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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04238117
Other study ID # CMRPG8G0941
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date July 31, 2018

Study information

Verified date January 2020
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in visual analogue scale (VAS) for pain record VAS score for pain before intervention and 2 weeks after intervention 2 weeks
Primary Change in salivary cortisol values record Salivary cortisol values before intervention and 2 weeks after intervention 2 weeks
Secondary Roland-Morris Disability Questionnaire (RMDQ) The RMDQ is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. 2 weeks
Secondary Chinese version of Oswestry Disability Index (ODI) The ODI includes 1 item on pain and 9 items on physical activity of daily living (personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). The total scores ranged from 0 to 40, higher scores indicated greater limitation of physical activities. 2 weeks
Secondary Perceived stress (PSS) PSS containes 7 items with positive subscales and 7 items with negative subscales. Each item is rated from 0 to 4 (0 = never, 4 = very often). 2 weeks
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