NCT04238117

Brief Summary

Over half of women after giving birth have low back pain (LBP), however, LBP is often accepted as a normal part of postpartum. Unsolved low back pain undoubtedly affects women's physical health and may be negatively affect their psychological health. This study was aimed to investigate the efficacy of laser acupuncture therapy (LAT) in postpartum LBP. Postpartum women with LBP admitted at a postpartum care center were recruited and randomly assigned to the intervention group or the control group. The participants in the intervention group underwent 10 sessions/2 weeks of LAT and received standard obstetric care. The participants in the control group only received standard obstetric care. Primary outcome measurements were Visual Analogue Scale (VAS) for pain and salivary cortisol values. Secondary outcome measurements were Chinese versions of the Roland and Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI) version 2.1and the Perceived Stress Scale (PSS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

January 14, 2020

Last Update Submit

January 19, 2020

Conditions

Lower Back PainPostpartum Period

Keywords

Laser acupuncture therapyLow back painPostpartumlow-level laser therapy

Outcome Measures

Primary Outcomes (2)

  • Change in visual analogue scale (VAS) for pain

    record VAS score for pain before intervention and 2 weeks after intervention

    2 weeks

  • Change in salivary cortisol values

    record Salivary cortisol values before intervention and 2 weeks after intervention

    2 weeks

Secondary Outcomes (3)

  • Roland-Morris Disability Questionnaire (RMDQ)

    2 weeks

  • Chinese version of Oswestry Disability Index (ODI)

    2 weeks

  • Perceived stress (PSS)

    2 weeks

Study Arms (2)

LA group

EXPERIMENTAL

The participants in LAT group underwent 10 sessions of LAT over 2 weeks, using a gallium aluminum arsenide Laser Pen. The participants in the LAT group received 0.375 J of energy at each of the following acupoints bilaterally: BL23 (Shenshu, B2), BL25 (Dachangshu, B2), BL26 (Guanyuanshu, B2), BL40 (Weizhong, B2) and SP6 (Sanyinjiao, B2).

Procedure: Laser acupuncture treatment

Control group

NO INTERVENTION

The participants of the control group received standard obstetric care.

Interventions

Laser acupuncture treatmentPROCEDURE

Laser acupuncture therapy (LAT) is a noninvasive technique that involves stimulation of traditional acupoints with low intensity, non thermal laser irradiation.

LA group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age not less than 20 years
  • Women postpartum within one month
  • Low back pain with visual analogue scale (VAS) score ≧1
  • Low back pain was not relieved by rest for 30 minutes.

You may not qualify if:

  • with systemic diseases
  • with cancers
  • with psychiatric diseases
  • under treatment for severe pain by a physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chun-Ting Liu

    Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 23, 2020

Study Start

November 1, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

January 23, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)