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Electroacupuncture Frequency-related Effects on Non-specific Low Back Pain in Older Adults.

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ClinicalTrials.gov Identifier: NCT03802045
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:

Background: Low back pain (LBP) is the most frequent complaint in the clinical practice. Electroacupuncture treatment may be effective, however, the evidence supporting this possibility is still limited, especially in older adults.

Methods: A five-arm randomized controlled trial with patients and evaluators blinded to the group allocation. A total of 125 participants with non-specific low back pain will be randomly assigned into one of five groups: three electroacupuncture groups (low, high and alternating frequency), a control and a placebo group. The electroacupuncture will be applied twice a week (30 minutes per session) for 5 weeks. The primary clinical outcome will be pain intensity. The secondary outcomes include: quality of pain, physical functioning, perceived overall effect, emotional functionality, patient satisfaction and psychosocial factors. Patients will be evaluated before the first session, immediately after the last, and followed-up after 6 and 12 months to check the effects in the medium and long term.

Discussion: Results of this trial will help clarify the therapeutic effect of different frequencies of electroacupuncture for chronic low back pain in older adults and to determine the most effective electroacupuncture frequency.


Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Electroacupuncture Device: Needle Device: Adhesive Moxa Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF) with 2Hz, high frequency EA (HF) with 100Hz, alternating frequency EA (AF) with 2 and 100Hz for 3 seconds each, control group (C) and placebo group (P), each containing 25 participants. The LF, HF and AF groups will be submitted to the treatment protocol, which will consist of the bilateral application of electroacupuncture using NKL® portable electrostimulator. The C and P groups will follow exactly the same protocol as the electroacupuncture groups, however the C group will not undergo electrical stimulation, as the acupuncturist will activate channels that are not connected to the patient. In the P group an adhesive moxa will be placed on each acupoint and the needle will be inserted over it. In addition, as in group C, the electrodes will be connected to the needles, however, no electrical current will be applied.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Prior to the first treatment session, the random allocation sequence will be implemented by a researcher not involved in the patient recruitment or evaluation, and will be generated through the randomization.com program, where each number will match one of five study groups.

After the numbers are generated, they will be placed in sealed, brown envelopes and numbered in series, then given to the acupuncturist. This person will open them according to the numerical sequence, prior to the first session.

Patients will remain blind regarding the category of their allocation throughout the data collection period of the study. Additionally, the evaluators responsible for the data collection will be blinded to the patient allocation. The acupuncturist, being responsible for the interventions, will be the only person not blind to the type of treatment to be performed.

Primary Purpose: Treatment
Official Title: Electroacupuncture Frequency-related Effects on Non-specific Low Back Pain in Older Adults: Protocol for a Randomized Controlled Trial
Estimated Study Start Date : January 21, 2019
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : December 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Low frequency EA
25 participants will receive bilateral application of electroacupuncture using a previously calibrated EL 608 electrostimulator (NKL® portable), with the following parameters: balanced asymmetrical biphasic polarized pulse with continuous pulse train with 2Hz; 100ms pulse duration and 0.5ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol. With the participant lying down in a ventral position, the needles will be inserted at a 90º inclination with the skin, to a depth at which that the patient reports the "deQi" sensation (≅ 1.5cm).
Procedure: Electroacupuncture

The interventions will be performed by acupuncture specialists with at least 3 years of clinical experience, who will receive prior training to ensure that they rigorously follow the study protocol and are familiar with the types of treatments, including details such as acupuncture points and manipulation of electroacupuncture parameters.

After the randomization, the acupuncturist will sequentially open the envelopes, and the individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF), high frequency EA (HF), alternating frequency EA (AF), control group (C) and placebo group (P), each containing 25 participants. The acupuncture points will be located and described according to the WHO Standard Acupuncture Locations. Based on the beneficial effects of previous clinical trials, the acupoints selected for this study will be: BL23, BL25, BL40, SP6 and KI3.

Other Name: Acupuncture

Device: Needle
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used.

Experimental: High frequency EA

25 participants will receive 25 participants will receive bilateral application of electroacupuncture using a previously calibrated EL 608 electrostimulator (NKL® portable), with the following parameters: balanced asymmetrical biphasic polarized pulse with continuous pulse train with 100Hz; 100ms pulse duration and 0.5ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol. With the participant lying down in a ventral position, the needles will be inserted at a 90º inclination with the skin, to a depth at which that the patient reports the "deQi" sensation (≅ 1.5cm).

Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.

Procedure: Electroacupuncture

The interventions will be performed by acupuncture specialists with at least 3 years of clinical experience, who will receive prior training to ensure that they rigorously follow the study protocol and are familiar with the types of treatments, including details such as acupuncture points and manipulation of electroacupuncture parameters.

