Manual Therapy Plus Capacitive and Resistive Electric Transfer Therapy in Individuals With Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Chronic low back pain is defined as back pain that lasts longer than 12 weeks. The aim of
      this clinical study is to investigate the efficacy of combining a program of manual
      techniques with the application of Capacitive and Resistive Electric Transfer (TECAR) therapy
      to treat chronic low back pain. Sixty adults with chronic low back pain will be randomly
      divided into three groups of 20 each. In the participants of the first group, a therapeutic
      protocol of manual soft tissue mobilization in the lumbar region will be applied. To the
      participants of the second group, the same protocol of manual techniques will be applied in
      combination with TECAR therapy, which will be applied through a conventional capacitive
      electrode as well as an antistatic electrode bracelet (making the hand of the physical
      therapist an antistatic electrode). The third group participants will receive no treatment.
      Both programs will include six treatments over two weeks. Pain in the last 24 hours with the
      Numeric Pain Rating Scale (NPRS), functional ability with the Roland-Morris Disability
      Questionnaire (RMDQ), Pressure Pain Threshold (PPT) in the lumbar region with an algometer,
      and lumbar flexion range of motion through fingertip-to-floor distance (FFD) test will be
      evaluated before and after the intervention with a follow-up one month later. For the
      statistical analysis of the results, a two-factor analysis of variance with repeated
      measurements will be applied, while the statistical significance index will be set at p <
      .05.
    

Detailed description: 
      Background: Chronic low back pain is defined as back pain that lasts longer than 12 weeks.

      Aim: The purpose of this clinical study is to investigate the efficacy of combining a program
      of manual techniques with the application of Capacitive and Resistive Electric Transfer
      (TECAR) therapy in people with chronic low back pain.

      Method: Sixty adults with chronic low back pain will be randomly divided into three groups of
      20 people each. In the participants of the first group, a therapeutic protocol of manual soft
      tissue mobilization in the lumbar region will be applied. To the participants of the second
      group, the same protocol of manual techniques will be applied in combination with TECAR
      therapy, which will be applied through a conventional capacitive electrode as well as an
      antistatic electrode bracelet (making the hand of the physical therapist an antistatic
      electrode). The third group participants will receive no treatment. Both programs will
      include six treatments over two weeks. Pain in the last 24 hours with the Numeric Pain Rating
      Scale (NPRS), functional ability with the Roland-Morris Disability Questionnaire (RMDQ),
      Pressure Pain Threshold (PPT) in the lumbar region with an algometer, and lumbar flexion
      range of motion through fingertip-to-floor distance (FFD) test will be evaluated before and
      after the intervention with a follow-up one month later. For the statistical analysis of the
      results, a two-factor analysis of variance with repeated measurements will be applied, while
      the statistical significance index will be set at p < .05.

      Expected results: The protocol proposed in this clinical study combines the beneficial
      effects of TECAR treatment with the benefits of applying manual techniques. Modern TECAR
      devices make it possible, through special resistive bracelet electrodes, to turn the hand of
      the therapist into a mobile electrode providing a simultaneous effect of the two therapeutic
      means through manual techniques and high-frequency current. For this reason, we expect the
      specific combination to be more effective than the individual application of manual
      techniques in improving the clinical picture of adults with chronic low back pain. For the
      statistical analysis of the results, a two-way ANOVA with repeated measurements will be
      applied.
    

Intervention name(s): Manual Therapy; Manual Therapy plus TECAR; Control
Intervention type(s): Other; Other; Other
Intervention description(s): The protocol will last 30 minutes and will include the application of the following manual techniques:
Lumbar soft tissue and joint cranial and lateral mobilization with the patient in the supine position
Bilateral medial lumbar soft tissue mobilization
Functional massage on the quadratus lumborum muscle with the patient in a lateral position on both sides
Extension with coupled sidebending mobilization of the thoracic area with the patient in a lateral position on both sides
Soft tissue lateral mobilization of the thoracic area with the patient in a lateral position on both sides; The participants of this group will be given the same manual protocol as the first group in combination with the application of high frequency current. Soft tissue mobilization manipulations will be applied in combination with a capacitive conventional electrode and with a special electrode bracelet that makes the therapist's own hand as an antistatic electrode. The frequencies of the high frequency current will be 300khz, 500khz, and 1MHz, while as a reference electrode a flexible self-adhesive ground will be used placed on the abdomen; Participants in this group will only receive general instructions about managing their back pain and counseling about avoiding activities that may worsen their symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty participants with chronic low back pain will be randomly assigned to three groups of 20 each. The allocation of the sample to the groups will be performed using a randomization program (https://www.randomizer.org/) by an independent researcher. In the first group, a manual protocol will be applied with the simultaneous application of a high-frequency current through TECAR, in the second group, the same manual protocol will be applied without the TECAR device, while the third group will not receive any treatment. Participants of the two intervention groups will follow a total of six treatments over a period of three weeks with a follow-up after one month.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Low back pain; Manual therapy; Capacitive and Resistive Electric Transfer Therapy