Laser Acupuncture Therapy in Postpartum Low Back Pain

Study Overview
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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).

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

Conditions
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Lower Back Pain, Postpartum Period

Intervention / Treatment
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* Procedure: Laser acupuncture treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: with systemic diseases with cancers with psychiatric diseases under treatment for severe pain by a physician.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LA group<br>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<br>* Laser acupuncture therapy (LAT) is a noninvasive technique that involves stimulation of traditional acupoints with low intensity, non thermal laser irradiation.<br>|
| No Intervention: Control group<br>The participants of the control group received standard obstetric care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum, Laser acupuncture therapy, Low back pain, low-level laser therapy