Symptoms and General Pathology

All Conditions

Nervous System Diseases

Rare Diseases

Back Pain

Pain

Neurologic Manifestations

Chronic Graft Versus Host Disease

Analgesics

All Drugs and Chemicals

Central Nervous System Depressants

Anti-Inflammatory Agents

Psychotropic Drugs

Analgesics, Opioid

Antidepressive Agents

Analgesics, Non-Narcotic

This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care.

This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care plus chiropractic care.

In both the intervention and control arms of the study, usual medical care will be defined as any and all medical care provided to patients with chronic non-cancer back or neck pain at an Ontario CHC, including: primary care provider consultation visits, prescription medication (e.g., muscle relaxants, anti-inflammatories, anti-depressants, opioid and non-opioid analgesics), referral for diagnostic testing (e.g., lab work, imaging) or specialist consultation, as well as other co-interventions (e.g., visits with nurses, dieticians, social workers, or physiotherapists) as required. All participants will also receive opioid-reduction encouragement as per each CHC's current practices. Due to socioeconomic disadvantages, most CHC patients will be unlikely to access private health care services, including chiropractic care, elsewhere. Nevertheless, the investigators will collect data on other health care utilization and conduct all analyses using an intention-to-treat principle.

Usual Medical Care

Treatment sessions may include high-velocity, low-amplitude spinal manipulative therapy, as well as any or all of the following: spinal mobilization, soft-tissue massage/trigger point therapy, education and reassurance (e.g., pain management, ergonomic and activities of daily living recommendations), and home advice (e.g., icing, spinal stretching, and core muscle strengthening exercises). Primary care providers will also engage participants in a formal collaborative effort with the chiropractic clinicians to reduce opioid use. Consistent with current clinical practice guidelines, participants will be provided up to a maximum of 12 chiropractic visits during the active care period, although participants may continue with treatment after the 8-week period (e.g., one visit, every 2-4 weeks) to manage further episodes of exacerbation/flare-up. Aside from the experimental intervention, participants in both study groups will follow the same protocol to minimize non-specific effects.

Usual Medical Care + Chiropractic Care

Peter C Emary, DC, PhD

Jason W Busse, DC, PhD

Amy L Brown, DC

The investigators will conduct a pilot cluster randomized controlled trial (RCT) of chiropractic care added to usual medical care, versus usual medical care alone, for adult patients prescribed opioid therapy for chronic non-cancer spinal pain at four community health centers (CHCs) in Ontario, Canada. These centers provide services to communities and vulnerable populations with high unemployment rates, multiple co-morbidities, and high rates of chronic musculoskeletal disorders that are commonly managed with prescription opioids.

The investigators hypothesize that a full-scale (definitive) cluster RCT on the impact of chiropractic care on prescription opioid use for chronic non-cancer spinal pain will be feasible within the Ontario CHC context.

The investigators will conduct a cluster-randomized, 2-arm, data analyst-blinded feasibility RCT at four Ontario CHCs. The CHCs will be paired on clinical characteristics (e.g., size of patient roster, geographic location), and one center from each pair will be randomized to the intervention and control groups. At each of the four centers, the investigators will recruit adult patients with active opioid prescriptions for chronic non-cancer spinal pain (minimum dose of 50 mg morphine equivalents daily) who are not currently receiving chiropractic care and are interested in reducing their opioid dose. Each center (cluster) will be allocated to provide 8 weeks of usual medical care plus chiropractic care or usual medical care alone to enrolled participants. Random cluster allocation will be performed by an investigator blinded to the intervention group assignment. To further minimize the possibility of selection bias, clusters will be identified and recruited before randomization, and all eligible (and consenting) patients in each cluster will be included. The pilot trial will be coordinated by the Methods Centre within the Department of Surgery at McMaster University.

The primary aims of this study will be to: (1) estimate recruitment rates at the individual centers, (2) explore adherence to the study protocol, (3) investigate completeness of data collection, and (4) assess the ability to follow-up participants. The investigators will incorporate qualitative methods during the pilot trial (i.e., convergent, mixed methods experimental design) to complement the feasibility measures. The investigators will also collect preliminary data on the outcomes planned for a definitive trial: opioid use, pain, disability, bothersomeness, satisfaction, other health care utilization, work status, quality of life, and adverse events at 2, 4, 8, and 12 weeks from allocation.

