Parkinson DiseaseNCT04874090
The Effectiveness of Acupuncture Therapy on Pain in Parkinson's Disease
A study testing Acupuncture and Exercises in people with Parkinson Disease and Pain, Neck, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder that is characterized by motor and nonmotor symptoms and its incidence increases with age. It has been reported that 40-90% of patients have pain symptoms in PD. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson Disease, Pain, Neck
- What is being tested?
- Acupuncture and Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2021to 1 Aug 2021
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being Parkinson's Disease
- Age 45-75
- Have a pain due to Parkinson's Disease
Who cannot join
- Presence of advanced dementia or mental disability
- Pain due to ınflammatory conditions
- Using anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Dry Needle Treatment Applied to Acupuncture Points in Parkinson's Disease on Pain
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder that is characterized by motor and nonmotor symptoms and its incidence increases with age. It has been reported that 40-90% of patients have pain symptoms in PD. Pain can be the result of motor fluctuations, dystonic muscle contractions, deep visceral pain, and musculoskeletal pain.
Read the detailed description
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder that is characterized by motor and nonmotor symptoms and its incidence increases with age. It is the second most common neurodegenerative disease after Alzheimer's.Bradykinesia, which is characterized by rigidity, resting tremor, postural instability, gait disturbance and progressive decrease in the speed and amplitude of repetitive movements throughout the course of the disease, are the main cardinal motor findings.Sensory dysfunction such as non-motor findings in PD, disruption in the sleep-wake cycle, neuropsychiatric findings such as dementia, confusion, hallucinations, delirium, depression, gastrointestinal dysfunction, autonomic nervous system disorders such as bladder dysfunction, orthostatic hypotension, and pain perception may develop.Although dopaminergic therapies in PD are the gold standard in the treatment of disorders such as bradykinesia, rigidity and tremor, adequate response cannot be obtained in the treatment of non-motor symptoms. For this reason, rehabilitative applications, especially pain symptom, and complementary medicine methods are very important.It has been reported that 40-90% of patients have pain symptoms in PD. Pain can be the result of motor fluctuations, dystonic muscle contractions, deep visceral pain, and musculoskeletal pain.
Acupuncture and dry needling therapy have been used clinically for a long time as pain relievers such as migraine pain, low back pain, chronic pain and cancer pain. On the other hand, there are very limited and very limited number of studies on the efficacy of dry needle therapy applied to acupuncture points in pain control in PD.In this study, our aim is to investigate the effectiveness of dry needling treatment applied to acupuncture points in neck pain due to PH on musculoskeletal pains.
- Conditions
- Parkinson Disease, Pain, Neck
- Being tested
- Acupuncture, Exercises
- Medical subject headings
- Parkinson Disease, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Investigator will apply the acupuncture treatment to the first group to the neck area. BL-15, BL-18, BL-23, BL-25, KB-4, Du-20, GB-20, CV-14, KB-10, Ex-26, Yin Tang, Ah-shi points will be used. 0.25x25 mm, sterile, steel, disposable, acupuncture needle will be used for acupuncture points and painful trigger points. The treatment will be applied twice a week, on average 10 sessions. Dry needling treatment will be applied to the patients by a certified physician. All patient will be performed the neck exercises program
ExercisesOther
Patient will perform neck exercises
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Investigator will apply the acupuncture treatment to the first group to the neck area. BL-15, BL-18, BL-23, BL-25, KB-4, Du-20, GB-20, CV-14, KB-10, Ex-26, Yin Tang, Ah-shi points will be used. 0.25x25 mm, sterile, steel, disposable, acupuncture needle will be used for acupuncture points and painful trigger points. The treatment will be applied twice a week, on average 10 sessions. Dry needling treatment will be applied to the patients by a certified physician. All patient will be performed the neck exercises program. Receives: Other: Acupuncture; Other: Exercises |
| Exercises group | Other | Patients will perform only neck exercises. Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuel Analog Scale
This scale consists of a 100 mm horizontal line and is marked from 0 to 10. In our study, patients were told that the "0" point was not pain at all, and the "10" point showed unbearable pain, and patients were asked to mark their pain intensity by considering their pain at rest.
Measured: Baseline
Visuel Analog Scale
This scale consists of a 100 mm horizontal line and is marked from 0 to 10. In our study, patients were told that the "0" point was not pain at all, and the "10" point showed unbearable pain, and patients were asked to mark their pain intensity by considering their pain at rest.
Measured: 6 weeks
Neck Disability Index
This index consists of 10 questions and is used to evaluate how and to what extent the neck pain affects the daily life activities of the patient. Neck disability index includes the severity of pain, self-care, load-lifting, reading, headache, concentration, driving, sleep, and social activity parameters. The patients are asked to mark the most appropriate for them from the 6 options given for each parameter. Each title is scored from 0 "(no disability) to 5" (complete disability). The total score is between 0 (no disability) and 50 (total disability). After the total score is obtained, the value calculated according to the formulation is concluded as % insufficiency. High scores indicate high disability, and low scores indicate a low disability level.
Measured: Baseline
Neck Disability Index
This index consists of 10 questions and is used to evaluate how and to what extent the neck pain affects the daily life activities of the patient. Neck disability index includes the severity of pain, self-care, load-lifting, reading, headache, concentration, driving, sleep, and social activity parameters. The patients are asked to mark the most appropriate for them from the 6 options given for each parameter. Each title is scored from 0 "(no disability) to 5" (complete disability). The total score is between 0 (no disability) and 50 (total disability). After the total score is obtained, the value calculated according to the formulation is concluded as % insufficiency. High scores indicate high disability, and low scores indicate a low disability level.
Measured: 6 weeks
Secondary outcomes (4)
Health Assesment Quality
This questionnaire consists of eight questions designed to assess the effects of individuals' health status on daily living. Day-to-day activities such as dressing, hygiene, eating, and walking are assessed, and high scores indicate poor health status.
Measured: Baseline
Health Assesment Quality
This questionnaire consists of eight questions designed to assess the effects of individuals' health status on daily living. Day-to-day activities such as dressing, hygiene, eating, and walking are assessed, and high scores indicate poor health status.
Measured: 6 weeks
MDS-Unified Parkinson's Disease Rating Scale
This is an extensive scale employed for the clinical evaluation of severity of PD. It consists of four sections including non-motor findings, motor problems, motor findings, and treatment complications. Fourteen motor findings (0 - no finding, or normal, 4- severe finding) in the second section of the scale and comprising the motor problems part.
Measured: Baseline
MDS-Unified Parkinson's Disease Rating Scale
This is an extensive scale employed for the clinical evaluation of severity of PD. It consists of four sections including non-motor findings, motor problems, motor findings, and treatment complications. Fourteen motor findings (0 - no finding, or normal, 4- severe finding) in the second section of the scale and comprising the motor problems part.
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 posted5 May 2021
- Study start20 May 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
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.
- More trials run by Abant Izzet Baysal UniversityThe 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
- Model description
- We have two groups. First group will recieve acupuncture treatment and exercise group, second group will recieve only exercise treatment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif yaksi, Abant Izzet Baysal University
- Investigators
- Elif Yakşi, MD, Principal investigator, Abant İzzet Baysal University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874090
- Sponsor's protocol ID
- AIBU-FTR-EY-04
- Status last verified
- Aug 2021
- First submitted
- 12 Apr 2021
- Last updated
- 3 Aug 2021
- Results posted
- 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 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Dry Needle Treatment Applied to Acupuncture Points in Parkinson's Disease on Pain
- ClinicalTrials.gov ID
- NCT04874090
- Acronym / sponsor ID
- AIBU-FTR-EY-04
- Conditions
- Parkinson Disease, Pain, Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 5 May 2021 (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.
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder that is characterized by motor and nonmotor symptoms and its incidence increases with age. It has been reported that 40-90% of patients have pain symptoms in PD. Pain can be the result of motor fluctuations, dystonic muscle contractions, deep visceral pain, and musculoskeletal pain.
Detailed description
Parkinson's Disease (PD) is a chronic, progressive, degenerative movement disorder that is characterized by motor and nonmotor symptoms and its incidence increases with age. It is the second most common neurodegenerative disease after Alzheimer's.Bradykinesia, which is characterized by rigidity, resting tremor, postural instability, gait disturbance and progressive decrease in the speed and amplitude of repetitive movements throughout the course of the disease, are the main cardinal motor findings.Sensory dysfunction such as non-motor findings in PD, disruption in the sleep-wake cycle, neuropsychiatric findings such as dementia, confusion, hallucinations, delirium, depression, gastrointestinal dysfunction, autonomic nervous system disorders such as bladder dysfunction, orthostatic hypotension, and pain perception may develop.Although dopaminergic therapies in PD are the gold standard in the treatment of disorders such as bradykinesia, rigidity and tremor, adequate response cannot be obtained in the treatment of non-motor symptoms. For this reason, rehabilitative applications, especially pain symptom, and complementary medicine methods are very important.It has been reported that 40-90% of patients have pain symptoms in PD. Pain can be the result of motor fluctuations, dystonic muscle contractions, deep visceral pain, and musculoskeletal pain.
