Back PainACCESS-DCNCT06160947
The Effect of Chiropractic Care on Opioid Use for Chronic Spinal Pain: A Feasibility Study
A study testing Usual Medical Care and Usual Medical Care + Chiropractic Care in people with Back Pain, run by McMaster University at 1 site in Canada.
Trial summary
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 Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Usual Medical Care and Usual Medical Care + Chiropractic Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clusters
- CHC in Canada
- Roster of ≥ 3,500 patients
- One or more opioid-reducing strategies implemented as part of their standard medical services (e.g., chart audits, tracked performance metrics related to high dose prescribing)
- Participants
- Adult patients (aged ≥ 18 years)
Show all 11Show fewer
- Diagnosis of chronic non-cancer spinal pain (i.e., back or neck pain of ≥ 12 weeks' duration, not associated with cancer)
- Actively receiving one or more opioid prescriptions (minimum dose of 50 mg MED, dispensed over a period of at least 3 consecutive months)
- Interested in reducing their opioid dose
- Cognitive ability and language skills required to complete the outcome measures
- Provision of informed consent
Who cannot join
- Clusters
- CHCs that employ chiropractors or have currently established chiropractic programs
- Participants
- Individuals already receiving chiropractic care
- Opioid-naive (or < 90 consecutive days of opioid prescription) at baseline
- Total active opioid dosage of < 50 mg MED at baseline
Show all 11Show fewer
- Spinal neoplasms or other 'red flag' diagnoses (e.g., fractures, infections, inflammatory arthritis, or cauda equina syndrome)
- Anticipated problems with the participant being available for follow-up (e.g., incarceration, or planned incarceration)
- The participant is or may be enrolled in a competing trial
- Prior enrolment in the ACCESS-DC trial
- Other reason to exclude the participant, as approved by the Methods Centre
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
McMaster University
Hamilton, Ontario, L8S 4K1
Peter C Emary, DC, PhD, 001-519-1470 ext. 352, emaryp@mcmaster.ca
Amy L Brown, DC, 001-519-1470 ext. 352, abrown@chiropractic.on.ca
About this study
Official title: Impact of Chiropractic Care on Opioid Use Among Adults With Chronic Non-Cancer Spinal Pain: A Pilot Cluster Randomized Controlled Trial (ACCESS-DC Pilot)
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 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 Canadian CHC context.
Read the detailed description
The investigators will conduct a cluster-randomized, 2-arm, data analyst-blinded feasibility RCT at four Canadian 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 26 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, and quality of life at 6, 12, 18, and 26 weeks from enrolment.
- Conditions
- Back Pain
- Being tested
- Usual Medical Care, Usual Medical Care + Chiropractic Care
- Keywords
- Clinical trials, randomized, Feasibility study, Analgesics, opioid, Chiropractic
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Medical CareOther
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 a Canadian 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 determined by their PCP. PCPs will also engage study participants in a formal effort to reduce their opioid use within the framework of each CHC's current opioid-reduction practices.
Usual Medical Care + Chiropractic CareOther
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, core muscle strengthening, and cardiovascular exercises). As part of the intervention, chiropractic clinicians will engage PCPs in a collaborative effort to support opioid tapering. Consistent with current clinical practice guidelines, participants will be provided up to a maximum of 18 chiropractic visits during the active care period, although participants may continue with treatment after the 12-week period (e.g., one visit, every 2-4 weeks) to manage episodes of exacerbation/flare-up.
| Study group | Role | What they receive |
|---|---|---|
| Usual Medical Care | Active comparator | This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care. Receives: Other: Usual Medical Care |
| Usual Medical Care + Chiropractic Care | Experimental | This group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care plus chiropractic care. Receives: Other: Usual Medical Care + Chiropractic Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Enrolment
Participant enrolment will be assessed by monitoring screening and enrolment metrics, including: 1) initiation of screening and recruitment at CHCs, 2) proportion of eligible patients approached for participation, 3) proportion of patients who provide informed consent, and 4) length of time required to enrol approximately six participants at each CHC. All outcome measures will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).
Measured: From start of enrollment up to 26 weeks (or study end)
Treatment Allocation
Feasibility of the treatment allocation will be assessed using the following metrics: 1) adherence to chiropractic care in addition to usual medical care allocation, and 2) adherence to usual medical care allocation. All outcome measures will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).
