A Study To Evaluate Methods To Evaluate Back Pain

NCT01045993 | Completed Results

• 1 other identifier: TC-09-20
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Pilot Study to Assess Methodologies

Outcome Measures

Primary Outcomes (1)

• Time to First Perceptible Relief (Confirmed by Meaningful Relief)

  "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

Secondary Outcomes (16)

• Time to Meaningful Relief

  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)

  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

  Baseline (time of wrap application or oral treatment administration) up to 8 hours

• Time to Treatment Failure

  Baseline (time of wrap application or oral treatment administration) up to 8 hours

• Individual Time-Point Pain Relief Scores

  At 60, 120, 180, 240, 300, 360, 420, and 480 minutes

Study Arms (4)

1

ACTIVE COMPARATOR

Heat device

Device: Heat Device

2

SHAM COMPARATOR

Placebo arm

Device: Sham Device

3

ACTIVE COMPARATOR

Marketed analgesic

Drug: marketed analgesic

4

PLACEBO COMPARATOR

(Oral) Placebo comparator

Drug: Placebo

Interventions

Heat Device DEVICE

8-Hour Heatwrap

Also known as: Heatwrap

1

Sham Device DEVICE

Inactive wrap worn for 8 hours

2

marketed analgesic DRUG

2 x 200 mg ibuprofen tablets

3

Placebo DRUG

2 x placebo tablets

4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Lower back pain
• Male or female in generally good health, from 18 to 55 years of age (inclusive)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Loma Linda, California, 92350, United States

Location

Related Publications (1)

• 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.

  PMID: 25419887 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No primary endpoint was prespecified in this Pilot study; 1 key efficacy endpoint was selected for reporting purposes only.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 1, 2013
• Results First Posted: April 1, 2013

Record last verified: 2013-02

Locations

US (1)