Parkinson DiseaseNCT02587754
Acupuncture in the Treatment of Fatigue in Parkinson's Disease
A study testing Acupuncture in people with Parkinson Disease and Fatigue, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
This study evaluates the efficacy of acupuncture in the treatment of fatigue in participants with Parkinson's Disease. Half of participants will receive real acupuncture while the half will receive placebo acupuncture. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Parkinson Disease, Fatigue
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2015to 27 Apr 2017
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PD based on criteria developed by Gelb et al which is adopted by the National Institute of Neurological Disorders and Stroke, US National Institute of Health.
- Age 21-85 years old
- Presence of persistent fatigue of a moderate level for at least 4 weeks' duration. Moderate fatigue is defined as a score of ≥10 on the general fatigue domain of the Multidimensional Fatigue Inventory.
- No acupuncture treatment in the past 6 months.
Who cannot join
- Significant cognitive, language or psychiatric illnesses which prevents the subject from understanding instructions and participating in the study.
- Needle phobia
- Comorbidity with a bleeding disorder
- Known anemia with hemoglobin level less than 10g/dl.
- Known congestive cardiac failure and/or end stage renal disease
- Female subjects of childbearing age
- Presence of symptomatic postural hypotension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture in the Treatment of Fatigue in Parkinson's Disease: a Pilot Randomized Controlled Study
This study evaluates the efficacy of acupuncture in the treatment of fatigue in participants with Parkinson's Disease. Half of participants will receive real acupuncture while the half will receive placebo acupuncture.
Read the detailed description
This will be a single centre, single blinded 2-group randomized controlled study, with participants receiving either verum acupuncture or placebo acupuncture.
A retractable non-invasive placebo needle will be used in the placebo arm. Both the real and placebo needles have a fine needle body and copy handle and look exactly the same. However, the placebo needle has a retractable shaft and blunt tip. When pressed onto the skin, it telescopes into the handle and the blunt tip stays on the skin instead of penetrating it. The plastic tube with adhesive foot-plate is placed on the skin to hold it in place. The real needle, on the other hand, has a normal sharp tip which allows it to pierce the skin.
The following acupoints will be needled: Stomach 36 (bilateral), Spleen 6 (bilateral), Kidney 3 (bilateral), Large Intestine 4 (bilateral), Pericardium 6 (bilateral), and Conception Vessel 6. These points were chosen based on Traditional Chinese Medicine theory (which attributed fatigue to deficiencies of spleen, kidney and qi).
Each acupuncture session will be based on a strict protocol, and conversation between acupuncturists and participants will be kept to a minimum.
Participants will be assessed at 3 intervals:
- Week 0 (baseline)
- Week 5 (completion of intervention)
- Week 9 (4 weeks after completion of intervention
- Conditions
- Parkinson Disease, Fatigue
- Being tested
- Acupuncture
- 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.
AcupunctureDevice
10 sessions of acupuncture, twice a week over 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Verum acupuncture | Active comparator | 10 sessions of verum acupuncture Receives: Device: Acupuncture |
| Placebo acupuncture | Placebo comparator | 10 sessions of placebo acupuncture via use of placebo acupuncture needles Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Fatigue score of the Multidimensional Fatigue Inventory
Measure of fatigue
Measured: General Fatigue score of the Multidimensional Fatigue Inventory at week 5
Secondary outcomes (7)
General Fatigue score of the Multidimensional Fatigue Inventory
Measure of fatigue
Measured: General Fatigue score of the Multidimensional Fatigue Inventory at week 9
Unified Parkinson's Disease Rating Scale (UPDRS)
Measure of severity of Parkinson's Disease
Measured: UPDRS score at week 5
Unified Parkinson's Disease Rating Scale (UPDRS)
Measure of severity of Parkinson's Disease
Measured: UPDRS score at week 9
Parkinson's Disease Questionnaire-39 (PD 39).
Measure of quality of life
Measured: PD 39 score at week 5
Parkinson's Disease Questionnaire-39 (PD 39).
