Sickle Cell DiseaseNCT04122378
Acupuncture for Pain in Sickle Cell Disease
A study testing acupuncture in people with Sickle Cell Disease, run by Deepika Darbari at 1 site in United States.
Trial summary
Sickle cell disease (SCD) is the most common genetic disorder in the United States affecting approximately 100,000 individuals primarily of African ancestry. Pain is the most common complication of SCD. Currently, the mainstay therapy for pain in SCD is opioids. Read more about this study
- Who is it for?
- Ages 8 to 22 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- acupuncture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2018to 13 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- subjects with SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSOArab)
- Admitted for management of pain at Children's National.
- Ability to provide informed consent/assent
Who cannot join
- Inability to give informed consent/assent as determined by the investigators
- SCD related complications such as acute chest syndrome requiring supplemental oxygen, fever with bacteremia or concern for serious infection ex. osteomyelitis Local -skin infection or condition not feasible for acupuncture
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Official title: A Pilot Study of Acupuncture for the Treatment of Pain in Sickle Cell Disease
Sickle cell disease (SCD) is the most common genetic disorder in the United States affecting approximately 100,000 individuals primarily of African ancestry. Pain is the most common complication of SCD. Currently, the mainstay therapy for pain in SCD is opioids. The CDC recommends using non-opioid, non-pharmacologic therapies for pain. There is a growing body of literature to support the use of various integrative therapies for pain.
Acupuncture therapy is a non-pharmacological Chinese medicine approach which has been used in many non-SCD conditions associated with pain. Proposed study will test acceptability and feasibility of use of acupuncture in SCD patients hospitalized for pain. It is hypothesized that the use of acupuncture as an adjuvant therapy will be acceptable to SCD patients admitted for pain control. Its impact on opioid use and circulating cytokines and neuropeptides will also be determined.
Read the detailed description
This study will evaluate the acceptability and tolerability of acupuncture in patients with SCD admitted for management of acute pain. SCD patients admitted for pain control will be approached for the study. The participants agreeing to receive acupuncture will receive acupuncture once daily for upto 5 days or the day of discharge.
For the primary endpoint of the study, the investigators will determine the proportions of eligible patients/families that are willing to accept acupuncture with their standard of care management of pain. The investigators anticipate ≥60% of patients will agree to accept acupuncture as part of their inpatient pain management.
The investigators also aim to explore whether the use of acupuncture affects opioid use during hospitalization. This secondary endpoint will evaluate opioid use in morphine milligram equivalent (MME) while hospitalized and other outcomes (side effects, pain control and function) which will be compared between the following two groups of patients
- Treatment group: Participants with SCD hospitalized for acute pain who agree to receive acupuncture (standard of care treatment plus acupuncture)
- Control group: Participants with SCD hospitalized for acute pain who decline to receive acupuncture (standard of care treatment alone) but agree to serve as controls to allow the study team to collect data on pain-related outcomes (secondary end-points above).
This study will also explore if acupuncture modifies the concentration of circulating cytokines and neuropeptides in the study participants. The study team will draw blood at baseline before acupuncture treatment and on the day of discharge or when the decision to discharge to home will be made by the inpatient team. Concentrations of circulating cytokines and neuropeptides will be compared between the groups. .
- Conditions
- Sickle Cell Disease
- Being tested
- acupuncture
- Keywords
- Pain, Acupuncture
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
The acupuncture will be provided by the licensed acupuncturist using standard methods.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Acupuncture will be provided up to once daily for one or more days till the day of discharge or 5 days, whichever occurs first. Patients will continue to receive their standard pain management regime including IV opioids, ketorolac and fluids. Minimum number of sessions received by the acupuncture group will be one. Receives: Other: acupuncture |
| Control Arm | No intervention | Standard of care for SCD patients who are hospitalized for acute pain and typically includes IV opioids, ketorolac and fluids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment ratio
Number of participants with SCD hospitalized for acute pain who enroll in the study on the acupuncture arm /total number of SCD patients hospitalized for acute pain who enroll in the study will be assessed. This information will determine if acupuncture is a acceptable treatment modality for patients with SCD hospitalized for pain.
Measured: Duration of the study upto 5 years
Secondary outcomes (1)
Opioid use in morphine milligram equivalents (MME)
Opioid use in MME will be calculated in both group of study participants (acupuncture with standard of care arm and standard of care arm) to determine if there are any difference in opioid use between the groups.
Measured: Duration of hospitalization up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start23 Oct 2018
- Primary completion1 Aug 2020
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Proposed study is a feasibility study of acupuncture therapy in patients with SCD admitted for management of acute pain. The primary goal of proposed study is to determine (1) if acupuncture is acceptable modality for management of pain in patients with SCD. The investigators will also explore (2) if acupuncture improves pain outcomes in SCD and (3) if use of acupuncture is associated with modulation of cytokines.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deepika Darbari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deepika Darbari, Children's National Research Institute
- Investigators
- Deepika Darbari, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122378
- Sponsor's protocol ID
- Pro00010719
- Status last verified
- Jul 2022
- First submitted
- 2 Oct 2019
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Reece-Stremtan S, Mahmood L, Margulies S, Martin B, Rohatgi R, Idiokitas R, Cohen IT, Zhang A, Thaniel L, Hardy SJ, Darbari DS. Acupuncture as an Adjunctive Treatment for Pain in Hospitalized Children With Sickle Cell Disease. J Pain Symptom Manage. 2021 Dec;62(6):1239-1244. doi: 10.1016/j.jpainsymman.2021.06.003. Epub 2021 Jun 9.