Measured: Baseline, 6-, 12-, 18- and 26-week follow-up
Refinement of Data Collection Methods
To refine the data collection methods, the following metrics will be reviewed: 1) proportion of participants with missing data for the primary clinical outcome, and 2) proportion of case report forms with missing data for the participant-reported outcomes (BQ, Bothersomeness questionnaire, EQ-5D-5L, and patient satisfaction). All outcome measures will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).
Measured: Baseline, 6-, 12-, 18- and 26-week follow-up
Compliance with the Protocol
The following outcomes will be used to assess compliance with the protocol: 1) participant compliance with scheduled appointments, 2) proportion of participants who complete each follow-up visit, 3) proportion of participants who withdraw consent to participate in the trial, and 4) proportion of participants who cannot be located. All outcomes will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).
Measured: Baseline, 6-, 12-, 18- and 26-week follow-up
Secondary outcomes (7)
Daily Prescribed Opioid Dosage
CHC information technology personnel will extract opioid prescription data from participants' individual electronic medical records to obtain the dose of chronic non-cancer spinal pain-related opioid prescriptions from baseline to 26-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.
Measured: Baseline, 6-, 12-, 18- and 26-week follow-up
Risk of Higher-Dose Opioid Prescriptions
CHC information technology personnel will extract opioid prescription data from participants' individual electronic medical records to obtain the dose of chronic non-cancer spinal pain-related opioid prescriptions. Opioid dosage will be dichotomized 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. A sensitivity analysis will also be conducted using a threshold of 50 mg MED.
Measured: Baseline, 6-, 12-, 18- and 26-week follow-up
Number of Opioid Prescriptions
CHC information technology personnel will extract opioid prescription data from participants' individual electronic medical records to obtain the number and type of chronic non-cancer spinal pain-related opioid prescriptions (i.e., unique opioid fills and subsequent refills) over the entire course of follow-up, tabulated at the end of follow-up.
Measured: Baseline, 6-, 12-, 18- and 26-week follow-up
Level of Pain Intensity, and Physical and Emotional Functioning as measured by the Bournemouth Questionnaire (BQ)
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.
Measured: Baseline, 6-, 12-, 18- and 26-week follow-up
Level of Bothersomeness of Spinal Pain
Self-rated level of bothersomeness on a 5-point Likert scale from "Not at all bothersome" to "Extremely bothersome".
Measured: Baseline, 6-, 12-, 18- and 26-week follow-up
Level of Patient Satisfaction
Self-rated satisfaction with care on a 5-point Likert scale from "Very satisfied" to "Very dissatisfied".
Measured: 6-, 12-, 18- and 26-week follow-up
Quality of Life as measured by the EuroQol 5 Domain (EQ-5D) (5 Level Version)
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".
Measured: Baseline, 6-, 12-, 18- and 26-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized, 2-arm, data analyst-blinded feasibility trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Peter C Emary, DC, PhD, McMaster University
- Investigators
- Peter C Emary, DC, PhD, Principal investigator, McMaster UniversityJason W Busse, DC, PhD, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160947
- Sponsor's protocol ID
- 17-2023
- Acronym
- ACCESS-DC
- Status last verified
- Oct 2026
- First submitted
- 27 Nov 2023
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Supporting information will be made available from the Central Contact Person/Principal Investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chiropractic Care on Opioid Use Among Adults With Chronic Non-Cancer Spinal Pain: A Pilot Cluster Randomized Controlled Trial (ACCESS-DC Pilot)
- ClinicalTrials.gov ID
- NCT06160947
- Acronym / sponsor ID
- ACCESS-DC / 17-2023
- Conditions
- Back Pain
- Keywords
- Clinical trials, randomized, Feasibility study, Analgesics, opioid, Chiropractic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- 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, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 Canadian CHC context.
