Low Back Pain Clinical Trial
Official title:
Effects of Acupuncture on the Radial Pressure Pulse-wave at Cunkou in Low Back Pain
Introduction: In TCM, Pulse Diagnosis has been one of the key diagnostic components in the
clinical examinations. Traditionally, the palpation of the pulse on the radial artery is
subjective among the physicians. With the development of the various devices to study the
radial pressure pulse wave (RPPW), these have provided a scientific and objective assessment
to assist the physicians on diagnosis and treatment. The primary objective of this
intervention study is to investigate the effects of Acupuncture on the RPPW at cunkou in Low
Back Pain (LBP) through the pulse sphygmograph. The secondary objective is to investigate the
effect of acupoint combinations on different type LBP based on TCM syndrome differentiation
through the primary and secondary outcome evaluations.
Methods: A single group, pre-post intervention study in which all participants receiving the
same intervention will be conducted. A total 80 participants that meet all the following
criteria will be enrolled: a. at least 20 years of age of either gender; b. chief complaint
being low back pain; c. diagnosis with Lumbago (ICD-9-CM 724.2) or low back pain: loin pain,
low back strain and lumbago NOS (not otherwise specified) (ICD-10-CM M54.4); d. diagnosis
with lumbago with sciatica (ICD-10-CM M54.5). All participants will undergo acupuncture at
BI23, BI25 & Bl40 after obtaining written informed consent. Objective and subjective baseline
assessments and outcome evaluations including Vital Signs, health status questionnaire,
Constitution in Chinese Medicines Questionnaire (CCMQ), Oswestry Disability Index, Faces Pain
Scale-Revised (FPS-R) will be performed. The primary outcome will be the assessment of RPPW
at cunkou ie at Cun, Guan & Chi of both hands using Pulse Sphygmograph before and after the
intervention. The secondary outcome involves evaluating low back pain using the
Fingertips-to-floor test & FPS-R before and after the intervention.
Expected Outcome: The results will be analyzed and provide information which can serve as
clinical evidence of the influence of acupuncture on the RPPW at cunkou. In addition, the
effectiveness of the acupoint combinations on the different type of LBP based on TCM syndrome
differentiation can be further investigated.
Introduction: In TCM, Pulse Diagnosis has been one of the key diagnostic components in the
clinical examinations. Traditionally, the palpation of the pulse on the radial artery is
subjective among the physicians. With the development of the various devices to study the
radial pressure pulse wave (RPPW), these have provided a scientific and objective assessment
to assist the physicians on diagnosis and treatment. The primary objective of this
intervention study is to investigate the effects of Acupuncture on the RPPW at cunkou in Low
Back Pain (LBP) through the pulse sphygmograph. The secondary objective is to investigate the
effect of acupoint combinations on different type LBP based on TCM syndrome differentiation
through the primary and secondary outcome evaluations.
Methods: A single group, pre-post intervention study in which all participants receiving the
same intervention will be conducted. A total 80 participants that meet all the following
criteria will be enrolled: a. at least 20 years of age of either gender; b. chief complaint
being low back pain; c. diagnosis with Lumbago (ICD-9-CM 724.2) or low back pain: loin pain,
low back strain and lumbago NOS (not otherwise specified) (ICD-10-CM M54.4); d. diagnosis
with lumbago with sciatica (ICD-10-CM M54.5). All participants will undergo acupuncture at
BI23, BI25 & Bl40 after obtaining written informed consent. Objective and subjective baseline
assessments and outcome evaluations including Vital Signs, health status questionnaire,
Constitution in Chinese Medicines Questionnaire (CCMQ), Oswestry Disability Index, Faces Pain
Scale-Revised (FPS-R) will be performed. The primary outcome will be the assessment of RPPW
at cunkou ie at Cun, Guan & Chi of both hands using Pulse Sphygmograph before and after the
intervention. The secondary outcome involves evaluating low back pain using the
Fingertips-to-floor test & FPS-R before and after the intervention.
Expected Outcome: The results will be analyzed and provide information which can serve as
clinical evidence of the influence of acupuncture on the RPPW at cunkou. In addition, the
effectiveness of the acupoint combinations on the different type of LBP based on TCM syndrome
differentiation can be further investigated.
Other information: The study will be conducted in China Medical University Hospital (Meide
Medical Building) Acupuncture Department at No. 166, Meide St, North District, Taichung, 404.
It is anticipated that there will be not more than minimum risks encountered by the
participants under careful needling by qualified TCM physician with minimum 10 years of
clinical experiences. Data collection shall begin as soon as the IRB approval from CMUH
Research Ethics Committee is obtained as well as the required equipment is available.
Expected completion date: 1 yr from IRB approval.
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