Laser Acupuncture Therapy in Postpartum Low Back Pain

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

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).

Study Overview

• Status: Completed
• Conditions: Lower Back Pain; Postpartum Period
• Intervention / Treatment: Procedure: Laser acupuncture treatment

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
No Intervention: Control group; The participants of the control group received standard obstetric care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chun-Ting Liu, Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 19, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Low back pain; Postpartum; low-level laser therapy; Laser acupuncture therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CMRPG8G0941

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No