Lower Back PainNCT04238117
Laser Acupuncture Therapy in Postpartum Low Back Pain
A study testing Laser acupuncture treatment in people with Lower Back Pain and Postpartum Period, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Lower Back Pain, Postpartum Period
- What is being tested?
- Laser acupuncture treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2017to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- with systemic diseases
- with cancers
- with psychiatric diseases
- under treatment for severe pain by a physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Lower Back Pain, Postpartum Period
- Being tested
- Laser acupuncture treatment
- Keywords
- Laser acupuncture therapy, Low back pain, Postpartum, low-level laser therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupuncture treatmentProcedure or surgery
Laser acupuncture therapy (LAT) is a noninvasive technique that involves stimulation of traditional acupoints with low intensity, non thermal laser irradiation.
| Study group | Role | What they receive |
|---|---|---|
| LA group | Experimental | 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). Receives: Procedure: Laser acupuncture treatment |
| Control group | No intervention | The participants of the control group received standard obstetric care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analogue scale (VAS) for pain
record VAS score for pain before intervention and 2 weeks after intervention
Measured: 2 weeks
Change in salivary cortisol values
record Salivary cortisol values before intervention and 2 weeks after intervention
Measured: 2 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Nov 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Ting Liu, Principal investigator, Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238117
- Sponsor's protocol ID
- CMRPG8G0941
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture Therapy in Postpartum Low Back Pain: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04238117
- Acronym / sponsor ID
- CMRPG8G0941
- Conditions
- Lower Back Pain, Postpartum Period
- Keywords
- Laser acupuncture therapy, Low back pain, Postpartum, low-level laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA group | Experimental | Procedure: Laser acupuncture treatmentThe 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). |
| Control group | No intervention | –The participants of the control group received standard obstetric care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- with systemic diseases
- with cancers
- with psychiatric diseases
- under treatment for severe pain by a physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupuncture treatmentLaser acupuncture therapy (LAT) is a noninvasive technique that involves stimulation of traditional acupoints with low intensity, non thermal laser irradiation. | Procedure or surgery | LA group |
Primary outcome
Change in visual analogue scale (VAS) for pain
Time frame: 2 weeks
record VAS score for pain before intervention and 2 weeks after intervention
Change in salivary cortisol values
Time frame: 2 weeks
record Salivary cortisol values before intervention and 2 weeks after intervention
3 secondary outcomes
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: 2 weeks
Chinese version of Oswestry Disability Index (ODI)
Time frame: 2 weeks
Perceived stress (PSS)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: No
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The Hidden Burden of Cerebral Palsy: Exploring the Relationship Between Gross Motor Function of Children, Maternal Low Back Pain, and Quality of Life
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Ting Liu principal investigator
Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture treatment in people with Lower Back Pain and Postpartum Period, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual analogue scale (VAS) for pain (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.