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A Study To Evaluate Methods To Evaluate Back Pain

21. februar 2013 opdateret af: Wyeth is now a wholly owned subsidiary of Pfizer

A Pilot Study To Evaluate Various Methodologies For Assessing The Treatment Of Low Back Pain

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

61

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Loma Linda, California, Forenede Stater, 92350
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
Heat device
Enhed: Heat Device
8-Hour Heatwrap
Andre navne:
  • Heatwrap
Sham-komparator: 2
Placebo arm
Enhed: Sham Device
Inactive wrap worn for 8 hours
Aktiv komparator: 3
Marketed analgesic
Medicin: marketed analgesic
2 x 200 mg ibuprofen tablets
Placebo komparator: 4
(Oral) Placebo comparator
Medicin: Placebo
2 x placebo tablets

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Perceptible Relief (Confirmed by Meaningful Relief)
Tidsramme: Baseline (time of wrap application or oral treatment administration) up to 4 hours
"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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Meaningful Relief
Tidsramme: Baseline (time of wrap application or oral treatment administration) up to 4 hours
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.
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)
Tidsramme: Baseline (time of wrap application or oral treatment administration) up to 8 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) up to 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
Tidsramme: Baseline (time of wrap application or oral treatment administration) up to 8 hours
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
Tidsramme: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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
Tidsramme: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) and 4 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) and 4 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) and 4 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) and 4 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) and 4 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) and 4 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) and 4 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) and 4 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) and 4 hours
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
Tidsramme: Baseline (time of wrap application or oral treatment administration) up to 8 hours
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2010

Primær færdiggørelse (Faktiske)

1. juli 2010

Studieafslutning (Faktiske)

1. juli 2010

Datoer for studieregistrering

Først indsendt

8. januar 2010

Først indsendt, der opfyldte QC-kriterier

8. januar 2010

Først opslået (Skøn)

11. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

1. april 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2013

Sidst verificeret

1. februar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TC-09-20

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Placeringer

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