assigned to one of two acupuncture treatment groups: traditional needling acupuncture or laser acupuncture without needles. Both treatments will last 30 minutes per session and may be given either twice weekly for 5 weeks (10 sessions total) or once weekly for 12 weeks (12 sessions total). The acupuncture points used are based on traditional Chinese medicine and tailored to the individual's specific condition. The laser acupuncture device is positioned close to the skin but does not make physical contact. During the 14 study visits over 6 to 8 weeks and follow-ups for 12 months, participants will complete health questionnaires and undergo tests including quantitative sensory testing to assess sensory function, and brain imaging techniques such as MRI, functional near-infrared spectroscopy, and electroencephalography to monitor brain activity before and after acupuncture sessions. Blood and urine samples, as well as inner eyelid images to examine hemoglobin levels, will be collected. The study will track changes in brain connectivity, sensory function, pain levels, psychological status, fatigue, sleep quality, and quality of life related to pain over the treatment period and follow-up.
CONDITIONS
Brief Title
Integrative Medicine in Pain Management in Sickle Cell Disease, 2.0
Who Can Participate
Age: 14Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Any gender
- Ages 14 to 17 (adolescents) and 18 to 80 (adults) years old
- Right-handed
- Outpatients or inpatients, or changing status between each
- Diagnosed with sickle cell disease (includes types SS, SC, or others) with chronic pain in the past 6 months or vaso-occlusive crisis in the past 12 months
- Currently prescribed analgesic therapy or other palliative treatments
- Willing to limit new pain medications or treatments during the study
- Able to travel to the study site for visits and acupuncture treatments up to twice weekly for 5 weeks
- Fluent in English and able to give written informed consent
You will not qualify if you...
- Suspected or confirmed COVID-19 infection
- Received acupuncture or related pain management in the last 6 months
- Known blood clotting problems or bleeding disorders that may affect acupuncture safety
- Concurrent autoimmune or inflammatory diseases causing pain greater than sickle cell pain
- History of head injury with significant loss of consciousness
- Peripheral neuropathy interfering with daily activities
- Severe psychiatric illnesses (e.g., schizophrenia, major depression with suicidal thoughts)
- Significant visual, motor, or hearing impairments affecting study activities
- Recent start or dose change of stimulant medications in past 30 days
- Contraindications to MRI such as metal implants, cardiac issues, seizure disorders, or certain dental materials
- History of vascular surgery or current vascular problems in lower limbs
- Involvement in workers' compensation, disability claims, or related legal settlements
- Participation in other therapeutic trials with overlapping purposes
- Pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 to 12 weeks
Participants receive acupuncture treatment sessions, either traditional needling acupuncture or laser acupuncture, to manage pain related to sickle cell disease. Treatments occur over either 5 weeks with two sessions per week or 12 weeks with one session per week. Each session lasts about 30 minutes.
10 to 12 sessions depending on group assignment
Follow-up
Duration - Up to 12 months
Participants attend monthly follow-up visits for up to 12 months after completing acupuncture treatment to assess pain-related quality of life and other health outcomes.
Monthly visits for up to 12 months
Trial Site Locations
Total: 1 location
1
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46075
Actively Recruiting
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Research Team
Y
Ying Wang, MD, PhD
Y
Ying Wang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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