You are here

A Study To Evaluate Methods To Evaluate Back Pain

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Loma Linda, California, 92350 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Lower back pain

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01045993
Pfizer
Completed
A Study To Evaluate Methods To Evaluate Back Pain

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Descriptive Information
Brief Title  ICMJE A Study To Evaluate Methods To Evaluate Back Pain
Official Title  ICMJE A Pilot Study To Evaluate Various Methodologies For Assessing The Treatment Of Low Back Pain
Brief SummaryThe study is designed to assess methods used in clinical research.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Device: Heat Device
    8-Hour Heatwrap
    Other Name: Heatwrap
  • Device: Sham Device
    Inactive wrap worn for 8 hours
  • Drug: marketed analgesic
    2 x 200 mg ibuprofen tablets
  • Drug: Placebo
    2 x placebo tablets
Study Arms  ICMJE
  • Active Comparator: 1
    Heat device
    Intervention: Device: Heat Device
  • Sham Comparator: 2
    Placebo arm
    Intervention: Device: Sham Device
  • Active Comparator: 3
    Marketed analgesic
    Intervention: Drug: marketed analgesic
  • Placebo Comparator: 4
    (Oral) Placebo comparator
    Intervention: Drug: Placebo
Publications *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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 17, 2010)
61
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2010)
60
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion DateJuly 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01045993
Other Study ID Numbers  ICMJE TC-09-20
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateFebruary 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now