Low Back PainTARGETNCT02647658
Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients
A study testing Guideline Based Care plus Psychologically Informed Physical Therapy and Guideline Based Care (GBC) in people with Low Back Pain, run by University of Pittsburgh at 5 sites in United States.
Trial summary
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Guideline Based Care plus Psychologically Informed Physical Therapy and Guideline Based Care (GBC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2016to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age or older
- Receiving care for acute low back pain during a primary care clinic visit
- Able to provide informed consent
Who cannot join
- Medical contraindications to physical therapy based on the judgment of the primary care provider as documented in the medical record (i.e., "red flag" signs and symptoms of a potentially serious condition such as cauda equina syndrome, major or rapidly progressing neurological deficit, cancer, spinal infection or fracture)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Boston Medical Center
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Intermountain Healthcare
Salt Lake City, Utah, 84111
About this study
Official title: Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Cluster Randomized Controlled Trial
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a pragmatic, cluster randomized trial. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines. The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP. The 1,860 patients expected to be enrolled at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period.
Read the detailed description
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. Most patients see chiropractors or primary care physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a cluster randomized trial. Both treatments can be delivered in an outpatient PCP setting. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines (Guideline Based Care, GBC). The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP (GBC+PIPT). PIPT is designed to help patients identify and overcome physical and psychological barriers to recovery. The 1,860 patients expected to be enrolled as part of quality improvement at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period. This study was designed with input from a variety of national and local stakeholders, including patients with LBP, providers, payers, professional organizations, purchasers, and policy representatives.
- Conditions
- Low Back Pain
- Being tested
- Guideline Based Care plus Psychologically Informed Physical Therapy, Guideline Based Care (GBC)
- Keywords
- acute low back pain, primary care, psychologically informed physical therapy, cluster randomized pragmatic trial, comparative effectiveness, secondary prevention
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline Based Care plus Psychologically Informed Physical TherapyBehavioural
PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
Guideline Based Care (GBC)Behavioural
Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
| Study group | Role | What they receive |
|---|---|---|
| GBC+PIPT | Experimental | Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) Receives: Behavioral: Guideline Based Care plus Psychologically Informed Physical Therapy |
| GBC | Active comparator | Guideline Based Care (GBC) Receives: Behavioral: Guideline Based Care (GBC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)
Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.
Measured: 6 months from baseline
Functional Disability
Measured using the 10-item Oswestry Disability Index (version 2.1a). Also known as the Oswestry Low Back Pain Disability Questionnaire.
A measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability.
Measured: 6 months
Secondary outcomes (7)
Number of Patients Referred to Physical Therapy
Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.
Measured: 12 months
Number of Patients Prescribed Opioids
Medication prescription for opioids measured using electronic health records over 12 months.
Measured: 12 months
Number of Patients With Orders for Diagnostic Imaging Tests
Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records
Measured: 12 months
Number of Patients Referred to Other Rehabilitation or Pain Management Specialist
Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records
Measured: 12 months
Number of Patients Referred to Surgery Specialist
Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records
Measured: 12 months
Number of Patients Undergoing Interventional Pain Procedures
Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records
Measured: 12 months
Number of Patients Who Had Back Surgery
Documentation that patient underwent back surgery in electronic health records
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion1 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Parallel assignment of clusters (clinics). Cluster randomized trial.
- Masking
- None (open label)
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, Intermountain Health Care, Inc., Johns Hopkins University, Medical University of South Carolina, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Anthony Delitto, University of Pittsburgh
- Investigators
- Anthony Delitto, PT, PhD, Principal investigator, University of PittsburghRobert Saper, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647658
- Sponsor's protocol ID
- PCS-1402-10867
- Acronym
- TARGET
- Status last verified
- Feb 2020
- First submitted
- 4 Jan 2016
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Roseen EJ, Smith CN, Essien UR, Cozier YC, Joyce C, Morone NE, Phillips RS, Gergen Barnett K, Patterson CG, Wegener ST, Brennan GP, Delitto A, Saper RB, Beneciuk JM, Stevans JM. Racial and Ethnic Disparities in the Incidence of High-Impact Chronic Pain Among Primary Care Patients with Acute Low Back Pain: A Cohort Study. Pain Med. 2023 Jun 1;24(6):633-643. doi: 10.1093/pm/pnac193.
PubMed 36534910Beneciuk JM, George SZ, Patterson CG, Smith CN, Brennan GP, Wegener ST, Roseen EJ, Saper RB, Delitto A. Treatment effect modifiers for individuals with acute low back pain: secondary analysis of the TARGET trial. Pain. 2023 Jan 1;164(1):171-179. doi: 10.1097/j.pain.0000000000002679. Epub 2022 May 9.
PubMed 35543647Delitto A, Patterson CG, Stevans JM, Freburger JK, Khoja SS, Schneider MJ, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Beneciuk JM, George SZ, Saper RB. Stratified care to prevent chronic low back pain in high-risk patients: The TARGET trial. A multi-site pragmatic cluster randomized trial. EClinicalMedicine. 2021 Mar 30;34:100795. doi: 10.1016/j.eclinm.2021.100795. eCollection 2021 Apr.
PubMed 33870150Middleton A, Fitzgerald GK, Delitto A, Saper RB, Gergen Barnett K, Stevans J. Implementing stratified care for acute low back pain in primary care using the STarT Back instrument: a process evaluation within the context of a large pragmatic cluster randomized trial. BMC Musculoskelet Disord. 2020 Nov 25;21(1):776. doi: 10.1186/s12891-020-03800-6.
PubMed 33238964Delitto A, Patterson CG, Stevans JM, Brennan GP, Wegener ST, Morrisette DC, Beneciuk JM, Freel JA, Minick KI, Hunter SJ, Ephraim PL, Friedman M, Simpson KN, George SZ, Daley KN, Albert MC, Tamasy M, Cash J, Lake DS, Freburger JK, Greco CM, Hough LJ, Jeong JH, Khoja SS, Schneider MJ, Sowa GA, Spigle WA, Wasan AD, Adams WG, Lemaster CM, Mishuris RG, Plumb DL, Williams CT, Saper RB. Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial). Contemp Clin Trials. 2019 Jul;82:66-76. doi: 10.1016/j.cct.2019.05.010. Epub 2019 May 25.
PubMed 31136834Beneciuk JM, George SZ, Greco CM, Schneider MJ, Wegener ST, Saper RB, Delitto A. Targeted interventions to prevent transitioning from acute to chronic low back pain in high-risk patients: development and delivery of a pragmatic training course of psychologically informed physical therapy for the TARGET trial. Trials. 2019 May 6;20(1):256. doi: 10.1186/s13063-019-3350-3.
PubMed 31060589
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02647658
- Acronym / sponsor ID
- TARGET / PCS-1402-10867
- Conditions
- Low Back Pain
- Keywords
- acute low back pain, primary care, psychologically informed physical therapy, cluster randomized pragmatic trial, comparative effectiveness, secondary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Boston Medical Center, Intermountain Health Care, Inc., Johns Hopkins University, Medical University of South Carolina, Patient-Centered Outcomes Research Institute
- Study start
- Mar 2016
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a pragmatic, cluster randomized trial. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines. The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP. The 1,860 patients expected to be enrolled at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period.
Detailed description
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. Most patients see chiropractors or primary care physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a cluster randomized trial. Both treatments can be delivered in an outpatient PCP setting. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines (Guideline Based Care, GBC). The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP (GBC+PIPT). PIPT is designed to help patients identify and overcome physical and psychological barriers to recovery. The 1,860 patients expected to be enrolled as part of quality improvement at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period. This study was designed with input from a variety of national and local stakeholders, including patients with LBP, providers, payers, professional organizations, purchasers, and policy representatives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment of clusters (clinics). Cluster randomized trial.
| Arm | Type | Receives |
|---|---|---|
| GBC+PIPT | Experimental | Behavioral: Guideline Based Care plus Psychologically Informed Physical TherapyGuideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT) |
| GBC | Active comparator | Behavioral: Guideline Based Care (GBC)Guideline Based Care (GBC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Receiving care for acute low back pain during a primary care clinic visit
- Able to provide informed consent
Key exclusion criteria (1 listed)
- Medical contraindications to physical therapy based on the judgment of the primary care provider as documented in the medical record (i.e., "red flag" signs and symptoms of a potentially serious condition such as cauda equina syndrome, major or rapidly progressing neurological deficit, cancer, spinal infection or fracture)
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 |
|---|---|---|
| Guideline Based Care plus Psychologically Informed Physical TherapyPCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement | Behavioural | GBC+PIPT |
| Guideline Based Care (GBC)Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives | Behavioural | GBC |
Primary outcome
Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)
Time frame: 6 months from baseline
Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.
