Cervical Spine SyndromeNCT04890743
Effectiveness of Various Electrotherapy Methods in Treating People With Cervical Spine Pain Syndrome.
A study testing Kinesiotherapy combined with electrotherapy (Convenctional TENS method)., Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method). and Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method) in people with Cervical Spine Syndrome, run by University of Rzeszow at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spine Syndrome
- What is being tested?
- Kinesiotherapy combined with electrotherapy (Convenctional TENS method)., Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method). and Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- informed written consent of the patient to participate in the study
- no contraindications to electrotherapy in the area of the cervical spine;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Laboratorium Czynników Fizykalnych w Rehabilitacji w Przyrodniczo-Medycznym Centrum Badań Innowacyjnych Uniwersytetu Rzeszowskiego
Rzeszów, Podkarpackie Voivodeship, 35-310 Rzeszów
Jolanta Zwolińska, PhD, 505095199, jolantazwolinska@op.pl
Lidia Perenc, prof.drhab., 722015220, lperenc@ur.edu.pl
About this study
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.
Read the 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)
- Conditions
- Cervical Spine Syndrome
- Being tested
- 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
- Keywords
- Cervical spine, Pain syndrome, Electrotherapy, TENS, Träbert ultrastimulation
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiotherapy combined with electrotherapy (Convenctional TENS method).Other
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Conventional TENS method).
Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method).Other
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Pseudo-acupuncture TENS method).
Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method)Other
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Trabert ultrastimulation method).
Kinesiotherapy combined with placebo electrotherapyOther
One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Conventional TENS group | Experimental | One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Conventional TENS method). Receives: Other: Kinesiotherapy combined with electrotherapy (Convenctional TENS method). |
| Pseudo-acupuncture TENS group | Experimental | One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Pseudo-acupuncture TENS method). Receives: Other: Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method). |
| Trabert ultrastimulation group | Experimental | One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Trabert ultrastimulation method). Receives: Other: Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method) |
| Placebo group | Placebo comparator | One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy. Receives: Other: Kinesiotherapy combined with placebo electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
A questionnaire for subcjective assessment of the state of the spine.
Measured: 1. Before a series of electrotherapy treatments.
Neck Disability Index
A questionnaire for subcjective assessment of the state of the spine.
Measured: 2. 7 to 10 days after the end of electrotherapy.
Neck Disability Index
A questionnaire for subcjective assessment of the state of the spine.
Measured: 3. 3 months after the end of electrotherapy.
Myotonometer
Measuring the tone of the vertebral muscles in the cervical.
Measured: 1. Before a series of electrotherapy treatments.
Myotonometer
Measuring the tone of the vertebral muscles in the cervical.
Measured: 2. 7 to 10 days after the end of electrotherapy.
Myotonometer
Measuring the tone of the vertebral muscles in the cervical.
Measured: 3. 3 months after the end of electrotherapy.
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.
Measured: 1. Before a series of electrotherapy treatments.
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.
Measured: 2. 7 to 10 days after the end of electrotherapy.
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.
Measured: 3. 3 months after the end of electrotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Apr 2022
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervical Spine SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanta Zwolińska, University of Rzeszow
- Investigators
- Lidia Perenc, docent prof, Study director, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890743
- Sponsor's protocol ID
- Urzeszow Club of Physical
- Status last verified
- Oct 2021
- First submitted
- 29 Apr 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25659245Martimbianco 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.
PubMed 31830313Martins-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.
PubMed 31987553
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Various Electrotherapy Methods in Treating People With Cervical Spine Pain Syndrome.
- ClinicalTrials.gov ID
- NCT04890743
- Acronym / sponsor ID
- Urzeszow Club of Physical
- Conditions
- Cervical Spine Syndrome
- Keywords
- Cervical spine, Pain syndrome, Electrotherapy, TENS, Träbert ultrastimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional TENS group | Experimental | Other: 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). |
| Pseudo-acupuncture TENS group | Experimental | 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). |
| Trabert ultrastimulation group | Experimental | 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). |
| Placebo group | Placebo comparator | Other: Kinesiotherapy combined with placebo electrotherapyOne of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- informed written consent of the patient to participate in the study
- no contraindications to electrotherapy in the area of the cervical spine;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Conventional TENS group |
| 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). | Other | Pseudo-acupuncture TENS group |
| 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). | Other | Trabert ultrastimulation group |
| Kinesiotherapy combined with placebo electrotherapyOne of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy. | Other | Placebo group |
Primary outcome
Neck Disability Index
Time frame: 1. Before a series of electrotherapy treatments.
A questionnaire for subcjective assessment of the state of the spine.
Neck Disability Index
Time frame: 2. 7 to 10 days after the end of electrotherapy.
A questionnaire for subcjective assessment of the state of the spine.
Neck Disability Index
Time frame: 3. 3 months after the end of electrotherapy.
A questionnaire for subcjective assessment of the state of the spine.
Myotonometer
Time frame: 1. Before a series of electrotherapy treatments.
Measuring the tone of the vertebral muscles in the cervical.
Myotonometer
Time frame: 2. 7 to 10 days after the end of electrotherapy.
Measuring the tone of the vertebral muscles in the cervical.
Myotonometer
Time frame: 3. 3 months after the end of electrotherapy.
Measuring the tone of the vertebral muscles in the cervical.
Visual Analog Scale
Time frame: 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.
Visual Analog Scale
Time frame: 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.
Visual Analog Scale
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Background: PubMed 25659245Cohen 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 publication: PubMed 31830313Martimbianco 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 publication: PubMed 31987553Martins-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.
- Review of clinical trials assessing the effectiveness of exercise therapy and electrotherapy.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lidia Perenc, docent prof study director
University of Rzeszow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotherapy combined with electrotherapy (Convenctional TENS method)., Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method). and Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method) in people with Cervical Spine Syndrome, run by University of Rzeszow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jolanta Zwolińska, PhD (505095199, jolantazwolinska@op.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (time frame: 1. Before a series of electrotherapy treatments.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04890743, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.