COPD Trial, Recruiting NCT06169488 Sponsor: Oslo University Hospital Condition: COPD
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COPD Trial, Recruiting

NCT06169488
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Men and women (who are not pregnant) between 20 and 65 years old who have had ongoing low back pain for at least one year
  • People who have already tried non-surgical treatments following standard guidelines — including self-management, exercise, and physical therapy — without getting satisfactory relief
  • People whose back-related disability scores between 30 and 60 on a standard disability questionnaire called the Oswestry Disability Index (ODI) at the start of the trial
  • People whose back pain is worse than any leg pain they experience
  • People who have degeneration (wear and tear) in one or two spinal discs in the lower back, along with at least one of the following findings on a scan: a specific bright spot on MRI called a High-Intensity Zone (HiZ), changes in the vertebrae near the disc (called Modic changes), or significant disc height loss of more than 50% compared to the disc above it

Who may not be able to join:

  • People with wear and tear affecting more than two spinal discs that would need treatment across more than two levels
  • People with a stress fracture in a vertebra (spondylolysis) or a type of spinal slippage caused by such a fracture (lytic spondylolisthesis)
  • People with a history of infection in the spine or spinal discs (spondylodiscitis)
  • People who have previously had spinal fusion surgery in the lower back
  • People with a spinal curve (scoliosis) greater than 20 degrees
  • People who show signs of a vertebral (spinal bone) fracture at or near the area being considered for surgery
  • People who currently smoke
  • People who, for reasons such as serious ongoing psychiatric illness, drug misuse, or plans to relocate away from the trial centres, may be unlikely to stick with the treatment or attend all follow-up appointments
  • People with significant nerve root compression (a pinched nerve) identified by MRI scan and clinical examination
  • People with a Body Mass Index (BMI) over 40
  • People who do not understand the Norwegian language
  • People with widespread muscle pain conditions, including fibromyalgia or myalgic encephalitis (ME/CFS)
  • People for whom MRI scans are not safe, for example due to a cardiac pacemaker, metal implants in the eye or brain, or claustrophobia
  • People with active cancer
  • People with a disabling neurological condition such as Parkinson's disease, ALS, or multiple sclerosis (MS)
  • People with severely disabling arthritis of the hip or knee (graded at Kellgren & Lawrence grade III or higher)
  • People taking high daily doses of strong opioid painkillers (morphine equivalents of 60mg or more per day) or regularly using morphine-containing pain patches
  • People who decline to be assigned to a specific treatment group within the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Christian Hellum, PhD, Oslo University Hospital, Division of Orthopedic Surgery, OUS Ullevål

Phone: +4767960000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
15 April 2024
Est. completion
1 October 2030

Where this trial is recruiting

🇳🇴 Norway

Primary endpoints

Oswestry Disability Index (ODI): Change in percent

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov