Effectiveness of Various Electrotherapy Methods in Treating People With Cervical Spine Pain Syndrome.
30. mai 2022 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
- Annen: Kinesiotherapy combined with electrotherapy (Convenctional TENS method).
- Annen: Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method).
- Annen: Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method)
- Annen: Kinesiotherapy combined with placebo electrotherapy
Detaljert beskrivelse
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)
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jolanta Zwolińska, PhD
- Telefonnummer: 505095199
- E-post: jolantazwolinska@op.pl
Studer Kontakt Backup
- Navn: Paulina Sałaga
- Telefonnummer: 731275361
- E-post: paulina.salaga@gmail.com
Studiesteder
-
-
Podkarpackie
-
Rzeszów, Podkarpackie, Polen, 35-310 Rzeszów
- Rekruttering
- Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego
-
Ta kontakt med:
- Jolanta Zwolińska, PhD
- Telefonnummer: 505095199
- E-post: jolantazwolinska@op.pl
-
Ta kontakt med:
- Lidia Perenc, prof.drhab.
- Telefonnummer: 722015220
- E-post: lperenc@ur.edu.pl
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 25 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Conventional TENS group
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 (Conventional TENS method).
|
|
Eksperimentell: 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).
|
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Pseudo-acupuncture TENS method).
|
|
Eksperimentell: Trabert ultrastimulation group
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 electrotherapy (Trabert ultrastimulation method).
|
|
Placebo komparator: Placebo group
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy.
|
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neck Disability Index
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Lidia Perenc, docent prof, University of Rzeszow
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. april 2022
Primær fullføring (Forventet)
30. november 2022
Studiet fullført (Forventet)
31. januar 2023
Datoer for studieregistrering
Først innsendt
29. april 2021
Først innsendt som oppfylte QC-kriteriene
17. mai 2021
Først lagt ut (Faktiske)
18. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juni 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. mai 2022
Sist bekreftet
1. oktober 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Urzeszow Club of Physical
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
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