Measure of quality of life
Measured: PD 39 score at week 9
Geriatric Depression Scale (GDS)
Measure of depression
Measured: GDS score at week 5
Geriatric Depression Scale (GDS)
Measure of depression
Measured: GDS score at week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm study comparing acupuncture with sham
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Responsible party
- Sponsor
- Investigators
- Keng H Kong, MBBS, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587754
- Sponsor's protocol ID
- 001
- Status last verified
- Apr 2017
- First submitted
- 16 Oct 2015
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in the Treatment of Fatigue in Parkinson's Disease: a Pilot Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02587754
- Acronym / sponsor ID
- 001
- Conditions
- Parkinson Disease, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 27 Oct 2015 (estimated)
- 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.
This study evaluates the efficacy of acupuncture in the treatment of fatigue in participants with Parkinson's Disease. Half of participants will receive real acupuncture while the half will receive placebo acupuncture.
Detailed description
This will be a single centre, single blinded 2-group randomized controlled study, with participants receiving either verum acupuncture or placebo acupuncture.
A retractable non-invasive placebo needle will be used in the placebo arm. Both the real and placebo needles have a fine needle body and copy handle and look exactly the same. However, the placebo needle has a retractable shaft and blunt tip. When pressed onto the skin, it telescopes into the handle and the blunt tip stays on the skin instead of penetrating it. The plastic tube with adhesive foot-plate is placed on the skin to hold it in place. The real needle, on the other hand, has a normal sharp tip which allows it to pierce the skin.
The following acupoints will be needled: Stomach 36 (bilateral), Spleen 6 (bilateral), Kidney 3 (bilateral), Large Intestine 4 (bilateral), Pericardium 6 (bilateral), and Conception Vessel 6. These points were chosen based on Traditional Chinese Medicine theory (which attributed fatigue to deficiencies of spleen, kidney and qi).
Each acupuncture session will be based on a strict protocol, and conversation between acupuncturists and participants will be kept to a minimum.
Participants will be assessed at 3 intervals:
- Week 0 (baseline)
- Week 5 (completion of intervention)
- Week 9 (4 weeks after completion of intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 arm study comparing acupuncture with sham
| Arm | Type | Receives |
|---|---|---|
| Verum acupuncture | Active comparator | Device: Acupuncture10 sessions of verum acupuncture |
| Placebo acupuncture | Placebo comparator | Device: Acupuncture10 sessions of placebo acupuncture via use of placebo acupuncture needles |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PD based on criteria developed by Gelb et al which is adopted by the National Institute of Neurological Disorders and Stroke, US National Institute of Health.
- Age 21-85 years old
- Presence of persistent fatigue of a moderate level for at least 4 weeks' duration. Moderate fatigue is defined as a score of ≥10 on the general fatigue domain of the Multidimensional Fatigue Inventory.
- No acupuncture treatment in the past 6 months.
Key exclusion criteria (7 listed)
- Significant cognitive, language or psychiatric illnesses which prevents the subject from understanding instructions and participating in the study.
- Needle phobia
- Comorbidity with a bleeding disorder
- Known anemia with hemoglobin level less than 10g/dl.
- Known congestive cardiac failure and/or end stage renal disease
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 |
|---|---|---|
| Acupuncture10 sessions of acupuncture, twice a week over 5 weeks. | Device | Placebo acupuncture, Verum acupuncture |
Primary outcome
General Fatigue score of the Multidimensional Fatigue Inventory
Time frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 5
Measure of fatigue
7 secondary outcomes
General Fatigue score of the Multidimensional Fatigue Inventory
Time frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 9
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: UPDRS score at week 5
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: UPDRS score at week 9
Parkinson's Disease Questionnaire-39 (PD 39).
Time frame: PD 39 score at week 5
Parkinson's Disease Questionnaire-39 (PD 39).
Time frame: PD 39 score at week 9
Geriatric Depression Scale (GDS)
Time frame: GDS score at week 5
Geriatric Depression Scale (GDS)
Time frame: GDS score at week 9
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 11 Jul 2017.
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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.
Keng H Kong, MBBS principal investigator
Tan Tock Seng Hospital
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 Parkinson Disease and Fatigue, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 7 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 11 Jul 2017. 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 Singapore. 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?
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?
General Fatigue score of the Multidimensional Fatigue Inventory (time frame: General Fatigue score of the Multidimensional Fatigue Inventory at week 5). 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 11 Jul 2017.