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

International Hellenic University

Status: Completed

Conditions: Chronic Low Back Pain

Treatments: Other: Manual Therapy; Other: Manual Therapy plus TECAR; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05680467

EC-06/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Duration of symptoms 12 weeks
• Women - Men
• Age range between 20 and 60 years
• Written consent to participate in the study

Exclusion criteria

• Neuropathic pain extending along the lower limb due to nerve root compression
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

"Soft Tissue Mobilization"

Experimental group

Description:

Participants allocated to this group will receive six sessions of soft tissue mobilization technique accord to Kaltenborn (2018) .

Treatment:

Other: Manual Therapy

"Soft Tissue Mobilization" and "TECAR"

Experimental group

Description:

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).

Treatment:

Other: Manual Therapy plus TECAR

"Control"

Active Comparator group

Description:

Control Group

Treatment:

Other: Control