NCT05396014 (BEST) is a Phase 4 clinical trial of Enhanced Self-Care (ESC) in Chronic Low-back Pain, sponsored by University of North Carolina, Chapel Hill.

Who is sponsoring NCT05396014?

NCT05396014 is sponsored by University of North Carolina, Chapel Hill.

What drugs are being tested in NCT05396014?

Interventions in NCT05396014: Enhanced Self-Care (ESC), Acceptance and Commitment Therapy (ACT), Evidence-Based Exercise and Manual Therapy (EBEM), Duloxetine.

What condition does NCT05396014 study?

NCT05396014 studies Chronic Low-back Pain.

Is NCT05396014 still recruiting?

NCT05396014 is currently completed. Last updated 23 July 2025.

Are results published for NCT05396014?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-07-23 · How we verify

NCT05396014: BEST

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The BEST Trial: Biomarkers for Evaluating Spine Treatments

Completed Phase 4 Results posted Last updated 23 July 2025

What this trial tests

Phase 4 trial testing Enhanced Self-Care (ESC) in Chronic Low-back Pain in 1,014 participants. Completed in 22 October 2024.

Timeline

12 September 2022

Primary endpoint
30 July 2024

22 October 2024

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	treatment
Enrollment	1,014
Start date	12 September 2022
Primary completion	30 July 2024
Estimated completion	22 October 2024
Sites	12 locations across United States

Drugs / interventions tested

Enhanced Self-Care (ESC)
Acceptance and Commitment Therapy (ACT)
Evidence-Based Exercise and Manual Therapy (EBEM)
Duloxetine (duloxetine) — full drug profile →

Conditions studied

Chronic Low-back Pain — all drugs for Chronic Low-back Pain →

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, any sex, with Chronic Low-back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient-Reported Pain Intensity and Interference Score Primary · Baseline, 24 Weeks

Patient-reported pain intensity and interference is measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a series of 3 questions. Results range from -10 to 10, with higher scores indicating increased pain intensity and interference at 24 Weeks compared to Baseline.

Group	Value	95% CI
Stage 1: Acceptance and Commitment Therapy (ACT)	4.16	3.74 – 4.58
Stage 1: Duloxetine	3.86	3.43 – 4.28
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)	3.57	3.15 – 3.99
Stage 1: Enhanced Self-Care Therapy (ESC)	4.72	4.3 – 5.14

Patient-Reported Outcomes Measurement Information System-Pain Interference Secondary · Baseline, 24 Weeks

Pain interference is measured by the 4-item PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference scale (PROMIS-PI, 4a). The PROMIS-PI, 4a is a series of 4 questions, and measures self-reported consequences of pain on relevant aspects of one's life. Results range from -34 to 34 (t-scores range from 41.6 to 75.6). For each t-score, 50 indicates the population mean with a standard deviation of 10. Lower scores indicate lower pain interference and a better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.

Group	Value	95% CI
Stage 1: Acceptance and Commitment Therapy (ACT)	59.03	57.67 – 60.39
Stage 1: Duloxetine	58.48	57.12 – 59.84
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)	57.61	56.25 – 58.97
Stage 1: Enhanced Self-Care Therapy (ESC)	60.13	58.77 – 61.49

Number of Participants Self-Reporting Taking Opioids Secondary · 24 Weeks

The number of participants self-reporting taking opioids ("Yes" response) is measured by a single question, "Are you currently taking any opioid pain medication on a daily basis?".

Group	Value	95% CI
Stage 1: Acceptance and Commitment Therapy (ACT)	8
Stage 1: Duloxetine	6
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)	8
Stage 1: Enhanced Self-Care Therapy (ESC)	9

Patient-Reported Outcomes Measurement Information System- Physical Function Secondary · Baseline, 24 Weeks

Physical function is measured by the Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) Short Form 6b. The PROMIS-PF Short Form 6b is a series of 6 questions. T-scores range from 21.6 to 58.7 and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -37.1 to 37.1, with higher physical function scores indicating a better outcome and increased physical functioning at 24 Weeks compared to Baseline. A higher physical function is the better outcome. PROMIS measures are not used for clinical decision making but to d

Group	Value	95% CI
Stage 1: Acceptance and Commitment Therapy (ACT)	42.14	40.81 – 43.46
Stage 1: Duloxetine	43.32	41.99 – 44.64
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)	43.11	41.78 – 44.43
Stage 1: Enhanced Self-Care Therapy (ESC)	41.18	39.86 – 42.5

Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression Score Secondary · Baseline, 24 Weeks

Depression score is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression scale from the PROMIS 29 profile. The PROMIS 4-item depression scale from the PROMIS 29 profile is a series of 4 questions. T-scores range from 41.0 to 79.4), and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -38.4 to 38.4, with higher scores indicating increased depression at 24 Weeks compared to Baseline. A lower depression score is the better outcome. PROMIS measures are not used for clinical decision making but to d

Group	Value	95% CI
Stage 1: Acceptance and Commitment Therapy (ACT)	49.22	47.71 – 50.74
Stage 1: Duloxetine	47.83	46.32 – 49.35
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)	49.03	47.51 – 50.54
Stage 1: Enhanced Self-Care Therapy (ESC)	50.19	48.68 – 51.71

Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety Secondary · Baseline, 24 Weeks

Anxiety score is measured by the Patient-Reported Outcomes Measurement Information System-Emotional Distress-Anxiety (PROMIS-EDA) scale 4a. The PROMIS-EDA 4a is a series of 4 questions. T-scores range from 40.3 to 81.6, and for each t-score, 50 indicates the population mean with a standard deviation of 10. Results range from -41.3 to 41.3, with higher scores indicating increased anxiety at 24 Weeks compared to Baseline. A lower anxiety score is the better outcome. PROMIS measures are not used for clinical decision making but to describe participant symptoms.

Group	Value	95% CI
Stage 1: Acceptance and Commitment Therapy (ACT)	49.73	48.1 – 51.35
Stage 1: Duloxetine	48.15	46.52 – 49.77
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)	49.14	47.52 – 50.77
Stage 1: Enhanced Self-Care Therapy (ESC)	50.43	48.8 – 52.05

Patient-Reported Outcomes Measurement Information System - Sleep Disturbance Secondary · Baseline, 24 Weeks

Sleep disturbance is measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) short form 6a. The PROMIS short form 6a is a series of 6 questions. T-scores range from 31.7 to 76.1 and for each t-score, 50 indicates the population mean with a standard deviation of 10). Results range from -44.4 to 44.4, with higher scores indicating increased sleep disturbance at 24 Weeks compared to Baseline. A lower sleep disturbance score is the better outcome. PPROMIS measures are not used for clinical decision making but to describe participant symptoms.

Group	Value	95% CI
Stage 1: Acceptance and Commitment Therapy (ACT)	52.61	50.98 – 54.25
Stage 1: Duloxetine	51.45	49.82 – 53.09
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)	51.91	50.28 – 53.54
Stage 1: Enhanced Self-Care Therapy (ESC)	53.21	51.58 – 54.84

Sleep Duration Secondary · Baseline, 24 Weeks

Sleep duration is measured by the Back Pain Consortium (BACPAC) sleep duration question, "During the past month, how many hours and minutes of actual sleep did you get at night? (This may be different than the number of hours and minutes you spent in bed)." Participants respond with a number of hours and minutes. Results range from -24 to 24 hours, with higher number of hours indicating increased sleep duration at 24 Weeks compared to Baseline.

Group	Value	95% CI
Stage 1: Acceptance and Commitment Therapy (ACT)	6.82	6.58 – 7.06
Stage 1: Duloxetine	6.74	6.49 – 6.98
Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)	6.73	6.49 – 6.97
Stage 1: Enhanced Self-Care Therapy (ESC)	6.67	6.43 – 6.91

Adverse events — posted to ClinicalTrials.gov

Time frame: All adverse events were recorded between the time the participant provided informed consent at Week -2 (Run-in Period: Weeks -2 to 0) through 4 weeks after their last treatment (Stage 1 intervention period: Weeks 0 to 12; Stage 2 intervention period: Weeks 12 to 24), up to 30 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Stage 1: Acceptance and Commitment Therapy (ACT)

Serious: 4/191 (2%)

Deaths: 0/191

Stage 1: Duloxetine

Serious: 1/172 (1%)

Deaths: 0/172

Stage 1: Evidence Based Exercise and Manual Therapy (EBEM)

Serious: 6/184 (3%)

Deaths: 0/184

Stage 1: Enhanced Self-Care Therapy (ESC)

Serious: 2/205 (1%)

Deaths: 0/205

Stage 2: Acceptance and Commitment Therapy (ACT)

Serious: 4/65 (6%)

Deaths: 0/65

Stage 2: Duloxetine

Serious: 0/71 (0%)

Deaths: 0/71

Stage 2: Evidence Based Exercise and Manual Therapy (EBEM)

Serious: 3/110 (3%)

Deaths: 0/110

Stage 2: Enhanced Self-Care Therapy (ESC)

Serious: 2/85 (2%)

Deaths: 0/85

Stage 2: ACT and Duloxetine

Serious: 1/33 (3%)

Deaths: 0/33

Stage 2: ACT and EBEM

Serious: 0/52 (0%)

Deaths: 0/52

Stage 2: ACT and ESC

Serious: 4/84 (5%)

Deaths: 0/84

Stage 2: Duloxetine and EBEM

Serious: 0/22 (0%)

Deaths: 0/22

Stage 2: Duloxetine and ESC

Serious: 1/54 (2%)

Deaths: 0/54

Stage 2: EBEM and ESC

Serious: 4/85 (5%)

Deaths: 0/85

Serious adverse events (29 terms)

Reaction	System	Stage 1: Acceptance and Co…	Stage 1: Duloxetine	Stage 1: Evidence Based Ex…	Stage 1: Enhanced Self-Car…	Stage 2: Acceptance and Co…	Stage 2: Duloxetine	Stage 2: Evidence Based Ex…	Stage 2: Enhanced Self-Car…	Stage 2: ACT and Duloxetine	Stage 2: ACT and EBEM	Stage 2: ACT and ESC	Stage 2: Duloxetine and EBEM	Stage 2: Duloxetine and ESC	Stage 2: EBEM and ESC
Atrial Fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chest pain	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Appendicitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Colitis ulcerative	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastroenteritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Incisional hernia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Intestinal mass	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ulcer	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cat scratch disease	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Accident	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cervical vertebral fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ligament rupture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Magnetic resonance imaging abnormal	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ketoacidosis	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Uterine polyp	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Migraine	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Prostate cancer	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Testis cancer	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Physical assault	Social circumstances	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	Stage 1: Acceptance and Co…	Stage 1: Duloxetine	Stage 1: Evidence Based Ex…	Stage 1: Enhanced Self-Car…	Stage 2: Acceptance and Co…	Stage 2: Duloxetine	Stage 2: Evidence Based Ex…	Stage 2: Enhanced Self-Car…	Stage 2: ACT and Duloxetine	Stage 2: ACT and EBEM	Stage 2: ACT and ESC	Stage 2: Duloxetine and EBEM	Stage 2: Duloxetine and ESC	Stage 2: EBEM and ESC
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Irritability	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Atrial Fibrillation, Chest pain, Abdominal pain, Appendicitis, Colitis ulcerative, Gastroenteritis, Gastrointestinal haemorrhage, Incisional hernia.

Data from ClinicalTrials.gov NCT05396014 adverse events section.

Sponsor's own description

The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)-sponsored clinical trial being conducted through the NIH Helping to End Addiction Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this trial is to inform a precision medicine approach to the treatment of Chronic Low-Back Pain by estimating the optimal treatment or combination of treatments based on patient features and response to the initial treatment. Interventions being evaluated in this trial are: (1) enhanced self-care (ESC), (2) acceptance and commitment therapy (ACT), (3) evidence-based exercise and manual therapy (EBEM), and (4) duloxetine.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

The Back Pain Consortium (BACPAC) Research Program: Structure, Research Priorities, and Methods.
Mauck MC, Lotz J, Psioda MA, Carey TS, et al · · 2023 · cited 32× · PMID 36622041 · DOI 10.1093/pm/pnac202
Individualized interventions and precision health: Lessons learned from a systematic review and implications for analytics-driven geriatric research.
Kahkoska AR, Freeman NLB, Jones EP, Shirazi D, et al · · 2023 · cited 4× · PMID 36524627 · DOI 10.1111/jgs.18141
The design and rationale of the Biomarkers for Evaluating Spine Treatments trial: a sequential multiple assignment randomized trial.
Mauck MC, Barth KS, Bell KM, Brooks AK, et al · · 2025 · cited 3× · PMID 40205455 · DOI 10.1093/pm/pnaf032
Baseline characteristics of participants in the Biomarkers for Evaluating Spine Treatments clinical trial: a sequential multiple assignment randomized trial for chronic low back pain†.
Rowland B, Barth KS, Bell KM, Brooks AK, et al · · 2025 · PMID 40794568 · DOI 10.1093/pm/pnaf073
Design and implementation of online acceptance and commitment therapy with enhanced therapist support for chronic low back pain (ACT for PAIN).
Jones Berkeley S, Wedin S, Patidar SM, Margolies SO, et al · · 2025 · PMID 40249098 · DOI 10.1093/pm/pnaf026
Integrating randomized and observational studies to estimate optimal dynamic treatment regimes.
Batorsky A, Anstrom KJ, Zeng D. · · 2024 · PMID 38804219 · DOI 10.1093/biomtc/ujae046

Verify or expand the search:

Other recruiting trials for Chronic Low-back Pain

Currently open trials in the same condition.

NCT06891625 — Movement Performance in Persons With Chronic Back Pain · NA · recruiting
NCT06568198 — Modulation Effect of tACS on Chronic Low Back Pain · Phase 2 · recruiting
NCT06825390 — AuriculoTherapy NeuroImaging · NA · recruiting
NCT04824248 — Weight Reduction in CLBP · NA · recruiting
NCT07055802 — Effects Of Inversion Table Therapy Vs MT On Pain And Lumbar Flexibility In Patients With Chronic Low Back Pain · NA · active not recruiting

Other University of North Carolina, Chapel Hill trials

Trials by the same sponsor.

NCT06841913 — Woodsmoke Exposure, Influenza Infection, and Nasal Immunity · Phase 4 · suspended
NCT07383428 — The INICIO-Guatemala Study · NA · not yet recruiting
NCT07528443 — Ultraprocessed Foods in Colombia · NA · not yet recruiting
NCT07507370 — CARED : A Novel Rapid Treatment Paradigm for Depression · NA · not yet recruiting
NCT07534254 — Piloting a Generative Artificial Intelligence Chatbot in a Mobile Weight Loss Program · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05396014 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 23 July 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05396014.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing