Chronic Pain Clinical Trial
— COEDOfficial title:
Chronic Opioid Use and Epidermal Nerve Fiber Density
This pilot study is being performed to examine whether epidermal axons are altered in patients taking opioid therapy for chronic non-cancer pain, and if epidermal axonal changes predict heightened pain sensitivity.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: Healthy/All: - Informed consent provided by the participant - Able to read and speak in English - Age 18 to 65 years - Likely to participate in all scheduled evaluations and study procedures IF they are a Chronic Non-Cancer Patients who do NOT take opioid medication they must meet all of the above criteria as well as: Diagnosis of non-cancer chronic pain syndrome (persistent pain lasting longer than 3 months) IF they are a Chronic Non-Cancer Patients who DO take opioid medication they must meet all of the above criteria as well as: - Chronic daily opioid use for longer than 3 months duration - Stable doses of opioid medications for at least 30 days prior to study visit Exclusion Criteria: - Pregnancy - Prisoner - Current clinically significant cardiac, or neurologic disease - Significant skin disorders in lower extremities - Circulatory insufficiency - Open wounds in lower extremity that may interfere with healing - Lidocaine allergy - Currently taking anticoagulation (e.g., Coumadin, Plavix, etc) - Current litigation for chronic pain - Active psychotic or suicidal symptoms - Current drug or alcohol abuse - Neuropathy in upper extremities (hands specifically, PI discretion). - Current or recent use of artificial fingernails or nail enhancements (last 6 months) - Other diagnoses that are not considered minor/stable (PI discretion) - Current or previous cancer diagnosis - Current or previous chemotherapy treatment - No chronic pain conditions (healthy) - Opioid use in the last year (healthy & non-opioid pts) |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Health System | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | IENFD | Intraepidermal Nerve Fiber Density | Baseline | |
Secondary | Fibromyalgianess | FMness is a measure of pain and co-morbid symptom extensiveness and severity. It is calculated from the 2011 FM Survey27 to derive a continuous metric of CNS pain amplification. | Baseline | |
Secondary | Clinical Pain Severity | Pain severity and interference will be assessed using the Brief Pain Inventory (BPI). The BPI asks patients to rate their worst, least and average pain intensity (0-10 NRS). | Baseline | |
Secondary | Neuropathic Pain Descriptors | The PainDETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that indicates neuropathic pain | Baseline | |
Secondary | Stress | The Perceived Stress Scale (PSS) is used to measure levels of stress. | Baseline | |
Secondary | Catastrophizing | Coping Strategies Questionnaire(CSQ-CAT) will quantify traits associated with pain progression and catastrophizing | Baseline | |
Secondary | Physical Functioning | The PROMIS short forms will be used for Fatigue, Sleep Disturbance, Sleep-Related Impairment, Physical Function, Anxiety and Depression | Baseline | |
Secondary | Sleep Disturbance | The PROMIS short forms will be used for Fatigue, Sleep Disturbance, Sleep-Related Impairment, Physical Function, Anxiety and Depression | Baseline | |
Secondary | Sleep Related Impairment | The PROMIS short forms will be used for Fatigue, Sleep Disturbance, Sleep-Related Impairment, Physical Function, Anxiety and Depression | Baseline | |
Secondary | Fatigue | The PROMIS short forms will be used for Fatigue, Sleep Disturbance, Sleep-Related Impairment, Physical Function, Anxiety and Depression | Baseline | |
Secondary | Anxiety | The PROMIS short forms will be used for Fatigue, Sleep Disturbance, Sleep-Related Impairment, Physical Function, Anxiety and Depression | Baseline | |
Secondary | Depression | The PROMIS short forms will be used for Fatigue, Sleep Disturbance, Sleep-Related Impairment, Physical Function, Anxiety and Depression | Baseline | |
Secondary | Impulsivity | Using the Kirby Delay Discounting Task, a type of impulsivity can be measured by determining the value participants see in rewards if they are offered at different time points (eg. $25 now OR $60 in 21 days).Impulsivity is a measure of a person's propensity towards reward-based behaviors. Patients in chronic pain and on opioids have been shown to have changes in their reward pathways. | Baseline | |
Secondary | Pressure Pain Sensitivity | Using the Multimodal Automated Sensory Testing (MAST) System, a computerized QST device, an ascending series of 5-s duration stimuli at 25-s intervals will be delivered beginning at 0.50 kg/cm2 and increasing in 0.50 kg/cm2 intervals up to tolerance or a maximum of 10 kg/cm2. Pain intensity and pressure pain threshold will be determined. | Baseline | |
Secondary | Conditioned Pain Modulation (CPM) | CPM is a measure of the integrity of descending analgesic pathways. CPM will be evaluated using two MAST pressure actuators positioned on opposite thumbnails. A reduction in test stimulus rating by conditioning stimulation implies functional (inhibitory) CPM. | Baseline | |
Secondary | Temporal Summation (TS) | TS is the perceived increase in pain intensity to repeated stimulation at a constant stimulus intensity and is reflective of CNS sensitization. A 256 mN pinprick stimulus (MRC Systems, Heidelberg, Germany) will be applied once to the forearm or hand, followed by a train of 10 identical stimuli (1 Hz). The series will be repeated three times. Participants report the pain intensity and the mean pain rating is used to calculate a wind-up ratio (WUR); a WUR >1 indicates temporal summation. | Baseline | |
Secondary | Pain genetics | A number of genes will be analyzed that have previously been studied for their role in pain sensitivity as well as susceptibility to the development of chronic idiopathic low back pain. Subsequent analysis will be performed based on research findings and other published data. | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01659073 -
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
|
N/A | |
Recruiting |
NCT05914311 -
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
|
N/A | |
Recruiting |
NCT05422456 -
The Turkish Version of Functional Disability Inventory
|
||
Enrolling by invitation |
NCT05422443 -
The Turkish Version of Pain Coping Questionnaire
|
||
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04385030 -
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
|
N/A | |
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05103319 -
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
|
||
Completed |
NCT03687762 -
Back on Track to Healthy Living Study
|
N/A | |
Completed |
NCT04171336 -
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
|
N/A | |
Completed |
NCT03179475 -
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
|
Phase 4 | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
Recruiting |
NCT06060028 -
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
|
N/A | |
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
Not yet recruiting |
NCT05812703 -
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
|