The Effectiveness of Acupuncture Therapy on Pain in Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Pain, Neck
• Intervention / Treatment: Other: Acupuncture; Other: Exercises

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bolu, Turkey, 14030
    • Elif Yakşi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; 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.	Other: Acupuncture; 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; Other: Exercises; Patient will perform neck exercises
Other: Exercises group; Patients will perform only neck exercises.	Other: Exercises; Patient will perform neck exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 weeks

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: May 1, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Neck Pain
• Other Study ID Numbers: AIBU-FTR-EY-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No