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

NCT04874090 | Completed

• 1 other identifier: AIBU-FTR-EY-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Pain, Neck

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Health Assesment Quality

  Baseline

• Health Assesment Quality

  6 weeks

• MDS-Unified Parkinson's Disease Rating Scale

  Baseline

• MDS-Unified Parkinson's Disease Rating Scale

  6 weeks

Study Arms (2)

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.

Other: Acupuncture; Other: Exercises

Exercises group

OTHER

Patients will perform only neck exercises.

Other: Exercises

Interventions

Acupuncture OTHER

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

Interventional group

Exercises OTHER

Patient will perform neck exercises

Exercises group; Interventional group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being Parkinson's Disease
• Age 45-75
• Have a pain due to Parkinson's Disease

You may not qualify if:

• Presence of advanced dementia or mental disability
• Pain due to ınflammatory conditions
• Using anticoagulant therapy

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Elif Yakşi

Bolu, 14030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Neck Pain

Interventions

Acupuncture Therapy; Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elif Yakşi, MD

  Abant İzzet Baysal University Medical Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: We have two groups. First group will recieve acupuncture treatment and exercise group, second group will recieve only exercise treatment

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: May 5, 2021
• Study Start: May 20, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)