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Completed

NCT Number: NCT04423445

Laser Acupuncture and Acupressure for Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

En Chu Kong Hospital

New Taipei City, 23702, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser acupuncture combined with acupressure

Other

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.

Other names: Control group

Primary outcomes

  1. 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

  1. life dysfunction

    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.

    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.

Sponsors and collaborators

Lead sponsor

En Chu Kong Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 9, 2020
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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