Autologous conditioned serum in the treatment of neck pain

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).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38950110

Enrollment

100

Registered

2023-02-27

Start date

2023-04-01

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical pain of degenerative, overload, and post-traumatic origin Signs and Symptoms

Interventions

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 plane

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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

Exclusion criteria

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 Anticoagulants that cannot be withdrawn 6.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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026