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

May 30, 2022 updated by: Jolanta Zwolińska, University of Rzeszow
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neck Disability Index
Time Frame: 1. Before a series of electrotherapy treatments.
A questionnaire for subcjective assessment of the state of the spine.
1. Before a series of electrotherapy treatments.
Neck Disability Index
Time Frame: 2. 7 to 10 days after the end of electrotherapy.
A questionnaire for subcjective assessment of the state of the spine.
2. 7 to 10 days after the end of electrotherapy.
Neck Disability Index
Time Frame: 3. 3 months after the end of electrotherapy.
A questionnaire for subcjective assessment of the state of the spine.
3. 3 months after the end of electrotherapy.
Myotonometer
Time Frame: 1. Before a series of electrotherapy treatments.
Measuring the tone of the vertebral muscles in the cervical.
1. Before a series of electrotherapy treatments.
Myotonometer
Time Frame: 2. 7 to 10 days after the end of electrotherapy.
Measuring the tone of the vertebral muscles in the cervical.
2. 7 to 10 days after the end of electrotherapy.
Myotonometer
Time Frame: 3. 3 months after the end of electrotherapy.
Measuring the tone of the vertebral muscles in the cervical.
3. 3 months after the end of electrotherapy.
Visual Analog Scale
Time Frame: 1. Before a series of electrotherapy treatments.
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
Time Frame: 2. 7 to 10 days after the end of electrotherapy.
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
Time Frame: 3. 3 months after the end of electrotherapy.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rzeszow

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lidia Perenc, docent prof, University of Rzeszow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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