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

NCT ID: NCT04890743

Last Updated: 2022-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-01-31

Brief Summary

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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

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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;

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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)

Conditions

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Cervical Spine Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will include healthy volunteers, students of the university in the area of Rzeszów with cervical spine pain syndrome caused by distance learning.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Conventional TENS group

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

Group Type EXPERIMENTAL

Kinesiotherapy combined with electrotherapy (Convenctional TENS method).

Intervention Type OTHER

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

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).

Group Type EXPERIMENTAL

Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method).

Intervention Type OTHER

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

Trabert ultrastimulation group

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

Group Type EXPERIMENTAL

Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method)

Intervention Type OTHER

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Kinesiotherapy combined with placebo electrotherapy

Intervention Type OTHER

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

Interventions

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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).

Intervention Type 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).

Intervention Type 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).

Intervention Type OTHER

Kinesiotherapy combined with placebo electrotherapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rzeszow

OTHER

Sponsor Role lead

Responsible Party

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Jolanta Zwolińska

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lidia Perenc, docent prof

Role: STUDY_DIRECTOR

University of Rzeszow

Locations

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

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Jolanta Zwolińska, PhD

Role: CONTACT

505095199

Paulina Sałaga

Role: CONTACT

731275361

Facility Contacts

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Jolanta Zwolińska, PhD

Role: primary

505095199

Lidia Perenc, prof.drhab.

Role: backup

722015220

References

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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.

Reference Type BACKGROUND
PMID: 25659245 (View on PubMed)

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.

Reference Type RESULT
PMID: 31830313 (View on PubMed)

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.

Reference Type RESULT
PMID: 31987553 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/25659245/

Review of clinical trials assessing the effectiveness of exercise therapy and electrotherapy.

https://pubmed.ncbi.nlm.nih.gov/31830313/

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.

https://pubmed.ncbi.nlm.nih.gov/31987553/

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.

Other Identifiers

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Urzeszow Club of Physical

Identifier Type: -

Identifier Source: org_study_id

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