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OpenTrials
Completed

NCT Number: NCT04238117

Laser Acupuncture Therapy in Postpartum Low Back Pain

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).

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Key information

Conditions

Lower Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Postpartum Period Signs and Symptoms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laser acupuncture treatment

Procedure

Laser acupuncture therapy (LAT) is a noninvasive technique that involves stimulation of traditional acupoints with low intensity, non thermal laser irradiation.

Primary outcomes

  1. Change in visual analogue scale (VAS) for pain

    Time frame: 2 weeks

    record VAS score for pain before intervention and 2 weeks after intervention

  2. Change in salivary cortisol values

    Time frame: 2 weeks

    record Salivary cortisol values before intervention and 2 weeks after intervention

Secondary outcomes

  1. Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: 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.

  2. Chinese version of Oswestry Disability Index (ODI)

    Time frame: 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.

  3. Perceived stress (PSS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2020
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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