Low Back PainNCT04423445
Laser Acupuncture and Acupressure for Low Back Pain
A study testing Laser acupuncture combined with acupressure in people with Low Back Pain, run by En Chu Kong Hospital at 1 site in Taiwan.
Trial summary
Background: Low back pain (LBP) is a common, huge health and socioeconomic health problem that affects physiological functions and reduces work efficiency in nurses. Objective: This study aimed to evaluate the effect of low-level laser acupuncture combined with acupressure (LAA) on pain intensity, pain interference… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Laser acupuncture combined with acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jan 2019to 22 May 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3
- no regular treatment for low back pain within six weeks
- willing to participate in this study
Who cannot join
- open wounds on lower back
- tumor on the back
- ankylosing spondylitis
- previous lumbar surgery
- coagulopathy or bleeding tendency
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Acupuncture Combined With Acupressure Improves Low Back Pain and Quality of Life: a Randomized Controlled Trial
Background: Low back pain (LBP) is a common, huge health and socioeconomic health problem that affects physiological functions and reduces work efficiency in nurses.
Objective: This study aimed to evaluate the effect of low-level laser acupuncture combined with acupressure (LAA) on pain intensity, pain interference and life dysfunction in hospital nurses with LBP.
Methods: This single-blinded randomized controlled trial enrolled a convenience sample of nurses from one teaching hospital. Seventy-six participants were randomly assigned to the LAA group (n=38) receiving low-level laser acupuncture and auricular acupressure for four weeks, and a control group (n=38) receiving a similar intervention but without laser energy and acupressure. Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) and Roland-Morris Disability Questionnaire (RDQ) at three time points: baseline before the intervention, and Week 2 and Week 4 during the intervention.
Read the detailed description
The enrollment criteria were age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3, no regular treatment for low back pain within six weeks, and willing to participate in this study. Exclusion criteria were open wounds on lower back, tumor on the back, ankylosing spondylitis, previous lumbar surgery, coagulopathy or bleeding tendency, or pregnancy.
- Conditions
- Low Back Pain
- Being tested
- Laser acupuncture combined with acupressure
- Keywords
- Acupuncture, acupressure, low back pain, low-level laser, life dysfunction, hospital nurses
- 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 combined with acupressureOther
Also called Control group
Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. The de qi sensation appears to be an established intervention efficacy indicator during auricular acupressure. After five days, the seed was removed, and a new seed was taped on the other ear.
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture combined with acupressure (LAA) | Experimental | A 4-week LAA intervention included low-level laser acupuncture and auricular acupressure. Six acupuncture points were selected, and three auricular points. Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. After five days, the seed was removed, and a new seed was taped on the other ear. Receives: Other: Laser acupuncture combined with acupressure |
| Control group | No intervention | Control participants received a similar intervention, but without laser energy output or acupressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity and interference
Primary pain outcomes were measured by the Chinese version of the Brief Pain Inventory-Short Form (BPI-SF), which consists of 11 items to measure pain intensity and interference with functionality. Regarding pain severity, 4 items allow patients to rate their pain experience in the past 24 hours or one week at its average, worst, and least levels, as well as their pain experience now, on an 11-point Likert-type scale (0 = no pain, 10 = most severe pain).
Measured: Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) : baseline before the intervention, and the change from pain intensity and interference at 1 month.
Secondary outcomes (1)
life dysfunction
Secondary outcomes were aspects of life dysfunction as measured by the Roland Morris Disability Questionnaire (RMDQ), which measures disability in daily life due to LBP. This questionnaire consists of 24 items, each one a statement that the patient is asked to indicate whether this statement applies to him/her.
Measured: Data were collected using the Roland-Morris Disability Questionnaire (RDQ) : baseline before the intervention, and the change from life dysfunction at 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Jan 2019
- Primary completion22 May 2019
- Study completion22 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- En Chu Kong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsueh-Hua Yang, En Chu Kong Hospital
- Investigators
- Hsueh-Hua Yang, MASTER, Principal investigator, EN CHU HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423445
- Sponsor's protocol ID
- ECKIRB1071102
- Status last verified
- Jun 2020
- First submitted
- 18 Apr 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang HH, Chung YC, Szeto PP, Yeh ML, Lin JG. Laser acupuncture combined with auricular acupressure improves low-back pain and quality of life in nurses: A randomized controlled trial. J Integr Med. 2023 Jan;21(1):26-33. doi: 10.1016/j.joim.2022.10.004. Epub 2022 Oct 17.
