Acupressure for Sickle Cell Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Disqualifiers: Autoimmune, Inflammatory, Psychiatric, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupressure analgesia in patients with sickle cell disease (SCD).
Will I have to stop taking my current medications?
The trial requires you to limit your current medications for pain control during the study visits, but it doesn't specify if you need to stop them completely. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Acupressure for Sickle Cell Disease?
Research shows that non-drug approaches like deep tissue massage and acupressure can help relieve pain and improve the quality of life for people with sickle cell disease. Additionally, many patients with sickle cell disease use complementary therapies like massage to manage pain, indicating potential benefits.
12345Is acupressure safe for humans?
Research shows that acupressure is generally safe and well-tolerated, with no treatment-related adverse events reported in studies involving adults on hemodialysis and children undergoing medical procedures. Reflexology, a form of acupressure, is also considered safe with no side effects, although massage therapies can have rare risks like soft tissue trauma or spinal issues, especially with spinal manipulation.
678910How does acupressure treatment differ from other treatments for sickle cell disease?
Acupressure for sickle cell disease is unique because it is a non-drug approach that uses pressure on specific points of the body to relieve pain and improve quality of life, unlike traditional treatments that often rely on medications like opioids.
134511Eligibility Criteria
This trial is for adolescents and adults aged 14-80 with Sickle Cell Disease who have had chronic pain or a vaso-occlusive crisis in the past year. Participants must speak English, give consent, limit other pain treatments during the study, and commit to bi-daily acupressure sessions for 5 weeks.Inclusion Criteria
I am between 14 and 80 years old.
I am willing to limit my pain medications during the study.
Fluent in English and capable of giving written informed consent
+3 more
Exclusion Criteria
I have had a head injury that caused me to lose consciousness significantly.
I do not have severe psychiatric conditions like schizophrenia or major depression with suicidal thoughts.
I have used acupuncture or similar methods for pain management in the last 6 months.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive remote self-administered acupressure treatment every other day
5 weeks
Remote self-administration
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of pain, sleep quality, and quality of life
6 months
Remote follow-up visits
Participant Groups
The study tests the effectiveness of acupressure analgesia on patients with Sickle Cell Disease. It involves two types of acupressure techniques to understand how they relieve pain and their underlying neurological mechanisms.
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Care + AcupressureExperimental Treatment1 Intervention
Participants will continue ongoing usual care and administer self-acupressure treatment.
Group II: Usual Care OnlyActive Control1 Intervention
Acupressure 1 is already approved in China, United States for the following indications:
🇨🇳 Approved in China as Acupressure for:
- Pain management
- Osteoarthritis
🇺🇸 Approved in United States as Acupressure for:
- Pain management
- Sickle cell disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, IrvineIrvine, CA
Indiana University School of MedicineIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
University of California, IrvineCollaborator
References
Non-pharmacologic management of sickle cell pain. [2011]Patients with sickle cell disease (SCD) suffer from both acute and chronic pain. The latter includes avascular necrosis of the hip joints mostly in the adult population. It has a negative impact on the quality of life of affected individuals and is often associated with depression, disability, unemployment and dependence on opioid analgesics. In this study, we show that a non-pharmacologic approach to management with deep tissue/deep pressure massage therapy technique, including neuromuscular trigger point treatment with acupressure, in patients with SCD has a salutary effect on pain relief and quality of life.
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.
The use and effectiveness of complementary and alternative medicine for pain in sickle cell anemia. [2022]Pain is the clinical hallmark for sickle cell disease (SCD). The objective of this study was to survey the extent and effectiveness of complementary and alternative medicine (CAM) use for pain control among adults with SCD. Of a total of 227 African-American adults with SCD, 208 (92%) admitted to using at least one type of CAM. The three most common types of CAM were prayer (61%), relaxation technique (44%), and massage (35%). Multiple logistic regression showed that marital status was associated with use of relaxation techniques (p = 0.044), and age between 18 and 24 years and at least a high school level of education were associated with use of prayer (p = 0.008 and p = 0.004 respectively). Our study showed that CAM use is common among adult patients with SCD. Further well designed prospective studies are needed to help develop best practices that emphasize an optimized balance of conventional and evidence based CAM therapies.
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.
