Laser Acupuncture and Acupressure for Low Back Pain

NCT ID: NCT04423445

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2019-05-22

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Laser acupuncture combined with acupressure (LAA)

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.

Group Type: EXPERIMENTAL

Laser acupuncture combined with acupressure

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Laser acupuncture combined with acupressure

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.

Intervention Type: OTHER

Other Intervention Names

Control group

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

En Chu Kong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsueh-Hua Yang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsueh-Hua Yang, MASTER

Role: PRINCIPAL_INVESTIGATOR

EN CHU HOSPITAL

Locations

En Chu Kong Hospital

New Taipei City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 36402666 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ECKIRB1071102

Identifier Type: -

Identifier Source: org_study_id