NCT05680467

Manual Therapy Plus Capacitive and Resistive Electric Transfer Therapy in Individuals With Chronic Low Back Pain

Short-term Effects of Manual Therapy Plus Capacitive and Resistive Electric Transfer Therapy in Pain Disability and Spinal Mobility in Individuals With Chronic Low Back Pain: A Randomized Clinical Trial Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: International Hellenic University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
OTHER	Manual Therapy	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
OTHER	Manual Therapy plus TECAR	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
OTHER	Control	Participants in this group will only receive general instructions about managing their back pain and counseling about avoiding activities that may worsen their symptoms.

Timeline

• Start date: 2022-12-15
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2023-01-11
• Last updated: 2023-03-28

Locations

1 site across 1 country: Greece