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The study is designed to assess methods used in clinical research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Heat device |
|
| 2 | Sham Comparator | Placebo arm |
|
| 3 | Active Comparator | Marketed analgesic |
|
| 4 | Placebo Comparator | (Oral) Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat Device | Device | 8-Hour Heatwrap |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Perceptible Relief (Confirmed by Meaningful Relief) | "First perceptible relief" defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled "first perceptible relief" (any pain relieving effect), provided the participant also depressed the second stopwatch labeled "meaningful relief" (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes). If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed. Confidence interval (CI) calculated using the method of Simon & Lee. | Baseline (time of wrap application or oral treatment administration) up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Meaningful Relief | Time to "meaningful relief" defined as elapsed time from start of treatment until participant depressed the second stopwatch indicating "meaningful relief" (meaningful to participant). Participant consider censored if participant did not depress the stopwatch by end of 4-hour in-patient evaluation, or became a treatment failure (rescue or discontinuation) during the time prior to depressing the second stopwatch. Censoring was at time of dropout if participant withdrew for non-efficacy related reasons during the 4-hour in-patient portion of the study. CI calculated using method of Simon & Lee. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Loma Linda | California | 92350 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25419887 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Eligible participants with at least moderate pain intensity on a 6-point categorical scale were randomized (N=61) to primary efficacy (heatwrap or oral placebo) or blinding groups ("sham" wrap or oral Ibuprofen). May have received rescue medication (oral acetaminophen) during the 4-hour evaluation period or at discharge after assessments completed.
Participants were recruited who had primary muscular low back pain (in the Investigator's best judgment), which was atraumatic (no traumatic injury within 48 hours of enrollment) and not caused by, or related to, any clinically significant, medical diseases, whose onset had occurred within the past 3 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | ThermaCare® | Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper. |
| FG001 | Sham Wrap (Inactive) | Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper. |
| FG002 | Oral Ibuprofen (IBU) | IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose. |
| FG003 | Oral Placebo | Oral Placebo matching Oral IBU. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ThermaCare® | Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper. |
| BG001 | Sham Wrap (Inactive) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Time to Meaningful Relief | Time to "meaningful relief" defined as elapsed time from start of treatment until participant depressed the second stopwatch indicating "meaningful relief" (meaningful to participant). Participant consider censored if participant did not depress the stopwatch by end of 4-hour in-patient evaluation, or became a treatment failure (rescue or discontinuation) during the time prior to depressing the second stopwatch. Censoring was at time of dropout if participant withdrew for non-efficacy related reasons during the 4-hour in-patient portion of the study. CI calculated using method of Simon & Lee. | ITT population. Median and/or upper limit of CI reported as 240 minutes if median or upper limit >240 minutes. | Posted | Median | 95% Confidence Interval | minutes | Baseline (time of wrap application or oral treatment administration) up to 4 hours |
|
Baseline up to 5 days after the 8 hour evaluation period.
