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.

Study Overview

• Status: Completed
• Conditions: Back Pain; 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
• Intervention / Treatment: Other: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; Acupuncture needle will be administered.	Other: Acupuncture; Disposable acupuncture needles will be inserted into acupoints (BL23, BL25, BL40) bilaterally for a depth of 10-30 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Radial Pressure Pulse-wave at cunkou (1)	Assessment 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.	30 min before acupuncture
Assessment of Radial Pressure Pulse-wave at cunkou (2)	Assessment 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.	10 min before acupuncture
Assessment of Radial Pressure Pulse-wave at cunkou (3)	Assessment 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.	10 min after acupuncture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion: Fingertip-to-Floor (FTF) test	As 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.	1) 10 min before acupuncture; 2) 10 min after needle removal
Faces Pain Scale - Revised (FPS-R)	The 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)	1) 20 min before acupuncture; 2) 10 min after needle removal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Signs - Body temperature	Body temperature will be measured using Exergen Comfort Scanner Temporal Thermometer in degree Celsius	1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention
Vital Signs - Blood Pressure	Systolic and Diastolic blood pressure will be measured using Terumo Digital Blood Pressure Monitor ES-P401 in mmHg.	1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention
Vital Signs - Pulse rate	Pulse rate will be measured using Terumo Digital Blood Pressure Monitor ES-P401 in beats/min.	1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention
Health Status Questionnaire	Age, gender, body weight, height, health status will be obtained through the questionnaire.	20 min before acupuncture
Constitution in Chinese Medicine Questionnaire (CCMQ)	A questionnaire developed to assess the basic body constitution of the participants which can be categorized into 9 types based on TCM principles	20 min before acupuncture
Oswestry Disability Index (ODI)	The 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.	20 min before acupuncture

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Yu-Chen Lee, M.D.,PhD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): March 14, 2019
• Study Completion (Actual): March 14, 2019

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Low Back Pain; Acupuncture; Back pain; Lumbago; pulse diagnosis; radial pressure pulse
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Back Pain; Low Back Pain; Sciatica
• Other Study ID Numbers: CMUH107-REC2-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No