The use of hyaluronic acid in the treatment of abnormal narrowing of the spinal canal in the lumbar spine
| ISRCTN | ISRCTN14155217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14155217 |
- Submission date
- 29/04/2022
- Registration date
- 16/05/2022
- Last edited
- 17/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Foraminal stenosis is the narrowing or tightening of the openings between the bones in the spine. These small openings are called the foramen. Foraminal stenosis is a specific type of spinal stenosis. Epidural administration of hyaluronic acid under ultrasound guidance followed by neuromobilization may hypothetically improve the sliding of the nerve sheaths in the tight space of the lateral recess and the intervertebral foramen, reducing the pain of the root type. The aim of this study is to assess pain after an epidural injection of hyaluronic acid with additional neuromobilization.
Who can participate?
Patients with pain complaints as a result of lumbar foraminal stenosis
What does the study involve?
The study involves the administration of a single dose of a hybrid form of hyaluronic acid called Sinovial HL, under ultrasound guidance, in the zone of expected compression of the nerve root from the intra-lamellar access. The Sinovial HL product (IBSA producer) is a very widely used preparation in osteoarthritis, but it is also registered for extra-articular administration (tendons, ligaments). After the injection, the patient is instructed on the method of neuromobilization in the spinal unloading position and will be asked to continue it throughout the observation period. Pain will be assessed before the intervention, after injection, and after neuromobilization.
What are the possible benefits and risks of participating?
Ultrasound-guided epidural injections are safe procedures but there may be complications such as infection at the injection site, and bleeding at the injection site, dural puncture, or nerve root. Improvement of the sliding (neurodynamics) of the nerve root within the radial recess under the influence of the action of hyaluronic acid with subsequent neuromobilization of the root may result in a reduction in pain and improved motor function of the limb.
Where is the study run from?
Sutherland Medical Center (Poland)
When is the study starting and how long is it expected to run for?
March 2022 to March 2023
Who is funding the study?
Sutherland Medical Center (Poland)
Who is the main contact?
Dr Piotr Godek
piotrgodek.smc@gmail.com
Contact information
Principal Investigator
Aleja Stanów Zjednoczonych 32/14
Warszawa
04-036
Poland
 ORCID ID |
0000-0001-7809-1289 |
|---|---|
| Phone | +48 (0)506 817 838 |
| piotrgodek.smc@gmail.com |
Study information
| Study design | Open-label prospective non-randomized controlled interventional clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The use of hyaluronic acid in the symptomatic treatment of foraminal stenosis of the lumbar spine |
| Study acronym | HALFS |
| Study objectives | Lumbar foraminal stenosis is a very common form of lumbar degenerative spondylosis. It is a late consequence of damage to the intervertebral disc, which leads to secondary hypertrophy of the intervertebral joints. Epidural administration of hyaluronic acid under ultrasound guidance followed by neuromobilization may hypothetically improve the sliding of the nerve sheaths in the tight space of the lateral recess and the intervertebral foramen, contributing to the improvement of the nerve root trophic and, consequently, reducing the pain of the root type. The aim of the study is to assess pain after an epidural injection of hyaluronic acid with additional neuromobilization. Principal hypothesis: Reduction of pain after epidural injection of hyaluronic acid with additional neuromobilization. |
| Ethics approval(s) | Approved 27/04/2022, Institutional Review Board at Wroclaw Medical University (ul. Pasteura 1, 50-367 Wrocław, Poland; +48 (0)71 784 17 10; bioetyka@umed.wroc.pl), ref: KB-344/2022 |
| Health condition(s) or problem(s) studied | Patients with pain complaints as a result of lumbar foraminal stenosis |
| Intervention | The project involves the administration of a single dose of a hybrid form of hyaluronic acid called Sinovial HL, under ultrasound guidance, in the zone of expected compression of the nerve root from the intra-lamellar access. The Sinovial HL product (IBSA producer) is a very widely used preparation in osteoarthritis, but it is also registered for extra-articular administration (tendons, ligaments). After the injection, the patient is instructed on the method of neuromobilization in the spinal unloading position and will be asked to continue it throughout the observation period. Before the intervention, after injection, and after neuromobilization, the NRS pain scale (0-10), the Oswestry scale (0-50), the Roland-Morris scale (0-24), and the SLR test (measured in degrees of elevation to the first symptoms) will be used to assess pain. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hyaluronic acid |
| Primary outcome measure | 1. Pain assessed using the Numerical Rating Scale (NRS, 1-10) at baseline and 1, 2, and 3 months after the intervention 2. Pain assessed using the Roland – Morris scale at baseline and 1, 2, and 3 months after the intervention 3. Pain assessed using the Straight Leg Raise Test (SLR test) at baseline and 1, 2, and 3 months after the intervention |
| Secondary outcome measures | Disability assessed using the Oswestry Low Back Pain Disability Questionnaire at baseline and 1, 2, and 3 months after the intervention |
| Overall study start date | 01/03/2022 |
| Completion date | 01/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Clinical symptoms of radicular pain in the lumbar region 2. MRI confirmed recital stenosis of degenerative origin 3. No other spine diseases (post-traumatic, systemic inflammatory diseases, cancer, birth defects) 4. Adults consenting to the injection 5. Mental contact ensuring cooperation in the period of neuromobilization |
| Key exclusion criteria | 1. Neurological deficit 2. The presence of other spine diseases (post-traumatic, systemic inflammatory diseases, neoplasms, birth defects) 3. Refusal to consent to the injection 4. Anticoagulants, other injection contraindications 5. Impeded contact with the patient, not promising cooperation during the period of neuromobilization |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 31/01/2023 |
Locations
Countries of recruitment
- Poland
Study participating centre
Warszawa
04-036
Poland
Sponsor information
Hospital/treatment centre
Aleja Stanów Zjednoczonych 32/14
Warszawa
04-036
Poland
| Phone | +48 (22) 673 60 43 |
|---|---|
| klinika@smc.waw.pl | |
| Website | https://www.smc.waw.pl/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 20/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author Dr Piotr Godek (piotrgodek.smc@gmail.com) on reasonable request. Raw data (taking into account the anonymity of patients) will become available from the end of the study for 5 years. The research results will be passed on to other researchers in order to compare these results with the results of their own research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/03/2023 | 17/04/2024 | Yes | No |
Editorial Notes
17/04/2024: Publication reference added.
13/05/2022: Trial's existence confirmed by the Bioethics Committee at the Medical University of Wrocław.
