Clinical trial · Interventional
Exploring Long-term Pain Relief with 5% Dextrose Added to Local Anesthetic
A Prospective, Open-label Self-controlled Trial to Assess Long-term Changes in Pain and Function with Addition of 5% Dextrose to Local Anesthetic Solutions - the PALPADE Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this single-arm, non-randomized, open-label trial is to determine whether adding a 5% dextrose solution to a local anesthetic can improve outcomes in patients with chronic non-cancer pain. The main question we aim to answer is whether adding a low-concentration (5%) dextrose solution to local anesthetics increases the effectiveness of trigger point injections and/or peripheral nerve blockade in the treatment of chronic non-cancer pain. Researchers will compare the outcomes of adding 5% dextrose to the usual local anesthetic solution with the outcomes of using the local anesthetic alone to determine if injection therapy is more effective when dextrose is added. Participants will: * Attend their scheduled injection treatments every two (2) weeks for a total of six (6) visits. * Complete a demographic form at the first visit, and the usual pre-visit questionnaires (the Waiting Room Form and the Brief Pain Inventory (BPI)) at every visit, as well as four (4) weeks after the sixth visit (approximately 16 weeks from the study start date). They will also need to complete two short questionnaires-the Patient Health Questionnaire (PHQ-9) and the Patient Global Impression of Change (PGIC)-at the specified intervals. * Complete all forms, which will be securely emailed to them.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Non-cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice for each patient. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice
- description
- The physician will add 1 mL of 50% dextrose solution (Pfizer Canada ULS, Kirkland, Québec) to the usual local anesthetic solution of choice for each patient. Solutions contain either 0.3% Ropivacaine, 1% Procaine, 0.5% Lidocaine, 0.25% Bupivacaine, or a mixture of 0.25% Bupivacaine and 2% Lidocaine in a 9:1 ratio.
- interventionNames
- Drug: Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice for each patient.
Primary outcomes (4)
- measure
- Brief Pain Inventory form (BPI)
- timeFrame
- BPI is administered at the following intervals: first visit (Baseline/week 1), the third visit (Week 5), the sixth and final visit (Week 11), and again four weeks after the end of the intervention period (Week 15).
- description
- The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men and women ≥ 18 years old, inclusive. 2. A primary diagnosis of chronic non-cancer pain as determined by their physician. 3. Present chronic pain symptoms of at least 3 months in duration. 4. Currently receiving injection therapy every 1-3 weeks for at least 6 months. 5. English proficiency Exclusion Criteria: 1. Age less than 18 years 2. Scar or infection at the blockade puncture site 3. Pregnancy 4. Unstable neurologic or psychiatric diagnosis, including schizophrenia, bipolar disorder, substance use disorder, depression or anxiety, dementia or neurodegenerative disorder 5. Serious acute life stressor, clinical illness, or organ disease within the past three months 6. Serious or significant traumatic injury, surgical or dental procedure within the past three months 7. Lack of English proficiency or unable to complete patient forms 8. Denial or withdrawal of consent, as per the informed consent form (ICF).
References
Publications (7)
- BACKGROUNDPatel KV, Amtmann D, Jensen MP, Smith SM, Veasley C, Turk DC. Clinical outcome assessment in clinical trials of chronic pain treatments. Pain Rep. 2021 Jan 21;6(1):e784. doi: 10.1097/PR9.0000000000000784. eCollection 2021 Jan-Feb. PMID 33521482
- BACKGROUNDBae G, Kim S, Lee S, Lee WY, Lim Y. Prolotherapy for the patients with chronic musculoskeletal pain: systematic review and meta-analysis. Anesth Pain Med (Seoul). 2021 Jan;16(1):81-95. doi: 10.17085/apm.20078. Epub 2020 Dec 16. PMID 33348947
- BACKGROUNDHauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016. PMID 27429562
- BACKGROUNDWee TC, Neo EJR, Tan YL. Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 May 20;19:108-117. doi: 10.1016/j.jcot.2021.05.015. eCollection 2021 Aug. PMID 34046305
- BACKGROUNDRabago D, Slattengren A, Zgierska A. Prolotherapy in primary care practice. Prim Care. 2010 Mar;37(1):65-80. doi: 10.1016/j.pop.2009.09.013. PMID 20188998
- BACKGROUNDHung CY, Hsiao MY, Chang KV, Han DS, Wang TG. Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis. J Pain Res. 2016 Oct 18;9:847-857. doi: 10.2147/JPR.S118669. eCollection 2016. PMID 27799816
- BACKGROUNDGoswami A. Prolotherapy. J Pain Palliat Care Pharmacother. 2012 Dec;26(4):376-8. doi: 10.3109/15360288.2012.734900. PMID 23216178