Trial · NCT02647658
Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients
NCT02647658, Not applicable, Completed, University of Pittsburgh; results first posted 2020-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients. Trials, record NCT02647658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02647658
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients
- NCT number
- NCT02647658
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,300 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Low Back Pain
- Interventions
- Guideline Based Care plus Psychologically Informed Physical Therapy, Guideline Based Care (GBC)
- First posted
- 2016-01-06
- Last updated
- 2020-02-10
- Results first posted
- 2020-02-10
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) | 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. |
| Primary | Functional Disability | 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. |
| Secondary | Number of Patients Referred to Physical Therapy | 12 months | Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months. |
| Secondary | Number of Patients Prescribed Opioids | 12 months | Medication prescription for opioids measured using electronic health records over 12 months. |
| Secondary | Number of Patients With Orders for Diagnostic Imaging Tests | 12 months | Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records |
| Secondary | Number of Patients Referred to Other Rehabilitation or Pain Management Specialist | 12 months | Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records |
| Secondary | Number of Patients Referred to Surgery Specialist | 12 months | Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records |
| Secondary | Number of Patients Undergoing Interventional Pain Procedures | 12 months | Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records |
| Secondary | Number of Patients Who Had Back Surgery | 12 months | Documentation that patient underwent back surgery in electronic health records |
| Other | Number of Patients Prescribed Opioids | Up to 21 days after initial visit for acute low back pain | Medication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) | 6 months from baseline | Among participants with assessment data at 6 months | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Functional Disability | 6 months | Participants with assessment data at 6 months. | score on a scale | MEAN |
| SECONDARY | Number of Patients Referred to Physical Therapy | 12 months | All screened excluding those not consented for EMR follow up at 12 months at 1 site. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Prescribed Opioids | 12 months | All screened excluding patients that did not consent to EMR data at 12 months at 1 site. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Orders for Diagnostic Imaging Tests | 12 months | All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Referred to Other Rehabilitation or Pain Management Specialist | 12 months | All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Referred to Surgery Specialist | 12 months | All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Undergoing Interventional Pain Procedures | 12 months | All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Had Back Surgery | 12 months | All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Patients Prescribed Opioids | Up to 21 days after initial visit for acute low back pain | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) | GBC+PIPT | 312 | Participants | ||
| Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) | Guideline Based Care | 318 | Participants | ||
| Functional Disability | GBC+PIPT | 27.3 | 95% Confidence Interval 25.4 to 29.3 | score on a scale | |
| Functional Disability | Guideline Based Care | 29.5 | 95% Confidence Interval 27.5 to 31.5 | score on a scale | |
| Number of Patients Referred to Physical Therapy | GBC+PIPT | 106 | Participants | ||
| Number of Patients Referred to Physical Therapy | Guideline Based Care | 77 | Participants | ||
| Number of Patients Prescribed Opioids | GBC+PIPT | 89 | Participants | ||
| Number of Patients Prescribed Opioids | Guideline Based Care | 86 | Participants | ||
| Number of Patients With Orders for Diagnostic Imaging Tests | GBC+PIPT | 74 | Participants | ||
| Number of Patients With Orders for Diagnostic Imaging Tests | Guideline Based Care | 73 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GBC+PIPT | 1,207 | 39 |
| Overall Study | STARTED | Guideline Based Care | 1,093 | 37 |
| Overall Study | 6 Month Assessment | GBC+PIPT | 658 | 38 |
| Overall Study | 6 Month Assessment | Guideline Based Care | 635 | 35 |
| Overall Study | COMPLETED | GBC+PIPT | 1,192 | 39 |
| Overall Study | COMPLETED | Guideline Based Care | 1,069 | 37 |
| Overall Study | NOT COMPLETED | GBC+PIPT | 15 | 0 |
| Overall Study | NOT COMPLETED | Guideline Based Care | 24 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GBC+PIPT | 8 | 1,207 |
| Total, all-cause mortality | Guideline Based Care | 12 | 1,093 |
| Total, other adverse events | GBC+PIPT | 0 | 0 |
| Total, other adverse events | Guideline Based Care | 0 | 0 |
| Total, serious adverse events | GBC+PIPT | 0 | 0 |
| Total, serious adverse events | Guideline Based Care | 0 | 0 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GBC+PIPT vs Guideline Based Care: Number of Patients Referred to Physical Therapy | Trial comparisons |
| GBC+PIPT vs Guideline Based Care: Number of Patients Prescribed Opioids | Trial comparisons |
| GBC+PIPT vs Guideline Based Care: Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP) | Trial comparisons |
| GBC+PIPT vs Guideline Based Care: Number of Patients Undergoing Interventional Pain Procedures | Trial comparisons |
| GBC+PIPT vs Guideline Based Care: Number of Patients Referred to Surgery Specialist | Trial comparisons |
| GBC+PIPT vs Guideline Based Care: Number of Patients Who Had Back Surgery | Trial comparisons |
| GBC+PIPT vs Guideline Based Care: Number of Patients Prescribed Opioids | Trial comparisons |
| GBC+PIPT vs Guideline Based Care: Number of Patients Referred to Physical Therapy | Trial comparisons |
| GBC+PIPT vs Guideline Based Care: deaths from any cause | Trial comparisons |
| GBC+PIPT vs Guideline Based Care: Number of Patients With Orders for Diagnostic Imaging Tests | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02647658
GET https://conductscience.org/api/trials/v1/NCT02647658/results?page=2