Sickle Cell Disease
Conditions
Keywords
sickle cell disease, pain, chronic pain, acupuncture
Brief summary
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.
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.
Interventions
OTHERAcupuncture
All subjects will receive a standardized 18 needle acupuncture protocol.
Sponsors
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
There is no masking. This study is unblinded.
Intervention model description
This study is an unblinded, uncontrolled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Pregnancy * Physically or cognitively unable to complete the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD. | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture All subjects will receive active acupuncture.
Acupuncture: All subjects will receive a standardized 18 needle acupuncture protocol. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | hospitalization unrelated to acupuncture | 1 |
| Overall Study | study suspension due to COVID pandemic | 3 |
Baseline characteristics
| Characteristic | Acupuncture |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
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.
Time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acupuncture | Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD. | Participants consented/started study | 6 participants |
| Acupuncture | Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD. | Participants completed | 5 participants |
| Acupuncture | Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD. | Participants not completed | 1 participants |
| Acupuncture | Feasibility of Performing Acupuncture for the Treatment of Chronic Pain in Adults With SCD. | Potential participants eligible | 6 participants |
Primary
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.
Time frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture | Protocol Acceptability Scale for Treating Sickle Cell Disease With Acupuncture | 16.4 score on a scale | Standard Deviation 2.8 |