Effects of Manual Therapy With TECAR in Woman With Chronic Neck Pain

NCT ID: NCT05727462

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-03-01

Brief Summary

The aim of our clinical study is to investigate the efficacy of combining a program of manual techniques for treating chronic neck pain with the simultaneous application of TECAR therapy, utilizing two specialized anti-static electrode bracelets. A total of 80 women with upper trapezius trigger points and neck pain persisting for more than 12 weeks will be randomly assigned to two groups. In the first group, combined treatment involving manual techniques and two TECAR anti-static electrode bracelets will be administered, while in the second group, the same protocol will be followed without the electrode bracelets. All participants will receive a total of 15 treatments over five weeks, with a follow-up assessment six months post-treatment. Pain will be measured using the Numerical Pain Rating Scale (NPRS), and pain thresholds at the upper trapezius muscle and suboccipital area will be evaluated with a digital algometer. Additionally, neck range of motion will be assessed with a goniometer, and functional ability will be evaluated using the "Neck Disability Index" questionnaire. Assessments will be conducted before and after the treatment period, with a follow-up assessment six months later. For statistical analysis, a multivariate analysis of variance (MANOVA) with repeated measures will be applied, with the significance level set at p < .05.

Detailed Description

Background: Chronic neck pain is defined as neck pain lasting more than 12 weeks and is often accompanied by painful trigger points in the neck muscles. The use of manual techniques, such as myofascial release and ischemic compression on painful points in the neck muscles, has been shown to reduce pain and improve functional ability and neck range of motion in individuals with chronic neck pain.

Aim: The aim of our clinical study is to investigate the efficacy of combining a program of manual techniques for treating chronic neck pain with the simultaneous application of TECAR therapy using two specialized anti-static electrode bracelets.

Method: Eighty women with upper trapezius trigger points and neck pain symptoms persisting for more than 12 weeks will be randomly assigned to two groups. The first group will receive a combined treatment of manual techniques with two TECAR anti-static electrode bracelets, while the second group will follow the same protocol without the electrode bracelets. All participants will undergo a total of 15 treatments over five weeks, with a follow-up assessment after six months. Pain will be measured using the Numerical Pain Rating Scale (NPRS), pressure pain threshold (PPT) of the upper trapezius muscle and suboccipital area will be evaluated with a digital algometer, neck range of motion (ROM) will be assessed using a goniometer, and functional ability will be measured with the "Neck Disability Index" questionnaire. Assessments will be conducted before and after the treatment period, with a follow-up assessment six months later. For statistical analysis, a multivariate analysis of variance (MANOVA) with repeated measures will be applied, with the significance level set at p < .05.

Expected Results: Modern TECAR devices, through special resistive bracelet electrodes, allow the therapist's hand to function as a mobile electrode. This enables the simultaneous effect of both therapeutic modalities-manual techniques and high-frequency current. Therefore, we expect the combination to be more effective than manual techniques alone in improving the clinical profile of adult women with chronic neck pain.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual Therapy with TECAR

Participants allocated to this group received 15 sessions of a manual therapy protocol applied by two resistive TECAR bracelet electrodes (one in each hand).

Group Type: EXPERIMENTAL

Manual Therapy with TECAR

Intervention Type: OTHER

The following myofascial release techniques will be applied:

Myofascial release of the upper trapezius Gross stretch, vertical gross stretch, and focused stretch of the upper trapezius Myofascial release at the cranial base Gross release of the sternocleidomastoid muscle

Additionally, the following ischemic compression technique will be applied:

Ischemic compression on the upper trapezius muscle Manual therapy manipulations will be administered in combination with a capacitive conventional electrode and two special electrode bracelets that turn the therapist's hands into anti-static electrodes. High-frequency currents will be applied at frequencies of 300 kHz, 500 kHz, and 1 MHz, with a flexible self-adhesive grounding electrode placed on the thoracic spine for reference.

Manual Therapy without TECAR bracelet electrodes

Participants allocated to this group received the same Manual Therapy protocol without the resistive TECAR bracelet electrodes

Group Type: ACTIVE_COMPARATOR

Manual Therapy without TECAR

Intervention Type: OTHER

Participants in this group will follow the same manual protocol as the first group, without the application of high-frequency current. Each manual therapy session will begin with a ten-minute preparation involving light massage and stretching. The massage will include the effleurage technique, followed by petrissage and kneading, focusing on the cervical and thoracic areas, particularly the upper trapezius, suboccipital region, and cervical paraspinal muscles. Stretching will be applied to the upper trapezius, levator scapulae, and sternocleidomastoid muscles.

Interventions

Manual Therapy with TECAR

The following myofascial release techniques will be applied:

Myofascial release of the upper trapezius Gross stretch, vertical gross stretch, and focused stretch of the upper trapezius Myofascial release at the cranial base Gross release of the sternocleidomastoid muscle

Additionally, the following ischemic compression technique will be applied:

Ischemic compression on the upper trapezius muscle Manual therapy manipulations will be administered in combination with a capacitive conventional electrode and two special electrode bracelets that turn the therapist's hands into anti-static electrodes. High-frequency currents will be applied at frequencies of 300 kHz, 500 kHz, and 1 MHz, with a flexible self-adhesive grounding electrode placed on the thoracic spine for reference.

Intervention Type: OTHER

Manual Therapy without TECAR

Participants in this group will follow the same manual protocol as the first group, without the application of high-frequency current. Each manual therapy session will begin with a ten-minute preparation involving light massage and stretching. The massage will include the effleurage technique, followed by petrissage and kneading, focusing on the cervical and thoracic areas, particularly the upper trapezius, suboccipital region, and cervical paraspinal muscles. Stretching will be applied to the upper trapezius, levator scapulae, and sternocleidomastoid muscles.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Women with chronic neck pain lasting at least three months Presence of at least one active or latent trigger point in the upper trapezius muscle Numerical Rating Pain Scale score greater than 3 Written consent to participate in the study

Exclusion Criteria

Participation in any form of treatment in the past three months (e.g., physiotherapy, massage, local anesthetic injections) History of neck trauma and/or surgery in the neck region Paresthesia in the neck area Implanted pacemaker Cancer Pregnancy Systemic musculoskeletal diseases, diagnosed neurodegenerative diseases (e.g., Parkinson's disease), epilepsy, or history of psychiatric disorders

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

International Hellenic University

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Lytras

Dimitrios Lytras PT, PhD, Senior Lecturer of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paris Iakovidis, Ph.D

Role: STUDY_CHAIR

Department of Physiotherapy, International Hellenic University

Locations

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Sindos Thessaloníki, Greece

Countries

Greece

Other Identifiers

EC-03/2023

Identifier Type: -

Identifier Source: org_study_id