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Clinical Trials/NCT04423445
NCT04423445CompletedNot Applicable

Laser Acupuncture Combined With Acupressure Improves Low Back Pain and Quality of Life: a Randomized Controlled Trial

En Chu Kong Hospital1 site in 1 country76 target enrollmentStarted: January 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
76
Locations
1
Primary Endpoint
pain intensity and interference

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Masking Description

This single-blinded randomized controlled trial

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Laser acupuncture combined with acupressure (LAA)

Experimental

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.

Intervention: Laser acupuncture combined with acupressure (Other)

Control group

No Intervention

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

Outcomes

Primary Outcomes

pain intensity and interference

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.

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 Outcomes

  • life dysfunction(Data were collected using the Roland-Morris Disability Questionnaire (RDQ) : baseline before the intervention, and the change from life dysfunction at 1 month.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hsueh-Hua Yang

Principal Investigator

En Chu Kong Hospital

Study Sites (1)

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