Effectiveness of Various Electrotherapy Methods in Treating People With Cervical Spine Pain Syndrome.
30 maj 2022 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
- Övrig: Kinesiotherapy combined with electrotherapy (Convenctional TENS method).
- Övrig: Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method).
- Övrig: Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method)
- Övrig: Kinesiotherapy combined with placebo electrotherapy
Detaljerad beskrivning
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)
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jolanta Zwolińska, PhD
- Telefonnummer: 505095199
- E-post: jolantazwolinska@op.pl
Studera Kontakt Backup
- Namn: Paulina Sałaga
- Telefonnummer: 731275361
- E-post: paulina.salaga@gmail.com
Studieorter
-
-
Podkarpackie
-
Rzeszów, Podkarpackie, Polen, 35-310 Rzeszów
- Rekrytering
- Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego
-
Kontakt:
- Jolanta Zwolińska, PhD
- Telefonnummer: 505095199
- E-post: jolantazwolinska@op.pl
-
Kontakt:
- Lidia Perenc, prof.drhab.
- Telefonnummer: 722015220
- E-post: lperenc@ur.edu.pl
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år till 25 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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).
|
|
Experimentell: 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).
|
|
Experimentell: 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-jämförare: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neck Disability Index
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Lidia Perenc, docent prof, University of Rzeszow
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Användbara länkar
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2022
Primärt slutförande (Förväntat)
30 november 2022
Avslutad studie (Förväntat)
31 januari 2023
Studieregistreringsdatum
Först inskickad
29 april 2021
Först inskickad som uppfyllde QC-kriterierna
17 maj 2021
Första postat (Faktisk)
18 maj 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 maj 2022
Senast verifierad
1 oktober 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Urzeszow Club of Physical
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