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

Digestive System Diseases

Mouth and Tooth Diseases

Neoplasms

Ear, Nose, and Throat Diseases

Mucositis

Oropharyngeal Neoplasms

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Anti-Arrhythmia Agents

Channel Blockers

Lidocaine

Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).

Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.

Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).

Acupuncture with Seirin® needles

usual medical care such as viscous Lidocaine for relief of pain

Usual medical care

Ting Bao, MD, DABMA

Patients are asked to be in this study if have oropharyngeal cancer and will be treated with chemotherapy and radiation.

This research is being done to find out if acupuncture can reduce the mouth inflammation and pain caused by chemotherapy and radiation. Chemoradiation may cause mouth inflammation and pain.

Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and joint pain. In this study we will assess the potential usefulness of acupuncture to decrease the severity of mucositis and mucositis-related mouth and throat pain in patients receiving chemoradiation for oropharyngeal cancer.

Mouth cancer patients receiving chemoradiation who have not had acupuncture within the last one month and who do not have a history of head and neck cancer may join this pilot study.

This is a single-center, randomized controlled pilot clinical trial (n=20) assessing the efficacy, feasibility and safety of acupuncture in reducing the severity of chemoradiation-induced oral mucositis (CRIOM) in patients with oropharyngeal cancer. Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16). All subjects will receive usual medical care in addition to the study intervention. The Oral Mucositis Daily Questionnaire for Head and Neck Cancer patients (OMDQ) will be used to assess patients' self-reported chemoradiation-induced mucositis severity at baseline (before 1st acupuncture session), and daily throughout the course of radiation, as well as at the 12 and 16 week follow up visits. At baseline, weekly during radiation therapy, and at the 12 and 16 week follow up appointments, patients will complete the Functional Assessment of Cancer Therapy (FACT-G), Esophagus Cancer subscale (ESC) QOL, and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale questionnaires. Oral mucositis will also be assessed objectively by a trained member of the research team using both the Oral Mucositis Assessment Scale (OMAS) and the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v3.0 measurement scale once a week for the first two weeks of chemoradiation treatment, then twice a week during weeks three through seven, and additionally once during week 8 and once at the 12 and 16 week follow up visits. Twice weekly measurements correspond to peak severity of mucositis during weeks three to seven, based on previous reports in the literature. Patients will be given a weekly diary to record oral analgesic intake. Lastly, 8 milliliters of blood and a saliva sample will be taken from the subjects at baseline (before 1st acupuncture session), weekly through radiation treatment, and at the week 12 and 16 follow up visits to measure changes in proinflammatory cytokines concentrations.

Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer

A Pilot Randomized Controlled Trial to Evaluate the Efficacy and Explore the Mechanism of Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer.

All acupuncture side effects will be recorded

Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.

University of Maryland, Baltimore

Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).

Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).

Usual medical care: usual medical care such as viscous Lidocaine for relief of pain

Acupuncture With Seirin® Needles

Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.

Usual medical care: usual medical care such as viscous Lidocaine for relief of pain

Total

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

The PI left the institution before the end of the study; therefore the study was withdrawn in clinicaltrials.gov and IRB closed.

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
Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer	NCT01883908	Mucositis Oropharyngeal C...	Acupuncture wit... Usual medical c...	18 Years -	University of Maryland, Baltimore
Acupuncture in Reducing the Severity of Chemoradiation-induced Mucositis in Patients With Oropharyngeal Cancer	NCT01883908	Mucositis Oropharyngeal C...	Acupuncture wit... Usual medical c...	18 Years -	University of Maryland, Baltimore

Spots Global Cancer Trial Database for usual medical care