Clinical trial NCT04890743: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spine Syndrome
Keywords: Cervical spine
Pain syndrome
Electrotherapy
TENS
Träbert ultrastimulation
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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:

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)

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.

Primary outcomes:
measure: Neck Disability Index
timeFrame: 1. Before a series of electrotherapy treatments.
measure: Neck Disability Index
timeFrame: 2. 7 to 10 days after the end of electrotherapy.
measure: Neck Disability Index
timeFrame: 3. 3 months after the end of electrotherapy.
measure: Myotonometer
timeFrame: 1. Before a series of electrotherapy treatments.
measure: Myotonometer
timeFrame: 2. 7 to 10 days after the end of electrotherapy.
measure: Myotonometer
timeFrame: 3. 3 months after the end of electrotherapy.
measure: Visual Analog Scale
timeFrame: 1. Before a series of electrotherapy treatments.
measure: Visual Analog Scale
timeFrame: 2. 7 to 10 days after the end of electrotherapy.
measure: Visual Analog Scale
timeFrame: 3. 3 months after the end of electrotherapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego
state: Podkarpackie
Study officials:
affiliation: University of Rzeszow
name: Lidia Perenc, docent prof
role: STUDY_DIRECTOR
References:
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.
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.
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.