Laser Acupuncture Therapy in Postpartum Low Back Pain

Lower Back Pain Clinical Trial

Official title:

Laser Acupuncture Therapy in Postpartum Low Back Pain: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238117
• Other study ID #: CMRPG8G0941
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain
• Postpartum Period

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