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Laser Acupuncture Therapy in Postpartum Low Back Pain

Primary Purpose

Lower Back Pain, Postpartum Period

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Laser acupuncture treatment
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain focused on measuring Laser acupuncture therapy, Low back pain, Postpartum, low-level laser therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LA group

Control group

Arm Description

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).

The participants of the control group received standard obstetric care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
January 14, 2020
Last Updated
January 19, 2020
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04238117
Brief Title
Laser Acupuncture Therapy in Postpartum Low Back Pain
Official Title
Laser Acupuncture Therapy in Postpartum Low Back Pain: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain, Postpartum Period
Keywords
Laser acupuncture therapy, Low back pain, Postpartum, low-level laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LA group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants of the control group received standard obstetric care.
Intervention Type
Procedure
Intervention Name(s)
Laser acupuncture treatment
Intervention Description
Laser acupuncture therapy (LAT) is a noninvasive technique that involves stimulation of traditional acupoints with low intensity, non thermal laser irradiation.
Primary Outcome Measure Information:
Title
Change in visual analogue scale (VAS) for pain
Description
record VAS score for pain before intervention and 2 weeks after intervention
Time Frame
2 weeks
Title
Change in salivary cortisol values
Description
record Salivary cortisol values before intervention and 2 weeks after intervention
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Roland-Morris Disability Questionnaire (RMDQ)
Description
The RMDQ is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale.
Time Frame
2 weeks
Title
Chinese version of Oswestry Disability Index (ODI)
Description
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.
Time Frame
2 weeks
Title
Perceived stress (PSS)
Description
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).
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu
Organizational Affiliation
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Laser Acupuncture Therapy in Postpartum Low Back Pain

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