Cluster-randomized, 2-arm, data analyst-blinded feasibility trial

Due to the nature of the intervention, it will not be possible to blind patients, study personnel, or clinicians to treatment allocation. However, data analysts and investigators responsible for interpreting results will be blinded to treatment allocation until all data have been analyzed and interpreted.

The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study

Impact of Chiropractic Care on Opioid Use Among Adults With Chronic Non-Cancer Spinal Pain: A Pilot Cluster Randomized Controlled Trial

Supporting information will be made available from the Central Contact Person/Principal Investigator on reasonable request.

Study personnel will collect data on adverse events (e.g., muscle soreness, joint pain, stiffness, headache, dizziness, nausea, vomiting, constipation, radiating symptoms, paresthesia, or fatigue) at each follow-up visit and record this information in an online data capture system (REDCap Cloud). Participants will be asked: "Did you experience any side effects or problems after your last treatment visit? If yes, please specify: (check all that apply) (Pain or stiffness; Numbness/Pins and needles; Headache; Dizziness; Nausea; Vomiting; Constipation; Tiredness/Fatigue; Other, please specify: __________________)".

Recruitment rate of participants, measured as the number of eligible participants recruited (i.e., consented and enrolled) per week at each center.

Participant retention, measured as the percentage of participants successfully followed for the 12-week study period. The investigators will consider the pilot successful if at least 80% follow-up is achieved at 12 weeks for the primary definitive trial outcomes (i.e., total prescribed opioid usage, and levels of pain intensity and function as measured by the Bournemouth Questionnaire).

Participant compliance with appointment schedules, measured as the percentage of scheduled appointments attended. The investigators will consider 70% attendance to signify feasibility.

Measured as the percentage of items completed on patient-reported outcome questionnaires. The investigators will claim feasibility with 80% or greater completion of the Bournemouth and EuroQol 5 Domain (5 level version) questionnaires.

Study personnel will extract opioid prescription data from participants' individual electronic medical records to obtain the number of chronic non-cancer spinal pain-related opioid prescriptions (i.e., unique opioid fills and subsequent refills) from baseline to 12-week follow-up. Opioid dosage will be measured in milligrams (mg) of morphine equivalents daily (MED). To calculate the MED for each prescribed opioid, the investigators will multiply the quantity x the mg per unit dispensed x drug-specific conversion factors. In addition, the investigators will dichotomize opioid dosage as either high (e.g., ≥ 90 mg) MED or low (e.g., \< 90 mg) MED at baseline and each follow-up interval. The threshold for opioid dose will be dependent on the central tendency of MED in the patient sample. The investigators will also conduct a sensitivity analysis using a threshold of 50 mg MED.

The BQ consists of 7 items (i.e., pain intensity, function in activities of daily living, function in social activities, anxiety, depression levels, fear avoidance behavior, and locus of control/self-efficacy), each scored from 0-10 ("0" = no disability, "10" = complete disability) for a total of 70. To optimize interpretability, the investigators will convert mean effects to risk differences using the anchor-based minimally important difference (MID) of the BQ established for chronic low back pain patients.

Self-rated level of bothersomeness on a 5-point Likert scale from "Not at all bothersome" to "Extremely bothersome".

Self-rated satisfaction with care on a 5-point Likert scale from "Very satisfied" to "Very dissatisfied".

(a) Self-rated health status measured on 5 domains (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on a 5-point Likert scale from "No problems" to "Extreme problems"; and (b) Self-rated health status measured on a visual analog scale from 0-100 ("0" = worst health imaginable, "100" = best health imaginable). The investigators will convert mean effects to risk differences using the anchor-based MID of the EQ-5D established for chronic low back pain patients to optimize interpretability.

Participants will be asked: "Have you sought help from any other practitioner, such as your GP \[general practitioner\] or another healthcare professional, for this present episode of your painful complaint? If yes, please specify: (check all that apply) (GP; Nurse practitioner; Nurse; Dietician; Social worker; Community health worker; Physiotherapist; Other, please specify: __________________)."

