Telephone Intervention for Pain Study (TIPS)

Not Applicable

Completed

• Conditions: Chronic Pain; Multiple Sclerosis; Amputation; Spinal Cord Injury

• Registration Number: NCT00663663
• Lead Sponsor: University of Washington

Brief Summary

Treatments teaching people how to manage pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments delivered over the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired amputation. Specifically, we want to determine if these treatments can help reduce the negative consequences that pain often causes in terms of a person's mood, daily activities, and enjoyment of life. We are also interested in finding out if these treatments decrease a person's pain.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-22
• Study Start: 2009-09
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-29
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• Definitive diagnosis of acquired amputation (AMP), multiple sclerosis (MS), or spinal cord injury (SCI) confirmed by participants' primary care physicians
• Average pain intensity in the past month of greater than 3 on 0-10 numeric rating scale;
• Pain is either worse or started since the onset of the disability;
• Pain of at least six months duration, with pain reportedly present greater than or equal to half of the days in the past six months;
• Read, write and understand English;
• Must be able to communicate over the phone (i.e., must be verbal);
• Age 18 years or older.

Exclusion Criteria

• Cognitive impairment defined as one or more errors on the Six-Item screener (Callahan et al., 2002).
• Current or previous participation in a psychological treatment for pain (obtained via self-report).
• Current participation in a psychological treatment for any reason on a regular basis(obtained via self-report).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average pain intensity	Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and Follow-up (6 and 12 months post-randomization).

Secondary Outcome Measures

Name	Time	Method
Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994)	pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).
Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002)	pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).
Pain Catastrophizing Scale (Sullivan et al., 1995)	pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization)

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States