Trial · NCT07254806
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analogue Scale (VAS) for low back pain | Week 52 | VAS is a sliding visual scale of 0 being "no pain" and 100 being "worst pain Imaginable' to assess changesfrom baseline in low back pain compared to Sham |
| Primary | Oswestry Disability Index (ODI) | Week 52 | ODI is a 10-item questionnaire used to measure functional disability in people with low back pain. It is a self-administered tool that assesses how back pain affects daily activities like walking, sleeping, and personal hygiene, with scores ranging from 0% (no disability) to 100% (maximum disability). |
| Primary | Adverse Events | Day 1 to Week 52 in each treatment group. | Incidence of grade 2 (moderate) or greater AEs and SAEs |
| Primary | Adverse events of special interest | Day 1 to Week 52 in each treatment group | Incidence of Adverse Events of Special Interest (AESI) to include any symptomatic injury of the target disc including annular tear, disc herniation/extrusion/prolapse as well as discitis. |
| Secondary | Visual Analogue Scale (VAS) | Week 4, 12 and 26, 78 and 104 | VAS is a sliding visual scale of 0 being "no pain" and 100 being "worst pain Imaginable' to assess changes from baseline in low back pain |
| Secondary | Oswestry Disability Index (ODI) | Week 4, 12 and 26, 78 and 105 | ODI is a 10-item questionnaire used to measure functional disability in people with low back pain. It is a self-administered tool that assesses how back pain affects daily activities like walking, sleeping, and personal hygiene, with scores ranging from 0% (no disability) to 100% (maximum disability). |
| Secondary | EQ-5D | Enrollment through Week 104 | EQ-5D is a validated too consisting of a set of questions covering five dimensions, with each dimension having a different severity level. 1. Mobility: Ranging from "no problems walking about" to "confined to bed". Self-care: Ranging from "no problems with self-care" to "unable to wash or dress myself". 2. Usual activities: Ranging from "no problems doing my usual activities" to "unable to do my usual activities" (e.g., work, study, housework). 3. Pain/discomfort: Ranging from "no pain or discomfort" to "extreme pain or discomfort". 4. Anxiety/depression: Ranging from "not anxious or depressed" to "extremely anxious or depressed". 5. Visual Analog Scale (EQ VAS): A scale (typically 0-100) where respondents mark their overall health from "worst imaginable" to "best imaginable". |
| Secondary | Disc Volume | Day 1 to Week 104 | MRI assessment of Disc Volume though Week 104 |
| Secondary | Pain Medication Use | Enrollment to Week 104 | Concomitant pain medication use for low back pain related to the target disc |
| Secondary | Concomitant Therapy | Enrollment to Week 104 | Concomitant medical therapy for low back pain (physical therapy, acupuncture, chiropractic manipulation, massage, and at-home, medically supervised exercise program etc.) use for low back pain |
| Secondary | Treatment Failure Rate | Enrollment to week 104 | Treatment failure rate (defined as an invasive non-surgical or surgical intervention) directly related to the target disc. |
| Secondary | Adverse Events | Enrollment to Week 104 | The incidence of grade 2 (moderate) or greater AEs and SAEs |
| Secondary | Adverse Events of Special Interest (AESI) | Enrollment to Week 104 | The incidence of Adverse Events of Special Interest (AESI) observed defined as any one of the followings symptomatic injury of the target disc including annular tear, disc, herniation/extrusion/prolapse or any case of discitis. |
| Other | MRI Based evaluations | Enrollment through Week 104 | MRI Evaluation of the lumbar spine will be reported as an aggregate in one report to assess of disc height, Modified Pfirrmann grade, Modic changes, annular tears/fissures, endplate integrity, herniation, and any additional noteworthy observations at 12, 26, 52, 78, and 104. |
| Other | X-ray evaluation of the lumbar spine | Screening through Week 104 | X-ray evaluation of flexion/extension will be assessed and measure in degrees of angles. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07254806/registered