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Effect of Acupuncture and Laser Acupuncture in the Treatment of People With Chronic Nonspecific Low Back Pain.

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Laser acupuncture
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Acupuncture, laser therapy, low back pain, acupuncture points

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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);

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Acupuncture treatment (ACP)

    Laser acupuncture treatment (LACP)

    Arm Description

    The experimental group will be treated with acupuncture

    The active comparator group will be treated with laser acupuncture

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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
    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"
    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.

    Full Information

    First Posted
    March 14, 2022
    Last Updated
    March 31, 2022
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05310214
    Brief Title
    Effect of Acupuncture and Laser Acupuncture in the Treatment of People With Chronic Nonspecific Low Back Pain.
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    June 10, 2022 (Anticipated)
    Study Completion Date
    September 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

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

    5. Study Description

    Brief 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 .
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    Acupuncture, laser therapy, low back pain, acupuncture points

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomised clinical trial
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture treatment (ACP)
    Arm Type
    Experimental
    Arm Description
    The experimental group will be treated with acupuncture
    Arm Title
    Laser acupuncture treatment (LACP)
    Arm Type
    Active Comparator
    Arm Description
    The active comparator group will be treated with laser acupuncture
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Laser acupuncture
    Intervention Description
    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".
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    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.
    Time Frame
    3 months
    Title
    Functional disability
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Pain Catastrophizing
    Description
    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
    Time Frame
    3 months
    Title
    Functional independence.
    Description
    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"
    Time Frame
    3 months
    Title
    Mobility of spine and pelvis
    Description
    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.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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);

    12. IPD Sharing Statement

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