A Study To Evaluate Methods To Evaluate Back Pain

Wyeth

Status: Completed

Conditions: Pain

Treatments: Device: Sham Device; Device: Heat Device; Drug: marketed analgesic; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01045993

TC-09-20

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Heat device

Treatment:

Device: Heat Device

2

Sham Comparator group

Description:

Placebo arm

Treatment:

Device: Sham Device

3

Active Comparator group

Description:

Marketed analgesic

Treatment:

Drug: marketed analgesic

4

Placebo Comparator group

Description:

(Oral) Placebo comparator

Treatment:

Drug: Placebo