Trial Title:
Exploring Long-term Pain Relief with 5% Dextrose Added to Local Anesthetic
NCT ID:
NCT06617065
Condition:
Chronic Non-cancer Pain
Conditions: Official terms:
Anesthetics
Anesthetics, Local
Conditions: Keywords:
Dextrose
Local anesthetics
Prolotherapy
Chronic pain
Interventional pain treatment
Peripheral nerve block
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice for each patient.
Description:
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.
Arm group label:
Addition of 1 mL of 50% dextrose solution to the usual local anesthetic solution of choice
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.
Detailed description:
Study Background:
There are many different approaches to treating chronic non-cancer pain, offering
potential benefits such as symptom reduction, improved function, and enhanced quality of
life. In most cases, conservative and noninvasive treatments are used first, with
interventional procedures pursued for more persistent, severe, or disabling symptoms,
either for diagnosis or treatment.
Injection treatments are typically considered when functional limitations persist despite
physiotherapy, pharmacotherapy, and other non-invasive treatments. Corticosteroid
injections into spinal and non-spinal joints, tendons, and ligaments are widely used, but
repeated use has been associated with cartilage damage and tissue atrophy. Consequently,
there is growing interest in other injectable solutions with potential benefits in pain
management, including local anesthetics, dextrose, and platelet-rich plasma (PRP).
Prolotherapy is a non-surgical regenerative injection technique in which dextrose is
delivered to tissues with degenerative damage, such as tendon insertions (entheses),
joints, ligaments, and surrounding joint spaces. These injections are administered in a
series of procedures at regular intervals. While the precise mechanism of action for
prolotherapy remains unclear, some evidence suggests that a localized inflammatory
cascade leads to collagen deposition and the release of growth factors. The increasing
interest in prolotherapy is supported by a growing number of published intervention
studies, which back anecdotal reports of its benefits in several painful conditions, with
minimal adverse effects.
Dextrose has also been used as a diluent for local anesthetics, as it is soluble and does
not cause pain or residual complications over time. Faiz et al. demonstrated that the
addition of 5% dextrose to 0.5% bupivacaine provided an earlier onset of sensory block
for the median nerve compared to normal saline. Additionally, Topol et al. showed
superior effects of 1% lidocaine with 12.5% dextrose over lidocaine alone in adolescents
with Osgood-Schlatter disease. While dextrose prolotherapy has been studied in several
localized pain conditions, there is a lack of data on its role in generalized myofascial
pain.
Our community-based pain clinic has been using repeated injections of local anesthetics
as maintenance therapy for patients with chronic non-cancer pain. The purpose of this
study is to assess the potential for dextrose to improve outcomes in these patients by
delivering their usual local anesthetic in a 5% dextrose solution. Patients will receive
six treatments over approximately three months, with long-term improvement measured by
comparing outcomes at baseline, at the end of treatment, and four weeks after the final
treatment, following the IMMPACT guidelines that inform this study's methodology.
This study is significant because it will be the first to compare the outcomes of
injection treatment using local anesthetics with dextrose to local anesthetics alone,
using a low concentration of dextrose, in a series of treatments to identify long-term
improvements in chronic non-cancer pain. The hypothesis is that injection therapy will be
more effective when dextrose is added, supporting the recommendation that dextrose should
be routinely included in local anesthetic solutions for injection-based pain treatments.
Our research question aims to determine 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.
METHODS and MATERIALS
Study Design:
This study will be a single-arm, non-randomized, open-label trial. Patients with chronic
non-cancer pain who are currently receiving routine care at a community-based pain clinic
will be invited to participate. Eligible patients must have been receiving peripheral
nerve blocks and trigger point injections for the management of their chronic pain for at
least six months prior to enrollment. A 50% dextrose solution will be used to achieve a
final concentration of 5% dextrose in addition to their usual local anesthetic solution.
The results will be compared with historical data from when they received only nerve
blocks.
DATA COLLECTION
Patient Demographics:
Demographic information will be collected, including age, gender, BMI, duration of
symptoms, employment status, and pain intensity (measured using a Visual Analogue Scale).
Additionally, during the initial visit, nurses will conduct a clinical assessment to
determine the primary diagnosis, review current medications, and screen for mental
illness, cognitive impairment, comorbidities, and prior spinal surgery.
Intervention:
The Principal Investigator will use a palpation-guided approach to choose injection
sites. Injection solutions will be prepared by clinic nurses. 1 mL of 50% dextrose
solution (Pfizer Canada ULS, Kirkland, Québec) will be added 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.
The palpation-guided injection technique uses a novel approach to identify hypersensitive
sensory fibres associated with pain generators in myofascial tissues and related
structures. The procedure involves lightly sliding the fingertips along the skin in a
linear direction (approximately 2-3 centimetres per second) until a palpable stress
response is detected, which can be described as a change in skin turgor or tissue tension
that can be felt by the examiner. This subtle but clearly discernible response may
represent a lower threshold activation of the nociceptive flexion reflex (NFR), a widely
used marker of central sensitization. Efforts are underway to evaluate the reliability of
this palpation technique and its potential as a reliable, noninvasive tool for evaluating
and treating painful disorders. Patients will receive this intervention a total of six
times every 1-3 weeks, following their usual injection treatment schedule.
Clinical Measures:
Intervention data and patient-reported outcomes data will be extracted from routinely
collected data, using the OceanMD platform. Patient-reported outcomes data will include
the Brief Pain Inventory form (BPI), Patient Health Questionnaire (PHQ-9), duration of
pain relief, and pain on a Visual Analogue Scale (VAS) ranging from 0 to 10 at the first
visit (baseline/week 1), the third visit (week 5), the sixth and final visit (end of the
intervention period/week 11), and again four weeks after the end of the intervention
period (week 15). In addition, the Patient's Global Impression of the Change (PGIC) will
also be measured at the end of the intervention (week 11) and four weeks later (week 15).
Intervention data will include the number of injections, injection sites, and local
anesthetic solutions used. Moreover, patients will fill out the usual waiting room
questionnaire at every visit.
Rescue Treatment:
Patients who require urgent care for an acute injury or pain flare will be assessed and
treated following usual protocols. Rescue injections and any other treatment administered
will be based solely on the physician's judgment and will be documented in the patient's
usual clinical chart notes (OSCAR EMR version 15).
Criteria for eligibility:
Criteria:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seekers Centre
Address:
City:
Ottawa
Zip:
K1Z 5Z9
Country:
Canada
Start date:
September 3, 2024
Completion date:
February 28, 2025
Lead sponsor:
Agency:
The Seekers Centre
Agency class:
Other
Source:
The Seekers Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06617065