PubMed 36402666
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture Combined With Acupressure Improves Low Back Pain and Quality of Life: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04423445
- Acronym / sponsor ID
- ECKIRB1071102
- Conditions
- Low Back Pain
- Keywords
- Acupuncture, acupressure, low back pain, low-level laser, life dysfunction, hospital nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- En Chu Kong HospitalUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 22 May 2019 (actual)
- First posted
- 9 Jun 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.
Background: Low back pain (LBP) is a common, huge health and socioeconomic health problem that affects physiological functions and reduces work efficiency in nurses.
Objective: This study aimed to evaluate the effect of low-level laser acupuncture combined with acupressure (LAA) on pain intensity, pain interference and life dysfunction in hospital nurses with LBP.
Methods: This single-blinded randomized controlled trial enrolled a convenience sample of nurses from one teaching hospital. Seventy-six participants were randomly assigned to the LAA group (n=38) receiving low-level laser acupuncture and auricular acupressure for four weeks, and a control group (n=38) receiving a similar intervention but without laser energy and acupressure. Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) and Roland-Morris Disability Questionnaire (RDQ) at three time points: baseline before the intervention, and Week 2 and Week 4 during the intervention.
Detailed description
The enrollment criteria were age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3, no regular treatment for low back pain within six weeks, and willing to participate in this study. Exclusion criteria were open wounds on lower back, tumor on the back, ankylosing spondylitis, previous lumbar surgery, coagulopathy or bleeding tendency, or pregnancy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture combined with acupressure (LAA) | Experimental | Other: Laser acupuncture combined with acupressureA 4-week LAA intervention included low-level laser acupuncture and auricular acupressure. Six acupuncture points were selected, and three auricular points. Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. After five days, the seed was removed, and a new seed was taped on the other ear. |
| Control group | No intervention | –Control participants received a similar intervention, but without laser energy output or acupressure. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3
- no regular treatment for low back pain within six weeks
- willing to participate in this study
Key exclusion criteria (6 listed)
- open wounds on lower back
- tumor on the back
- ankylosing spondylitis
- previous lumbar surgery
- coagulopathy or bleeding tendency
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 combined with acupressureAlso: Control groupParticipants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. The de qi sensation appears to be an established intervention efficacy indicator during auricular acupressure. After five days, the seed was removed, and a new seed was taped on the other ear. | Other | Laser acupuncture combined with acupressure (LAA) |
Primary outcome
pain intensity and interference
Time frame: Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) : baseline before the intervention, and the change from pain intensity and interference at 1 month.
Primary pain outcomes were measured by the Chinese version of the Brief Pain Inventory-Short Form (BPI-SF), which consists of 11 items to measure pain intensity and interference with functionality. Regarding pain severity, 4 items allow patients to rate their pain experience in the past 24 hours or one week at its average, worst, and least levels, as well as their pain experience now, on an 11-point Likert-type scale (0 = no pain, 10 = most severe pain).
1 secondary outcome
life dysfunction
Time frame: Data were collected using the Roland-Morris Disability Questionnaire (RDQ) : baseline before the intervention, and the change from life dysfunction at 1 month.
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 9 Jun 2020.
- Derived from this study: PubMed 36402666Yang HH, Chung YC, Szeto PP, Yeh ML, Lin JG. Laser acupuncture combined with auricular acupressure improves low-back pain and quality of life in nurses: A randomized controlled trial. J Integr Med. 2023 Jan;21(1):26-33. doi: 10.1016/j.joim.2022.10.004. Epub 2022 Oct 17.
- Individual participant dataSharing planned: No
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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.
Hsueh-Hua Yang, MASTER principal investigator
EN CHU 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 combined with acupressure in people with Low Back Pain, run by En Chu Kong 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 3 inclusion and 6 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 9 Jun 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?
pain intensity and interference (time frame: Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) : baseline before the intervention, and the change from pain intensity and interference at 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423445, which also lists 1 linked publication.
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 9 Jun 2020.