Sickle Cell DiseaseNCT04156399

Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study

A study testing Acupuncture in people with Sickle Cell Disease, run by University of Illinois Chicago at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sickle Cell Disease
What is being tested?: Acupuncture
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2020to 15 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults with Sickle Cell Disease
Receiving care at the University of Illinois Sickle Cell Disease clinic
Moderate to severe level of pain (3 or higher on a 0-10 scale) within the last 3 months

Who cannot join

Pregnancy
Physically or cognitively unable to complete the study procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Illinois at Chicago College of Nursing
Chicago, Illinois, 60612

Other trials in United States

About this study

The investigators long-term goal is to demonstrate the effectiveness of acupuncture for the treatment of adults with chronic pain due to sickle cell disease (SCD), a debilitating pain syndrome characterized by acute and chronic pain. The objective of this study is to explore the feasibility and acceptability of acupuncture with adult patients with SCD. All participants will receive acupuncture treatments twice per week for 5 weeks. Subjects will complete measures at baseline and post-treatment, and a measure of study acceptability at post-treatment. The investigators will describe the procedures and potential challenges to implementing the acupuncture protocol, and expect to identify and rectify any procedural problems that subjects report regarding the 10-session study protocol.

Read the detailed description

The investigators will conduct the study with adults with chronic pain from SCD, 18 years old or greater. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will complete measures that include pain, fatigue, anxiety, depressive symptoms, injustice experience, and pain catastrophizing. Subjects will also complete a measure of study acceptability, the Protocol Acceptability Scale for Treating SCD with Acupuncture at post-treatment. The investigators will describe the procedures and potential challenges to implementing the acupuncture protocol and the range in the subjects' Acceptability Scale scores. The investigators will expect to identify and rectify any procedural problems that subjects will report regarding the 10-session study protocol.

Conditions: Sickle Cell Disease
Being tested: Acupuncture
Keywords: sickle cell disease, pain, chronic pain, acupuncture
Medical subject headings: Anemia, Sickle Cell, Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureOther
All subjects will receive a standardized 18 needle acupuncture protocol.

Study groups in NCT04156399
Study group	Role	What they receive
Acupuncture	Experimental	All subjects will receive active acupuncture. Receives: Other: Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD.
Feasibility was measured in terms of participant enrollment and retention and participant completion of study measures. The investigators screened 9 potential participants of which 6 were found to be eligible and all 6 consented to participate and started the study (100% recruitment of eligible SCD patients). Of the 6, 2 completed 10 treatments; 3 completed 8 or 9 treatments by the time the coronavirus disease 2019 (COVID-19) started, but had not missed any treatments and would have most likely completed if the study had not been halted, and completed all pre and post measures (83% retention). The 6th person could not complete because she was hospitalized, but probably would have completed otherwise.
Feasibility and acceptability were the only pre-specified outcome measures.
Measured: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture
Protocol Acceptability Scale for Treating SCD with Acupuncture is a 10-item instrument with scores ranging from 0 to 20 used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study/did not like acupuncture/did not enjoy participating", and 2 means "liked the study/liked acupuncture/enjoyed participating". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 10 questions, divided the total score for the 10 questions by the maximum possible points for the measure, and converted the total mean scores to percentage of participants who liked the study/liked acupuncture/enjoyed participating.
Feasibility \& acceptability were the specified outcome measures.
Measured: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202015 Mar 2020

First posted7 Nov 2019
Study start15 Jan 2020
Primary completion15 Mar 2020
Study completion15 Mar 2020

Why it stopped: Due to the Coronavirus Disease 2019 (COVID-19) pandemic

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
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: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: This study is an unblinded, uncontrolled trial.
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04156399
Sponsor's protocol ID: 2019-1077
Status last verified: Feb 2022
First submitted: 1 Nov 2019
Last updated: 12 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Li H, Patil CL, Molokie RE, Njoku F, Steffen AD, Doorenbos AZ, Schlaeger JM. Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study. Acupunct Med. 2021 Dec;39(6):612-618. doi: 10.1177/09645284211017303. Epub 2021 Jun 3.
PubMed 34080441

