Clinical trial NCT05680467: Manual Therapy Plus Capacitive and Resistive Electric Transfer Therapy in Individuals With Chronic Low Back Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Chronic Low back pain
Manual therapy
Capacitive and Resistive Electric Transfer Therapy
Lead sponsor: International Hellenic University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in low back pain intensity with Numeric Pain Rating Scale (NPRS)
timeFrame: pre-treatment, week: 1, 2, 6
measure: Changes in Pressure Pain Threshold (PPT) with pressure algometry
timeFrame: pre-treatment, week: 1, 2, 6
measure: Changes in functional capacity with the Greek Version of Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: pre-treatment, week: 1, 2, 6
measure: Changes in lumbar spine flexion range of motion with the Fingertip-To-Floor Test
timeFrame: Time Frame: pre-treatment, week: 1, 2, 6
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit
state: Sindos Thessaloníki
Study officials:
References: