Laser Acupuncture Therapy in Postpartum Low Back Pain

Not Applicable

Completed

• Conditions: Lower Back Pain; Postpartum Period
• Interventions: Procedure: Laser acupuncture treatment

• Registration Number: NCT04238117
• Lead Sponsor: Chang Gung Memorial Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-19
• Last Update Submitted: 2020-01-19
• Study First Posted: 2020-01-23
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LA group	Laser acupuncture treatment	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).

Primary Outcome Measures

Name	Time	Method
Change in salivary cortisol values	2 weeks	record Salivary cortisol values before intervention and 2 weeks after intervention
Change in visual analogue scale (VAS) for pain	2 weeks	record VAS score for pain before intervention and 2 weeks after intervention

Secondary Outcome Measures

Name	Time	Method
Perceived stress (PSS)	2 weeks	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).
Roland-Morris Disability Questionnaire (RMDQ)	2 weeks	The RMDQ is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.
Chinese version of Oswestry Disability Index (ODI)	2 weeks	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.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan