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Completed

NCT Number: NCT04611529

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) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore

New York, 10026, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Present to Emergency Department (ED) primary for management of Low Back Pain (LBP), defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
  • Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
  • Patient is to be discharged home.
  • Age 18-69. Enrollment will be limited to adults younger than 70 years because of the increased risk of adverse medication effects in the elderly.
  • Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
  • Pain duration <2 weeks (336 hours).
  • Prior to the acute attack of LBP, back pain must occur less frequently than once per month.
  • Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
  • Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire

Exclusion criteria

  • Not available for follow-up
  • Pregnant
  • Any analgesic medication use on a daily or near-daily basis
  • Allergic to or intolerant of investigational medications
  • Open wounds or skin breakdown of the lower back
  • Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR <60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)

Treatment and study plan

Ibuprofen 400 mg

Drug

Ibuprofen 400mg

Topical diclofenac

Drug

Diclofenac 1% gel 4gm

Primary outcomes

  1. Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score

    Time frame: Baseline to 48 hours

    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).

Secondary outcomes

  1. Worst Low Back Pain (LBP)

    Time frame: 48 hours

    Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized.

  2. Use of Medication for Low Back Pain (LBP)

    Time frame: 48 hours

    Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized.

  3. Frequency of Low Back Pain (LBP)

    Time frame: 48 hours

    Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized.

  4. Return to Usual Activities

    Time frame: 48 hours

    The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group.

  5. Number of Visits to Any Healthcare Provider

    Time frame: 48 hours

    The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group.

  6. Treatment Satisfaction

    Time frame: 48 hours

    Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group.

  7. Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score

    Time frame: 7 days

    Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report questionnaire 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 7-day follow-up with positive scores being indicative of improvement (less pain disability).

  8. Worst Low Back Pain (LBP)

    Time frame: 7 days

    Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized.

  9. Use of Medication for Low Back Pain (LBP)

    Time frame: 7 days

    Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized.

  10. Frequency of Low Back Pain

    Time frame: 7 days

    Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized.

  11. Return to Usual Activities

    Time frame: 7 days

    The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group.

  12. Number of Visits to Any Healthcare Provider

    Time frame: 7 days

    The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group.

  13. Treatment Satisfaction

    Time frame: 7 days

    Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2020
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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