The Effectiveness of Acupuncture Therapy on Pain in Parkinson's Disease
Primary Purpose
Parkinson Disease, Pain, Neck
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupuncture
Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Being Parkinson's Disease
- Age 45-75
- Have a pain due to Parkinson's Disease
Exclusion Criteria:
- Presence of advanced dementia or mental disability
- Pain due to ınflammatory conditions
- Using anticoagulant therapy
Sites / Locations
- Elif Yakşi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Interventional group
Exercises group
Arm Description
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.
Patients will perform only neck exercises.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT04874090
First Posted
April 12, 2021
Last Updated
August 2, 2021
Sponsor
Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT04874090
Brief Title
The Effectiveness of Acupuncture Therapy on Pain in Parkinson's Disease
Official Title
Investigation of the Effectiveness of Dry Needle Treatment Applied to Acupuncture Points in Parkinson's Disease on Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Pain, Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We have two groups. First group will recieve acupuncture treatment and exercise group, second group will recieve only exercise treatment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercises group
Arm Type
Other
Arm Description
Patients will perform only neck exercises.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
Patient will perform neck exercises
Primary Outcome Measure Information:
Title
Visuel Analog Scale
Description
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.
Time Frame
Baseline
Title
Visuel Analog Scale
Description
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.
Time Frame
6 weeks
Title
Neck Disability Index
Description
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.
Time Frame
Baseline
Title
Neck Disability Index
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Health Assesment Quality
Description
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.
Time Frame
Baseline
Title
Health Assesment Quality
Description
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.
Time Frame
6 weeks
Title
MDS-Unified Parkinson's Disease Rating Scale
Description
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.
Time Frame
Baseline
Title
MDS-Unified Parkinson's Disease Rating Scale
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being Parkinson's Disease
Age 45-75
Have a pain due to Parkinson's Disease
Exclusion Criteria:
Presence of advanced dementia or mental disability
Pain due to ınflammatory conditions
Using anticoagulant therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Yakşi, MD
Organizational Affiliation
Abant İzzet Baysal University Medical Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elif Yakşi
City
Bolu
ZIP/Postal Code
14030
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Acupuncture Therapy on Pain in Parkinson's Disease
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