Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04611529 · ClinicalTrials.gov registry record · Phase 4
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
A Phase 4 study of Low Back Pain, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 198
- Enrollment target
- 1
- Study location
NCT04611529: Completed Phase 4 study of Low Back Pain, sponsored by Montefiore Medical Center.
NCT04611529 is a Phase 4 study of Low Back Pain that has completed, run by Montefiore Medical Center. The registered enrollment target is 198 participants, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04611529, a Phase 4 study of Low Back Pain, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 198 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.
Primary Outcome
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability).
Conditions Studied
Interventions
- DRUG Ibuprofen 400 mg
- DRUG Topical diclofenac
Study Locations (1)
New York
- Montefiore - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 4 |
What the finished NCT04611529 record still lists
NCT04611529 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Ibuprofen 400 mg is the first listed.
NCT04611529 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04611529 about?
NCT04611529 is a clinical study titled "Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.". This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) O...
What is the current status of trial NCT04611529?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 198 participants. The study started on 2021-03-02. Estimated completion is 2023-06-30.
What conditions does trial NCT04611529 study?
This clinical trial studies the following conditions: Low Back Pain.
What interventions are being tested in trial NCT04611529?
The interventions under investigation include: Ibuprofen 400 mg (DRUG), Topical diclofenac (DRUG).
Who is sponsoring clinical trial NCT04611529?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04611529 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04611529's enrollment target sits among peer trials
198 32nd of 122 higher than 89 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Endogenous Opioid Response to Injections
RECRUITING · Phase 4
-
Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain
RECRUITING · Phase 4
-
Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial
RECRUITING · Phase 4
-
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
RECRUITING · Phase 4
-
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
COMPLETED · Phase 4
-
Brain Imaging of Lidoderm for Chronic Back Pain
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05203328 · 198 participants · NA
Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy
- NCT05426967 · 198 participants · NA
rTMS for Military TBI-related Depression
- NCT05561114 · 198 participants · Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
- NCT05585190 · 198 participants · NA
Stand Up for Your Health with a Sit-stand Desk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI