Exploring Long-term Pain Relief with 5% Dextrose Added to Local Anesthetic

NCT06617065 | Active Not Recruiting

• 1 other identifier: 11997-RNahas
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Non-cancer Pain

Keywords

Dextrose; Local anesthetics; Prolotherapy; Chronic pain; Interventional pain treatment; Peripheral nerve block

Outcome Measures

Primary Outcomes (4)

• Brief Pain Inventory form (BPI)

  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.

  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).

• Patient Health Questionnaire (PHQ-9)

  The PHQ-9 is a depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).

  The PHQ-9 is administered at the following intervals: At the 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).

• Visual Analogue Scale (VAS)

  VAS consists of a 10 cm horizontal line with the endpoints defining extreme limits such as no pain at all and pain as bad as possible.

  The VAS is administered at the following intervals: At the 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).

• Patient's Global Impression of the Change (PGIC)

  The PGIC is a short questionnaire that provides a responsive and interpretable assessment of how a participant evaluates changes in their status.

  The PGIC is administered at the following intervals: At the end of the intervention (Week 11) and four weeks after the end of the intervention period (Week 15).

Study Arms (1)

Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice

EXPERIMENTAL

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.

Drug: Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice for each patient.

Interventions

Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice for each patient. DRUG

The principal investigator will use a palpation-guided approach to select the injection sites. Injection solutions will be prepared by the assisting nurse. For each patient, 1 mL of a 50% dextrose solution (Pfizer Canada ULS, Kirkland, Québec) will be added to the usual local anesthetic solution of choice. 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.

Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥ 18 years old, inclusive.
• A primary diagnosis of chronic non-cancer pain as determined by their physician.
• Present chronic pain symptoms of at least 3 months in duration.
• Currently receiving injection therapy every 1-3 weeks for at least 6 months.
• English proficiency

You may not qualify if:

• Age less than 18 years
• Scar or infection at the blockade puncture site
• Pregnancy
• Unstable neurologic or psychiatric diagnosis, including schizophrenia, bipolar disorder, substance use disorder, depression or anxiety, dementia or neurodegenerative disorder
• Serious acute life stressor, clinical illness, or organ disease within the past three months
• Serious or significant traumatic injury, surgical or dental procedure within the past three months
• Lack of English proficiency or unable to complete patient forms
• Denial or withdrawal of consent, as per the informed consent form (ICF).

Sponsors & Collaborators

• The Seekers Centre: lead

Study Sites (1)

Seekers Centre

Ottawa, Ontario, K1Z 5Z9, Canada

Location

Related Publications (7)

• Patel 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 BACKGROUND

• Bae 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 BACKGROUND

• Hauser 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 BACKGROUND

• Wee 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 BACKGROUND

• Rabago 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 BACKGROUND

• Hung 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 BACKGROUND

• Goswami A. Prolotherapy. J Pain Palliat Care Pharmacother. 2012 Dec;26(4):376-8. doi: 10.3109/15360288.2012.734900.

  PMID: 23216178 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician/Clinic director/ Principal investigator

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: September 3, 2024
• Primary Completion: January 30, 2025
• Study Completion: February 28, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD will be made available to approved researchers 12 months after the publication of the main study results. This period allows sufficient time for meticulous data preparation for external use.
• Access Criteria: Access to IPD will be granted to researchers who submit scientifically valid proposals that align with ethical guidelines. A review committee will evaluate proposals based on their objectives, methodology, and compliance with data protection standards. Successful applicants will be required to sign a data use agreement outlining secure data handling and confidentiality requirements. Instructions for secure data access, including anonymization protocols and secure transfer methods, will be provided to approved researchers.

Locations

CA (1)