Participants will be asked: "Since starting treatment at this clinic, have you sought help from any other practitioner, such as your GP or another healthcare professional, for your complaint? If yes, please specify: (check all that apply) (GP; Nurse practitioner; Nurse; Dietician; Social worker; Community health worker; Physiotherapist; Other, please specify: __________________)."

Participants will be asked: (a) "Are you currently employed? If yes, what is your occupation: __________________. If no, are you: (please check only one answer) (Retired; Home-maker; Student; Home on doctor's advice; Unemployed; Other, please specify: __________________)"; (b) "Are you receiving any disability benefits because of your spine pain? (please check only one answer) (Yes; No, but it's possible that I will; No, but it's likely I will; No, and it's very unlikely I will)"; and (c) "Are you currently involved with a lawyer (or ongoing litigation) as a result of your spine pain? (please check only one answer) (Yes; No, but it's possible that I will; No, but it's likely I will; No, and it's very unlikely I will)".

Surgical Methods Centre, McMaster University

Michael G. DeGroote Institute for Pain Research and Care

Ontario Chiropractic Association

Alliance for Healthier Communities

Michael G. DeGroote National Pain Centre

Canadian Chiropractic Research Foundation

McMaster University

Postdoctoral fellow, Michael G. DeGroote Institute for Pain Research and Care

Chronic Pain

Pain, Intractable

Subjects will be treated monthly for 6 months by Pain Medicine Specialist (PMS) per standard protocol. The PCP will not be involved in the treatment.

Subjects will be treated monthly for 6 months by the Primary Care Provider (PCP).The PCP will be involved and a multimodal therapeutic strategy will be communicated to the PCP by the PMS. The PCP will make dosage based on an algorithm provided by the PMS on how to adjust drug doses over time. It is not intended that the PCP may have ongoing engagement with the PMS. A direct line of communication will be set up between the PCP and the data integration clinical coordinator to handle serious medical concerns.

For the PCP group treatment will be performed (pain treatment/medications) by the Primary Care Physician in his/her office/clinic.

Group 2 (PCP Treatment)

For the PMS group treatment will be performed (pain treatment/medications) by the Pain Medicine Specialist in his/her office/clinic.

Group 1 (PMS Treatment)

Asokumar Buvanendran, MD

This study will demonstrate that functional improvement measures over a 6-month period for chronic low back patients under the care of Primary Care Provider (PCP), using a therapeutic plan formulated initially by the Pain Medicine Specialist (PMS), are equivalent to those under the care of the PMS only. Chronic low back pain patient will be initially be evaluated by the PMS. If no interventional pain therapy is required, a multimodal therapeutic plan (pharmacological and/or non-pharmacological) will be formulated to manage the chronic low back pain. Patients will be randomized into one of the two groups: Group 1 - Subjects will be treated monthly for the following 6 months by PMS, and Group 2 - Subjects will be treated by their own PCP for monthly visits for 6 months.

In this trial, each chronic low back pain patient presenting to the Rush University Pain Center will initially be evaluated by the PMS.The initial evaluation visit, as part of the routine care for all new low back patients, will include the following: a full physical examination, review of medical health and medication history, and radiological imaging (EHR will be used for the study). In addition, all new patients will need to provide a urine drug screening test and will need to undergo psychological testing and evaluation.

A determination will be made by the PMS on whether the best treatment modality includes an interventional approach or non-interventional. If no interventional pain therapy is required, a multimodal therapeutic plan (pharmacological and/or non-pharmacological) will be formulated to manage the chronic low back pain. A complete workup will be performed to accomplish this task.

If a non-interventional treatment (pharmacological and non-pharmacological) is selected, that can be implemented by a PCP, the patients will be informed of the study, and if interested, a Prescreening Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) form will be obtained from patient to give permission to contact their PCP. At that point, the patients' PCPs will be contacted, presented with the study information, and asked if they want to participate in the study. If the PCP agrees, the Main Study Informed Consent will be obtained from the patient. Patients meeting criteria would then be randomized into one of two treatment groups for continued treatment over the next 6 months. This initial multimodal therapeutic treatment can be altered by the respective treatment groups (PMS or PCP) to which study subject has been randomized.

