Trial · NCT07245121
Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.
NCT07245121, Not applicable, Recruiting, National and Kapodistrian University of Athens
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain. Trials, record NCT07245121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07245121
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.
- NCT number
- NCT07245121
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 60 participants, estimated
- Lead sponsor
- National and Kapodistrian University of Athens
- Conditions
- Chronic Pain, Perineural Analgesia, Prolotherapy, Knee Osteoarthritis
- Interventions
- Dextrose 5% and Lidocaine, Lidocaine
- First posted
- 2025-11-24
- Last updated
- 2025-12-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Severity Score (PSS) at 15 days after the 3rd (last) infiltration | 15 days after the 3rd infiltration of the first participant up to 15 days after the 3rd infiltration of the last participant | The primary outcome will be estimated by the Brief Pain Inventory (BPI) score, a numerical scale used to assess pain. This score is the arithmetic average of four items related to pain intensity: worst pain, least pain, average pain, and current pain (SCORE RANGE: 0= No pain, 1-3= Mild pain, 4-6= Moderate pain, 7-10= Severe pain). |
| Secondary | Pain Severity Score (PSS) at baseline, 30 and 90 days after the 3rd infiltration | A measurement before the first infiltration of the first participant up to 90 days after the 3rd infiltration of the last participant. | It will be estimated by the Brief Pain Inventory (BPI) score. This score is the arithmetic average of four items related to pain intensity: worst pain, least pain, average pain, and current pain (SCORE RANGE: 0= No pain, 1-3= Mild pain, 4-6= Moderate pain, 7-10= Severe pain). |
| Secondary | Pain Interference Score (PIS) | From before the first infiltration of the first participant up to 3 months after the last infiltration of the last participant. | Pain Interference Score from the relevant items of the Brief Pain Inventory (BPI) Score at baseline, 15, 30 and 90 days after the last infiltration. This score is the arithmetic average of seven items that assess how pain interferes with daily functions: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life (SCORE RANGE: 0= No interference, 1-3= Mild interference, 4-6= Moderate interference, 7-10= Severe interference). |
| Secondary | Short-term changes 24h after the first infiltration | 24 hours after the first infiltration of the first participant up to 24 hours after the first infiltration of the last participant. | Pain intensity at the affected knee during movement will be assessed, according to Numerical Rating Scale (NRS), where patients assign a number from 0 to 10 to describe their pain level, with 0 meaning "no pain" and 10 meaning "the worst pain imaginable". Furthermore, the duration of the analgesia provided by the perineural injection will be recorded, along with the patient's level of optimism regarding the treatment's effectiveness and its impact on improving daily life. |
| Secondary | WOMAC Questionnaire | Baseline, 15, 30 and 90 days after completion of the therapy of the first participant until 90 days after completion of therapy of the last participant. | Patients physical function will be evaluated by WOMAC questionnaire, which is divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). The 24-item questionnaire uses a 0-4 scale (None to Extreme), where scores are summed for each subscale (Pain 0-20, Stiffness 0-8, Function 0-68). Higher WOMAC scores indicate worse symptoms and greater functional limitations. Measurement will be made at: baseline, 15, 30 and 90 days after completion of the therapy. Further subitems of WOMAC questionnaire might also be evaluated. |
| Secondary | 30 seconds chair stand test (30CST) | Baseline, 15, 30 and 90 days after completion of the therapy of the first participant until 90 days after completion of therapy of the last participant. | 30 seconds chair stand test, where the number of successful attempts to stand up from a chair approximately 43 cm high, with a straight back and no arms for 30 seconds will be measured. Measurement will be made at: Baseline, 15, 30 and 90 days after completion of the therapy. |
| Secondary | The Global Impression of Change (GIC) scale | 3 months after completion of therapy for the first participant up to 3 months after completion of therapy for the last participant. | Score according to the Global Impression of Change (GIC) scale (a subjective patient rating of overall improvement after treatment). It will be documented at 90 days after the 3rd infiltration. |
| Other | Subanalyses of the scales used | Baseline, 15, 30 and 90 days after completion of the therapy of the first participant until 90 days after completion of therapy of the last participant | Subanalyses of questions, eg. usage of analgesics |
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.
Papers16
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/NCT07245121
GET https://conductscience.org/api/trials/v1/NCT07245121/registered