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

Primary Purpose

Cervical Spine Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Kinesiotherapy combined with electrotherapy (Convenctional TENS method).
Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method).
Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method)
Kinesiotherapy combined with placebo electrotherapy
Sponsored by
University of Rzeszow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spine Syndrome focused on measuring Cervical spine, Pain syndrome, Electrotherapy, TENS, Träbert ultrastimulation

Eligibility Criteria

19 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu RzeszowskiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Conventional TENS group

Pseudo-acupuncture TENS group

Trabert ultrastimulation group

Placebo group

Arm Description

One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Conventional TENS method).

One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Pseudo-acupuncture TENS method).

One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Trabert ultrastimulation method).

One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy.

Outcomes

Primary Outcome Measures

Neck Disability Index
A questionnaire for subcjective assessment of the state of the spine.
Neck Disability Index
A questionnaire for subcjective assessment of the state of the spine.
Neck Disability Index
A questionnaire for subcjective assessment of the state of the spine.
Myotonometer
Measuring the tone of the vertebral muscles in the cervical.
Myotonometer
Measuring the tone of the vertebral muscles in the cervical.
Myotonometer
Measuring the tone of the vertebral muscles in the cervical.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 29, 2021
Last Updated
May 30, 2022
Sponsor
University of Rzeszow
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1. Study Identification

Unique Protocol Identification Number
NCT04890743
Brief Title
Effectiveness of Various Electrotherapy Methods in Treating People With Cervical Spine Pain Syndrome.
Official Title
Effectiveness of Various Electrotherapy Methods in Treating People With Cervical Spine Pain Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rzeszow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Study participants will be tested: Before a series of electrotherapy treatments. 7 to 10 days after the end of electrotherapy. 3 months after the end of electrotherapy. The study will use 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 a questionnaire for subcjective assessment of the state of the spine Neck Disability Index, measuring the tone of the vertebral muscles in the cervical (myotonometer), a visual analog scale used to assess the severity of symptoms (Visual Analog Scale -VAS) Intervention; irradiation of the neck area with a sollux lamp with a blue filter individual exercises conducted according to the prepared author's mobility improvement program electrotherapy treatments: Trabert currents TENS currents (conventional) TENS currents (pseudo-acupuncture)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spine Syndrome
Keywords
Cervical spine, Pain syndrome, Electrotherapy, TENS, Träbert ultrastimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will include healthy volunteers, students of the university in the area of Rzeszów with cervical spine pain syndrome caused by distance learning.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants of all 4 groups will benefit from a unified kinesiotherapeutic program. Then, after the randomization, participants will undergo treatments, but they will not know what type of therapy they will undergo.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional TENS group
Arm Type
Experimental
Arm Description
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Conventional TENS method).
Arm Title
Pseudo-acupuncture TENS group
Arm Type
Experimental
Arm Description
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Pseudo-acupuncture TENS method).
Arm Title
Trabert ultrastimulation group
Arm Type
Experimental
Arm Description
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Trabert ultrastimulation method).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy.
Intervention Type
Other
Intervention Name(s)
Kinesiotherapy combined with electrotherapy (Convenctional TENS method).
Intervention Description
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Conventional TENS method).
Intervention Type
Other
Intervention Name(s)
Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method).
Intervention Description
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Pseudo-acupuncture TENS method).
Intervention Type
Other
Intervention Name(s)
Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method)
Intervention Description
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Trabert ultrastimulation method).
Intervention Type
Other
Intervention Name(s)
Kinesiotherapy combined with placebo electrotherapy
Intervention Description
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy.
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
A questionnaire for subcjective assessment of the state of the spine.
Time Frame
1. Before a series of electrotherapy treatments.
Title
Neck Disability Index
Description
A questionnaire for subcjective assessment of the state of the spine.
Time Frame
2. 7 to 10 days after the end of electrotherapy.
Title
Neck Disability Index
Description
A questionnaire for subcjective assessment of the state of the spine.
Time Frame
3. 3 months after the end of electrotherapy.
Title
Myotonometer
Description
Measuring the tone of the vertebral muscles in the cervical.
Time Frame
1. Before a series of electrotherapy treatments.
Title
Myotonometer
Description
Measuring the tone of the vertebral muscles in the cervical.
Time Frame
2. 7 to 10 days after the end of electrotherapy.
Title
Myotonometer
Description
Measuring the tone of the vertebral muscles in the cervical.
Time Frame
3. 3 months after the end of electrotherapy.
Title
Visual Analog Scale
Description
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.
Time Frame
1. Before a series of electrotherapy treatments.
Title
Visual Analog Scale
Description
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.
Time Frame
2. 7 to 10 days after the end of electrotherapy.
Title
Visual Analog Scale
Description
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.
Time Frame
3. 3 months after the end of electrotherapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jolanta Zwolińska, PhD
Phone
505095199
Email
jolantazwolinska@op.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Paulina Sałaga
Phone
731275361
Email
paulina.salaga@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lidia Perenc, docent prof
Organizational Affiliation
University of Rzeszow
Official's Role
Study Director
Facility Information:
Facility Name
Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego
City
Rzeszów
State/Province
Podkarpackie
ZIP/Postal Code
35-310 Rzeszów
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jolanta Zwolińska, PhD
Phone
505095199
Email
jolantazwolinska@op.pl
First Name & Middle Initial & Last Name & Degree
Lidia Perenc, prof.drhab.
Phone
722015220
Email
lperenc@ur.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25659245
Citation
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.
Results Reference
background
PubMed Identifier
31830313
Citation
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.
Results Reference
result
PubMed Identifier
31987553
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/25659245/
Description
Review of clinical trials assessing the effectiveness of exercise therapy and electrotherapy.
URL
https://pubmed.ncbi.nlm.nih.gov/31830313/
Description
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.
URL
https://pubmed.ncbi.nlm.nih.gov/31987553/
Description
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.

Learn more about this trial

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

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