Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617065
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Exploring Long-term Pain Relief with 5 Dextrose Added to Local Anesthetic
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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 05 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 125 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 studys 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 andor 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 03 Ropivacaine 1 Procaine 05 Lidocaine 025 Bupivacaine or a mixture of 025 Bupivacaine and 2 Lidocaine in a 91 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 baselineweek 1 the third visit week 5 the sixth and final visit end of the intervention periodweek 11 and again four weeks after the end of the intervention period week 15 In addition the Patients 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 physicians judgment and will be documented in the patients usual clinical chart notes OSCAR EMR version 15
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 05 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 125 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 studys 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 andor 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 03 Ropivacaine 1 Procaine 05 Lidocaine 025 Bupivacaine or a mixture of 025 Bupivacaine and 2 Lidocaine in a 91 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 baselineweek 1 the third visit week 5 the sixth and final visit end of the intervention periodweek 11 and again four weeks after the end of the intervention period week 15 In addition the Patients 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 physicians judgment and will be documented in the patients usual clinical chart notes OSCAR EMR version 15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None