Parkinson DiseaseNCT03178175
Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease
A study testing Acupuncture and Needle Insertion in people with Parkinson Disease and Acupuncture, run by Chang Bing Show Chwan Memorial Hospital at 1 site in Taiwan.
Trial summary
This plan is to evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for PD patients. This is a randomized, controlled, single-blind clinical trial. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease, Acupuncture
- What is being tested?
- Acupuncture and Needle Insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Dec 2016to 11 Dec 2018
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 50-75
- Meet the diagnostic criteria of Parkinson's disease: UK (United Kingdom) Parkinson's disease society brain bank clinical diagnostic criteria
- Disease severity of Hoehn-Yahr stage: stage I to III
- clinical condition stable, not adjusting medicine in recent 3 months
- no falling episode in recent 1 year
- live independently
Who cannot join
- already enrolled in another studies
- can't cooperate this evaluation examinations due to poor visual acuity, impaired cognitive function, musculoskeletal system disorder, or psychiatric illness
- any other condition would make participants not to cooperative this study
- can't tolerate acupuncture procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease: A Single Blinded Randomised Controlled Study
This plan is to evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for PD patients. This is a randomized, controlled, single-blind clinical trial.
Read the detailed description
BACKGROUND: Parkinson's disease (PD) is an age-related progressive neurodegenerative disease. The etiology and pathogenetic mechanisms that cause PD are still not fully understood. Scalp acupuncture (SA), a common treatment modality within complementary and alternative medicine, has been widely used for PD.
OBJECTIVE: To evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for PD patients.
DESIGN: Randomized, controlled, single-blind clinical trial. SETTING: Department of Neurology, Chang Bing Show Chwan Memorial Hospital in Changhua County.
PARTICIPANTS: Patients with PD of grade 1 to 3 of Hoehn \& Yahr (H\&Y) scale (N = 26).
INTERVENTIONS: SA group (Si Shen Cong and Baihui) or control group. The techniques were administered by traditional chinese medicine trained in SA and evaluated at baseline and at 20 and 30 minutes.
MAIN OUTCOME MEASURE: Motor score subscale of Unified Parkinson's Disease Rating Scale (UPDRS) was used to measure the motor performances. Balance ability in each patient was assessed as follows: subjects were placed on a force platform (SPS, SYNAPSYS posturography system) to assess the displacement area from the centre of gravity, either with eyes open or closed, in a standing posture. The mini balance evaluation systems test (the mini-BESTest) was used to measure the performance of balance and walking speed. The test was repeated twice each in baseline period, SA period and post-SA period. The Mann-Whitney U test, Chi-square test, and Fisher's exact test were used to compare the baseline characteristics of the 2 groups. One-way repeated measures ANOVA was used to examine the differences among different time points (before, during, and after acupuncture treatment) within a group. Association between continuous variables was evaluated with Spearman's rank correlation coefficient.
- Conditions
- Parkinson Disease, Acupuncture
- Being tested
- Acupuncture, Needle Insertion
- Keywords
- Scalp acupuncture, Parkinson's disease, Balance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
In the acupuncture with "De Qi" group, using stainless tiny needles is inserted to the specific acupoints over the scalp (Si Shen Cong and Baihui) until the "De Qi" phenomenon occurs. The duration is about 30 minutes, and all patients will receive the procedure 16 times within 2 months.
Needle InsertionProcedure or surgery
In the Sham acupuncture group, using stainless tiny needles is inserted to the specific acupoints over the scalp (Si Shen Cong and Baihui) but the needle doesn't reach the exact depth and "De Qi" phenomena doesn't occur. The duration is about 30 minutes, and all patients will receive this procedure 16 times within 2 months.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture with "De Qi" | Experimental | all participants in this group will receive the standard procedure of acupuncture. Receives: Procedure: Acupuncture |
| Sham acupuncture | Sham comparator | In this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth. Receives: Procedure: Needle Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance function evaluation
check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)
Measured: 15-20 minutes
Secondary outcomes (1)
Motor function evaluation
check participant's motor function by UPDRS (Unified Parkinson's Disease Rating Score)
Measured: 15-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start29 Dec 2016
- Primary completion1 Dec 2018
- Study completion11 Dec 2018
Why it stopped: This study will be terminated due to poor patient recruitments.