Detailed description
The investigators will conduct a cluster-randomized, 2-arm, data analyst-blinded feasibility RCT at four Canadian 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 26 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, and quality of life at 6, 12, 18, and 26 weeks from enrolment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Cluster-randomized, 2-arm, data analyst-blinded feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Usual Medical Care | Active comparator | Other: Usual Medical CareThis group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care. |
| Usual Medical Care + Chiropractic Care | Experimental | Other: Usual Medical Care + Chiropractic CareThis group will consist of eligible, consenting, participants attending centers randomized to ongoing usual medical care plus chiropractic care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clusters
- CHC in Canada
- Roster of ≥ 3,500 patients
- One or more opioid-reducing strategies implemented as part of their standard medical services (e.g., chart audits, tracked performance metrics related to high dose prescribing)
- Participants
Key exclusion criteria (11 listed)
- Clusters
- CHCs that employ chiropractors or have currently established chiropractic programs
- Participants
- Individuals already receiving chiropractic care
- Opioid-naive (or < 90 consecutive days of opioid prescription) at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Medical CareIn 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 a Canadian 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 determined by their PCP. PCPs will also engage study participants in a formal effort to reduce their opioid use within the framework of each CHC's current opioid-reduction practices. | Other | Usual Medical Care |
| Usual Medical Care + Chiropractic CareTreatment 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, core muscle strengthening, and cardiovascular exercises). As part of the intervention, chiropractic clinicians will engage PCPs in a collaborative effort to support opioid tapering. Consistent with current clinical practice guidelines, participants will be provided up to a maximum of 18 chiropractic visits during the active care period, although participants may continue with treatment after the 12-week period (e.g., one visit, every 2-4 weeks) to manage episodes of exacerbation/flare-up. | Other | Usual Medical Care + Chiropractic Care |
Primary outcome
Participant Enrolment
Time frame: From start of enrollment up to 26 weeks (or study end)
Participant enrolment will be assessed by monitoring screening and enrolment metrics, including: 1) initiation of screening and recruitment at CHCs, 2) proportion of eligible patients approached for participation, 3) proportion of patients who provide informed consent, and 4) length of time required to enrol approximately six participants at each CHC. All outcome measures will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).
Treatment Allocation
Time frame: Baseline, 6-, 12-, 18- and 26-week follow-up
Feasibility of the treatment allocation will be assessed using the following metrics: 1) adherence to chiropractic care in addition to usual medical care allocation, and 2) adherence to usual medical care allocation. All outcome measures will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).
Refinement of Data Collection Methods
Time frame: Baseline, 6-, 12-, 18- and 26-week follow-up
To refine the data collection methods, the following metrics will be reviewed: 1) proportion of participants with missing data for the primary clinical outcome, and 2) proportion of case report forms with missing data for the participant-reported outcomes (BQ, Bothersomeness questionnaire, EQ-5D-5L, and patient satisfaction). All outcome measures will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).
Compliance with the Protocol
Time frame: Baseline, 6-, 12-, 18- and 26-week follow-up
The following outcomes will be used to assess compliance with the protocol: 1) participant compliance with scheduled appointments, 2) proportion of participants who complete each follow-up visit, 3) proportion of participants who withdraw consent to participate in the trial, and 4) proportion of participants who cannot be located. All outcomes will be aggregated and interpreted via a "traffic light" approach (i.e., "green light" - proceed with RCT, "yellow light" - proceed with changes, "red light" - do not proceed unless changes are possible).
7 secondary outcomes
Daily Prescribed Opioid Dosage
Time frame: Baseline, 6-, 12-, 18- and 26-week follow-up
Risk of Higher-Dose Opioid Prescriptions
Time frame: Baseline, 6-, 12-, 18- and 26-week follow-up
Number of Opioid Prescriptions
Time frame: Baseline, 6-, 12-, 18- and 26-week follow-up
Level of Pain Intensity, and Physical and Emotional Functioning as measured by the Bournemouth Questionnaire (BQ)
Time frame: Baseline, 6-, 12-, 18- and 26-week follow-up
Level of Bothersomeness of Spinal Pain
Time frame: Baseline, 6-, 12-, 18- and 26-week follow-up
Level of Patient Satisfaction
Time frame: 6-, 12-, 18- and 26-week follow-up
Quality of Life as measured by the EuroQol 5 Domain (EQ-5D) (5 Level Version)
Time frame: Baseline, 6-, 12-, 18- and 26-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Supporting information will be made available from the Central Contact Person/Principal Investigator on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter C Emary, DC, PhD principal investigator
McMaster University
Jason W Busse, DC, PhD study director
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Medical Care and Usual Medical Care + Chiropractic Care in people with Back Pain, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter C Emary, DC, PhD (001-519-653-1470 ext. 352, emaryp@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Enrolment (time frame: From start of enrollment up to 26 weeks (or study end)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.