After the randomization, the acupuncturist will sequentially open the envelopes, and the individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF), high frequency EA (HF), alternating frequency EA (AF), control group (C) and placebo group (P), each containing 25 participants. The acupuncture points will be located and described according to the WHO Standard Acupuncture Locations. Based on the beneficial effects of previous clinical trials, the acupoints selected for this study will be: BL23, BL25, BL40, SP6 and KI3.

Other Name: Acupuncture

Device: Needle
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used.

Experimental: Alternating frequency EA

25 participants will receive 25 participants will receive bilateral application of electroacupuncture using a previously calibrated EL 608 electrostimulator (NKL® portable), with the following parameters: balanced asymmetrical biphasic polarized pulse with continuous pulse train with 100Hz and 2Hz for 3 seconds each; 100ms pulse duration and 0.5ms pulse width; and the maximum current (amplitude) intensity tolerated by the patient and intensified so that sensory habituation is avoided. Trichotomy will be carried out when necessary and the skin will be disinfected with 70% alcohol. With the participant lying down in a ventral position, the needles will be inserted at a 90º inclination with the skin, to a depth at which that the patient reports the "deQi" sensation (≅ 1.5cm).

Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.

Procedure: Electroacupuncture

The interventions will be performed by acupuncture specialists with at least 3 years of clinical experience, who will receive prior training to ensure that they rigorously follow the study protocol and are familiar with the types of treatments, including details such as acupuncture points and manipulation of electroacupuncture parameters.

After the randomization, the acupuncturist will sequentially open the envelopes, and the individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF), high frequency EA (HF), alternating frequency EA (AF), control group (C) and placebo group (P), each containing 25 participants. The acupuncture points will be located and described according to the WHO Standard Acupuncture Locations. Based on the beneficial effects of previous clinical trials, the acupoints selected for this study will be: BL23, BL25, BL40, SP6 and KI3.

Other Name: Acupuncture

Device: Needle
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used.

Active Comparator: Control Group

25 participants will follow exactly the same protocol as the experimental groups, however they will not undergo electrical stimulation, as the acupuncturist will activate channels that are not connected to the patient.

Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.

Device: Needle
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used.

Placebo Comparator: Placebo Group

25 participants will will follow exactly the same protocol as the experimental groups, however an adhesive moxa (Dong Yang®) will be placed on each acupoint and the needle will be inserted over it, so that the participant only feels the needle prick, but without perforation of the skin and the "deQi" sensation. In addition, as in the control group, the electrodes will be connected to the needles, however, no electrical current will be applied.

Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used. The sessions will last 30 minutes, twice a week, for 5 weeks, totaling 10 sessions.

Device: Needle
Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used.

Device: Adhesive Moxa
In the placebo group an adhesive moxa will be placed on each acupoint and the needle will be inserted over it.




Primary Outcome Measures :
  1. Pain intensity - Numerical Rating Scale (NRS) [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    Will be measure using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Participants will be asked to rate their average pain levels in the 24 hours prior to the assessment.

  2. Pain intensity - Pressure pain threshold (PPT) [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    The PPT will be measured using a pressure algometer (EMG system, Brazil). The assessed region will be marked with a tape measure and a dermatographic pencil. Two points will be marked bilaterally: 5 cm to the right and left of the spinous process of L3 and L5. A control point will be marked on the anterior tibial muscle of the right leg, 5 cm lateral to the tuberosity of the tibia. The circular tip of the algometer will be positioned perpendicular to the participant's skin and gradually pressed until the participant reports that the pressure has become painful and unbearable. Three measurements will be taken at each point with an interval of 1 minute.


Secondary Outcome Measures :
  1. Quality of pain [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    This will be analyzed using the McGill Pain Questionnaire, a valid and reliable instrument containing 78 pain descriptors divided into 4 categories (sensory, affective, evaluative and miscellaneous) and 20 subcategories, to which scores of 1 to 5 are attributed. The result is obtained by first scoring the words according to their position within the set of descriptors of each subcategory. The maximum score in the sensory category is 42, in the affective 14, in the evaluative 5 and in the miscellaneous 17. Then, the analysis is performed by adding these values associated with their categories. Higher scores equate to more intense pain.

  2. Perceived overall effect [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    The patient's self-perception regarding the treatment will be evaluated using the Global Effect Perception Scale, a 11-point numerical scale ranging from -5 (much worse) to +5 (much better), where higher scores represent better recovery.

  3. Emotional functionality - Depression [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    Depression will be assessed using the Beck Depression Inventory (BDI), a self-administered questionnaire that contains 21 items, with a score ranging from 0 to 3, where a higher score indicates more depressive symptoms.

