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

Neck Pain Clinical Trial

Official title:

Effects of a Protocol of Soft Tissue Mobilization Techniques With or Without TECAR Treatment on Pain, Local Sensitivity, Neck Range of Motion, and Functional Ability in Woman With Chronic Neck Pain: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05727462
• Other study ID #: EC-03/2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2024
• Source: International Hellenic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our clinical study is to investigate the efficacy of combining a program of manual techniques for the treatment of chronic neck pain with the simultaneous application of TECAR through the use of two special anti-static electrode bracelets. 80 women with trigger points in the neck muscles and neck pain symptoms for more than 12 weeks will be randomly divided into two groups. In the first group, the combined treatment of manual techniques with two TECAR anti-static electrode bracelets will be applied, while in the second group, the same protocol will be applied without the electrode bracelets. All participants will undergo a total of 15 treatments over five weeks with a follow-up after six months. Pain with the numbered pain scale (PNS pain), pain threshold of the upper part of the trapezius muscle, the sternocleidomastoid, the levator scapulae, and the splenius capitis with a digital algometer, range of motion of the neck with a goniometer and functional ability with the "Neck Disability Index" questionnaire will be assessed before and after treatment period with a follow-up six months 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

Description:

Background: Chronic neck pain is neck pain lasting more than 12 weeks. It is often characterized by the presence of painful trigger points in the neck muscles. The application of manual techniques such as myofascial release and gentle pressure on the painful points of the neck muscles has been shown to help reduce pain and improve functional ability and range of motion of the neck in people with chronic neck pain.

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

Method: 80 women with trigger points in the neck muscles and neck pain symptoms for more than 12 weeks will be randomly divided into two groups. In the first group, the combined treatment of manual techniques with two TECAR anti-static electrode bracelets will be applied, while in the second group, the same protocol will be applied without the electrode bracelets. All participants will undergo a total of 15 treatments over five weeks with a follow-up after six months. Pain with the numbered pain scale (PNS pain), pain threshold of the upper part of the trapezius muscle, the sternocleidomastoid, the levator scapulae, and the splenius capitis with a digital algometer, range of motion of the neck with a goniometer and functional ability with the "Neck Disability Index" questionnaire will be assessed before and after treatment period with a follow-up six months 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: Modern TECAR devices enable, through special resistive bracelet electrodes, to turn the hand of the therapist into a mobile electrode. In this way, a simultaneous effect of the two therapeutic means (manual techniques and high-frequency current) is possible. For this reason, we expect the combination to be more effective than the individual application of manual techniques in improving the clinical picture of adult women with chronic neck pain.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women with chronic neck pain with a duration of symptoms for at least three months

• Existence of at least one active or latent trigger point in any of the muscles:

levator scapulae, upper trapezius, sternocleidomastoid, splenius capitis

• Written consent to participate in the study

Exclusion Criteria:

• Participation in any kind of treatment during the past 3 months (e.g., physiotherapy, massage, local injections of anesthetic blocks)

• Background of neck trauma and/or surgery in the neck region

• Implanted pacemakers

• Pregnancy

• Cancer

• Systemic musculoskeletal diseases, diagnosed neurodegenerative diseases (e.g., Parkinson's), epilepsy, and history of psychiatric disorders

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Manual Therapy with TECAR
Manual Therapy with TECAR The following manipulation of myofascial release will be applied: Upper trapezius myofascial release, unilateral gross stretch, vertical gross stretch and focused stretch. Cranial base myofascial release Gross and focused release of the sternocleidomastoid muscle. Gross and focused release of the levator scapulae muscle. Additionally, the following manipulation of ischemic compression will be applied: Ischemic compression on upper trapezius, sternocleidomastoid, levator scapulae, and splenius capitis muscles. Manual Therapy manipulations will be applied in combination with a capacitive conventional electrode and with two special electrode bracelets that turn the therapist's hands into an anti-static 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 thoracic spine.
• Manual Therapy without TECAR
The participants of this group will be given the same manual protocol as the first group without the application of high-frequency current. Before each manual therapy session, light massage and stretching was applied for five minutes as preparation for the manipulations. The massage included the effleurage technique followed by petrissage and kneading on the cervical and thoracic areas (on the upper three parts of the trapezius muscle, in the suboccipital area, and on the paraspinal cervical muscles). Stretching was applied to the following muscles: upper part of the trapezius, levator scapulae, and the sternocleidomastoid muscle.

Locations

Country	Name	City	State
Greece	Department of Physiotherapy, Faculty of Health Sciences International Hellenic University	Thessaloníki	Sindos Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
International Hellenic University

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)	This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain (Childs et al, 2005). The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity	pre-treatment, week 5, 6-month follow-up
Primary	Changes in Pressure Pain Threshold (PPT) with pressure algometry	Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT was assessed by a digital algometer. Pressure pain threshold was assessed over the upper border of the trapezius muscle halfway between the midline and the lateral border of the acromion, the levator scapulae muscle 2 cm above the lower insertion located in the upper medial border of the scapulae, Sternocleidomastoid muscle and to splenius capitis 2 cm. Lateral to the spinous processus of the axis. The metal rod of the algometer was placed vertically on the site and the examiner applied gradually increasing pressure at a rate of 1Kg/s. PPT was calculated in kg/cm2.	pre-treatment, week 5, 6-month follow-up
Primary	Changes in functional capacity with the Greek Version of Neck disability index questionnaire	It is a self-reported ten-item scale. Each item assesses different neck pain complaints. Most of the items are related to restrictions in activities of daily living, and each item is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating the highest disability. The total score ranges from 0 to 50. Disability Index (NDI) has sufficient support in the literature, being the most commonly used to report neck pain.	pre-treatment, week 5, 6-month follow-up
Primary	Changes in Cervical Range of Motion with bubble inclinometers	Cervical active range of motion was measured with 2 bubble inclinometers. One was placed on the top of the head and the second on the spinous process of C7.Active cervical flexion, extension, turn and side bending range of motion were assessed with participants sitting in upright position. Range of motion was measured in degrees.	pre-treatment, week 5, 6-month follow-up