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The effect of a newly developed patch treatment for disc hernia

A pilot controlled study on the efficacy of a diffusional patch (ArtCure®) for the treatment of disc hernia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN06273186
Enrollment
80
Registered
2014-01-09
Start date
2014-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Disc hernia/low back pain/neck pain Musculoskeletal Diseases Low back pain

Interventions

Artcure patch treatment with complete bed rest in disc hernia and healthy control cases. All of the cases admitted to the hospital with cervical or lumbar disc herniation that is resistant to medical

Sponsors

Metuas Medical Company (Turkey)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with severe low back or neck pain due to disc hernia between the ages of 20 and 60 who are willing to take part 2. Age-matched healthy control cases without low back pain and disc hernia

Exclusion criteria

Exclusion criteria: 1. Severe para-vertebral muscle spasm 2. Lumbar spinal stenosis 3. Foraminal stenosis 4. Calcified lumbar or cervical hernia 5. Loss of cervical or lumbar lordosis accompanying disc hernia 6. Loss of strength in any muscle group more than 2/5 7. Known dermal atophy 8. Accompanying asthma

Design outcomes

Primary

MeasureTime frame
1. Complete resolution of the pain [48 hours post-treatment visual analogue scale (VAS) score = 0] 2. More than 5 points decrease in the VAS score in the 48 hours post-treatment 3. Complete resolution of the neurologic deficit in 48 hours

Secondary

MeasureTime frame
1. VAS and neurological examinations will be performed at the baseline, 24 and 48 hours after the treatment 2. Pre- and post-treatment MRIs will be taken before the treatment and 6-8 weeks after the treatment

Countries

Turkey

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026