Internet-based Behavioral Pain Management

NCT01918189 | Completed Results

• 1 other identifier: D0998-R
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed project is to develop and test how well an internet-based behavioral pain self-management program, the Pain EASE program, can be used for treating low back pain in Veterans. Veterans' experiences with usability and satisfaction with the Pain EASE program will also be examined. Behavioral interventions such as exercise and cognitive behavior therapy are known to be effective for low back pain but are often not readily available or easily accessed. Veterans will be able to access the Pain EASE program via their computer with an internet connection, which will increase access to this type of treatment. Study participants will receive 10 weeks of access to the Pain EASE program, which will teach them pain coping skills to manage their low back pain. The primary outcome is pain-related functional interference.

Conditions

Chronic Low Back Pain

Keywords

back pain; low back pain; chronic pain; cognitive behavior therapy; behavior therapy

Outcome Measures

Primary Outcomes (1)

• Multidimensional Pain Inventory Interference Subscale

  Self-report measure of pain-related functional interference. The 9-item Interference subscale, scores ranging from 0-6, of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)-Interference scale assesses pain-related interference. Lower scores indicate less pain-related interference (i.e., better outcome). A reduction in WHYMPI-Interference Scale scores of 0.6 or greater has been identified as an indicator of meaningful improvement in physical functioning. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value).

  baseline and 10 weeks post-baseline

Secondary Outcomes (5)

• Numeric Rating Scale of Pain Intensity

  baseline and 10 weeks post-baseline

• Profile of Mood States

  baseline and 10 weeks post-baseline

• Multidimensional Fatigue Inventory

  baseline and 10 weeks post-baseline

• Medical Outcomes Study Sleep Scale

  baseline and 10 weeks post-baseline

• Beck Depression Inventory

  baseline and 10 weeks post-baseline

Study Arms (1)

10 week Pain EASE access

EXPERIMENTAL

behavioral pain self-management intervention (Pain EASE) delivered via the Internet

Behavioral: behavioral pain self-management intervention Pain EASE

Interventions

behavioral pain self-management intervention Pain EASE BEHAVIORAL

10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing

10 week Pain EASE access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of at least a moderate level of chronic low back pain (i.e., numeric rating scale pain scores of 4) and presence of low back pain for a period of 3 months;
• Availability of a computer with Internet access;
• Indication of the "preparation", "action", or "maintenance" stage of readiness to change on a brief five item staging checklist and a rating of at least 4 or greater on a 0 (not at all interested) to 10 (extremely interested) rating scale designed to ensure participants' interest in receiving pain self-management via the Internet;
• Veteran receiving care at VA Connecticut Healthcare System

You may not qualify if:

• life threatening or acute medical condition that could impair participation (e.g., severe COPD, lower limb amputation, terminal cancer);
• psychiatric condition (e.g., active substance abuse, psychosis or suicidality) that could impair participation
• surgical interventions for pain during their participation in this study
• sensory deficits that would impair participation (e.g., visual impairment affecting ability to navigate Internet-based intervention).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

Related Publications (2)

• Reuman L, Solar C, MacLean RR, Halat AM, Rajeevan H, Williams DA, Heapy AA, Bair MJ, Krein SL, Kerns RD, Higgins DM. If you personalize it, will they use it?: Self-reported and observed use of a tailored, internet-based pain self-management program. Transl Behav Med. 2022 May 26;12(5):693-701. doi: 10.1093/tbm/ibab165.

  PMID: 35192703 DERIVED

• Higgins DM, Buta E, Williams DA, Halat A, Bair MJ, Heapy AA, Krein SL, Rajeevan H, Rosen MI, Kerns RD. Internet-Based Pain Self-Management for Veterans: Feasibility and Preliminary Efficacy of the Pain EASE Program. Pain Pract. 2020 Apr;20(4):357-370. doi: 10.1111/papr.12861. Epub 2020 Jan 28.

  PMID: 31778281 DERIVED

MeSH Terms

Conditions

Back Pain; Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Diana M. Higgins, PhD
• Organization: VA Boston Healthcare System

diana.higgins2@va.gov

857-364-2221

Study Officials

• Diana M. Higgins, PhD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 7, 2013
• Study Start: July 1, 2014
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 18, 2019
• Results First Posted: October 11, 2019

Record last verified: 2019-11

Locations

US (1)