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis

All Sickle Cell Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acupuncture for Adults With Sickle Cell Disease (SCD): A Feasibility Study
ClinicalTrials.gov ID: NCT04156399
Acronym / sponsor ID: 2019-1077
Conditions: Sickle Cell Disease
Keywords: sickle cell disease, pain, chronic pain, acupuncture
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to the Coronavirus Disease 2019 (COVID-19) pandemic
Enrolment: 6 participants (actual)
Lead sponsor: University of Illinois ChicagoUniversity, hospital or other
Study start: 15 Jan 2020 (actual)
Primary completion: 15 Mar 2020 (actual)
Study completion: 15 Mar 2020 (actual)
First posted: 7 Nov 2019 (actual)
Results: Posted 12 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This study is an unblinded, uncontrolled trial.

Arm	Type	Receives
Acupuncture	Experimental	Other: AcupunctureAll subjects will receive active acupuncture.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults with Sickle Cell Disease
Receiving care at the University of Illinois Sickle Cell Disease clinic
Moderate to severe level of pain (3 or higher on a 0-10 scale) within the last 3 months

Key exclusion criteria (2 listed)

Pregnancy
Physically or cognitively unable to complete the study procedures

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
AcupunctureAll subjects will receive a standardized 18 needle acupuncture protocol.	Other	Acupuncture

Primary outcome

Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD.
Time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Feasibility was measured in terms of participant enrollment and retention and participant completion of study measures. The investigators screened 9 potential participants of which 6 were found to be eligible and all 6 consented to participate and started the study (100% recruitment of eligible SCD patients). Of the 6, 2 completed 10 treatments; 3 completed 8 or 9 treatments by the time the coronavirus disease 2019 (COVID-19) started, but had not missed any treatments and would have most likely completed if the study had not been halted, and completed all pre and post measures (83% retention). The 6th person could not complete because she was hospitalized, but probably would have completed otherwise. Feasibility and acceptability were the only pre-specified outcome measures.
Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture
Time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
Protocol Acceptability Scale for Treating SCD with Acupuncture is a 10-item instrument with scores ranging from 0 to 20 used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study/did not like acupuncture/did not enjoy participating", and 2 means "liked the study/liked acupuncture/enjoyed participating". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 10 questions, divided the total score for the 10 questions by the maximum possible points for the measure, and converted the total mean scores to percentage of participants who liked the study/liked acupuncture/enjoyed participating. Feasibility \& acceptability were the specified outcome measures.

Results and safety

Results posted to the registry on 12 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acupuncture	6	2

Primary outcome: Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD.

Time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion). Number. Unit: participants

Measure	Acupuncture n = 5
Potential participants eligible	6
Participants consented/started study	6
Participants completed	5
Participants not completed	1

Primary outcome: Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture

Time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion). Mean (Standard Deviation). Unit: score on a scale

Measure	Acupuncture n = 5
Value	16.4 (2.8)

Adverse events

Time frame: 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acupuncture	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): A limitation of the study is that it had to be terminated early due to COVID-19 lockdowns, resulting in only 6 recruited and 5 participants analyzed. Another limitation is the inability to complete all acupuncture sessions on 3 participants due to the pandemic. In addition, the one-armed design reduced the ability to test significant changes in measures (pain intensity, pain interference, fatigue, sleep disturbance, depression, anxiety, and anger) before and after the acupuncture intervention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34080441Li H, Patil CL, Molokie RE, Njoku F, Steffen AD, Doorenbos AZ, Schlaeger JM. Acupuncture for chronic pain in adults with sickle cell disease: a mixed-methods pilot study. Acupunct Med. 2021 Dec;39(6):612-618. doi: 10.1177/09645284211017303. Epub 2021 Jun 3.
Individual participant dataSharing planned: No

Related trials for Sickle Cell Disease

Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
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RecruitingObservational study
HPC Offered for PRESERVE Expansion
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RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
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Not yet recruitingPhase 1
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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.

Judith M Schlaeger, PhD principal investigator

UIC

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 University of Illinois Chicago 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 2 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: stopped early, as of the sponsor's last update on 12 Apr 2022. 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?

Yes. Results are posted in the registry (first posted 12 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD. (time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)). The study lists 2 primary outcomes in all. 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 NCT04156399, 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 12 Apr 2022.