Autologous conditioned serum in the treatment of neck pain
| ISRCTN | ISRCTN38950110 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38950110 |
- Submission date
- 16/02/2023
- Registration date
- 27/02/2023
- Last edited
- 18/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
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 | 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 |
| Participant information sheet | Not available in web format, please use contact deatails to request a participant informattion sheet |
| 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). |
| Study acronym | SPINE: Study on Pain In Neck Evaluation |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2023 |
| Date of final enrolment | 31/12/2023 |
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 | 31/08/2024 |
|---|---|
| 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 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 26/02/2024 | 18/03/2025 | Yes | No |
Editorial Notes
05/12/2023: The intention to publish date was changed from 31/01/2024 to 31/08/2024.
29/03/2023: The following changes were made to the trial record:
1. The scientific title was changed from "Comparison of the effects of fascial PROlotherapy and Facet joint Injections in the Treatment of neck pain (PROFIT): a randomized controlled trial" to "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)."
2. The acronym was changed from "PROFIT" to "SPINE: Study on Pain In Neck Evaluation".
3. The study hypothesis was changed.
4. The ethics details were updated.
5. The study design was changed from "Single-center prospective randomized non-placebo study" to "A prospective, two-armed, controlled, randomized, open-label, interventional clinical trial".
6. The primary outcome measure was changed.
7. The secondary outcome measures were changed.
8. The target number of participants was changed from 120 to 100.
9. The recruitment start date was changed from 01/03/2023 to 01/04/2023.
10. The recruitment end date was changed from 30/09/2023 to 31/12/2023.
11. The plain English summary was updated to reflect these changes.
20/02/2023: Trial's existence confirmed by the Institutional Review Board at Wroclaw Medical University.