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Bing Show Chwan Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Hsien Hung, M.D., Principal investigator, Chang Bing Show Chang Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178175
- Sponsor's protocol ID
- 1051004
- Status last verified
- Feb 2019
- First submitted
- 31 May 2017
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Management of Balance Impairment in Patients With Parkinson's Disease: A Single Blinded Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03178175
- Acronym / sponsor ID
- 1051004
- Conditions
- Parkinson Disease, Acupuncture
- Keywords
- Scalp acupuncture, Parkinson's disease, Balance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study will be terminated due to poor patient recruitments.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Chang Bing Show Chwan Memorial HospitalUniversity, hospital or other
- Study start
- 29 Dec 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 6 Jun 2017 (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.
This plan is to evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for PD patients. This is a randomized, controlled, single-blind clinical trial.
Detailed description
BACKGROUND: Parkinson's disease (PD) is an age-related progressive neurodegenerative disease. The etiology and pathogenetic mechanisms that cause PD are still not fully understood. Scalp acupuncture (SA), a common treatment modality within complementary and alternative medicine, has been widely used for PD.
OBJECTIVE: To evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for PD patients.
DESIGN: Randomized, controlled, single-blind clinical trial. SETTING: Department of Neurology, Chang Bing Show Chwan Memorial Hospital in Changhua County.
PARTICIPANTS: Patients with PD of grade 1 to 3 of Hoehn \& Yahr (H\&Y) scale (N = 26).
INTERVENTIONS: SA group (Si Shen Cong and Baihui) or control group. The techniques were administered by traditional chinese medicine trained in SA and evaluated at baseline and at 20 and 30 minutes.
MAIN OUTCOME MEASURE: Motor score subscale of Unified Parkinson's Disease Rating Scale (UPDRS) was used to measure the motor performances. Balance ability in each patient was assessed as follows: subjects were placed on a force platform (SPS, SYNAPSYS posturography system) to assess the displacement area from the centre of gravity, either with eyes open or closed, in a standing posture. The mini balance evaluation systems test (the mini-BESTest) was used to measure the performance of balance and walking speed. The test was repeated twice each in baseline period, SA period and post-SA period. The Mann-Whitney U test, Chi-square test, and Fisher's exact test were used to compare the baseline characteristics of the 2 groups. One-way repeated measures ANOVA was used to examine the differences among different time points (before, during, and after acupuncture treatment) within a group. Association between continuous variables was evaluated with Spearman's rank correlation coefficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture with "De Qi" | Experimental | Procedure: Acupunctureall participants in this group will receive the standard procedure of acupuncture. |
| Sham acupuncture | Sham comparator | Procedure: Needle InsertionIn this group, all participants will receive acupuncture needle insertion but not exact acupoint's location and depth. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 50-75
- Meet the diagnostic criteria of Parkinson's disease: UK (United Kingdom) Parkinson's disease society brain bank clinical diagnostic criteria
- Disease severity of Hoehn-Yahr stage: stage I to III
- clinical condition stable, not adjusting medicine in recent 3 months
- no falling episode in recent 1 year
Key exclusion criteria (4 listed)
- already enrolled in another studies
- can't cooperate this evaluation examinations due to poor visual acuity, impaired cognitive function, musculoskeletal system disorder, or psychiatric illness
- any other condition would make participants not to cooperative this study
- can't tolerate acupuncture procedure
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 |
|---|---|---|
| AcupunctureIn the acupuncture with "De Qi" group, using stainless tiny needles is inserted to the specific acupoints over the scalp (Si Shen Cong and Baihui) until the "De Qi" phenomenon occurs. The duration is about 30 minutes, and all patients will receive the procedure 16 times within 2 months. | Procedure or surgery | acupuncture with "De Qi" |
| Needle InsertionIn the Sham acupuncture group, using stainless tiny needles is inserted to the specific acupoints over the scalp (Si Shen Cong and Baihui) but the needle doesn't reach the exact depth and "De Qi" phenomena doesn't occur. The duration is about 30 minutes, and all patients will receive this procedure 16 times within 2 months. | Procedure or surgery | Sham acupuncture |
Primary outcome
Balance function evaluation
Time frame: 15-20 minutes
check participants' balance function by mini-BESTest (mini-Balance Evaluation Systems Test)
1 secondary outcome
Motor function evaluation
Time frame: 15-20 minutes
Results and safety
The study was stopped early (reason given: This study will be terminated due to poor patient recruitments.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Chao Hsien Hung, M.D. principal investigator
Chang Bing Show Chang Memorial 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 and Needle Insertion in people with Parkinson Disease and Acupuncture, run by Chang Bing Show Chwan Memorial Hospital at 1 site in Taiwan.
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 6 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: stopped early, as of the sponsor's last update on 1 Mar 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 Taiwan. 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 was stopped early (reason given: This study will be terminated due to poor patient recruitments.). Results are not available in the source record.
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?
Balance function evaluation (time frame: 15-20 minutes). 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 1 Mar 2019.