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Laser Acupuncture and Acupressure for Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture combined with acupressure
Sponsored by
En Chu Kong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain focused on measuring Acupuncture, acupressure, low back pain, low-level laser, life dysfunction, hospital nurses

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3
  • no regular treatment for low back pain within six weeks
  • willing to participate in this study

Exclusion Criteria:

  • open wounds on lower back
  • tumor on the back
  • ankylosing spondylitis
  • previous lumbar surgery
  • coagulopathy or bleeding tendency
  • pregnancy

Sites / Locations

  • En Chu Kong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laser acupuncture combined with acupressure (LAA)

Control group

Arm Description

A 4-week LAA intervention included low-level laser acupuncture and auricular acupressure. Six acupuncture points were selected, and three auricular points. Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. After five days, the seed was removed, and a new seed was taped on the other ear.

Control participants received a similar intervention, but without laser energy output or acupressure.

Outcomes

Primary Outcome Measures

pain intensity and interference
Primary pain outcomes were measured by the Chinese version of the Brief Pain Inventory-Short Form (BPI-SF), which consists of 11 items to measure pain intensity and interference with functionality. Regarding pain severity, 4 items allow patients to rate their pain experience in the past 24 hours or one week at its average, worst, and least levels, as well as their pain experience now, on an 11-point Likert-type scale (0 = no pain, 10 = most severe pain).

Secondary Outcome Measures

life dysfunction
Secondary outcomes were aspects of life dysfunction as measured by the Roland Morris Disability Questionnaire (RMDQ), which measures disability in daily life due to LBP. This questionnaire consists of 24 items, each one a statement that the patient is asked to indicate whether this statement applies to him/her.

Full Information

First Posted
April 18, 2020
Last Updated
June 6, 2020
Sponsor
En Chu Kong Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04423445
Brief Title
Laser Acupuncture and Acupressure for Low Back Pain
Official Title
Laser Acupuncture Combined With Acupressure Improves Low Back Pain and Quality of Life: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
May 22, 2019 (Actual)
Study Completion Date
May 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
En Chu Kong Hospital

4. Oversight

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

5. Study Description

Brief Summary
Background: Low back pain (LBP) is a common, huge health and socioeconomic health problem that affects physiological functions and reduces work efficiency in nurses. Objective: This study aimed to evaluate the effect of low-level laser acupuncture combined with acupressure (LAA) on pain intensity, pain interference and life dysfunction in hospital nurses with LBP. Methods: This single-blinded randomized controlled trial enrolled a convenience sample of nurses from one teaching hospital. Seventy-six participants were randomly assigned to the LAA group (n=38) receiving low-level laser acupuncture and auricular acupressure for four weeks, and a control group (n=38) receiving a similar intervention but without laser energy and acupressure. Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) and Roland-Morris Disability Questionnaire (RDQ) at three time points: baseline before the intervention, and Week 2 and Week 4 during the intervention.
Detailed Description
The enrollment criteria were age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3, no regular treatment for low back pain within six weeks, and willing to participate in this study. Exclusion criteria were open wounds on lower back, tumor on the back, ankylosing spondylitis, previous lumbar surgery, coagulopathy or bleeding tendency, or pregnancy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Acupuncture, acupressure, low back pain, low-level laser, life dysfunction, hospital nurses

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
This single-blinded randomized controlled trial
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser acupuncture combined with acupressure (LAA)
Arm Type
Experimental
Arm Description
A 4-week LAA intervention included low-level laser acupuncture and auricular acupressure. Six acupuncture points were selected, and three auricular points. Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. After five days, the seed was removed, and a new seed was taped on the other ear.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control participants received a similar intervention, but without laser energy output or acupressure.
Intervention Type
Other
Intervention Name(s)
Laser acupuncture combined with acupressure
Other Intervention Name(s)
Control group
Intervention Description
Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. The de qi sensation appears to be an established intervention efficacy indicator during auricular acupressure. After five days, the seed was removed, and a new seed was taped on the other ear.
Primary Outcome Measure Information:
Title
pain intensity and interference
Description
Primary pain outcomes were measured by the Chinese version of the Brief Pain Inventory-Short Form (BPI-SF), which consists of 11 items to measure pain intensity and interference with functionality. Regarding pain severity, 4 items allow patients to rate their pain experience in the past 24 hours or one week at its average, worst, and least levels, as well as their pain experience now, on an 11-point Likert-type scale (0 = no pain, 10 = most severe pain).
Time Frame
Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) : baseline before the intervention, and the change from pain intensity and interference at 1 month.
Secondary Outcome Measure Information:
Title
life dysfunction
Description
Secondary outcomes were aspects of life dysfunction as measured by the Roland Morris Disability Questionnaire (RMDQ), which measures disability in daily life due to LBP. This questionnaire consists of 24 items, each one a statement that the patient is asked to indicate whether this statement applies to him/her.
Time Frame
Data were collected using the Roland-Morris Disability Questionnaire (RDQ) : baseline before the intervention, and the change from life dysfunction at 1 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3 no regular treatment for low back pain within six weeks willing to participate in this study Exclusion Criteria: open wounds on lower back tumor on the back ankylosing spondylitis previous lumbar surgery coagulopathy or bleeding tendency pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsueh-Hua Yang, MASTER
Organizational Affiliation
EN CHU HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
En Chu Kong Hospital
City
New Taipei City
ZIP/Postal Code
23702
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36402666
Citation
Yang HH, Chung YC, Szeto PP, Yeh ML, Lin JG. Laser acupuncture combined with auricular acupressure improves low-back pain and quality of life in nurses: A randomized controlled trial. J Integr Med. 2023 Jan;21(1):26-33. doi: 10.1016/j.joim.2022.10.004. Epub 2022 Oct 17.
Results Reference
derived

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Laser Acupuncture and Acupressure for Low Back Pain

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