Acupuncture and dry needling therapy have been used clinically for a long time as pain relievers such as migraine pain, low back pain, chronic pain and cancer pain. On the other hand, there are very limited and very limited number of studies on the efficacy of dry needle therapy applied to acupuncture points in pain control in PD.In this study, our aim is to investigate the effectiveness of dry needling treatment applied to acupuncture points in neck pain due to PH on musculoskeletal pains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We have two groups. First group will recieve acupuncture treatment and exercise group, second group will recieve only exercise treatment
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Acupuncture, Other: ExercisesInvestigator will apply the acupuncture treatment to the first group to the neck area. BL-15, BL-18, BL-23, BL-25, KB-4, Du-20, GB-20, CV-14, KB-10, Ex-26, Yin Tang, Ah-shi points will be used. 0.25x25 mm, sterile, steel, disposable, acupuncture needle will be used for acupuncture points and painful trigger points. The treatment will be applied twice a week, on average 10 sessions. Dry needling treatment will be applied to the patients by a certified physician. All patient will be performed the neck exercises program. |
| Exercises group | Other | Other: ExercisesPatients will perform only neck exercises. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being Parkinson's Disease
- Age 45-75
- Have a pain due to Parkinson's Disease
Key exclusion criteria (3 listed)
- Presence of advanced dementia or mental disability
- Pain due to ınflammatory conditions
- Using anticoagulant therapy
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 |
|---|---|---|
| AcupunctureInvestigator will apply the acupuncture treatment to the first group to the neck area. BL-15, BL-18, BL-23, BL-25, KB-4, Du-20, GB-20, CV-14, KB-10, Ex-26, Yin Tang, Ah-shi points will be used. 0.25x25 mm, sterile, steel, disposable, acupuncture needle will be used for acupuncture points and painful trigger points. The treatment will be applied twice a week, on average 10 sessions. Dry needling treatment will be applied to the patients by a certified physician. All patient will be performed the neck exercises program | Other | Interventional group |
| ExercisesPatient will perform neck exercises | Other | Exercises group, Interventional group |
Primary outcome
Visuel Analog Scale
Time frame: Baseline
This scale consists of a 100 mm horizontal line and is marked from 0 to 10. In our study, patients were told that the "0" point was not pain at all, and the "10" point showed unbearable pain, and patients were asked to mark their pain intensity by considering their pain at rest.
Visuel Analog Scale
Time frame: 6 weeks
This scale consists of a 100 mm horizontal line and is marked from 0 to 10. In our study, patients were told that the "0" point was not pain at all, and the "10" point showed unbearable pain, and patients were asked to mark their pain intensity by considering their pain at rest.
Neck Disability Index
Time frame: Baseline
This index consists of 10 questions and is used to evaluate how and to what extent the neck pain affects the daily life activities of the patient. Neck disability index includes the severity of pain, self-care, load-lifting, reading, headache, concentration, driving, sleep, and social activity parameters. The patients are asked to mark the most appropriate for them from the 6 options given for each parameter. Each title is scored from 0 "(no disability) to 5" (complete disability). The total score is between 0 (no disability) and 50 (total disability). After the total score is obtained, the value calculated according to the formulation is concluded as % insufficiency. High scores indicate high disability, and low scores indicate a low disability level.
Neck Disability Index
Time frame: 6 weeks
This index consists of 10 questions and is used to evaluate how and to what extent the neck pain affects the daily life activities of the patient. Neck disability index includes the severity of pain, self-care, load-lifting, reading, headache, concentration, driving, sleep, and social activity parameters. The patients are asked to mark the most appropriate for them from the 6 options given for each parameter. Each title is scored from 0 "(no disability) to 5" (complete disability). The total score is between 0 (no disability) and 50 (total disability). After the total score is obtained, the value calculated according to the formulation is concluded as % insufficiency. High scores indicate high disability, and low scores indicate a low disability level.
4 secondary outcomes
Health Assesment Quality
Time frame: Baseline
Health Assesment Quality
Time frame: 6 weeks
MDS-Unified Parkinson's Disease Rating Scale
Time frame: Baseline
MDS-Unified Parkinson's Disease Rating Scale
Time frame: 6 weeks
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 3 Aug 2021.
- 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.
Elif Yakşi, MD principal investigator
Abant İzzet Baysal University Medical Faculty
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 Exercises in people with Parkinson Disease and Pain, Neck, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 3 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 3 Aug 2021. 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 Turkey (Türkiye). 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?
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?
Visuel Analog Scale (time frame: Baseline). The study lists 4 primary outcomes in all. 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 3 Aug 2021.