Plain English Summary
Background and study aims
Neck pain is a very common health problem that has a negative impact on quality of life and significant burden on health systems. Autologous conditioned serum (ACS, Orthokine) injections are a safe and widespread form of treatment for musculoskeletal inflammatory and degenerative diseases. ACS is based on the competitive binding of proteins with the interleukin receptor (mainly IL-1) as well as anti-inflammatory and anti-oedematous effects. However, the optimal route of serum administration in the treatment of neck pain has not yet been proven.
The aim of the study is to investigate whether infiltration of cervical fascia with ACS will have the same therapeutic efficacy as standard periarticular administration in the treatment of neck pain.
Who can participate?
Patients aged 18 years and over with cervical (neck) pain
What does the study involve?
Participants will be randomly assigned to one of two groups:
Group A: Autologous Conditioned Serum (ACS) injections into the fascial planes of the cervical section at palpation points under ultrasound guidance, four injections every 3 days.
Group B: Autologous Conditioned Serum (ACS) injections into the joint column of the cervical section under ultrasound guidance, four injections every 3 days.
The total duration of treatment is 10 days.
What are the possible benefits and risks of participating?
If the new technique proves equally effective compared to the standard technique of applying serum to the joint column, it will be an excellent treatment option for patients on chronic anticoagulant treatment where there is a significant risk of bleeding in perivertebral injections.
Any intervention related to injection, even performed under ultrasound control, is associated with minimal risk of bleeding, nerve damage, infection, or temporary pain at the site of the drug administration. However, this risk is relatively low due to ultrasound control of needle guidance and extensive experience.
Where is the study run from?
Sutherland Medical Center (Poland)
When is the study starting and how long is it expected to run for?
December 2022 to December 2023
Who is funding the study?
Sutherland Medical Center (Poland)
Who is the main contact?
Dr Piotr Godek, piotrgodek.smc@gmail.com
Study website
Contact information
Type
Principal Investigator
Contact name
Dr Piotr Godek
ORCID ID
http://orcid.org/0000-0001-7809-1289
Contact details
Aleja Stanów Zjednoczonych 32/14
Warszawa
04-036
Poland
+48 (0)506 817 838
piotrgodek.smc@gmail.com
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Comparison of the analgesic non-inferiority of ultrasound-guided injections of ACS (Orthokine) into the cervical fascial planes versus application along the cervical facet joints in patients with neck pain: A randomized, open-label, controlled clinical trial. (Protocol).
Acronym
SPINE: Study on Pain In Neck Evaluation
Study hypothesis
Current study hypothesis as of 29/03/2023:
Infiltration of cervical fascia with ACS will have the same therapeutic efficacy as standard periarticular administration in the treatment of neck pain
_____
Previous study hypothesis:
The application of autologous conditioned serum (ACS) to alleviate low-grade inflammation (LGI) in the fascial compartments reduces pain more than deep intra-articular injections, in the treatment of cervical spine pain.
Ethics approval(s)
Approved 01/02/2023, Institutional Review Board at Wroclaw Medical University (50-367 Wrocław, ul. J.Mikulicza-Radeckiego 4a, Poland; +48 (0)71 784 17 10; bioetyka@umed.wroc.pl), ref: KB-81/2022
Study design
Prospective two-armed controlled randomized open-label interventional clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
GP practice
Study type
Treatment
Patient information sheet
Not available in web format, please use contact deatails to request a participant informattion sheet
Condition
Cervical pain of degenerative, overload, and post-traumatic origin
Intervention
Randomization is carried out using computer-generated random numbers (simple randomization). The participants are randomly assigned to groups in a 1:1 ratio:
Group A: injections into the fascial planes of the cervical section at palpation points under ultrasound guidance, four Autologous Conditioned Serum (ACS) injections every 3 days
Group B: injections into the joint column of the cervical section under ultrasound guidance, four Autologous Conditioned Serum (ACS) injections every 3 days
The total duration of treatment is 10 days.
Intervention type
Other
Primary outcome measure
Current primary outcome measure as of 29/03/2023:
1. Pain is assessed using the Numerical Rating Scale (NRS, 1-10) at baseline (T0) and 6 weeks (T1), and 12 weeks (T2) after the intervention
2. Neck disability is assessed using the Neck Disability Index at baseline (T0) and 6 weeks (T1) and 12 weeks (T2) after the intervention
3. Assessment of proprioception using the Dynamic Proprioception Test (DPT: shape outline error) at baseline (T0) and 6 weeks (T1) and 12 weeks (T2) after the intervention
Three primary outcome criteria are defined and will be tested in hierarchical order: (1) Change in pain NRS from baseline to week 12 in the experimental group. (2) Change in pain NRS from baseline to week 12 in the control group. (3) Non-inferiority between groups in pain NRS from
baseline to week 12.
_____
Previous primary outcome measure:
1. Pain is assessed using the Numerical Rating Scale (NRS, 1-10) at baseline and 1, 6, and 12 months after the intervention
2. Neck disability is assessed using the Neck Disability Index at baseline and 1, 6, and 12 months after the intervention
Secondary outcome measures
Current secondary outcome measures as of 29/03/2023:
Safety will be assessed using the adverse event form.
_____
Previous secondary outcome measures:
Assessment of proprioception using the Dynamic Proprioception Test (shape tracing error). This test is used as a pre-treatment test and at the end of follow-up, i.e. 12 weeks after the end of therapy.
Overall study start date
01/12/2022
Overall study end date
31/12/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults (aged 18 years and over)
2. Pain in the cervical section of degenerative, overload, post-traumatic origin
3. Consenting to the injection
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
100
Participant exclusion criteria
1. Pregnant women
2. People with cancer
3. Presence of systemic inflammatory diseases
4. Injuries requiring surgical treatment
5. Anticoagulants that cannot be withdrawn
6. No consent to injection
7. No doctor approval
Recruitment start date
01/04/2023
Recruitment end date
31/12/2023
Locations
Countries of recruitment
Poland
Study participating centre
Sutherland Medical Center
Aleja Stanów Zjednoczonych 32/14
Warszawa
04-036
Poland
Sponsor information
Organisation
Sutherland Medical Center
Sponsor details
Aleja Stanów Zjednoczonych 32/14
Warszawa
04-036
Poland
+48 (22) 673 60 43
klinika@smc.waw.pl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
31/08/2024
Individual participant data (IPD) sharing plan
The datasets generated during and/or analyzed 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.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|