N/A Completed N=61 Randomized Single-blind Treatment

A Study To Evaluate Methods To Evaluate Back Pain

Source: ClinicalTrials.gov NCT01045993 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2013

Primary outcomePrimary: Time to First Perceptible Relief (Confirmed by Meaningful Relief) — 96.5; 38.7; 54.0; 240 minutes — p=0.046

Summary

The study is designed to assess methods used in clinical research.

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to First Perceptible Relief (Confirmed by Meaningful Relief)	96.5; 38.7; 54.0; 240	0.046 sig
SECONDARY Time to Meaningful Relief	215.7; 104.0; 135.1; 240	0.046 sig
SECONDARY Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)	22.0; 15.6; 17.0; 11.5	<0.001 sig
SECONDARY Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours	167.0; 140.6; 105.0; 74.5	0.002 sig
SECONDARY Time to Treatment Failure	—	—
SECONDARY Individual Time-Point Pain Relief Scores	1.4; 1.0; 1.0; 0.6; 2.1; 1.6	0.012 sig
SECONDARY Change From Baseline in Individual Time-point Back Stiffness Scores	9.4; 8.4; -3.0; 1.3; 14.7; 17.6	0.012 sig
SECONDARY Change From Baseline (Bsl) in Combined Flexibility Score: Extension	13.7; -4.1; 12.7; 4.3; 17.7; 8.4	0.268
SECONDARY Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side	13.9; 14.0; 3.8; 0.7; 9.5; 2.3	0.067
SECONDARY Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation	9.9; 24.1; 12.1; -0.2; 13.0; 35.9	0.043 sig
SECONDARY Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension	1.4; -1.1; 0.5; 1.2	0.797
SECONDARY Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side	0.1; 0.4; -0.3; -0.2	0.371
SECONDARY Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation	0.6; 1.3; -0.6; -0.6	0.122
SECONDARY Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension	4.7; -0.8; 10.4; -0.6; 2.7; 7.4	0.355
SECONDARY Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side	7.9; 5.0; 6.6; -0.3; 4.2; 4.6	0.054
SECONDARY Change From Baseline in Pain Measurement for Flexibility Measure: Rotation	7.4; 17.4; 15.7; 0.2; 5.4; 19.4	0.088
SECONDARY Number of Participants Per Categorical Score for Global Assessment of Study Treatment	0; 1; 0; 6; 0; 0	<0.001 sig

Eligibility Criteria

Inclusion Criteria

Lower back pain
Male or female in generally good health, from 18 to 55 years of age (inclusive)

Exclusion Criteria

Pregnant or lactating
Subject has evidence or history of radiculopathy, i.e. sciatica extending below the knee (numbness, tingling, or shooting pain), or other neurologic deficits (abnormal straight leg raise test, patellar reflexes, and/or bowel and bladder function);
Subject has a history of previous back surgery;
Subject has back pain resulting from traumatic injury involving physical evidence of bruising, swelling, or inflammation to the abdomen or low back area which occurred less than 48 hours prior to enrollment
Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study
Is a member or relative of the study site staff, CRO or Sponsor organization directly involved with the study or had a household member or relative participate concurrently or previously in this study
Has previously been enrolled in this study

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Data sourced from ClinicalTrials.gov (NCT01045993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.