Laser Acupuncture Therapy in Postpartum Low Back Pain

NCT ID: NCT04238117

Last Updated: 2020-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Lower Back Pain Postpartum Period

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LA group

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).

Group Type EXPERIMENTAL

Laser acupuncture treatment

Intervention Type PROCEDURE

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

Control group

The participants of the control group received standard obstetric care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Laser acupuncture treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. with systemic diseases
2. with cancers
3. with psychiatric diseases
4. under treatment for severe pain by a physician.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun-Ting Liu

Role: PRINCIPAL_INVESTIGATOR

Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMRPG8G0941

Identifier Type: -

Identifier Source: org_study_id

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