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Interferential Current Treatment Reduces Low Back Pain and Improves Functionality in Patients With Chronic Low Back Pain.

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
physiotherapy treatment
Sponsored by
Universidade Federal do Oeste do Para
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Interferential Current, Chronic low back pain, Quality of life, Occupational disease, Physical functionality

Eligibility Criteria

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

Inclusion Criteria: Individuals of both genders Aged between 18 and 65 years Voluntarily sought the Clinic's physiotherapy service Low back pain for more than 12 weeks Medical request and diagnosis of low back pain with or without pain radiating to the lower limbs Immunization against COVID 19. Signature of the free detailed term clarified. (FDTC) Exclusion Criteria: Physiotherapy treatment carried out in a period equal to or less than 8 weeks before starting the research Reporting any contraindications inherent to the use of electrotherapy Participants with fractures or spinal surgery Involved in a legal medical dispute Diagnosis of fibromyalgia Patients with flu-like symptoms during the research period Participants who have more than 2 (two) absences will be excluded from the research.

Sites / Locations

  • Luiz Paulo Sobral Pereia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Intervenction

Control Group 01

Control Group 02

Arm Description

We used the SONOPULSE II device from the manufacturer IBRAMED, the electrodes measuring nine centimeters in length and five centimeters in width, from the manufacturer ARKTUS, of the adhesive plate type. According to the IBRAMED manual (2011, p. 47), the application is produced by two medium frequency currents through four electrodes, quadripolar method. The current type is tetrapolar interferential and the stimulation mode is automatic vector; the carrier frequency of 4000HZ, AMF modulation frequency of 50HZ, and the sweep frequency of SWEEP will be 20HZ. SWEEP sweep modes with 6 seconds of rise from the modulation frequency to the threshold the sweep frequency upon reaching the threshold immediately decays over the next 6 seconds. The positioning of the four-leaf clover type electrodes and the intensity of the strong current, however comfortable, according to the patient's report.

he treatment is based on non-invasive methods, highlighting manual therapy techniques, especially joint manipulation therapy. Manual therapy techniques are adjustments in lumbar rotation. Joint adjustment is a controlled lever-like force with direction, amplitude, and speed that is applied to specific, tissue-adjacent joints. While joint mobilization is manual therapy without the impulse, the joint remains within the physiological range of motion (SILVA et al., 2012). Therefore, a high-velocity, low-amplitude (HVA) manual maneuver was applied. The thrust (impulse) is carried out in the para-physiological environment, between the physiological and anatomical barriers. preload phase before the manipulation, thrust phase where the maneuver is performed with high speed and low amplitude and the resolution phase where the manipulation ends. The maneuver is detailed by the authors Bergmann & Peterson (2010).

The procedure adopted in this group was based on the guidelines and recommendations for non-pharmacological treatment of the Associação Médica Brasileira AMB (RACHED, R.D.V.A. et al, 2013) use of 1 MHZ Ultrasound with a power of 1W/cm2, continuous IBRAMED device for 10 minutes, Wave Diathermy Short for 15 minutes/day, HTM brand, TENS 50 HZ and 50 ms intensity phase according to the patient's threshold, 30 minutes, IBRAMED brand

Outcomes

Primary Outcome Measures

Isolated comparative evaluation method, before and after, in the three arms with Application of Rolland Morris Questionnaires
Application of Rolland Morris Questionnaires before and after intervention, this questionnaires assesses mild and moderate pain and disability
Isolated comparative evaluation method, before and after, in the three arms, Application of Owestry Questionnaire
Application of Owestry Questionnaire before and after intervention, this questionnaires evaluates more severe disabilities
Isolated comparative evaluation method, before and after, in the three arms, Application analogue visual score for pain
Application analogue visual score for pain before and after intervention, evaluates the level of pain according to the patient's reference

Secondary Outcome Measures

Full Information

First Posted
April 12, 2023
Last Updated
April 24, 2023
Sponsor
Universidade Federal do Oeste do Para
Collaborators
Fundação Amazônia de Amparo a Estudos e Pesquisas FAPESPA
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1. Study Identification

Unique Protocol Identification Number
NCT05843136
Brief Title
Interferential Current Treatment Reduces Low Back Pain and Improves Functionality in Patients With Chronic Low Back Pain.
Official Title
Interferential Current Treatment Reduces Low Back Pain and Improves Functionality in Patients With Chronic Low Back Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Oeste do Para
Collaborators
Fundação Amazônia de Amparo a Estudos e Pesquisas FAPESPA

