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

Sponsor

Universidade Federal do Oeste do Para (Other)

Overall Status

Completed

CT.gov ID

NCT05843136

Collaborator

Fundação Amazônia de Amparo a Estudos e Pesquisas FAPESPA (Other)

Enrollment

Location

Arms

14.3

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain	Other: physiotherapy treatment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 02The 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:

Single (Participant)

Masking Description:

only the participant was blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 5, 2022

Actual Primary Completion Date :

Jan 10, 2023

Actual Study Completion Date :

Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervenction 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.	Other: physiotherapy treatment 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
Active Comparator: Control Group 01 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).	Other: physiotherapy treatment 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
Active Comparator: Control Group 02 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	Other: physiotherapy treatment 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

Arm

Intervention/Treatment

Experimental: Intervenction

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.

Other: physiotherapy treatment

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

Active Comparator: Control Group 01

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).

Other: physiotherapy treatment

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

Active Comparator: Control Group 02

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

Other: physiotherapy treatment

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

Outcome Measures

Primary Outcome Measures

Isolated comparative evaluation method, before and after, in the three arms with Application of Rolland Morris Questionnaires [12 months]
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 [12 months]
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 [12 months]
Application analogue visual score for pain before and after intervention, evaluates the level of pain according to the patient's reference

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.