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ThermaCare® | Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (13.0) | Non-systematic Assessment |
No primary endpoint was prespecified in this Pilot study; 1 key efficacy endpoint was selected for reporting purposes only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sham Device |
| Device |
Inactive wrap worn for 8 hours |
|
| marketed analgesic | Drug | 2 x 200 mg ibuprofen tablets |
|
| Placebo | Drug | 2 x placebo tablets |
|
| Baseline (time of wrap application or oral treatment administration) up to 4 hours |
| Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8) | TOTPAR 0-8 sum of pain relief from 0 through 8 hours, weighted by the time duration between the current timepoint and the previous timepoint. Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. Total possible score 0 to 40; higher score indicated better relief. | Baseline (time of wrap application or oral treatment administration) up to 8 hours |
| Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours | Time weighted sum of change calculated as sum of change from baseline in back stiffness scores from 0 through 8 hours, weighted by time duration between current timepoint and previous timepoint. Based on hourly (from baseline) back stiffness assessment rating from 0 (no muscle stiffness) to 100 (most possible muscle stiffness). Sum of change derived by subtracting score at post-dosing time point from baseline score. Total possible score -800 to 800; higher positive value was indicative of greater improvement. | Baseline (time of wrap application or oral treatment administration) up to 8 hours |
| Time to Treatment Failure | Time to treatment failure defined as time from dosing to the time of rescue medication within the scheduled duration of the study (8 hours); or for participants who withdrew from the study due to lack of efficacy without taking rescue medication, the time of the last assessment was considered the time to treatment failure; or if participant did not take rescue medication, or did not discontinue due to lack of efficacy, the time to treatment failure was considered censored at 8 hours (the scheduled duration of the study). | Baseline (time of wrap application or oral treatment administration) up to 8 hours |
| Individual Time-Point Pain Relief Scores | Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. | At 60, 120, 180, 240, 300, 360, 420, and 480 minutes |
| Change From Baseline in Individual Time-point Back Stiffness Scores | Low back muscle stiffness rated hourly (from baseline) by the participant by placing a line on a visual analog scale (VAS) from 0 millimeters (mm) to 100 mm in length with 0=no muscle stiffness up to 100 (most possible stiffness). | At 60, 120, 180, 240, 300, 360, 420, and 480 minutes |
| Change From Baseline (Bsl) in Combined Flexibility Score: Extension | Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees minus 5, and x degrees plus 5. Flexibility score derived using standardized value and VAS score (participant rating of pain by marking level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for extension flexibility were average of the extension flexibility data on the combined score (range -66 to 552); higher value indicated greater improvement. | Baseline (time of wrap application or oral treatment administration) and 4 hours |
| Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus (+/-) 10 degrees for left, and right (L, R), movement. Angle at Bsl and 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain to 100=worst pain). Final derived data for overall flexibility was the average of side-to-side (L, R) flexibility data on the combined score (range -81 to 264); higher value=greater improvement. | Baseline (time of wrap application or oral treatment administration) and 4 hours |
| Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus (+/-) 30 degrees for left, and right (L, R), movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for overall flexibility were the average of rotation (L, R) flexibility data on combined score (range -80 to 155); higher value=greater improvement. | Baseline (time of wrap application or oral treatment administration) and 4 hours |
| Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension | Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement of 20 degrees for extension (as if performing a sit-up) to the degree of movement at which participant perceives discomfort or pain. Higher score indicated greater improvement. | Baseline (time of wrap application or oral treatment administration) and 4 hours |
| Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side | Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement +/- 10 degrees for left, and right, side-to-side movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right side-to-side scores. Higher score indicated greater improvement. | Baseline (time of wrap application or oral treatment administration) and 4 hours |
| Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation | Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum rotation at waist of +/- 30 degrees for left, and right, movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right rotation scores. Higher score indicated greater improvement. | Baseline (time of wrap application or oral treatment administration) and 4 hours |
| Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | Flexibility assessed using Paris Plinth table with maximum extension of 20 degrees movement (as if performing a sit-up). When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher score indicated greater discomfort/pain. | Baseline (time of wrap application or oral treatment administration) and 4 hours |
| Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | Flexibility assessed using Paris Plinth table with maximum side-to-side movement of +/- 10 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain. | Baseline (time of wrap application or oral treatment administration) and 4 hours |
| Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | Flexibility assessed using Paris Plinth table with maximum rotation at waist of +/- 30 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain. | Baseline (time of wrap application or oral treatment administration) and 4 hours |
| Number of Participants Per Categorical Score for Global Assessment of Study Treatment | At hour 8, or at the time of rescue, if it occurred, participants performed a global assessment in their diary in response to the question: How would you rate the study treatment as a pain reliever? Very Poor=0, Poor=1, Fair=2, Good=3, Very Good=4, Excellent=5. | Baseline (time of wrap application or oral treatment administration) up to 8 hours |
Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
| BG002 | Oral Ibuprofen (IBU) | IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose. |
| BG003 | Oral Placebo | Oral Placebo matching Oral IBU. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Number of participants with categorical score for pain intensity | Participant rated the severity of their pain on a 6-point scale in response to the question "How much pain are you experiencing in your lower back right now". Scored as None=0, Mild=1, Moderate=2, Moderately severe=3, Severe=4, Extreme=5. Participant was asked to remember the level of pain experienced at this time as a reference for any pain relief experienced at later time points. | Number | participants |
|
| Back Stiffness Score | Participant rated their low back muscle stiffness by placing a line on a visual analog scale (VAS) in response to the question "Please indicate a number from 0 through 100 that best describes your low back muscle stiffness". VAS scaled as 0 millimeters (mm) to 100 mm in length with 0 (no muscle stiffness) up to 100 (most possible stiffness). | Mean | Standard Deviation | millimeters |
|
| Flexibility Assessment: Extension (Angle) | Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at baseline standardized to 100 for assessment of maximum angle (x degrees) up to the degree of movement at which participant perceives discomfort or pain, x degrees minus 5, and x degrees plus 5. Greater degree of angle indicated greater flexibility. | Mean | Standard Deviation | degree of angle |
|
| Flexibility Assessment: Extension (visual analog scale ([VAS]) | Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees and discomfort rated on VAS. Movement increased 5 degrees beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher scores indicated greater pain. | Mean | Standard Deviation | millimeters |
|
| Flexibility Assessment: Side-to-Side (Angle) | Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus 10 degrees for left (L), and right (R), movement. Angle at baseline standardized to 100 for assessment of maximum angle (x degrees) up to the degree of movement at which participant perceives discomfort or pain, x degrees minus 5, and x degrees plus 5. Greater degree of angle indicated greater flexibility. | Mean | Standard Deviation | degree of angle |
|
| Flexibility Assessment: Side-to-side (VAS) | Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus 10 degrees for left, and right, movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees and discomfort rated on VAS. Movement increased 5 degrees beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher scores indicated greater pain. | Mean | Standard Deviation | millimeters |
|
| Flexibility Assessment: Rotation (Angle) | Flexibility assessed using Paris Plinth table with maximum rotation at waist movement of plus or minus 30 degrees for left, and right, movement. Angle at baseline standardized to 100 for assessment of maximum angle (x degrees) up to the degree of movement at which participant perceives discomfort or pain, x degrees minus 5, and x degrees plus 5. Greater degree of angle indicated greater flexibility. | Mean | Standard Deviation | degree of angle |
|
| Flexibility Assessment: Rotation (VAS) | Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus 30 degrees for left, and right, movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees and discomfort rated on VAS. Movement increased 5 degrees beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher scores indicated greater pain. | Mean | Standard Deviation | millimeters |
|
Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
| OG001 | Sham Wrap (Inactive) | Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper. |
| OG002 | Oral Ibuprofen (IBU) | IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose. |
| OG003 | Oral Placebo | Oral Placebo matching Oral IBU. |
|
|
|
| Primary | Time to First Perceptible Relief (Confirmed by Meaningful Relief) | "First perceptible relief" defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled "first perceptible relief" (any pain relieving effect), provided the participant also depressed the second stopwatch labeled "meaningful relief" (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes). If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed. Confidence interval (CI) calculated using the method of Simon & Lee. | Intent-to-treat population (ITT): all randomized participants who applied/dosed with study product and had a baseline assessment. Median and/or upper limit of CI reported as 240 minutes if >240 minutes. No primary endpoint was prespecified in this Pilot study; 1 key efficacy endpoint was selected for reporting purposes only. | Posted | Median | 95% Confidence Interval | minutes | Baseline (time of wrap application or oral treatment administration) up to 4 hours |
|
|
|
|
| Secondary | Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8) | TOTPAR 0-8 sum of pain relief from 0 through 8 hours, weighted by the time duration between the current timepoint and the previous timepoint. Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. Total possible score 0 to 40; higher score indicated better relief. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (time of wrap application or oral treatment administration) up to 8 hours |
|
|
|
|
| Secondary | Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours | Time weighted sum of change calculated as sum of change from baseline in back stiffness scores from 0 through 8 hours, weighted by time duration between current timepoint and previous timepoint. Based on hourly (from baseline) back stiffness assessment rating from 0 (no muscle stiffness) to 100 (most possible muscle stiffness). Sum of change derived by subtracting score at post-dosing time point from baseline score. Total possible score -800 to 800; higher positive value was indicative of greater improvement. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (time of wrap application or oral treatment administration) up to 8 hours |
|
|
|
|
| Secondary | Time to Treatment Failure | Time to treatment failure defined as time from dosing to the time of rescue medication within the scheduled duration of the study (8 hours); or for participants who withdrew from the study due to lack of efficacy without taking rescue medication, the time of the last assessment was considered the time to treatment failure; or if participant did not take rescue medication, or did not discontinue due to lack of efficacy, the time to treatment failure was considered censored at 8 hours (the scheduled duration of the study). | ITT population. Time to treatment failure not calculable as there were no treatment failures in this study. No participants required use of rescue medication or discontinued study prior to 8 hour evaluation. | Posted | Baseline (time of wrap application or oral treatment administration) up to 8 hours |
|
|
| Secondary | Individual Time-Point Pain Relief Scores | Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | At 60, 120, 180, 240, 300, 360, 420, and 480 minutes |
|
|
|
|
| Secondary | Change From Baseline in Individual Time-point Back Stiffness Scores | Low back muscle stiffness rated hourly (from baseline) by the participant by placing a line on a visual analog scale (VAS) from 0 millimeters (mm) to 100 mm in length with 0=no muscle stiffness up to 100 (most possible stiffness). | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | At 60, 120, 180, 240, 300, 360, 420, and 480 minutes |
|
|
|
|
| Secondary | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees minus 5, and x degrees plus 5. Flexibility score derived using standardized value and VAS score (participant rating of pain by marking level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for extension flexibility were average of the extension flexibility data on the combined score (range -66 to 552); higher value indicated greater improvement. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (time of wrap application or oral treatment administration) and 4 hours |
|
|
|
|
| Secondary | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus (+/-) 10 degrees for left, and right (L, R), movement. Angle at Bsl and 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain to 100=worst pain). Final derived data for overall flexibility was the average of side-to-side (L, R) flexibility data on the combined score (range -81 to 264); higher value=greater improvement. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (time of wrap application or oral treatment administration) and 4 hours |
|
|
|
|
| Secondary | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus (+/-) 30 degrees for left, and right (L, R), movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for overall flexibility were the average of rotation (L, R) flexibility data on combined score (range -80 to 155); higher value=greater improvement. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (time of wrap application or oral treatment administration) and 4 hours |
|
|
|
|
| Secondary | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension | Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement of 20 degrees for extension (as if performing a sit-up) to the degree of movement at which participant perceives discomfort or pain. Higher score indicated greater improvement. | ITT population. | Posted | Mean | Standard Deviation | degrees | Baseline (time of wrap application or oral treatment administration) and 4 hours |
|
|
|
|
| Secondary | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side | Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement +/- 10 degrees for left, and right, side-to-side movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right side-to-side scores. Higher score indicated greater improvement. | ITT population. | Posted | Mean | Standard Deviation | degrees | Baseline (time of wrap application or oral treatment administration) and 4 hours |
|
|
|
|
| Secondary | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation | Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum rotation at waist of +/- 30 degrees for left, and right, movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right rotation scores. Higher score indicated greater improvement. | ITT population. | Posted | Mean | Standard Deviation | degrees | Baseline (time of wrap application or oral treatment administration) and 4 hours |
|
|
|
|
| Secondary | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | Flexibility assessed using Paris Plinth table with maximum extension of 20 degrees movement (as if performing a sit-up). When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher score indicated greater discomfort/pain. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (time of wrap application or oral treatment administration) and 4 hours |
|
|
|
|
| Secondary | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | Flexibility assessed using Paris Plinth table with maximum side-to-side movement of +/- 10 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (time of wrap application or oral treatment administration) and 4 hours |
|
|
|
|
| Secondary | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | Flexibility assessed using Paris Plinth table with maximum rotation at waist of +/- 30 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain. | ITT population. | Posted | Mean | Standard Deviation | scores on a scale | Baseline (time of wrap application or oral treatment administration) and 4 hours |
|
|
|
|
| Secondary | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | At hour 8, or at the time of rescue, if it occurred, participants performed a global assessment in their diary in response to the question: How would you rate the study treatment as a pain reliever? Very Poor=0, Poor=1, Fair=2, Good=3, Very Good=4, Excellent=5. | ITT population. | Posted | Number | participants | Baseline (time of wrap application or oral treatment administration) up to 8 hours |
|
|
|
|
| 0 |
| 26 |
| 2 |
| 26 |
| EG001 | Sham Wrap (Inactive) | Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper. | 0 | 5 | 0 | 5 |
| EG002 | Oral Ibuprofen (IBU) | IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose. | 0 | 5 | 0 | 5 |
| EG003 | Oral Placebo | Oral Placebo matching Oral IBU. | 0 | 25 | 0 | 25 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after the disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| 120 minutes |
|
| 180 minutes |
|
| 240 minutes |
|
| 300 minutes |
|
| 360 minutes |
|
| 420 minutes |
|
| 480 minutes |
|
120 minutes timepoint |
| ANOVA |
P-value from ANOVA model with treatment term only in the model. |
| 0.016 |
Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. |
| 95 |
| No |
| Superiority or Other |
| 180 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | <0.001 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 240 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.002 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 300 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | <0.001 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 360 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | <0.001 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 420 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.003 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 480 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.001 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 120 minutes |
|
| 180 minutes |
|
| 240 minutes |
|
| 300 minutes |
|
| 360 minutes |
|
| 420 minutes |
|
| 480 minutes |
|
120 minutes timepoint |
| ANOVA |
P-value from ANOVA model with treatment term only in the model. |
| 0.002 |
Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. |
| 95 |
| No |
| Superiority or Other |
| 180 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.033 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 240 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.096 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 300 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.002 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 360 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.005 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 420 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.008 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| 480 minutes timepoint | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.004 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| At Minus 5 degrees |
|
| At Plus 5 degrees (beyond maximum) |
|
At Minus 5 degrees |
| ANOVA |
P-value from ANOVA model with treatment term only in the model. |
| 0.419 |
Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. |
| 95 |
| No |
| Superiority or Other |
| At Plus 5 degrees (beyond maximum) | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.086 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| At Minus 5 degrees |
|
| At Plus 5 degrees (beyond maximum) |
|
At Minus 5 degrees |
| ANOVA |
P-value from ANOVA model with treatment term only in the model. |
| 0.757 |
Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. |
| 95 |
| No |
| Superiority or Other |
| At Plus 5 degrees (beyond maximum) | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.219 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| At Minus 5 degrees |
|
| At Plus 5 degrees (beyond maximum) |
|
At Minus 5 degrees |
| ANOVA |
P-value from ANOVA model with treatment term only in the model. |
| 0.388 |
Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. |
| 95 |
| No |
| Superiority or Other |
| At Plus 5 degrees (beyond maximum) | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.039 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| At Minus 5 degrees |
|
| At Plus 5 degrees (beyond maximum) |
|
At Minus 5 degrees |
| ANOVA |
P-value from ANOVA model with treatment term only in the model. |
| 0.371 |
Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. |
| 95 |
| No |
| Superiority or Other |
| At Plus 5 degrees (beyond maximum) | ANOVA | P-values from ANOVA model with treatment treatment term only in the model. | 0.216 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| At Minus 5 degrees |
|
| At Plus 5 degrees (beyond maximum) |
|
At Minus 5 degrees |
| ANOVA |
P-value from ANOVA model with treatment term only in the model. |
| 0.600 |
Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. |
| 95 |
| No |
| Superiority or Other |
| At Plus 5 degrees (beyond maximum) | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.294 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| At Minus 5 degrees |
|
| At Plus 5 degrees (beyond maximum) |
|
At Minus 5 degrees |
| ANOVA |
P-value from ANOVA model with treatment term only in the model. |
| 0.625 |
Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. |
| 95 |
| No |
| Superiority or Other |
| At Plus 5 degrees (beyond maximum) | ANOVA | P-value from ANOVA model with treatment term only in the model. | 0.034 | Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05. | 95 | No | Superiority or Other |
| Poor=1 |
|
| Fair=2 |
|
| Good=3 |
|
| Very good=4 |
|
| Excellent=5 |
|
| Response missing |
|