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

NCT05843136 | Completed

• 1 other identifier: CAEE: 52035721.9.0000.0171
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Interferential Current; Chronic low back pain; Quality of life; Occupational disease; Physical functionality

Outcome Measures

Primary Outcomes (3)

• 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

  12 months

• 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

  12 months

• 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

  12 months

Study Arms (3)

Intervenction

EXPERIMENTAL

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

Control Group 01

ACTIVE COMPARATOR

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

Control Group 02

ACTIVE COMPARATOR

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

Interventions

physiotherapy treatment OTHER

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

Control Group 01; Control Group 02; Intervenction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Oeste do Para: lead
• Fundação Amazônia de Amparo a Estudos e Pesquisas FAPESPA: collaborator

Study Sites (1)

Luiz Paulo Sobral Pereia

Santarém, Pará, 680005150, Brazil

Location

MeSH Terms

Conditions

Occupational Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: only the participant was blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's in Health Sciences

Model Details: 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

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 6, 2023
• Study Start: January 5, 2022
• Primary Completion: January 10, 2023
• Study Completion: March 15, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)