Group 1 (PMS treatment): Subjects will continue to be followed for the next 6 months by the PMS (typically every month for the treatment of chronic pain) per standard protocol. The PCP will not be involved in the treatment.

Group 2 (PCP treatment): Subjects will be followed by the PCP for the next 6 months. The PCP will be involved using EHR and a multimodal therapeutic strategy will be communicated to the PCP by the PMS. The PCP will make dosage based on an algorithm provided by the PMS on how to adjust drug doses over time (general template-See below). It is not intended that the PCP may have ongoing engagement with the PMS. While the PCP may request clarification by the PMS during the first week of subject treatment, any further contact between the PCP and the PMS would result in the subjects being withdrawn from the study. In addition, a direct line of communication will be set up between the PCP and the data integration clinical coordinator to handle serious medical concerns. In case of serious medical events, the subject will be withdrawn from the study and appropriate medical care will be provided by the PMS or PCP.

Group 1 \& 2: Subjects in both groups will undergo the following:

1. Urine drug screening test (qualitative); includes amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, ethanol, and opioids
2. Receive a sample copy of an opioid contract/agreement
3. PMS will query the Illinois prescription monitoring program for that patient to determine the various health care providers who are prescribing narcotics or other controlled medications.
4. Undergo a psychological test and evaluation by the Rush University Pain Center psychologist (including the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)13), to determine risk of drug abuse.

Template for treatment of low back pain to be provided for PCP.

This template is only a suggestion, and clinical and medical judgment for each patient will be decided by the PMS. Listed are the categories of pharmacological and non-pharmacological modalities, but the PMS will formulate a patient-specific prescriptive plan after evaluation at the initial work-up:

1. Non-steroidal anti-inflammatory drugs (NSAIDs): preferably COX-2 inhibitor for all patients. If NSAIDs are prescribed, GI prophylaxis needs to be provided.14,15 This would be prescribed to all patients and will be provided daily and not 'as needed' medication, unless there are adverse events that prevent its administration.
2. Muscle relaxants: such pharmacological agents include baclofen, tizanidine, or lorazepam to relieve painful muscle spasms16
3. Opioids: long-acting opioids (oxycodone, controlled- release), short-acting opioids (e.g. hydrocodone/acetaminophen)14,15,17
4. Anticonvulsants: mainly gabapentin or pregabalin18
5. Transcutaneous electrical nerve stimulation (TENS) unit19 At the end of the 6-month treatment period (end of study), patients will be given the option to continue the treatment with their group or changing to any other treatment available.

A research study nurse, blinded to group allocation, will call patients (from both groups) every month to collect BPI questionnaire responses over the phone. In addition, a general measure of functional health and well-being, the SF-36 health-related quality of life outcome measure (Short-Form 36 Health Survey), will be collected during the same call.21 The SF-36 total score can be used as an overall health measure, or as a measure of two different health domains: physical health (including bodily pain) and mental health, as well as further division into more specific subscales. A baseline BPI and SF-36 will be obtained from each subject's initial visit record (EHR). The research study nurse will enter data obtained from the phone calls directly into the Rush University Pain Centers (RUPC) EHR on the eClinicalWorks platform.

To evaluate procedural variations, side effects and secondary outcomes over the 6 month follow-up treatment period, a data integration clinical coordinator (DICC), not blinded to group allocation, will query electronic and physical health records, from both the PCP and PMS, as well as corresponding HIS's.

Improving Outcomes and Lowering Costs by Integration of Primary Care Providers and Pain Medicine Physicians for Pain Pts

Improving Functional Outcomes and Lowering Health Care Costs by Enhanced Integration of Primary Care Providers and Pain Medicine Physicians for Chronic Non-cancer Pain Patients

The Brief Pain Inventory (BPI) short form is a self-report questionnaire using items (questions) on a 11-point scale (0-10), and will be used to assess impact of pain on daily activities, and pain severity.

We will gather data approximately on a monthly basis (Baseline, 1 month, 2 month, 3 month, 4 month, 5 month, 6 month).

A data integration clinical coordinator (DICC), not blinded to group allocation, will query electronic and physical health records, from both the PCP and PMS

The Short Form-36 Health Survey (SF-36) form is a health-related quality of lif questionnaire which measures two different health domains: physical health (including bodily pain) and mental health, as well as further division into more specific subscales.

The Patient Satisfaction Questionnaire (PSQ-18) assesses global satisfaction with medical care as well as satisfaction with six aspects of care: technical quality, interpersonal manner, communication, financial aspects of care, time spent with doctor, and accessibility of care

Pfizer

Rush University Medical Center

Professor, Department of Anesthesiology

Cancer Pain

Morphine

New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump

Patients who were part of the previous IDE study, still have an active Prometra Programmable Intrathecal Infusion Pump, and are willing to continue in a study protocol.

There are two enrollment groups (arms). One is for new patients who are going to have a Prometra Pump implanted. The other arm is for patients who were part of the IDE study prior to FDA approval of the pump, and are willing to continue to be followed as part of a study.

Prometra Programmable Intrathecal Infusion Pump

Cory Brantley

The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.

This study is proposed under part of the post-Premarket Approval (PMA) requirements. This study is a prospective, non-randomized, open-label, multicenter study. It will be performed at 10-30 centers in the US and enroll a maximum of 400 subjects. Subjects will be followed for a total of five years.

Prometra Post-Approval Study

A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System

Tabulation of device-related adverse events

Tabulation of device-related serious adverse events

The effect of race and ethnicity on granuloma formation

The effect of alternative drugs on granuloma formation

The primary hypothesis is that the 5-year rate of patients with granuloma formation will be noninferior to that in the literature. The literature rate was found to be approximately 3% and the noninferiority margin will be three percentage points.

Tabulation of pump failures, including time to occurrence and type

Tabulation of occurences of premature pump battery depletions

Flowonix Medical

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Wounds and Injuries

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Osteoporosis

Fractures, Bone

Neoplasm Metastasis

Multiple Myeloma

Neoplasms, Plasma Cell

Bone Neoplasms

Fractures, Compression

Bone Diseases

Bone Diseases, Metabolic

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Metabolic Diseases

Acute Graft Versus Host Disease

Balloon Kyphoplasty

Prof. Johnell, MD

The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.

FREE Study - Fracture Reduction Evaluation

An International Multicentric, Multidisciplinary Prospective and Randomized Study to Compare Minimally Invasive Reduction and Fixation Using the KyphX System and Radiopaque PMMA Cement to Medical Therapy Alone for the Treatment of Painful, Acute Osteopenic Vertebral Body Compression Fractures

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study	NCT06160947	Back Pain	Usual Medical C... Usual Medical C...	18 Years -	McMaster University
Improving Outcomes and Lowering Costs by Integration of Primary Care Providers and Pain Medicine Physicians for Pain Pts	NCT02484937	Back Pain Chronic Pain Pain, Intractab...	Group 2 (PCP Tr... Group 1 (PMS Tr...	18 Years -	Rush University Medical Center
Prometra Post-Approval Study	NCT01854229	Chronic Pain Cancer Pain Intractable Pai... Back Pain	Prometra Progra...	22 Years -	Flowonix Medical
Prometra Post-Approval Study	NCT01854229	Chronic Pain Cancer Pain Intractable Pai... Back Pain	Prometra Progra...	22 Years -	Flowonix Medical
FREE Study - Fracture Reduction Evaluation	NCT00211211	Osteopenia Osteoporosis Multiple Myelom... Bone Neoplasms	Balloon Kyphopl...	21 Years -	Medtronic Spinal and Biologics
Prometra Post-Approval Study	NCT01854229	Chronic Pain Cancer Pain Intractable Pai... Back Pain	Prometra Progra...	22 Years -	Flowonix Medical

Spots Global Cancer Trial Database for back pain

Every month we try and update this database with for back pain cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for back pain

Every month we try and update this database with for back pain cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for back pain cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.