A Study To Evaluate Methods To Evaluate Back Pain
21 de fevereiro de 2013 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
61
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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California
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Loma Linda, California, Estados Unidos, 92350
- Pfizer Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 55 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 1
Heat device
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8-Hour Heatwrap
Outros nomes:
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Comparador Falso: 2
Placebo arm
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Inactive wrap worn for 8 hours
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Comparador Ativo: 3
Marketed analgesic
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2 x 200 mg ibuprofen tablets
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Comparador de Placebo: 4
(Oral) Placebo comparator
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2 x placebo tablets
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to First Perceptible Relief (Confirmed by Meaningful Relief)
Prazo: Baseline (time of wrap application or oral treatment administration) up to 4 hours
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"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.
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Baseline (time of wrap application or oral treatment administration) up to 4 hours
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to Meaningful Relief
Prazo: Baseline (time of wrap application or oral treatment administration) up to 4 hours
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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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Baseline (time of wrap application or oral treatment administration) up to 4 hours
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Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)
Prazo: Baseline (time of wrap application or oral treatment administration) up to 8 hours
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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.
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Baseline (time of wrap application or oral treatment administration) up to 8 hours
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Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours
Prazo: Baseline (time of wrap application or oral treatment administration) up to 8 hours
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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.
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Baseline (time of wrap application or oral treatment administration) up to 8 hours
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Time to Treatment Failure
Prazo: Baseline (time of wrap application or oral treatment administration) up to 8 hours
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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).
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Baseline (time of wrap application or oral treatment administration) up to 8 hours
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Individual Time-Point Pain Relief Scores
Prazo: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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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.
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At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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Change From Baseline in Individual Time-point Back Stiffness Scores
Prazo: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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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).
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At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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Change From Baseline (Bsl) in Combined Flexibility Score: Extension
Prazo: Baseline (time of wrap application or oral treatment administration) and 4 hours
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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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side
Prazo: Baseline (time of wrap application or oral treatment administration) and 4 hours
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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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation
Prazo: Baseline (time of wrap application or oral treatment administration) and 4 hours
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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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension
Prazo: Baseline (time of wrap application or oral treatment administration) and 4 hours
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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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side
Prazo: Baseline (time of wrap application or oral treatment administration) and 4 hours
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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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation
Prazo: Baseline (time of wrap application or oral treatment administration) and 4 hours
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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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension
Prazo: Baseline (time of wrap application or oral treatment administration) and 4 hours
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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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side
Prazo: 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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline in Pain Measurement for Flexibility Measure: Rotation
Prazo: 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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Number of Participants Per Categorical Score for Global Assessment of Study Treatment
Prazo: Baseline (time of wrap application or oral treatment administration) up to 8 hours
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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.
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Baseline (time of wrap application or oral treatment administration) up to 8 hours
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de fevereiro de 2010
Conclusão Primária (Real)
1 de julho de 2010
Conclusão do estudo (Real)
1 de julho de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
8 de janeiro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de janeiro de 2010
Primeira postagem (Estimativa)
11 de janeiro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
1 de abril de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de fevereiro de 2013
Última verificação
1 de fevereiro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TC-09-20
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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