Developing an algorithm for classification of people with sciatica in the Greek health system
| ISRCTN | ISRCTN14792164 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14792164 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2604 4/2/2020 |
| Sponsor | University of West Attica |
| Funder | University of West Attica |
- Submission date
- 05/02/2020
- Registration date
- 10/02/2020
- Last edited
- 07/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
A large percentage of people with low back pain, also complain of sciatica. Sciatica is pain that spreads down one leg from the lower back and buttocks. Usually, the pain extends below the knee sometimes to the foot and there may also be tingling or numbness of the skin.
The cause of sciatica varies and may be due to problems with the spine. Finding the cause of sciatica often involves the use of expensive imaging methods (magnetic resonance imaging) which can be misleading. Therefore research is increasingly focused on exploring more effective evaluation tools to categorize these patients with the aim of selecting the most appropriate technique for their treatment.
In the international physiotherapy community, some evaluation tools for sciatica have been proposed, but in Greece, no such study has ever been performed. This study aims to collect knowledge of the evaluation and categorization of patients with sciatica, with the hope of enhancing the quality of physiotherapy services and alleviating the symptoms of suffering patients.
Who can participate?
Adults aged 18 and above, who are referred from their spine specialist with sciatica or suspected sciatica. They must also have a mobile phone that can receive and send SMS texts or have access to a landline telephone, they must be willing to participate and the must understand to read and speak Greek
What does the study involve?
Patients referred with sciatica will be assessed from a specialist physiotherapist in order to categorize their symptoms and develop a method for classification in the greek health system
What are the possible benefits and risks of participating?
There are no risks involved in this research. The patients will not receive any treatment only standard clinical assessments and they will be asked to fill in some self-reported questionnaires
Where is the study run from?
The University of West Attica (Greece)
When is the study starting and how long is it expected to run for?
February 2019 to December 2022
Who is funding the study?
The University of West Attica (Greece)
Who is the main contact?
1. Nikolaos Kontakiotis PhD Cand, MSc, MMACP, MCSP
kontak766@hotmail.com
2. Prof. Georgios Gioftsos
gioftsos@uniwa.gr
Contact information
Scientific
Athens physio clinic
86 Imittou street
Pagrati
Athens
11634
Greece
| Phone | +30 6972157943 |
|---|---|
| kontak766@hotmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-blinded, observational epidemiological multicentre study for algorithm development |
| Secondary study design | Epidemiological study |
| Study type | Participant information sheet |
| Scientific title | Investigation into the distinct clinical characteristics of people with sciatica in order to develop an algorithm for their classification in the Greek health system |
| Study acronym | Sciatica classification algorithm |
| Study objectives | Can the evaluation tools of sciatica develop a reliable categorization algorithm for patients suffering from sciatica in order to find better treatment in the primary Greek health system? |
| Ethics approval(s) | Approved 09/06/2020, Ethics and Deontology Committee of the University of West Attica (Agiou Spiridonos 28, Egaleo, Athens, Greece, 12243; +30 (0)2105387294; adeltsidou@uniwa.gr), ref: 2604 4/2/2020, protocol number: 38313 |
| Health condition(s) or problem(s) studied | Sciatica |
| Intervention | All patients will be informed about the purpose of this study by an information sheet and about the assessment that they will get for their symptoms. Before the start of the assessment, they will sign a consent form, ensuring their participation and anonymity. Their anonymity due to sensitive personal data will be secured during the study, but also after the publication of the results. Finally, they will be allowed to withdraw from the survey at any time they wish. Patients referred with sciatica from spine specialists will be examined by a specialist musculoskeletal physiotherapist. The specialist musculoskeletal physiotherapist will be responsible for conducting all evaluation tests and recording all data. Initially, each patient will be evaluated to determine whether or not they will be accepted into the study by answering some simple questions that will confirm the study's eligibility criteria. The assessment will have three parts. The order will be randomized in the below three parts: 1. Questionnaires 2. Neurologic examination 3. Neurodynamics Patients will perform all three parts of the assessment with random order. Questionnaires will be completed in the presence of the specialist musculoskeletal physiotherapist to avoid any confusion. The specialist musculoskeletal physiotherapist will perform the neurological examination and quantitative aesthetic tests with the tool kit to draw conclusions about the neurological dysfunction. The third part of the assessment will be the performance of the neurodynamics test in order to evaluate the symptoms of the patients. All data will be recorded in detail and carefully to be statistically analyzed when the necessary number of patients is collected in order to develop an algorithm subgrouping these patients to low, medium and high risk in the Greek health system. |
| Intervention type | Other |
| Primary outcome measure(s) |
Development of an algorithm to categorize patients as low, medium and high-risk based on their sciatica symptoms assessed by questionnaires, neurologic examination, and neurodynamics evaluation at baseline without follow up |
| Key secondary outcome measure(s) |
1. Disability is measured using the Roland Morris Disability Questionnaire at baseline at baseline without follow up |
| Completion date | 01/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Patients with sciatica diagnosed by spine specialist in a private or public hospital and referred to physiotherapy 2. Pain in the lumbar region that reflects at the lower extremity in either a dermatomal distribution or not 3. Subjective neurological symptoms in one lower extremity, such as numbness, tingling, burning, weight sensation and crippling pain 4. Aged 18-75 years old 5. Ablity to read and communicate in Greek 6. Willingness to participate in the study |
| Key exclusion criteria | 1. Suspected serious spinal pathology or clinical red-flags such as cauda equina syndrome, suspicion of spinal tumours, infection, fractures and inflammatory spondyloarthropathy 2. Previous lumbar spine surgery 3. Previous lower extremity surgery 4. Currently receiving ongoing care from or have been in consultation with a secondary care doctor or physiotherapist for the same problem in the last 3 months 5. Serious co-morbidity preventing them from attending the research clinic and/or undergoing assessment and interventions 6. Severe enduring mental health condition 7. Pregnancy 8. Current participation in any other research study because of symptoms of back and leg pain or sciatica 9. Scoliosis of the spine >10 degrees, as measured on an X-ray 10. Taking steroid medications to treat neurological symptoms during the research period |
| Date of first enrolment | 30/06/2020 |
| Date of final enrolment | 01/09/2022 |
Locations
Countries of recruitment
- Greece
Study participating centre
Pagrati
Athens
11634
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Nikolaos Kontakiotis (kontak766@hotmail.com). Type of data: row data of primary and secondary outcome measures. Availability: from 01/12/2021. Access criteria: systematic reviews, quantitative synthesis for studies in the same scope of interest, peer review reasons. Consent from participants is obtained according to GDPR data protection. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/03/2022: The following changes were made to the trial record:
1. The overall end date was changed from 22/01/2023 to 01/12/2022.
2. The intention to publish date was changed from 01/03/2022 to 01/12/2023.
3. The plain English summary was updated to reflect these changes.
06/10/2021: The recruitment end date has been changed from 01/10/2021 to 01/09/2022.
30/06/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/03/2020 to 30/06/2020.
2. The recruitment end date was changed from 01/03/2021 to 01/10/2021.
3. The ethics approval details were added.
01/06/2020: Recruitment has been resumed.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
10/02/2020: Trial’s existence confirmed by the University of West Attica.
