Clinical trial NCT05727462: Effects of Manual Therapy With TECAR in Woman With Chronic Neck Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck Pain
Myofascial trigger points
Manual Therapy
TECAR
Physiotherapy
Lead sponsor: International Hellenic University
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An assessor-blind randomized controlled trial lasting five weeks, with a six-month follow-up, will be conducted on 80 adult women with chronic neck pain and at least one trigger point in the upper trapezius muscle. Participants will be randomly allocated into two groups of 40 each (intervention and control). The intervention group will receive a combined treatment of manual techniques with two TECAR anti-static electrode bracelets, while the control group will follow the same protocol without the electrode bracelets. All participants will undergo a total of 15 treatments over the five-week period.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)
timeFrame: pre-treatment, week 5, 6-month follow-up
measure: Changes in Pressure Pain Threshold (PPT) with pressure algometry
timeFrame: pre-treatment, week 5, 6-month follow-up
measure: Changes in functional capacity with the Greek Version of Neck disability index questionnaire
timeFrame: pre-treatment, week 5, 6-month follow-up
measure: Changes in Cervical Range of Motion through goniometry
timeFrame: pre-treatment, week 5, 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
state: Sindos Thessaloníki
Study officials:
affiliation: Department of Physiotherapy, International Hellenic University
name: Paris Iakovidis, Ph.D
role: STUDY_CHAIR
References: