Parkinsons DiseaseNCT01360229
Acupuncture for Fatigue in Parkinson's Disease
A study testing Acupuncture and Acupuncture to treat fatigue in Parkinson disease in people with Parkinsons Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Parkinsons Disease
- What is being tested?
- Acupuncture and Acupuncture to treat fatigue in Parkinson disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2015
- 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 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PD
- Patients 40-99 years of age
- Patients who have significant fatigue
- Patients must be on a stable medication regimen for the treatment of PD
Who cannot join
- Patients who have had previous acupuncture within the past six months
- Patients who have had deep brain stimulation (DBS)
- Patients with dementia, depression, or sleep disorder
- Patients who are currently taking medications known to affect fatigue, such as stimulants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease
This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.
- Conditions
- Parkinsons Disease
- Being tested
- Acupuncture, Acupuncture to treat fatigue in Parkinson disease
- Keywords
- Parkinsons Disease, Fatigue
- Medical subject headings
- Parkinson Disease, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes
Acupuncture to treat fatigue in Parkinson diseaseOther
Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Subjects receive a sham acupuncture. | Sham comparator | Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. Receives: Other: Acupuncture to treat fatigue in Parkinson disease |
| Randomized Subjects receive real acupuncture. | Active comparator | Subjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups
The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2014
- Study completionMay 2015
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.
- Other trials for Parkinsons DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
- Investigators
- Benzi Kluger, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360229
- Sponsor's protocol ID
- 10-0533
- Status last verified
- Jul 2019
- First submitted
- 23 May 2011
- Last updated
- 12 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as a Symptomatic Treatment for Fatigue in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01360229
- Acronym / sponsor ID
- 10-0533
- Conditions
- Parkinsons Disease
- Keywords
- Parkinsons Disease, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Aug 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Posted 12 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safety and effectively treat fatigue in Parkinson's Disease (PD). Eligible subjects will receive either real or sham acupuncture twice weekly for six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized Subjects receive a sham acupuncture. | Sham comparator | Other: Acupuncture to treat fatigue in Parkinson diseaseSubjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. |
| Randomized Subjects receive real acupuncture. | Active comparator | Procedure: AcupunctureSubjects will be randomized in a 1:1 ratio to receive either real or sham acupuncture. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with PD
- Patients 40-99 years of age
- Patients who have significant fatigue
- Patients must be on a stable medication regimen for the treatment of PD
Key exclusion criteria (4 listed)
- Patients who have had previous acupuncture within the past six months
- Patients who have had deep brain stimulation (DBS)
- Patients with dementia, depression, or sleep disorder
- Patients who are currently taking medications known to affect fatigue, such as stimulants
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 |
|---|---|---|
| AcupunctureSubjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes | Procedure or surgery | Randomized Subjects receive real acupuncture. |
| Acupuncture to treat fatigue in Parkinson diseaseSubjects will be randomized in a 1:1 ratio to receive sham acupuncture. | Other | Randomized Subjects receive a sham acupuncture. |
Primary outcome
Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups
Time frame: 6 weeks
The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Benzi Kluger, MD principal investigator
University of Colorado, Denver
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 and Acupuncture to treat fatigue in Parkinson disease in people with Parkinsons Disease, run by University of Colorado, Denver 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 4 inclusion and 4 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 12 Aug 2019. 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. Some participants in this study may receive a placebo. 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 Aug 2019). 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?
Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2019.