  4. Patient satisfaction [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    The evaluation of the patient's satisfaction with the treatment will be carried out using the MedRisk questionnaire of patient satisfaction with physiotherapeutic care. This questionnaire contains 20 items, covering global aspects of the treatment (2 items), aspects related to the service provided (8 items), and aspects about the therapist-patient relationship (10 items). Following a Likert-type scale, the patient's response will range from 1 (strongly disagree) to 5 (strongly agree), where higher scores represent greater satisfaction with the treatment.

  5. Psychosocial factors [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    The risk of a poor prognosis due to psychosocial factors will be assessed using the STarT Back Screening Tool (SBST), a self-administered questionnaire with 9 items (4 related to referred pain and 5 related to psychosocial factors) where the patient has the response options "I agree" (1 point) and "I Disagree" (zero points) in the first eight items, and "Nothing", "A little" or "Moderate" (zero points each), "A lot" or "Extremely" (one point each) in the ninth item. If the total score is between 0-3 points, the patient is classified as low risk for poor prognosis. When the total score is greater than 3 points the score of the psychosocial subscale, questions 5 to 9, is then considered. If the score of this subscale is less than or equal to 3 points, the patient is classified as medium risk and scores greater than 3 points are considered to indicate a high risk for poor prognosis.

  6. Physical functioning - Roland Morris Disability Questionnaire [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    This measure will be assessed through the Roland Morris Disability Questionnaire. This is a self-administered questionnaire, adapted to the Portuguese language, which aims to evaluate physical incapacity due to low back pain. This contains 24 items pertaining to activities that can be impaired due to LBP. Individuals need to select the items that apply to their pain on that day. The selected items are summed for a total score ranging from 0 to 24, with higher scores indicating more severe functional incapacity.

  7. Emotional functionality - Anxiety [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    Anxiety will be assessed using the Global Anxiety - Visual Analog Scale (GA-VAS). This is composed of a 100mm line, where the left extremity is related to the absence of anxiety, and the right extremity is related to the worst possible anxiety. The individual is asked to assess the intensity of their anxiety in the previous 24 hours and to mark this on the line. The distance from the left edge of the line to the mark placed by the patient is measured in millimeters. Greater measurements indicate greater anxiety.

  8. Physical functioning - Five Times Sit to Stand Test [ Time Frame: prior to the start of treatment, immediately after the end of treatment (5 weeks), and at 6 and 12 months after the final treatment ]
    This measure will be assessed through the Five Times Sit to Stand Test (FTSST). The patient initiates the FTSST sitting in a chair without arm support, with the upper limbs crossed over the chest, feet positioned at hip width and knees in 90° flexion. They will be asked to stand and sit five times as fast as possible. A timer will be used to measure the task execution time. The test will be performed twice and the mean time will be calculated.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over 60 years of age
  • Either gender
  • Diagnosis of nonspecific low back pain of more than 3 months duration, with or without radiating leg pain, with a minimum pain intensity score of 4 on the 11-point pain numerical rating scale (NRS - Brazilian Portuguese version)
  • Walk independently (with or without walking devices)
  • Agree to voluntarily participate in this study and sign the consent form.

Exclusion Criteria:

  • Previous surgery on the spinal column
  • Have a known or suspected serious spinal pathology (e.g., cancer, vertebral fracture, spinal infection or cauda equina syndrome)
  • Fear of needles
  • Have participated in acupuncture treatment in the previous 30 days
  • Wheelchair users
  • Unable to sign the consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802045


Contacts
Contact: Sarina F Torres, Master´s 41985120128 ext 55 sarinaftorres@gmail.com
Contact: Amélia P Marques, PhD 113893-4401 ext 55 pasqual@usp.br

Locations
Brazil
Federal University of Parana Recruiting
Curitiba, Parana, Brazil, 82590-300
Contact: Sarina F Torres, Master´s    41985120128 ext 55    sarinaftorres@gmail.com   
Contact: Ana Carolina B de Macedo, PhD    4199944080 ext 55    acbrandtmacedo@gmail.com   
University of Sao Paulo General Hospital Recruiting
São Paulo, Sao Paulo, Brazil, 05402000
Contact: Sarina F Torres, Master´s    41985120128 ext 55    sarinaftorres@gmail.com   
Contact: Amélia P Marques, PhD    113893-4401 ext 55    pasqual@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital

Publications:
WHO standard acupuncture point locations in the Western Pacific Region. Manila, Philippines. 2009:1-242.

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03802045     History of Changes
Other Study ID Numbers: USaoPauloSA
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within one year of study completion.
Access Criteria: Data access requests will be reviewed by an external independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Sao Paulo General Hospital:
Acupuncture
Electroacupuncture
Low back pain
Elderly

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms