Efficacy of a Telehealth Pain Self-Management Intervention in Employed Adults With Physical Disability: A Randomized Controlled Trial

CompletedNot a drug-phase studyMS (type not specified)NCT04248725

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Change in Pain InterferenceMean Difference (Net) -2.70.004

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • E-TIPS

Results by group

Change in Pain Interference

Baseline (week 0) and 12 weeks (post-treatment)

GroupValueIntervalNumber analysed
E-TIPS-4.0 T-score-8.5–0.1102
Usual Care-1.3 T-score-5–2100

E-TIPS

-4

Usual Care

-1.3

p = 0.004; Mean Difference (Net) -2.7

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
E-TIPS1021 (1.0%)0
Usual Care1000 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change in Pain Interference

    Baseline (week 0) and 12 weeks (post-treatment)

    PainQuality of life (reported by participants)

Other measures (2)

  • Change in Pain Self-efficacy

    Baseline (week 0) and 12 weeks (post-treatment)

    PainQuality of life (reported by participants)
  • Change in Average Pain Intensity

    Baseline (week 0) and 12 weeks (post-treatment)

    Pain

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* 18 years of age or older * Self-reported physical disability * Chronic pain defined as daily pain of ≥ 3 months duration and ≥ 3 average pain intensity in the past week on a 0-10 numerical rating scale * Experiences pain for more than 45 out of the past 90 days (defined as 50% of the time or greater) * Reads, speaks, and understands English * Has access to and is able to communicate over the telephone with our without assistive devices * Is employed, working 15-20 hours per week or more, on average, or earning in excess of substantial gainful activity (approximately $1200/month) We will enroll individuals with a range of physical disabilities to maximize the generalizability of the results, because there is no evidence that the type of disability affects responsiveness to the proposed treatment

Exclusion criteria

* Under the age of 18 * Cannot read, speak, or understand English * No self-reported physical disability * Currently unemployed * Plans to retire or leave employment within the study period * Working fewer than 15-20 hours per week, on average, and earning less than approximately $1200 per month * Cannot communicate or complete assessments over the phone or internet * Chronic pain defined as daily pain of ≤ 3 months duration and ≤ 3 average pain intensity in the past week on a 0-10 numerical rating scale * Experiences pain for fewer than 45 out of the past 90 days (defined as 50% of the time or less) * Currently participating in another pain study or cognitive behavioral therapy (CBT) study

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The E-TIPS trial will evaluate an evidence-based, telehealth pain self-management intervention compared to standard care (a waitlist) for chronic pain in adults with physical disabilities who are employed. Participants from anywhere in the US will be randomized to either E-TIPS, a cognitive-behavioral pain self-management intervention delivered by telephone, or a waitlist control. Outcomes, including pain interference, will be assessed at baseline, mid-treatment, post-treatment, and 6-month follow up.

Papers

Loading reviews and guidelines…

History

    1. Started

      Mar 2020

    2. Main results due

      Sept 2023

    3. Finished

      Mar 2024

    4. Results posted

      Jan 2025

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