4. Oversight

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

5. Study Description

Brief Summary
. 24 individuals were evaluated, with low back pain for more than 12 weeks and aged between 12 and 65 years. The current used in the lumbar region of the participants was of the tetrapolar interferential type and the stimulation mode was the automatic vector, carrier of 4,000 HZ, modulation frequency (AMF) of 50 HZ, sweep frequency of SWEEP of 20HZ. The assessment of pain and functionality was performed using the data collection instrument, the Visual Analogue Pain Scale (VAS), Rolland Morris Disability Questionnaire (RMDQ) and the Owestry Disability Questionnaire (ODQ) respectively. The present study demonstrates that treatment with interferential current promotes chemical improvement in participants, which opens up new perspectives on the use of this therapeutic approach.
Detailed Description
Low back pain is characterized by pain and represents a change in health that affects mainly adults, although electrostimulation represents an important tool in the treatment of patients with chronic nonspecific low back pain, the clinical efficacy of the interferential current used in physiotherapy still lacks reinforcement for clinical validation. In this way, the present study evaluated whether the use of interferential current contributes to reducing chronic low back pain and analyzed whether the electrotherapeutic protocol can benefit the physical functionality of patients with chronic low back pain. 24 individuals were evaluated, with low back pain for more than 12 weeks and aged between 12 and 65 years. The current used in the lumbar region of the participants was of the tetrapolar interferential type and the stimulation mode was the automatic vector, carrier of 4,000 HZ, modulation frequency (AMF) of 50 HZ, sweep frequency of SWEEP of 20HZ. The assessment of pain and functionality was performed using the data collection instrument, the Visual Analogue Pain Scale (VAS), Rolland Morris Disability Questionnaire (RMDQ) and the Owestry Disability Questionnaire (ODQ) respectively. Data analysis was performed using the JAMOVI 2.2.5 software. Our data showed that individuals with interferential current showed significant improvement in pain relief, as well as in the functional pattern of pain improvement. The present study demonstrates that treatment with interferential current promotes chemical improvement in participants, which opens up new perspectives on the use of this therapeutic approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Interferential Current, Chronic low back pain, Quality of life, Occupational disease, Physical functionality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The research is a randomized clinical trial, was submitted and approved by the Human Ethics Committee (CEP) with opinion 5,175,882, CAEE: 52035721.9.0000.0171. Participants were chosen at random, with single-blind masking, Random Allocation ® software was used to generate random numbers for the intervention and control groups, non-probalistic convenience sample. There were three groups: interventional, control 01 and control 02
Masking
Participant
Masking Description
only the participant was blinded
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervenction
Arm Type
Experimental
Arm Description
We used the SONOPULSE II device from the manufacturer IBRAMED, the electrodes measuring nine centimeters in length and five centimeters in width, from the manufacturer ARKTUS, of the adhesive plate type. According to the IBRAMED manual (2011, p. 47), the application is produced by two medium frequency currents through four electrodes, quadripolar method. The current type is tetrapolar interferential and the stimulation mode is automatic vector; the carrier frequency of 4000HZ, AMF modulation frequency of 50HZ, and the sweep frequency of SWEEP will be 20HZ. SWEEP sweep modes with 6 seconds of rise from the modulation frequency to the threshold the sweep frequency upon reaching the threshold immediately decays over the next 6 seconds. The positioning of the four-leaf clover type electrodes and the intensity of the strong current, however comfortable, according to the patient's report.
Arm Title
Control Group 01
Arm Type
Active Comparator
Arm Description
he treatment is based on non-invasive methods, highlighting manual therapy techniques, especially joint manipulation therapy. Manual therapy techniques are adjustments in lumbar rotation. Joint adjustment is a controlled lever-like force with direction, amplitude, and speed that is applied to specific, tissue-adjacent joints. While joint mobilization is manual therapy without the impulse, the joint remains within the physiological range of motion (SILVA et al., 2012). Therefore, a high-velocity, low-amplitude (HVA) manual maneuver was applied. The thrust (impulse) is carried out in the para-physiological environment, between the physiological and anatomical barriers. preload phase before the manipulation, thrust phase where the maneuver is performed with high speed and low amplitude and the resolution phase where the manipulation ends. The maneuver is detailed by the authors Bergmann & Peterson (2010).
Arm Title
Control Group 02
Arm Type
Active Comparator
Arm Description
The procedure adopted in this group was based on the guidelines and recommendations for non-pharmacological treatment of the Associação Médica Brasileira AMB (RACHED, R.D.V.A. et al, 2013) use of 1 MHZ Ultrasound with a power of 1W/cm2, continuous IBRAMED device for 10 minutes, Wave Diathermy Short for 15 minutes/day, HTM brand, TENS 50 HZ and 50 ms intensity phase according to the patient's threshold, 30 minutes, IBRAMED brand
Intervention Type
Other
Intervention Name(s)
physiotherapy treatment
Intervention Description
this is an interventional study of the use of 3 physiotherapy treatment techniques in order to evaluate the effectiveness of interferential current in relieving chronic low back pain
Primary Outcome Measure Information:
Title
Isolated comparative evaluation method, before and after, in the three arms with Application of Rolland Morris Questionnaires
Description
Application of Rolland Morris Questionnaires before and after intervention, this questionnaires assesses mild and moderate pain and disability
Time Frame
12 months
Title
Isolated comparative evaluation method, before and after, in the three arms, Application of Owestry Questionnaire
Description
Application of Owestry Questionnaire before and after intervention, this questionnaires evaluates more severe disabilities
Time Frame
12 months
Title
Isolated comparative evaluation method, before and after, in the three arms, Application analogue visual score for pain
Description
Application analogue visual score for pain before and after intervention, evaluates the level of pain according to the patient's reference
Time Frame
12 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: Individuals of both genders Aged between 18 and 65 years Voluntarily sought the Clinic's physiotherapy service Low back pain for more than 12 weeks Medical request and diagnosis of low back pain with or without pain radiating to the lower limbs Immunization against COVID 19. Signature of the free detailed term clarified. (FDTC) Exclusion Criteria: Physiotherapy treatment carried out in a period equal to or less than 8 weeks before starting the research Reporting any contraindications inherent to the use of electrotherapy Participants with fractures or spinal surgery Involved in a legal medical dispute Diagnosis of fibromyalgia Patients with flu-like symptoms during the research period Participants who have more than 2 (two) absences will be excluded from the research.
Facility Information:
Facility Name
Luiz Paulo Sobral Pereia
City
Santarém
State/Province
Para
ZIP/Postal Code
680005150
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Interferential Current Treatment Reduces Low Back Pain and Improves Functionality in Patients With Chronic Low Back Pain.

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