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

NCT03501771 | Completed

• 1 other identifier: CMUH107-REC2-022
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Range of Motion: Fingertip-to-Floor (FTF) test

  1) 10 min before acupuncture; 2) 10 min after needle removal

• Faces Pain Scale - Revised (FPS-R)

  1) 20 min before acupuncture; 2) 10 min after needle removal

Other Outcomes (6)

• Vital Signs - Body temperature

  1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention

• Vital Signs - Blood Pressure

  1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention

• Vital Signs - Pulse rate

  1) 30 min before acupuncture;2) 10 min before acupuncture; 3) 10 min after intervention

Study Arms (1)

Acupuncture

EXPERIMENTAL

Acupuncture needle will be administered.

Other: Acupuncture

Interventions

Acupuncture OTHER

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

Acupuncture

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 20 years of age of either gender;
• chief complaint being low back pain;
• 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);
• diagnosis with lumbago with sciatica (ICD-10-CM M54.5).

You may not qualify if:

• 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
• Participation in other clinical trials within 3 months
• Allergic to metal

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yu-Chen Lee, M.D.,PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single group, pre-post intervention study

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 18, 2018
• Study Start: April 25, 2018
• Primary Completion: March 14, 2019
• Study Completion: March 14, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

TW (1)