Interactive Voice Response (IVR)-Based Treatment for Chronic Low Back Pain

NCT01025752 | Completed Results

• 1 other identifier: IIR 09-058
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will test how well an innovative method, interactive voice response (IVR), can be used for delivering an treatment for chronic low back pain. The use of IVR will improve the accessibility of treatment to Veterans. IVR is a computerized interface that allows patients to use their telephone to: 1) obtain pre-recorded didactic information, 2) report data regarding pain-related symptoms and adherence to pain coping skill practice, and 3) receive personalized therapist feedback. Although CBT has been shown to be effective in reducing pain intensity, traditional CBT requires patients to make frequent office visits. The use of IVR will allow Veterans to access CBT from their home via a touch-tone telephone, thereby allowing them to access treatment at their convenience without travel to the VA for an outpatient appointment. Veterans with chronic low back pain will be randomized in equal numbers to receive either standard CBT or IVR-based CBT. Veterans in both conditions will receive 10 session of treatment designed to help them manage their chronic pain using pain coping skills. The primary outcome measure will be pain intensity.

Conditions

Chronic Low Back Pain

Keywords

chronic pain; cognitive behavior therapy; low back pain

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Rating Scale of Pain Intensity

  An 11-point NRS for pain was administered to patients, with 0 representing "No Pain" and 10 representing "Worst Possible Pain." Patients were asked to rate the level of pain that best represented their experience of worst pain, least pain and average pain over the past week. We computed the change from baseline.

  post-treatment (12 weeks), 3 and 6 months post-baseline

Secondary Outcomes (6)

• Change in Multidimensional Pain Inventory Interference Subscale

  post-treatment (12 weeks), 3 and 6 months post-baseline

• Change in Roland Morris Disability Questionnaire

  post-treatment (12 weeks), 3 and 6 months post-baseline

• Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale

  post-treatment (12 weeks), 3 and 6 months post-baseline

• Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale

  post-treatment (12 weeks), 3 and 6 months post-baseline

• Change in Beck Depression Inventory-II

  post-treatment (12 weeks), 3 and 6 months post-baseline

Study Arms (2)

Arm 1

EXPERIMENTAL

Ten session IVR-based cognitive behavior therapy intervention for chronic low back pain

Behavioral: IVR based cognitive behavioral therapy

Arm 2

ACTIVE COMPARATOR

Ten session face to face cognitive behavior therapy for chronic low back pain

Behavioral: Face to face cognitive behavior therapy

Interventions

Face to face cognitive behavior therapy BEHAVIORAL

Ten session face to face cognitive behavior therapy for chronic low back pain

Arm 2

IVR based cognitive behavioral therapy BEHAVIORAL

Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy

Arm 1

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 pain (i.e., pain scores of \> or = 4) and presence of pain for a period of \> or = 3 months
• ability to participate safely in the walking portion of the intervention as evidenced by ability to walk at least one block
• availability of a touch-tone telephone and computer with internet access in the participant's residence
• 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 chronic obstructive pulmonary disease, 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., hearing loss to a degree that telephone usage is not possible).

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Michigan: collaborator

Study Sites (1)

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

West Haven, Connecticut, 06516, United States

Location

Related Publications (4)

• Heapy AA, Higgins DM, LaChappelle KM, Kirlin J, Goulet JL, Czlapinski RA, Buta E, Piette JD, Krein SL, Richardson CR, Kerns RD. Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. BMC Musculoskelet Disord. 2016 Feb 16;17:85. doi: 10.1186/s12891-016-0924-z.

  PMID: 26879051 RESULT

• MacLean RR, Buta E, Higgins DM, Driscoll MA, Edmond SN, LaChappelle KM, Ankawi B, Krein SL, Piette JD, Heapy AA. Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial. Pain Med. 2023 Jul 5;24(7):846-854. doi: 10.1093/pm/pnac192.

  PMID: 36484691 DERIVED

• Heapy AA, Tankha H, Higgins DM, Driscoll M, LaChappelle KM, Goulet JL, Buta E, Piette JD, Kerns RD, Krein SL. Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention. J Behav Med. 2021 Apr;44(2):260-269. doi: 10.1007/s10865-020-00193-8. Epub 2021 Jan 1.

  PMID: 33386530 DERIVED

• Heapy AA, Higgins DM, Goulet JL, LaChappelle KM, Driscoll MA, Czlapinski RA, Buta E, Piette JD, Krein SL, Kerns RD. Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. JAMA Intern Med. 2017 Jun 1;177(6):765-773. doi: 10.1001/jamainternmed.2017.0223.

  PMID: 28384682 DERIVED

MeSH Terms

Conditions

Chronic Pain; Low Back Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Alicia Heapy
• Organization: VA Connecticut Healthcare System

alicia.heapy@va.gov

203-932-5711

Study Officials

• Alicia A. Heapy, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: May 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 3, 2018
• Results First Posted: August 3, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)