Vertebrogenic Pain SyndromeNCT04695665
Therapy of Pain Syndromes According to McGill's Method in Physiotherapy
A study testing Cervical pain, Thoracic pain and Lumbar pain in people with Vertebrogenic Pain Syndrome, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The goal of this study is to determine the applicability of McGill ́s method to patients with diagnoses, collectively referred to as Vertebrogenic Algic syndrome, by comparing the measured data of proband with different diagnosis locations Vertebrogenic Algic syndrome in the Czech Republic. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Vertebrogenic Pain Syndrome
- What is being tested?
- Cervical pain, Thoracic pain and Lumbar pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Mar 2020to 30 May 2020
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- cervical pain syndrome
- thoracic pain syndrome
- lumbar pain syndrome
Who cannot join
- red falgs
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Charles University, Faculty of physical education and sport
Prague
About this study
Official title: The Effectiveness of McGill's Method in the Treatment of Vertebrogenic Algic Syndrome
The goal of this study is to determine the applicability of McGill ́s method to patients with diagnoses, collectively referred to as Vertebrogenic Algic syndrome, by comparing the measured data of proband with different diagnosis locations Vertebrogenic Algic syndrome in the Czech Republic.
Read the detailed description
This is a pilot experimental research involving 10 probands diagnosed with Vertebrogenic Algic syndrome in the cervical spine, 10 probands diagnosed with Vertebrogenic Algic syndrome in the thoracic spine and 10 probands diagnosed with Vertebrogenic Algic syndrome in the lumbar spine. Each participant undergo a kinesiological examination according to the McGill ́s principles together with an SF-36 questionnaire. Measured values are compared and provided a basis for testing the hypotheses. The study uses methods of research, observation, querying and comparison of collected data.
- Conditions
- Vertebrogenic Pain Syndrome
- Being tested
- Cervical pain, Thoracic pain, Lumbar pain
- Keywords
- pain syndrome, efficiency, stabilization, McGill method
- Medical subject headings
- Back Pain, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical painOther
Exercise program for cervical spine according to McGill's approach.
Thoracic painOther
Exercise program for thoracic spine according to McGill's approach.
Lumbar painOther
Exercise program for lumbar spine according to McGill's approach.
| Study group | Role | What they receive |
|---|---|---|
| Cervical pain | Active comparator | Only patients with positive Cervical pain syndrome. Receives: Other: Cervical pain |
| Thoracic pain | Active comparator | Only patients with positive Thoracic pain syndrome. Receives: Other: Thoracic pain |
| Lumbar pain | Active comparator | Only patients with positive Lumbar pain syndrome. Receives: Other: Lumbar pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
change in pain perception measured on a visual analog scale - from 0 (without pain) to 10 (maximum pain)
Measured: 4 weeks, 2 times a week exercising for 60 minutes
multi-segmental efficiency
comparison of the effectiveness of therapy of the three evaluated groups against each other by Short Form (SF36) Healthy survey questionnaire, the scale from 100 to 900, lower value indicate a higher effect
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Mar 2020
- Primary completion15 Mar 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebrogenic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malá Jitka, Charles University, Czech Republic
- Investigators
- Jitka Malá, Ph.D., Principal investigator, Charles University, Faculty of physical education and sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695665
- Sponsor's protocol ID
- Vlasák, McGill
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of McGill's Method in the Treatment of Vertebrogenic Algic Syndrome
- ClinicalTrials.gov ID
- NCT04695665
- Acronym / sponsor ID
- Vlasák, McGill
- Conditions
- Vertebrogenic Pain Syndrome
- Keywords
- pain syndrome, efficiency, stabilization, McGill method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 5 Jan 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.
The goal of this study is to determine the applicability of McGill ́s method to patients with diagnoses, collectively referred to as Vertebrogenic Algic syndrome, by comparing the measured data of proband with different diagnosis locations Vertebrogenic Algic syndrome in the Czech Republic.
Detailed description
This is a pilot experimental research involving 10 probands diagnosed with Vertebrogenic Algic syndrome in the cervical spine, 10 probands diagnosed with Vertebrogenic Algic syndrome in the thoracic spine and 10 probands diagnosed with Vertebrogenic Algic syndrome in the lumbar spine. Each participant undergo a kinesiological examination according to the McGill ́s principles together with an SF-36 questionnaire. Measured values are compared and provided a basis for testing the hypotheses. The study uses methods of research, observation, querying and comparison of collected data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervical pain | Active comparator | Other: Cervical painOnly patients with positive Cervical pain syndrome. |
| Thoracic pain | Active comparator | Other: Thoracic painOnly patients with positive Thoracic pain syndrome. |
| Lumbar pain | Active comparator | Other: Lumbar painOnly patients with positive Lumbar pain syndrome. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- cervical pain syndrome
- thoracic pain syndrome
- lumbar pain syndrome
Key exclusion criteria (1 listed)
- red falgs
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 |
|---|---|---|
| Cervical painExercise program for cervical spine according to McGill's approach. | Other | Cervical pain |
| Thoracic painExercise program for thoracic spine according to McGill's approach. | Other | Thoracic pain |
| Lumbar painExercise program for lumbar spine according to McGill's approach. | Other | Lumbar pain |
Primary outcome
Pain relief
Time frame: 4 weeks, 2 times a week exercising for 60 minutes
change in pain perception measured on a visual analog scale - from 0 (without pain) to 10 (maximum pain)
multi-segmental efficiency
Time frame: 4 weeks
comparison of the effectiveness of therapy of the three evaluated groups against each other by Short Form (SF36) Healthy survey questionnaire, the scale from 100 to 900, lower value indicate a higher effect
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- 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.
Jitka Malá, Ph.D. principal investigator
Charles University, Faculty of physical education and sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical pain, Thoracic pain and Lumbar pain in people with Vertebrogenic Pain Syndrome, run by Charles University, Czech Republic at 1 site in Czechia.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jan 2021. 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 Czechia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 4 weeks, 2 times a week exercising for 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2021.