NCT01918189

Internet-based Behavioral Pain Management

Completed NA Results posted Last updated 18 November 2019

What this trial tests

NA trial testing behavioral pain self-management intervention Pain EASE in Chronic Low Back Pain in 59 participants. Completed in 31 December 2018.

Timeline

1 July 2014

Primary endpoint
31 October 2018

31 December 2018

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	1 July 2014
Primary completion	31 October 2018
Estimated completion	31 December 2018
Sites	1 location across United States

Drugs / interventions tested

• behavioral pain self-management intervention Pain EASE

Conditions studied

• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Chronic Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Multidimensional Pain Inventory Interference Subscale Primary · baseline and 10 weeks post-baseline

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 ba

Group	Value	95% CI
10 Week Pain EASE Access	0.53	0.15 – 0.92

Numeric Rating Scale of Pain Intensity Secondary · baseline and 10 weeks post-baseline

self-report measure of pain intensity measured on a 0-10 likert scale. Participants are asked, "Please rate your pain by indicating the number that best describes your average pain over the past week on a 0 (no pain) to 10 (pain as bad as you can imagine) scale". Scores of 1-3 reflect mild pain, 4-6 moderate pain, and 7-10 severe pain. Lower scores reflect less pain, and therefore, better outcome. 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).

Group	Value	95% CI
Behavioral Pain Self-management Intervention (Pain EASE)	-0.24	-0.29 – 0.20

Profile of Mood States Secondary · baseline and 10 weeks post-baseline

Total mood symptoms score reported. The 65-item Profile of Mood States (POMS) is a multidimensional measure of emotional functioning designed to assess six dimensions of mood "over the past week, including today". Each item is scored on a 0-5 Likert scale, where 0= "not at all" and 5= "extremely". Total Mood Disturbance score ranges from 0 to 200. Higher scores reflect poorer functioning. Lower scores correspond to better outcomes. 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).

Group	Value	95% CI
Behavioral Pain Self-management Intervention (Pain EASE)	-9.57	-17.72 – -1.42

Multidimensional Fatigue Inventory Secondary · baseline and 10 weeks post-baseline

General fatigue scale reported. Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI), which is a 20 item measure that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and how subscale statements regarding fatigue represent their experiences. Score range from 4 to 20. Higher total scores correspond with more acute levels of fatigue. Lower scores correspond to better outcomes. Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline valu

Group	Value	95% CI
Behavioral Pain Self-management Intervention (Pain EASE)	-0.3	-1.17 – 0.56

Medical Outcomes Study Sleep Scale Secondary · baseline and 10 weeks post-baseline

The MOS Sleep Scale is a 12 item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, awaken short of breath or with headache, adequacy of sleep, somnolence, a problems index 1 and a problems index 2). An additional single item assesses quantity of sleep. The sleep domains and problems index are scored on a 0 - 100 possible range, and higher scores indicate more of the concept being measured. Lower scores on sleep disturbance, for example, reflect less disturbed sleep, which is a better outcome. Outcome was calculated as a change from base

Group	Value	95% CI
Behavioral Pain Self-management Intervention (Pain EASE)	-4.95	-12.27 – 2.38

Beck Depression Inventory Secondary · baseline and 10 weeks post-baseline

Depressive symptom severity was assessed using the 21-item Beck Depression Inventory. Scores range from 0 - 63. Higher scores indicate more severe depression symptomatology. Lower scores correspond to better outcomes (i.e., less depressive symptom severity). 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).

Group	Value	95% CI
Behavioral Pain Self-management Intervention (Pain EASE)	-2.31	-4.37 – -0.25

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 weeks of active study participation. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

10 Week Pain EASE Access

Serious: 1/58 (2%)

Deaths: 0/58

Serious adverse events (1 terms)

Reaction	System	10 Week Pain EASE Access
psychiatric emergency room visit	Psychiatric disorders	—

Most-reported serious reactions: psychiatric emergency room visit.

Data from ClinicalTrials.gov NCT01918189 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. If you personalize it, will they use it?: Self-reported and observed use of a tailored, internet-based pain self-management program.
   Reuman L, Solar C, MacLean RR, Halat AM, et al · · 2022 · cited 3× · PMID 35192703 · DOI 10.1093/tbm/ibab165