Functional Disability
Time frame: 6 months
Measured using the 10-item Oswestry Disability Index (version 2.1a). Also known as the Oswestry Low Back Pain Disability Questionnaire. A measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability.
7 secondary outcomes
Number of Patients Referred to Physical Therapy
Time frame: 12 months
Number of Patients Prescribed Opioids
Time frame: 12 months
Number of Patients With Orders for Diagnostic Imaging Tests
Time frame: 12 months
Number of Patients Referred to Other Rehabilitation or Pain Management Specialist
Time frame: 12 months
Number of Patients Referred to Surgery Specialist
Time frame: 12 months
Number of Patients Undergoing Interventional Pain Procedures
Time frame: 12 months
Number of Patients Who Had Back Surgery
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36534910Roseen EJ, Smith CN, Essien UR, Cozier YC, Joyce C, Morone NE, Phillips RS, Gergen Barnett K, Patterson CG, Wegener ST, Brennan GP, Delitto A, Saper RB, Beneciuk JM, Stevans JM. Racial and Ethnic Disparities in the Incidence of High-Impact Chronic Pain Among Primary Care Patients with Acute Low Back Pain: A Cohort Study. Pain Med. 2023 Jun 1;24(6):633-643. doi: 10.1093/pm/pnac193.
- Derived from this study: PubMed 35543647Beneciuk JM, George SZ, Patterson CG, Smith CN, Brennan GP, Wegener ST, Roseen EJ, Saper RB, Delitto A. Treatment effect modifiers for individuals with acute low back pain: secondary analysis of the TARGET trial. Pain. 2023 Jan 1;164(1):171-179. doi: 10.1097/j.pain.0000000000002679. Epub 2022 May 9.
- Derived from this study: PubMed 33870150Delitto A, Patterson CG, Stevans JM, Freburger JK, Khoja SS, Schneider MJ, Greco CM, Freel JA, Sowa GA, Wasan AD, Brennan GP, Hunter SJ, Minick KI, Wegener ST, Ephraim PL, Beneciuk JM, George SZ, Saper RB. Stratified care to prevent chronic low back pain in high-risk patients: The TARGET trial. A multi-site pragmatic cluster randomized trial. EClinicalMedicine. 2021 Mar 30;34:100795. doi: 10.1016/j.eclinm.2021.100795. eCollection 2021 Apr.
- Derived from this study: PubMed 33238964Middleton A, Fitzgerald GK, Delitto A, Saper RB, Gergen Barnett K, Stevans J. Implementing stratified care for acute low back pain in primary care using the STarT Back instrument: a process evaluation within the context of a large pragmatic cluster randomized trial. BMC Musculoskelet Disord. 2020 Nov 25;21(1):776. doi: 10.1186/s12891-020-03800-6.
- Derived from this study: PubMed 31136834Delitto A, Patterson CG, Stevans JM, Brennan GP, Wegener ST, Morrisette DC, Beneciuk JM, Freel JA, Minick KI, Hunter SJ, Ephraim PL, Friedman M, Simpson KN, George SZ, Daley KN, Albert MC, Tamasy M, Cash J, Lake DS, Freburger JK, Greco CM, Hough LJ, Jeong JH, Khoja SS, Schneider MJ, Sowa GA, Spigle WA, Wasan AD, Adams WG, Lemaster CM, Mishuris RG, Plumb DL, Williams CT, Saper RB. Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial). Contemp Clin Trials. 2019 Jul;82:66-76. doi: 10.1016/j.cct.2019.05.010. Epub 2019 May 25.
- Derived from this study: PubMed 31060589Beneciuk JM, George SZ, Greco CM, Schneider MJ, Wegener ST, Saper RB, Delitto A. Targeted interventions to prevent transitioning from acute to chronic low back pain in high-risk patients: development and delivery of a pragmatic training course of psychologically informed physical therapy for the TARGET trial. Trials. 2019 May 6;20(1):256. doi: 10.1186/s13063-019-3350-3.
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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. This study is not recruiting at the moment.
Anthony Delitto, PT, PhD principal investigator
University of Pittsburgh
Robert Saper, MD, MPH principal investigator
Boston Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guideline Based Care plus Psychologically Informed Physical Therapy and Guideline Based Care (GBC) in people with Low Back Pain, run by University of Pittsburgh at 5 sites in United States.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) (time frame: 6 months from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647658, which also lists 6 linked publications.
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 10 Feb 2020; AzTrials last refreshed its copy on 1 Nov 2026.