A pragmatic clinical study to compare the effectiveness of pharmacopuncture and acupuncture treatment strategies in patients with chronic neck pain
This study aims to confirm the comparative effectiveness of pharmacopuncture by conducting a pragmatic randomized controlled clinical trial with 128 patients suffering from chronic neck pain. The trial will compare patients treated with a pharmacopuncture-based strategy (64 patients) to those treated with an acupuncture-based strategy (64 patients). As this is a pragmatic clinical trial, participants will be randomly assigned to either the pharmacopuncture or acupuncture groups. However, the specific methods of pharmacopuncture and acupuncture to be used will not be predetermined. Instead, they will be determined based on the clinical judgment of the traditional Korean medicine doctor according to the patient's condition. All methods used will be recorded in the CRF (Case Report Form).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
128
The physicians will decide the specific methods of pharmacopuncture based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms.
The physicians will decide the specific methods of acupuncture based on the clinical judgment according to each participant's conditions. All applied treatment methods are documented in the case report forms.
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, Daejeon, South Korea
Kyung Hee University Korean Medicine Hospital
Seoul, Dongdaemun-gu, South Korea
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
Dongguk University Bundang Oriental Hospital
Seongnam, GGyeonggi-do, South Korea
Neck pain Numeric Rating Scale, NRS
Change from baseline to Week 5 on the Numeric Rating Scale of neck pain
Time frame: Week 5
Neck and arm pain Numeric Rating Scale
The pain intensity of neck and arm over the past week
Time frame: Week 1,2,3,4,5,8,12
Neck and arm pain Visual Analogue Scale
The pain intensity of neck and arm over the past week
Time frame: Week 1,2,3,4,5
Northwick Park Questionnaire
A self-reported questionnaire consisting of 9 items related to the impact of neck pain on daily activities
Time frame: Week 1,5,8,12
Neck disability index
The degree of neck disability in daily life
Time frame: Week 1,5,8,12
Patient Global Impression of Change
The subject's subjective improvement
Time frame: Week 5,8,12
Health-related Quality of Life Instrument with 8 Items
A tool developed to measure the health-related quality of life in Koreans
Time frame: Week 1,5,8,12
5-Level EuroQol-5 Dimension
A tool that evaluates health status from multiple perspectives, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: Week 1,5,8,12
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Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, South Korea
Haeundae Jaseng Hospital of Korean Medicine
Busan, South Korea
Adverse events
An undesirable and unintended sign, symptom, or disease that occurs after a procedure during the clinical study.
Time frame: Week 1,2,3,4,5,8,12