PubMed 34118373
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Acupuncture for the Treatment of Pain in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04122378
- Acronym / sponsor ID
- Pro00010719
- Conditions
- Sickle Cell Disease
- Keywords
- Pain, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Deepika DarbariUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sickle cell disease (SCD) is the most common genetic disorder in the United States affecting approximately 100,000 individuals primarily of African ancestry. Pain is the most common complication of SCD. Currently, the mainstay therapy for pain in SCD is opioids. The CDC recommends using non-opioid, non-pharmacologic therapies for pain. There is a growing body of literature to support the use of various integrative therapies for pain.
Acupuncture therapy is a non-pharmacological Chinese medicine approach which has been used in many non-SCD conditions associated with pain. Proposed study will test acceptability and feasibility of use of acupuncture in SCD patients hospitalized for pain. It is hypothesized that the use of acupuncture as an adjuvant therapy will be acceptable to SCD patients admitted for pain control. Its impact on opioid use and circulating cytokines and neuropeptides will also be determined.
Detailed description
This study will evaluate the acceptability and tolerability of acupuncture in patients with SCD admitted for management of acute pain. SCD patients admitted for pain control will be approached for the study. The participants agreeing to receive acupuncture will receive acupuncture once daily for upto 5 days or the day of discharge.
For the primary endpoint of the study, the investigators will determine the proportions of eligible patients/families that are willing to accept acupuncture with their standard of care management of pain. The investigators anticipate ≥60% of patients will agree to accept acupuncture as part of their inpatient pain management.
The investigators also aim to explore whether the use of acupuncture affects opioid use during hospitalization. This secondary endpoint will evaluate opioid use in morphine milligram equivalent (MME) while hospitalized and other outcomes (side effects, pain control and function) which will be compared between the following two groups of patients
- Treatment group: Participants with SCD hospitalized for acute pain who agree to receive acupuncture (standard of care treatment plus acupuncture)
- Control group: Participants with SCD hospitalized for acute pain who decline to receive acupuncture (standard of care treatment alone) but agree to serve as controls to allow the study team to collect data on pain-related outcomes (secondary end-points above).
This study will also explore if acupuncture modifies the concentration of circulating cytokines and neuropeptides in the study participants. The study team will draw blood at baseline before acupuncture treatment and on the day of discharge or when the decision to discharge to home will be made by the inpatient team. Concentrations of circulating cytokines and neuropeptides will be compared between the groups. .
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Proposed study is a feasibility study of acupuncture therapy in patients with SCD admitted for management of acute pain. The primary goal of proposed study is to determine (1) if acupuncture is acceptable modality for management of pain in patients with SCD. The investigators will also explore (2) if acupuncture improves pain outcomes in SCD and (3) if use of acupuncture is associated with modulation of cytokines.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: acupunctureAcupuncture will be provided up to once daily for one or more days till the day of discharge or 5 days, whichever occurs first. Patients will continue to receive their standard pain management regime including IV opioids, ketorolac and fluids. Minimum number of sessions received by the acupuncture group will be one. |
| Control Arm | No intervention | –Standard of care for SCD patients who are hospitalized for acute pain and typically includes IV opioids, ketorolac and fluids. |
Who may qualify
- Ages
- 8 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- subjects with SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSOArab)
- Admitted for management of pain at Children's National.
- Ability to provide informed consent/assent
Key exclusion criteria (3 listed)
- Inability to give informed consent/assent as determined by the investigators
- SCD related complications such as acute chest syndrome requiring supplemental oxygen, fever with bacteremia or concern for serious infection ex. osteomyelitis Local -skin infection or condition not feasible for acupuncture
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureThe acupuncture will be provided by the licensed acupuncturist using standard methods. | Other | Treatment Arm |
Primary outcome
Recruitment ratio
Time frame: Duration of the study upto 5 years
Number of participants with SCD hospitalized for acute pain who enroll in the study on the acupuncture arm /total number of SCD patients hospitalized for acute pain who enroll in the study will be assessed. This information will determine if acupuncture is a acceptable treatment modality for patients with SCD hospitalized for pain.
1 secondary outcome
Opioid use in morphine milligram equivalents (MME)
Time frame: Duration of hospitalization up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Results publication: PubMed 34118373Reece-Stremtan S, Mahmood L, Margulies S, Martin B, Rohatgi R, Idiokitas R, Cohen IT, Zhang A, Thaniel L, Hardy SJ, Darbari DS. Acupuncture as an Adjunctive Treatment for Pain in Hospitalized Children With Sickle Cell Disease. J Pain Symptom Manage. 2021 Dec;62(6):1239-1244. doi: 10.1016/j.jpainsymman.2021.06.003. Epub 2021 Jun 9.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepika Darbari, MD principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Sickle Cell Disease, run by Deepika Darbari at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment ratio (time frame: Duration of the study upto 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.