ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03501771
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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.


Condition or disease Intervention/treatment Phase
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 Other: Acupuncture Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single group, pre-post intervention study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Acupuncture on the Radial Pressure Pulse-wave at Cunkou in Low Back Pain
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : January 27, 2019
Estimated Study Completion Date : January 27, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Assessment of Radial Pressure Pulse-wave at cunkou (1) [ Time Frame: 30 min before acupuncture ]
    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.

  2. Assessment of Radial Pressure Pulse-wave at cunkou (2) [ Time Frame: 10 min before acupuncture ]
    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.

  3. Assessment of Radial Pressure Pulse-wave at cunkou (3) [ Time Frame: 10 min after acupuncture ]
    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.


Secondary Outcome Measures :
  1. Range of Motion: Fingertip-to-Floor (FTF) test [ Time Frame: 1) 10 min before acupuncture; 2) 10 min after needle removal ]
    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.

  2. Faces Pain Scale - Revised (FPS-R) [ Time Frame: 1) 20 min before acupuncture; 2) 10 min after needle removal ]
    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)


Other Outcome Measures:
  1. Vital Signs - Body temperature [ Time Frame: 1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention ]
    Body temperature will be measured using Exergen Comfort Scanner Temporal Thermometer in degree Celsius

  2. Vital Signs - Blood Pressure [ Time Frame: 1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention ]
    Systolic and Diastolic blood pressure will be measured using Terumo Digital Blood Pressure Monitor ES-P401 in mmHg.

  3. Vital Signs - Pulse rate [ Time Frame: 1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention ]
    Pulse rate will be measured using Terumo Digital Blood Pressure Monitor ES-P401 in beats/min.

  4. Health Status Questionnaire [ Time Frame: 20 min before acupuncture ]
    Age, gender, body weight, height, health status will be obtained through the questionnaire.

  5. Constitution in Chinese Medicine Questionnaire (CCMQ) [ Time Frame: 20 min before acupuncture ]
    A questionnaire developed to assess the basic body constitution of the participants which can be categorized into 9 types based on TCM principles

  6. Oswestry Disability Index (ODI) [ Time Frame: 20 min before acupuncture ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501771


Contacts
Contact: Yu-Chen Lee, M.D.,PhD 886-975-682023 d5167@mail.cmuh.org.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Yu-Chen Lee, Doctor    0975-682023    d5167@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Yu-Chen Lee, M.D.,PhD China Medical University Hospital

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03501771     History of Changes
Other Study ID Numbers: CMUH107-REC2-022
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China Medical University Hospital:
Acupuncture
Back pain
Low Back Pain
Lumbago
pulse diagnosis
radial pressure pulse

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Sciatica
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuralgia
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases