Acupuncture for Sickle Cell Disease Pain Management
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Must not be taking: Stimulants
Disqualifiers: Covid-19, Autoimmune diseases, Severe psychiatric, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupuncture analgesia in patients with sickle cell disease.
Do I need to stop taking my current medications for the trial?
The trial does not require you to stop taking your current medications, but you must be willing to limit any new medications or treatments for pain control during the study visits.
What data supports the effectiveness of acupuncture as a treatment for sickle cell disease pain management?
Research suggests that acupuncture may help manage pain in sickle cell disease, as it has been effective in other pain conditions and is considered a promising non-opioid therapy. Some studies report positive outcomes in pain relief for sickle cell patients using acupuncture, highlighting its potential as a simple and convenient treatment option.
12345Is acupuncture safe for managing pain in sickle cell disease?
Acupuncture is generally considered safe, but it can have minor side effects like dizziness or local reactions, and rare serious events like organ injuries or infections. It's important to ensure the acupuncturist is well-trained to minimize risks.
678910How does acupuncture differ from other treatments for sickle cell disease pain management?
Acupuncture is a unique treatment for sickle cell disease pain management because it is a non-drug therapy that involves inserting thin needles into specific points on the body to relieve pain. Unlike opioids, which are commonly used for pain relief but have many side effects, acupuncture offers a non-opioid alternative that has shown promise in improving pain control without the associated risks of medication.
123511Eligibility Criteria
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.Inclusion Criteria
Right-handed
I can be treated as an outpatient or inpatient.
I can visit the study site regularly for 5 weeks to receive acupuncture.
+8 more
Exclusion Criteria
I have not started or changed the dose of stimulant medications in the last 30 days.
I do not have severe vision, hearing, or movement problems affecting study activities.
Known non-SCD related Severe psychiatric illnesses
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive either needling or laser acupuncture treatment for pain management in sickle cell disease
5 weeks
10 visits (in-person)
Extended Treatment
Participants receive additional acupuncture sessions, either needling or laser, once per week
12 weeks
12 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Monthly visits (in-person)
Participant Groups
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.
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.
Acupuncture is already approved in United States, European Union, China, Australia for the following indications:
🇺🇸 Approved in United States as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
- Neuropathy
🇪🇺 Approved in European Union as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
🇨🇳 Approved in China as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
- Neuropathy
🇦🇺 Approved in Australia as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University School of MedicineIndianapolis, IN
Loading ...
Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
References
Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol. [2023]People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems.
Acupuncture for pediatric sickle cell pain management: A promising non-opioid therapy. [2020]To describe the use of acupuncture for pain management in children with sickle cell disease.
Acupuncture and blood studies in sickle-cell anemia. [2006]The author recently treated a case of sickle-cell crisis as an emergency for pain relief using acupuncture because all other conventional therapies failed. The result was so effective, dramatic and encouraging that four other cases of genotype SS/SC were also treated. These cases are reported, (though small in number) to bring attention to this easy, simple, cheap and convenient therapy and to stimulate research among practicing acupuncturists and clinicians.
Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain. [2023]Objective: This study aimed to explore perspectives of people living with sickle cell disease (SCD) and SCD clinic providers and staff about the use of acupuncture and guided relaxation for treating chronic SCD pain. Data obtained were to inform an implementation blueprint for an effectiveness implementation clinical trial (GRACE Trial) testing whether acupuncture or guided relaxation reduces chronic pain when compared with usual care. Design: Qualitative research design. Methods: We conducted 33 semistructured interviews with people with SCD and SCD clinic providers and staff. Interviews were transcribed and coded. A deductive content analysis process was used to identify themes. Results: Four themes were identified: Receptivity to Acupuncture and Guided Relaxation, Limited Awareness, Complementary and Integrative Health (CIH) Therapy Preference, and Access Barriers. Both patients and clinic providers and staff were open to the use of acupuncture and guided relaxation for chronic pain treatment. After learning about these CIH therapies, some patients expressed a preference for one therapy over the other. They also discussed their ability to successfully engage with each therapy. There is a need to dispel misconceptions about the therapies by increasing understanding of how each therapy is implemented and functions to reduce pain. We identified several potential barriers that might affect the success of the trial and future health system integration, including time, transportation, and technology. Conclusion: This study is one of the first to present perspectives of both patients with SCD and clinic providers and staff on the use of acupuncture and guided relaxation for chronic SCD pain. Stakeholders' early input and perspectives highlighted that they welcome nonpharmacological CIH therapies. Implementation of a clinical trial and future health system integration will require the addressing misinformation and identifying strategies to overcome access barriers. Clinical trial registration number: NCT04906447.
