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

NCT ID: NCT03501771

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-25
• Study Completion Date: 2019-03-14

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

Acupuncture needle will be administered.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

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

Interventions

Acupuncture

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chen Lee, M.D.,PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH107-REC2-022

Identifier Type: -

Identifier Source: org_study_id