Effectiveness of Various Electrotherapy Methods in Treating People With Cervical Spine Pain Syndrome.

Volunteers will take part in the study; Students of the university in the area of Rzeszow reporting chronic spinal ailments participation in remote learning. Applicant participants will be randomised into 3 groups of subjected to various electrotherapy procedures.

Study Overview

• Status: Recruiting
• Conditions: Cervical Spine Syndrome
• Intervention / Treatment: Other: Kinesiotherapy combined with electrotherapy (Convenctional TENS method).; Other: Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method).; Other: Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method); Other: Kinesiotherapy combined with placebo electrotherapy

Detailed Description

Study participants will be tested:

1. Before a series of electrotherapy treatments.
2. 7 to 10 days after the end of electrotherapy.

3. 3 months after the end of electrotherapy. The study will use

   1. a self-authored survey taking into account: basic personal data (age, gender, value and BMI, lifestyle and degree of load on the cervical spine), information on the nature, intensity and frequency of the presence of pain in the spine cervical system, taking into account possible adverse reactions
   2. a questionnaire for subcjective assessment of the state of the spine Neck Disability Index,
   3. measuring the tone of the vertebral muscles in the cervical (myotonometer),
   4. a visual analog scale used to assess the severity of symptoms (Visual Analog Scale -VAS) Intervention;
   1. irradiation of the neck area with a sollux lamp with a blue filter
   2. individual exercises conducted according to the prepared author's mobility improvement program

   3. electrotherapy treatments:

      • Trabert currents
      • TENS currents (conventional)
      • TENS currents (pseudo-acupuncture)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jolanta Zwolińska, PhD; Phone Number: 505095199; Email: jolantazwolinska@op.pl
• Study Contact Backup: Name: Paulina Sałaga; Phone Number: 731275361; Email: paulina.salaga@gmail.com

Study Locations

• Poland
  • Podkarpackie
    • Rzeszów, Podkarpackie, Poland, 35-310 Rzeszów
      • Recruiting
      • Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego
      • Contact: Jolanta Zwolińska, PhD; Phone Number: 505095199; Email: jolantazwolinska@op.pl
      • Contact: Lidia Perenc, prof.drhab.; Phone Number: 722015220; Email: lperenc@ur.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• informed written consent of the patient to participate in the study
• no contraindications to electrotherapy in the area of the cervical spine;

Exclusion Criteria:

• poor tolerance of electrotherapy treatments;
• breaks between consecutive treatments longer than 3 days;
• failure to complete a series of kinesiotherapy and electrotherapy treatments;
• use of any stimulants during the observation period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conventional TENS group; One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Conventional TENS method).	Other: Kinesiotherapy combined with electrotherapy (Convenctional TENS method).; One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Conventional TENS method).
Experimental: Pseudo-acupuncture TENS group; One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Pseudo-acupuncture TENS method).	Other: Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method).; One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Pseudo-acupuncture TENS method).
Experimental: Trabert ultrastimulation group; One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Trabert ultrastimulation method).	Other: Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method); One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Trabert ultrastimulation method).
Placebo Comparator: Placebo group; One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy.	Other: Kinesiotherapy combined with placebo electrotherapy; One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck Disability Index	A questionnaire for subcjective assessment of the state of the spine.	1. Before a series of electrotherapy treatments.
Neck Disability Index	A questionnaire for subcjective assessment of the state of the spine.	2. 7 to 10 days after the end of electrotherapy.
Neck Disability Index	A questionnaire for subcjective assessment of the state of the spine.	3. 3 months after the end of electrotherapy.
Myotonometer	Measuring the tone of the vertebral muscles in the cervical.	1. Before a series of electrotherapy treatments.
Myotonometer	Measuring the tone of the vertebral muscles in the cervical.	2. 7 to 10 days after the end of electrotherapy.
Myotonometer	Measuring the tone of the vertebral muscles in the cervical.	3. 3 months after the end of electrotherapy.
Visual Analog Scale	A Visual Analog Scale used to assess the severity of symptoms. It enables the Patient to fine-tune the pain level on a scale from 0 to 10, where 0 is no pain at all and 10 is the maximum imaginable.	1. Before a series of electrotherapy treatments.
Visual Analog Scale	A Visual Analog Scale used to assess the severity of symptoms. It enables the Patient to fine-tune the pain level on a scale from 0 to 10, where 0 is no pain at all and 10 is the maximum imaginable.	2. 7 to 10 days after the end of electrotherapy.
Visual Analog Scale	A Visual Analog Scale used to assess the severity of symptoms. It enables the Patient to fine-tune the pain level on a scale from 0 to 10, where 0 is no pain at all and 10 is the maximum imaginable.	3. 3 months after the end of electrotherapy.

Collaborators and Investigators

• Sponsor: University of Rzeszow
• Investigators: Study Director: Lidia Perenc, docent prof, University of Rzeszow

Publications and helpful links

General Publications

• Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
• Martimbianco ALC, Porfirio GJ, Pacheco RL, Torloni MR, Riera R. Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain. Cochrane Database Syst Rev. 2019 Dec 12;12(12):CD011927. doi: 10.1002/14651858.CD011927.pub2.
• Martins-de-Sousa PH, Guimaraes Almeida MQ, da Silva Junior JM, Santos AS, Costa Araujo GG, de Oliveira Pires F, Fidelis-de-Paula-Gomes CA, Koga Ferreira VT, Dibai-Filho AV. Program of therapeutic exercises associated with electrotherapy in patients with chronic neck pain: Protocol for a randomized controlled trial. J Bodyw Mov Ther. 2020 Jan;24(1):25-30. doi: 10.1016/j.jbmt.2019.04.008. Epub 2019 Apr 25.

Helpful Links

• Review of clinical trials assessing the effectiveness of exercise therapy and electrotherapy.
• In the study included adults with chronic neck pain (lasting > 12 weeks) that compared TENS alone or in combination with other treatments versus active or inactive treatments. The primary outcomes were pain, disability and adverse events.
• The objective of this study will be to evaluate the clinical effects of adding high- and low-frequency transcutaneous electrical nerve stimulation (TENS) in a program of specific therapeutic exercises for the treatment of patients with chronic neck pain.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: TENS; Cervical spine; Electrotherapy; Pain syndrome; Träbert ultrastimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: Urzeszow Club of Physical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No