Laser Acupuncture and Acupressure for Low Back Pain

NCT04423445 | Completed

• 1 other identifier: ECKIRB1071102
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Acupuncture; acupressure; low back pain; low-level laser; life dysfunction; hospital nurses

Outcome Measures

Primary Outcomes (1)

• 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).

  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 Outcomes (1)

• 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.

Study Arms (2)

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.

Other: Laser acupuncture combined with acupressure

Control group

NO INTERVENTION

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

Interventions

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.

Also known as: Control group

Laser acupuncture combined with acupressure (LAA)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• En Chu Kong Hospital: lead

Study Sites (1)

En Chu Kong Hospital

New Taipei City, 23702, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 36402666 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupressure; Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hsueh-Hua Yang, MASTER

  EN CHU HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This single-blinded randomized controlled trial
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: June 9, 2020
• Study Start: January 15, 2019
• Primary Completion: May 22, 2019
• Study Completion: May 22, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)