Clinical trial NCT03501771: Effects of Acupuncture on the Radial Pressure Pulse-wave at Cunkou in Low Back Pain
Official title: Effects of Acupuncture on the Radial Pressure Pulse-wave at Cunkou in Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Low Back Pain, Mechanical
Low Back Pain, Recurrent
Low Back Pain, Postural
Low Back Strain
Lumbago
Lumbago With Sciatica
Lumbago With Sciatica, Unspecified Side
Back Pain
Keywords: Acupuncture
Back pain
Low Back Pain
Lumbago
pulse diagnosis
radial pressure pulse
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group, pre-post intervention study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. at least 20 years of age of either gender;
2. chief complaint being low back pain;
3. 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);
4. diagnosis with lumbago with sciatica (ICD-10-CM M54.5).

Exclusion Criteria:

* Pregnancy or lactation
* CHF, carcinomas under chemotherapy, psychological/psychiatric disorders
* Heart diseases with transplanted device such as pacemaker.
* Acute infections eg Upper Respiratory Infection (URI), Urinary Tract Infections (UTI), Acute gastroenteritis.
* Inability to undergo evaluation with the Pulse Sphygmograph
* Alcohol abuse or drug addiction
* Communication disorder
* Refusal to provide informed consent or participate in the study
* Exclusion at Project Investigator's discretion
* Participation in other clinical trials within 3 months
* Allergic to metal

Primary outcomes:
measure: Assessment of Radial Pressure Pulse-wave at cunkou (1)
timeFrame: 30 min before acupuncture
measure: Assessment of Radial Pressure Pulse-wave at cunkou (2)
timeFrame: 10 min before acupuncture
measure: Assessment of Radial Pressure Pulse-wave at cunkou (3)
timeFrame: 10 min after acupuncture
Secondary outcomes:
measure: Range of Motion: Fingertip-to-Floor (FTF) test
timeFrame: 1) 10 min before acupuncture; 2) 10 min after needle removal
measure: Faces Pain Scale - Revised (FPS-R)
timeFrame: 1) 20 min before acupuncture; 2) 10 min after needle removal
Other outcomes:
measure: Vital Signs - Body temperature
timeFrame: 1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention
measure: Vital Signs - Blood Pressure
timeFrame: 1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention
measure: Vital Signs - Pulse rate
timeFrame: 1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention
measure: Health Status Questionnaire
timeFrame: 20 min before acupuncture
measure: Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: 20 min before acupuncture
measure: Oswestry Disability Index (ODI)
timeFrame: 20 min before acupuncture
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Yu-Chen Lee, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References: