Low Back Pain Clinical Trial
Official title:
Effects of Acupuncture on the Radial Pressure Pulse-wave at Cunkou in Low Back Pain
Verified date | March 2019 |
Source | China Medical University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | March 14, 2019 |
Est. primary completion date | March 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
China Medical University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | Health Status Questionnaire | Age, gender, body weight, height, health status will be obtained through the questionnaire. | 20 min before acupuncture | |
Other | 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 | |
Other | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
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