Trial · NCT07296653
Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP)
NCT07296653, Early phase 1, Recruiting, National and Kapodistrian University of Athens
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP). Trials, record NCT07296653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07296653
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prolotherapy in Acupoints in Chronic Non-specific Low Back Pain (cLBP)
- NCT number
- NCT07296653
- Status
- Recruiting
- Phases
- Early phase 1
- Enrollment
- 60 participants, estimated
- Lead sponsor
- National and Kapodistrian University of Athens
- Conditions
- Chronic Non-specific Low Back Pain
- Interventions
- Dextrose 15% and lidocaine 1% infiltration, Lidocaine 1% infiltration
- First posted
- 2025-12-22
- Last updated
- 2025-12-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain severity score 15 days after completion of the intervention | 15 days after completion of infiltrations of first participant until 15 days after completion of infiltration of the last participant. | Pain severity score from the short Brief Pain Inventory (BPI) form, 15 days after completion of the infiltrations. Minimum value: 0 and Maximum value: 10 Higher scores correspond to worse outcome - i.e. greater pain severity or greater interference with functioning. |
| Secondary | Pain severity score at 90 days after completion of the therapy | From 90 days after completion of the infiltrations of the first participant until 1 month after completion of infiltrations of the last participant. Just before the first infiltration a baseline measurement will be also made. | Pain severity score from BPI short form 90 days after completion of the infiltrations. |
| Secondary | Oswestry disability index (ODI) at baseline, 15, 30 and 90 days after completion of therapy | Before first infiltration of the first participant up to 3 months after completion of the therapy of the last one. | Oswestry scale score |
| Secondary | Short term changes after the first infiltration | 24 hours (Day 1) after first infiltration of the first participant until 24 hours after first infiltration of the last participant. | Pain decrease, duration of analgesia and optimism at 24 hours (Day 1) after completion of the first session. Pain reduction after the first session will be analyzed as prognostic factor for the pain improvement. |
| Secondary | TUG (timed up and go) test | Just before the first infiltration until 3 months after completion of the therapy of the last participant | TUG test in seconds at baseline, 15 minutes before and after 1st Infiltration and Day 15, Day 30, and Day 90 after the 3rd infiltration |
| Secondary | Global impression of change | From one month after completion of therapy of the first participant until 3 months after completion of therapy of the last participant. | Global impression of change 90 days after completion of the therapy |
| Secondary | Roland-Morris Low Back Pain disability questionnaire | Baseline evaluation, Day 15 and Day 90 after the 3rd infiltration | Baseline evaluation, Day 15 and Day 90 after the 3rd infiltration |
| Secondary | Pain intensity score after completion of the interventions programmed | Day 1, Day 7, Day 15, Day 30, Day 90 after the infiltrations | Pain severity score from the Numeric Rating Scale (0-10) used to quantify pain intensity (0=no pain, 10=worst pain imaginable) |
| Other | Subanalyses of the scales measured | Time frames are pre-determined as stated from the above mentioned scales: DAY 1, DAY 15, DAY 30, (immediately after the interventions), DAY 90 after the first infiltration | Subanalyses of questions from the above mentioned scales (BPI + Oswestry Disability Index + Rolland + TUG + ΝRS + Global Impression of Change) eg. usage of analgesics, changes in life attitudes, changes in movement/work/food habits, undergoing other parallel treatments or hospitalizations |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers30
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07296653
GET https://conductscience.org/api/trials/v1/NCT07296653/papers?page=2