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A Study To Evaluate Methods To Evaluate Back Pain

Last updated on May 9, 2018

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

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A Study To Evaluate Methods To Evaluate Back Pain
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Pain
  • 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
  • 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
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.
 
Completed
61
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01045993
TC-09-20
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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