Acupuncture for pain management in children with sickle cell disease. [2020]Pain associated with sickle cell disease (SCD) is frequently treated with opioids which have many side effects. There is a need for adjuvant non-opioid therapies that can improve pain control. Acupuncture, an integrative approach, has been shown to be useful in non-SCD pain conditions but has been used to a very limited extent in SCD. In this report we present a single academic pediatric center experience showing acceptability, feasibility and improved pain experience with adjuvant acupuncture therapy in children with SCD and suggest that acupuncture should be explored as a treatment option for managing pain in SCD.
Acupuncture-related adverse events: a systematic review of the Chinese literature. [2022]to systematically review the Chinese-language literature on acupuncture-related adverse events.
Safety of Acupuncture: Overview of Systematic Reviews. [2022]Acupuncture is increasingly used worldwide. It is becoming more accepted by both patients and healthcare providers. However, the current understanding of its adverse events (AEs) is fragmented. We conducted this overview to collect all systematic reviews (SRs) on the AEs of acupuncture and related therapies. MEDLINE and EMBASE were searched from inception to December 2015. Methodological quality of included reviews was assessed with a validated instrument. Evidence was narratively reported. Seventeen SRs covering various types of acupuncture were included. Methodological quality of the reviews was overall mediocre. Four major categories of AEs were identified, which are organ or tissue injuries (13 reviews, median: 36 cases, median deaths: 4), infections (11 reviews, median: 17 cases, median deaths: 0.5), local AEs or reactions (12 reviews, median: 8.5 cases, no deaths were reported), and other complications such as dizziness or syncope (11 reviews, median: 21 cases, no deaths were reported). Minor and serious AEs can occur during the use of acupuncture and related modalities, contrary to the common impression that acupuncture is harmless. Serious AEs are rare, but need significant attention as mortality can be associated with them. Referrals should consider acupuncturists' training credibility, and patient safety should be a core part of acupuncture education.
Adverse effects of acupuncture. Which are clinically significant? [2022]To review potentially serious adverse events associated with acupuncture.
Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. [2021]In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs) to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence.
Safety of acupuncture by Korean Medicine Doctors: a prospective, practice-based survey of 37,490 consultations. [2022]To evaluate safety of acupuncture treatment by Korean Medicine Doctors (KMDs), a prospective, practice-based survey on adverse events (AEs) associated with acupuncture was conducted.
Acupuncture: an evaluation in the painful crises of sickle cell anaemia. [2021]An evaluation of acupuncture for pain relief was made in 10 patients with sickle cell anaemia during 16 pain crises. A model was developed in which the patient served as his own control and in which both patient and examiner were unaware of whether an acupuncture point or a sham site was treated. The results show (1) that pain relief was obtained in 15 of the 16 painful episodes regardless of whether an acupuncture point or a sham site was treated, demonstrating considerable overlap between the effects of needling acupuncture points and sham sites; (2) that needling at acupuncture points for pain relief is not significantly superior to treatment at sham sites; (3) that needling, per se, whether at acupuncture points of at sham sites can be useful for alleviating pain in sickle cell crises. The model could be useful for evaluation of pain relief by needling in other diseases.