Low Back PainNCT05310214
Effect of Acupuncture and Laser Acupuncture in the Treatment of People With Chronic Nonspecific Low Back Pain.
A study testing Acupuncture and Laser acupuncture in people with Low Back Pain, run by University of Nove de Julho.
Trial summary
The aim of this randomized clinical trial will be to compare the efficacy between acupuncture and laser acupuncture on pain and disability in people with chronic nonspecific low back pain . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Acupuncture and Laser acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 30 Sep 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years;
- Non-specific LBP for at least three months
- Pain intensity of at least 2 points measured using the Numeric Pain Rating Scale
Who cannot join
- Pregnancy;
- Any contraindication to ACP or having undergone treatment in the previous six months
- Having undergone spinal surgery in the previous six months;
- Serious spinal pathology (e.g. metastasis, spinal fracture, inflammatory, and infective diseases, caudal equine syndrome, canal stenosis, osteoporosis, rheumatoid arthritis and lumbar radiculopathy);
- Currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecysticis, renal calculi, peritonitis, appendicitis);
About this study
Official title: Effect of Acupuncture and Laser Acupuncture on Pain and Functional Capacity in People With Chronic Nonspecific Low Back Pain: a Randomised Controlled, Blinded Clinical Trial
The aim of this randomized clinical trial will be to compare the efficacy between acupuncture and laser acupuncture on pain and disability in people with chronic nonspecific low back pain .
Read the detailed description
Forty-four patients with chronic cnLBP of more than three months duration will be randomly allocated to two groups: acupuncture group (ACP) (n = 22) and laser acupuncture group (LACP) (n = 22).Interventions will last one hour, and will happen twice a week for 5 weeks. The primary clinical outcomes will be pain intensity (11-point numeric pain rating scale) as measured and functional disability (Oswestry Disability Index).The secondary outcomes will be the Pain Catastrophizing Scale, Patient-Specific Functional Scale and fingertip-to-floor test. Evaluations will be performed before and after the first session, after 5 weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05).
- Conditions
- Low Back Pain
- Being tested
- Acupuncture, Laser acupuncture
- Keywords
- Acupuncture, laser therapy, low back pain, acupuncture points
- 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.
AcupunctureOther
Treatment with ACP will be performed by inserting sterile acupuncture needles 0.25 x 13 mm into the acupoints BL23 (Shenshu), BL25 (Dachangshu), BL40 (Weizhong), BL62 (Qixue), SI3 (Houxi) and Jiaji , for the treatment of chronic non-specific low back pain. Interventions will last one hour, and will happen twice a week for 5 weeks.
In order to increase the effectiveness of blinding for both groups, in this study the model was adopted: "combined simulated control". In this case, Sham acupuncture points will be used to simulate the treatment, as follows: i) Arms: 3 cm above the lateral epicondyle of the elbow, ii) Lumbar spine: Iliac crest on the same line as the greater trochanter of the femur. Thus, in the ACP group, the placebo LACP (without dosemetry) will be applied to these 4 points together with the real treatment.
Laser acupunctureOther
The use of LACP (808 nm wavelength, 100 mW, energy 6 J per acp point), on acupoints BL23 (Shenshu), BL25 (Dachangshu), BL40 (Weizhong), BL62 (Qixue), SI3 (Houxi) and Jiaji will be used as a treatment for nonspecific chronic low back pain. Interventions will last one hour, and will happen twice a week for 5 weeks.
Sham acupuncture points will be used to simulate the treatment, as follows: i) Arms: 3 cm above the lateral epicondyle of the elbow, ii) Lumbar spine: Iliac crest on the same line as the greater trochanter of the femur. These sham points will be inserted superficially so that the depth is sufficient to keep them fixed during the experiment, without individuals reporting the "dequi".
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture treatment (ACP) | Experimental | The experimental group will be treated with acupuncture Receives: Other: Acupuncture |
| Laser acupuncture treatment (LACP) | Active comparator | The active comparator group will be treated with laser acupuncture Receives: Other: Laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The Numeric Pain Rating Scale will be used to determine the level of pain intensity perceived by the patient using an 11-point scale on which 0 represents the absence of pain and 10 represents the worst pain imaginable.
Measured: 3 months
Functional disability
The Oswestry Disability Index will be used to determine the functional disability of participants. Questionnaire examines perceived level of disability in 10 everyday activities of daily living. The 6 statements are scored from 0 to 5 with the first statement scoring 0 through to the last at 5. Interpretation of Scores
- 0% to 20% - minimal disability
- 21%-40% - moderate disability
- 41%-60%- severe disability
- 61%-80%- crippled
- 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
Measured: 3 months
Secondary outcomes (3)
Pain Catastrophizing
The Pain Catastrophizing Scale will be used to assess catastrophic thinking related to pain. 13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time. Higher score indicates higher level of catastrophizing
Item scores are summed into a total score (PCS-T) and three subscale scores:
- Rumination: Items 8, 9, 10, and 11 (response: 0-16 points)
- Magnification: Items 6, 7, 13 (response: 0-12 points)
- Helplessness: Items 1, 2, 3, 4, 5, and 12 (response: 0-24points) A total score above 30 indicates clinically relevant level of catastrophizing
Measured: 3 months
Functional independence.
The Patient-Specific Functional Scale will be used to assess the participant's levels of functional independence. Patients are asked to rate (on an 11-point scale) the current level of difficulty associated with each activity. Following the intervention, patients are asked again to rate the activities previously identified (and are given the chance to nominate new problematic activities that might have arisen during that time).
"0" represents "unable to perform" and "10" represents "able to perform at prior level"
Measured: 3 months
Mobility of spine and pelvis
The fingertip-to-floor test will be used to evaluate the mobility of both the whole spine and the pelvis in the overall motion of bending forward.
If the fingertip-to-floor test is "0"cm or the patient is able to place their palms to the floor with no pain, a different outcome measure should be considered.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion10 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiano Politti, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310214
- Sponsor's protocol ID
- GA-2022
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture and Laser Acupuncture on Pain and Functional Capacity in People With Chronic Nonspecific Low Back Pain: a Randomised Controlled, Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05310214
- Acronym / sponsor ID
- GA-2022
- Conditions
- Low Back Pain
- Keywords
- Acupuncture, laser therapy, low back pain, acupuncture points
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 4 Apr 2022 (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.
The aim of this randomized clinical trial will be to compare the efficacy between acupuncture and laser acupuncture on pain and disability in people with chronic nonspecific low back pain .
Detailed description
Forty-four patients with chronic cnLBP of more than three months duration will be randomly allocated to two groups: acupuncture group (ACP) (n = 22) and laser acupuncture group (LACP) (n = 22).Interventions will last one hour, and will happen twice a week for 5 weeks. The primary clinical outcomes will be pain intensity (11-point numeric pain rating scale) as measured and functional disability (Oswestry Disability Index).The secondary outcomes will be the Pain Catastrophizing Scale, Patient-Specific Functional Scale and fingertip-to-floor test. Evaluations will be performed before and after the first session, after 5 weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Acupuncture treatment (ACP) | Experimental | Other: AcupunctureThe experimental group will be treated with acupuncture |
| Laser acupuncture treatment (LACP) | Active comparator | Other: Laser acupunctureThe active comparator group will be treated with laser acupuncture |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years;
- Non-specific LBP for at least three months
- Pain intensity of at least 2 points measured using the Numeric Pain Rating Scale
Key exclusion criteria (5 listed)
- Pregnancy;
- Any contraindication to ACP or having undergone treatment in the previous six months
- Having undergone spinal surgery in the previous six months;
- Serious spinal pathology (e.g. metastasis, spinal fracture, inflammatory, and infective diseases, caudal equine syndrome, canal stenosis, osteoporosis, rheumatoid arthritis and lumbar radiculopathy);
- Currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecysticis, renal calculi, peritonitis, appendicitis);
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 |
|---|---|---|
| AcupunctureTreatment with ACP will be performed by inserting sterile acupuncture needles 0.25 x 13 mm into the acupoints BL23 (Shenshu), BL25 (Dachangshu), BL40 (Weizhong), BL62 (Qixue), SI3 (Houxi) and Jiaji , for the treatment of chronic non-specific low back pain. Interventions will last one hour, and will happen twice a week for 5 weeks. In order to increase the effectiveness of blinding for both groups, in this study the model was adopted: "combined simulated control". In this case, Sham acupuncture points will be used to simulate the treatment, as follows: i) Arms: 3 cm above the lateral epicondyle of the elbow, ii) Lumbar spine: Iliac crest on the same line as the greater trochanter of the femur. Thus, in the ACP group, the placebo LACP (without dosemetry) will be applied to these 4 points together with the real treatment. | Other | Acupuncture treatment (ACP) |
| Laser acupunctureThe use of LACP (808 nm wavelength, 100 mW, energy 6 J per acp point), on acupoints BL23 (Shenshu), BL25 (Dachangshu), BL40 (Weizhong), BL62 (Qixue), SI3 (Houxi) and Jiaji will be used as a treatment for nonspecific chronic low back pain. Interventions will last one hour, and will happen twice a week for 5 weeks. Sham acupuncture points will be used to simulate the treatment, as follows: i) Arms: 3 cm above the lateral epicondyle of the elbow, ii) Lumbar spine: Iliac crest on the same line as the greater trochanter of the femur. These sham points will be inserted superficially so that the depth is sufficient to keep them fixed during the experiment, without individuals reporting the "dequi". | Other | Laser acupuncture treatment (LACP) |
Primary outcome
Pain intensity
Time frame: 3 months
The Numeric Pain Rating Scale will be used to determine the level of pain intensity perceived by the patient using an 11-point scale on which 0 represents the absence of pain and 10 represents the worst pain imaginable.
Functional disability
Time frame: 3 months
The Oswestry Disability Index will be used to determine the functional disability of participants. Questionnaire examines perceived level of disability in 10 everyday activities of daily living. The 6 statements are scored from 0 to 5 with the first statement scoring 0 through to the last at 5. Interpretation of Scores 1. 0% to 20% - minimal disability 2. 21%-40% - moderate disability 3. 41%-60%- severe disability 4. 61%-80%- crippled 5. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
3 secondary outcomes
Pain Catastrophizing
Time frame: 3 months
Functional independence.
Time frame: 3 months
Mobility of spine and pelvis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Laser acupuncture in people with Low Back Pain, run by University of Nove de Julho.
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 5 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: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 (time frame: 3 months). 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 4 Apr 2022.