A pilot study: the effect of healing touch on anxiety, stress, pain, pain medication usage, and physiological measures in hospitalized sickle cell disease adults experiencing a vaso-occlusive pain episode. [2013]This pilot study was conducted to determine the effectiveness of Healing Touch on anxiety, stress, pain, pain medication usage, and selected physiological measures of hospitalized adults with sickle cell disease experiencing a vaso-occlusive pain episode.
Massage for children undergoing hematopoietic cell transplantation: a qualitative report. [2023]Background. No in-depth qualitative research exists about the effects of therapeutic massage with children hospitalized to undergo hematopoietic cell transplantation (HCT). The objective of this study is to describe parent caregivers' experience of the effects of massage/acupressure for their children undergoing HCT. Methods. We conducted a qualitative analysis of open-ended interviews with 15 parents of children in the intervention arm of a massage/acupressure trial. Children received both practitioner and parent-provided massage/acupressure. Results. Parents reported that their child experienced relief from pain and nausea, relaxation, and greater ease falling asleep. They also reported increased caregiver competence and closeness with their child as a result of learning and performing massage/acupressure. Parents supported a semistandardized massage protocol. Conclusion. Massage/acupressure may support symptom relief and promote relaxation and sleep among pediatric HCT patients if administered with attention to individual patients' needs and hospital routines and may relieve stress among parents, improve caregiver competence, and enhance the sense of connection between parent and child.
Adverse events of massage therapy in pain-related conditions: a systematic review. [2022]Pain-related massage, important in traditional Eastern medicine, is increasingly used in the Western world. So the widening acceptance demands continual safety assessment. This review is an evaluation of the frequency and severity of adverse events (AEs) reported mainly for pain-related massage between 2003 and 2013. Relevant all-languages reports in 6 databases were identified and assessed by two coauthors. During the 11-year period, 40 reports of 138 AEs were associated with massage. Author, year of publication, country of occurrence, participant related (age, sex) or number of patients affected, the details of manual therapy, and clinician type were extracted. Disc herniation, soft tissue trauma, neurologic compromise, spinal cord injury, dissection of the vertebral arteries, and others were the main complications of massage. Spinal manipulation in massage has repeatedly been associated with serious AEs especially. Clearly, massage therapies are not totally devoid of risks. But the incidence of such events is low.
Exploring approaches to patient safety: the case of spinal manipulation therapy. [2022]The purpose of this study was to gain insight into the current safety culture around the use of spinal manipulation therapy (SMT) by regulated health professionals in Canada and to explore perceptions of readiness for implementing formal mechanisms for tracking associated adverse events.
The SIESTA Trial: A Randomized Study Investigating the Efficacy, Safety, and Tolerability of Acupressure versus Sham Therapy for Improving Sleep Quality in Patients with End-Stage Kidney Disease on Hemodialysis. [2020]Objectives. To compare the effectiveness of real acupressure versus sham acupressure therapy in improving sleep quality in patients receiving hemodialysis (HD) or hemodiafiltration (HDF). Methods. A multicenter, single-blind, randomized controlled trial was conducted in two Australian dialysis units located in Princess Alexandra Hospital and Logan Hospital, respectively. Forty-two subjects with self-reported poor sleep quality were randomly assigned to real (n = 21) or sham (n = 21) acupressure therapy delivered thrice weekly for four consecutive weeks during routine dialysis sessions. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) score measured at week four adjusted for baseline PSQI measurements. Secondary outcomes were quality of life (QOL) (SF-8), adverse events, and patient acceptability (treatment acceptability questionnaire, TAQ). Results. The two groups were comparable on global PSQI scores (difference 0.19, 95% confidence interval [CI] -1.32 to 1.70) and on the subscale scores. Similar results were observed for QOL both in the mental (difference -3.88, 95% CI -8.63 to 0.87) and the physical scores (difference 2.45, 95% CI -1.69 to 6.58). There were no treatment-related adverse events and acupressure was perceived favorably by participants. Conclusion. Acupressure is a safe, well-tolerated, and highly acceptable therapy in adult hemodialysis patients in a Western healthcare setting with uncertain implications for therapeutic efficacy.
Reflexology--its place in modern healthcare. [2004]1. Reflexology is a safe treatment promoting homeostasis. 2. It is an ancient method of healing which is regaining popularity. 3. Reflexology has no side-effects, only so-called healing crises--stepping stones to better health. 4. Reflexology is now an established branch of paramedical medicine, and should be available to NHS patients.
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.