TY - JOUR
T1 - A comparative effectiveness study of usual care, simple Chuna manual therapy, and complex Chuna manual therapy for the treatment of pelvic biomechanical lesions in patients with non-acute low back pain
T2 - a protocol for multicenter, randomized controlled trial
AU - Park, Sun Young
AU - Shin, Yeong Jae
AU - Ha, In Hyuk
AU - Yun, Jung Min
AU - Jang, Jun Su
AU - Lee, Sanghun
AU - Yim, Mi Hong
AU - Choi, Woosu
AU - Suh, Hae Sun
AU - Yoon, Hyuna
AU - Ryu, Dahye
AU - Lee, Yeon Woo
AU - Heo, In
AU - Hwang, Man Suk
AU - Hwang, Eui Hyoung
AU - Shin, Byung Cheul
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/12
Y1 - 2024/12
N2 - Background: Chuna manual therapy (CMT), a Korean manual therapy technique predominantly used for treating low back pain (LBP) and related disorders, lacks well-conceived research focusing on its comparative effectiveness, safety, and economic evaluation, particularly with respect to complex CMT with established CMT diagnostic algorithms. This study aims to illustrate a protocol for a randomized clinical study for comparative effectiveness and cost-effectiveness of complex CMT with simple CMT and usual care. Methods: This is a protocol for a three-armed, multicenter, assessor-blinded, pragmatic, randomized controlled trial study. A total of 81 patients suffering from non-acute LBP with pelvic biomechanical lesions (PBL), characterized by a pain duration of at least two weeks and a Numeric Rating Scale (NRS) score of 5 or higher, will be recruited from two Korean medicine hospitals. These participants will be randomly assigned to one of three groups: complex CMT plus usual care (UC; n = 27), simple CMT plus UC (n = 27), or UC groups (n = 27). They will undergo treatment for 4 weeks, and follow-up assessments will be performed 8 weeks after treatment completion. The primary outcome will be the NRS score of LBP, and secondary outcomes will include the Oswestry Disability Index, Patient Global Impression of Change, credibility and expectancy questionnaire, three-dimensional posture analysis indicators, quality of life assessment, economic evaluation, and safety assessments. Discussion: This will be the first study to assess the comparative effectiveness, safety, and cost-effectiveness of complex CMT compared to UC and simple/complex CMT in patients with LBP and PBL. We will also analyze useful diagnostic methods to help in clinical practice for CMT diagnosis. Trial registration: Clinical Research Information Service (CRIS), KCT0009210. Registered on February 28, 2024.
AB - Background: Chuna manual therapy (CMT), a Korean manual therapy technique predominantly used for treating low back pain (LBP) and related disorders, lacks well-conceived research focusing on its comparative effectiveness, safety, and economic evaluation, particularly with respect to complex CMT with established CMT diagnostic algorithms. This study aims to illustrate a protocol for a randomized clinical study for comparative effectiveness and cost-effectiveness of complex CMT with simple CMT and usual care. Methods: This is a protocol for a three-armed, multicenter, assessor-blinded, pragmatic, randomized controlled trial study. A total of 81 patients suffering from non-acute LBP with pelvic biomechanical lesions (PBL), characterized by a pain duration of at least two weeks and a Numeric Rating Scale (NRS) score of 5 or higher, will be recruited from two Korean medicine hospitals. These participants will be randomly assigned to one of three groups: complex CMT plus usual care (UC; n = 27), simple CMT plus UC (n = 27), or UC groups (n = 27). They will undergo treatment for 4 weeks, and follow-up assessments will be performed 8 weeks after treatment completion. The primary outcome will be the NRS score of LBP, and secondary outcomes will include the Oswestry Disability Index, Patient Global Impression of Change, credibility and expectancy questionnaire, three-dimensional posture analysis indicators, quality of life assessment, economic evaluation, and safety assessments. Discussion: This will be the first study to assess the comparative effectiveness, safety, and cost-effectiveness of complex CMT compared to UC and simple/complex CMT in patients with LBP and PBL. We will also analyze useful diagnostic methods to help in clinical practice for CMT diagnosis. Trial registration: Clinical Research Information Service (CRIS), KCT0009210. Registered on February 28, 2024.
KW - Chuna manual therapy
KW - Cost-benefit analysis
KW - Low back pain
KW - Protocol
KW - Randomized clinical trial
KW - Spinal manipulation
UR - http://www.scopus.com/inward/record.url?scp=85205605583&partnerID=8YFLogxK
U2 - 10.1186/s12906-024-04653-5
DO - 10.1186/s12906-024-04653-5
M3 - Article
C2 - 39363267
AN - SCOPUS:85205605583
SN - 2662-7671
VL - 24
JO - BMC Complementary Medicine and Therapies
JF - BMC Complementary Medicine and Therapies
IS - 1
M1 - 353
ER -