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Effects of Acupuncture on the Radial Pressure Pulse-wave at Cunkou in Low Back Pain

Effects of Acupuncture on the Radial Pressure Pulse-wave at Cunkou in Low Back Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03501771
Enrollment
42
Registered
2018-04-18
Start date
2018-04-25
Completion date
2019-03-14
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Low Back Pain, Low Back Pain, Mechanical, Low Back Pain, Postural, Low Back Pain, Recurrent, Low Back Strain, Lumbago, Lumbago With Sciatica, Lumbago With Sciatica, Unspecified Side

Keywords

Acupuncture, Back pain, Low Back Pain, Lumbago, pulse diagnosis, radial pressure pulse

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.

Interventions

OTHERAcupuncture

Disposable acupuncture needles will be inserted into acupoints (BL23, BL25, BL40) bilaterally for a depth of 10-30 mm

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A single group, pre-post intervention study

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Radial Pressure Pulse-wave at cunkou (1)30 min before acupunctureAssessment of Radial Pressure Pulse-wave at cunkou ie at Cun, Guan & Chi of both hands before and after the intervention using Pulse Sphygmograph at 30 min before acupuncture.
Assessment of Radial Pressure Pulse-wave at cunkou (2)10 min before acupunctureAssessment of Radial Pressure Pulse-wave at cunkou ie at Cun, Guan & Chi of both hands before and after the intervention using Pulse Sphygmograph at 10 min before acupuncture.
Assessment of Radial Pressure Pulse-wave at cunkou (3)10 min after acupunctureAssessment of Radial Pressure Pulse-wave at cunkou ie at Cun, Guan & Chi of both hands before and after the intervention using Pulse Sphygmograph at 10 min after acupuncture.

Secondary

MeasureTime frameDescription
Range of Motion: Fingertip-to-Floor (FTF) test1) 10 min before acupuncture; 2) 10 min after needle removalAs LBP patients will find bending forward causes more pain and limited movement, the FTF test will be conducted which the participants will be asked to bend forward and attempt to reach the floor with their index finger. the distance between the fingertip and the floor will be measured in cm.
Faces Pain Scale - Revised (FPS-R)1) 20 min before acupuncture; 2) 10 min after needle removalThe intensity of pain is measure using FPS-R developed by International Association for the Study of Pain (IASP) for pain. It is incorporated into the questionnaire with a scale of 0 (no pain) to 10 (worst pain possible)

Other

MeasureTime frameDescription
Vital Signs - Body temperature1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after interventionBody temperature will be measured using Exergen Comfort Scanner Temporal Thermometer in degree Celsius
Oswestry Disability Index (ODI)20 min before acupunctureThe Oswestry Disability Index version 2.0 is a questionnaire developed by the Medical Research Council Group will be adopted. A Chinese 2.1 version translated by researchers in Kaohsiung Medical University already available in Taiwan will be used in the trial.
Vital Signs - Blood Pressure1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after interventionSystolic and Diastolic blood pressure will be measured using Terumo Digital Blood Pressure Monitor ES-P401 in mmHg.
Health Status Questionnaire20 min before acupunctureAge, gender, body weight, height, health status will be obtained through the questionnaire.
Vital Signs - Pulse rate1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after interventionPulse rate will be measured using Terumo Digital Blood Pressure Monitor ES-P401 in beats/min.
Constitution in Chinese Medicine Questionnaire (CCMQ)20 min before acupunctureA questionnaire developed to assess the basic body constitution of the participants which can be categorized into 9 types based on TCM principles

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026