Clinical trial NCT01045993: A Study To Evaluate Methods To Evaluate Back Pain
Official title: A Pilot Study To Evaluate Various Methodologies For Assessing The Treatment Of Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pilot Study to Assess Methodologies
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-11
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Time to First Perceptible Relief (Confirmed by Meaningful Relief)
timeFrame: Baseline (time of wrap application or oral treatment administration) up to 4 hours
Secondary outcomes:
measure: Time to Meaningful Relief
timeFrame: Baseline (time of wrap application or oral treatment administration) up to 4 hours
measure: Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)
timeFrame: Baseline (time of wrap application or oral treatment administration) up to 8 hours
measure: Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours
timeFrame: Baseline (time of wrap application or oral treatment administration) up to 8 hours
measure: Time to Treatment Failure
timeFrame: Baseline (time of wrap application or oral treatment administration) up to 8 hours
measure: Individual Time-Point Pain Relief Scores
timeFrame: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
measure: Change From Baseline in Individual Time-point Back Stiffness Scores
timeFrame: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
measure: Change From Baseline (Bsl) in Combined Flexibility Score: Extension
timeFrame: Baseline (time of wrap application or oral treatment administration) and 4 hours
measure: Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side
timeFrame: Baseline (time of wrap application or oral treatment administration) and 4 hours
measure: Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation
timeFrame: Baseline (time of wrap application or oral treatment administration) and 4 hours
measure: Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension
timeFrame: Baseline (time of wrap application or oral treatment administration) and 4 hours
measure: Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side
timeFrame: Baseline (time of wrap application or oral treatment administration) and 4 hours
measure: Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation
timeFrame: Baseline (time of wrap application or oral treatment administration) and 4 hours
measure: Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension
timeFrame: Baseline (time of wrap application or oral treatment administration) and 4 hours
measure: Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side
timeFrame: Baseline (time of wrap application or oral treatment administration) and 4 hours
measure: Change From Baseline in Pain Measurement for Flexibility Measure: Rotation
timeFrame: Baseline (time of wrap application or oral treatment administration) and 4 hours
measure: Number of Participants Per Categorical Score for Global Assessment of Study Treatment
timeFrame: Baseline (time of wrap application or oral treatment administration) up to 8 hours
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Stark J, Petrofsky J, Berk L, Bains G, Chen S, Doyle G. Continuous low-level heatwrap therapy relieves low back pain and reduces muscle stiffness. Phys Sportsmed. 2014 Nov;42(4):39-48. doi: 10.3810/psm.2014.11.2090.