Manual Therapy Plus Capacitive and Resistive Electric Transfer Therapy in Individuals With Chronic Low Back Pain
NCT ID: NCT05680467
Last Updated: 2023-03-28
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-12-15
2023-03-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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"Soft Tissue Mobilization"
Participants allocated to this group will receive six sessions of soft tissue mobilization technique accord to Kaltenborn (2018) .
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
"Soft Tissue Mobilization" and "TECAR"
Participants allocated to this group will receive the same manual therapy protocol with Group 1 in combination with Capacitive and Resistive Electric Transfer Therapy (TECAR).
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
"Control"
Control Group
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.
Interventions
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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
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
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.
Eligibility Criteria
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Inclusion Criteria
* Women - Men
* Age range between 20 and 60 years
* Written consent to participate in the study
Exclusion Criteria
* Previous spine surgery
* History of spine trauma or fracture
* Implanted pacemakers
* Pregnancy
* Cancer
* Systemic musculoskeletal diseases, diagnosed neurodegenerative diseases (e.g., Parkinson's), epilepsy, and history of psychiatric disorders
20 Years
60 Years
ALL
No
Sponsors
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International Hellenic University
OTHER
Responsible Party
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Dimitrios Lytras
Dimitrios Lytras, Principal Investigator, Senior Lecturer of Physiotherapy
Locations
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Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit
Thessaloniki, Sindos Thessaloníki, Greece
Countries
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Other Identifiers
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EC-06/2022
Identifier Type: -
Identifier Source: org_study_id
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