TEXT4myBACK: A Text Message Intervention to Improve Function in People With Low Back Pain—Protocol of a Randomized Controlled Trial

Abstract

Objective To describe the protocol of a randomized controlled trial that will investigate the effects of the TEXT4myBACK self-management text message intervention compared with control, in people with low back pain. Methods A single-blind (assessor and statistician) randomized controlled trial with economic analysis and process evaluation will be conducted. 304 people with non-specific low back pain of less than 12 weeks will be enrolled and randomly allocated either to TEXT4myBACK intervention or control groups. The TEXT4myBACK intervention group will receive four semi-personalized text messages per week providing advice, motivation and information about low back pain, physical activity, sleep, mood, use of care, medication during 12 weeks. The control group will receive one text message with a link to a low back pain and diet online information package. Outcomes will be assessed at baseline, 3, 6 and 12 months. The primary outcome will be function assessed with the Patient-Specific Functional Scale. Secondary outcomes will include pain intensity, physical activity participation, sedentary behavior, global impression of change, health-related quality of life and eHealth literacy. Data on demographic characteristics, smallest worthwhile change (ie, smallest function scored needed to be achieved at the end of the intervention to consider it to be worthwhile), health care utilization and adverse events (ie, any new health issue that occurs during participation in the study) will be collected. An economic and process evaluation will also be conducted. Impact This study will assess if a self-management text message intervention is effective and cost-effective in improving function of people with low back pain. This study can inform clinical practice of a simple, scalable and affordable intervention for managing low back pain.

Evaluating acceptability and feasibility of a mobile health intervention to improve self-efficacy in prescription opioid tapering in patients with chronic pain: protocol for a pilot randomised, single-blind, controlled trial

“…The main question in this survey reflecting acceptability is whether participants would recommend the intervention to be used for supporting patients with chronic non-cancer pain during opioid tapering 42. The survey contains Likert scales, descriptive and open responses, and is adapted from the TEXT4MYBACK pilot study 43 44. This survey was specifically developed for evaluating the acceptability of mHealth interventions (text messaging) for patients with chronic pain.…”

A Digital Video and Text Messaging Intervention to Support People With Chronic Pain During Opioid Tapering: Content Development Using Co-design

“…In response to consumer feedback, the mHealth content design and aims are to support users to successfully reduce or discontinue their prescription opioid medication when engaging in a voluntary taper. On the basis of self-efficacy theory [34,36], as well as clinical resources and research on pain management [40][41][42][43][44][45][46] and opioid tapering [6,33,37,[47][48][49][50], members of the research group (MRM, AG, AGM, CEAJ, and PG) drafted content for the preliminary video script and texts. This content was drawn from digital and traditional written resources and included information about pain self-management education, cognitive behavioral therapy concepts, and informational and supportive content from previous chronic pain and tapering research [7,9,15,16,40,[42][43][44][45][47][48][49][50][51].…”

“…On the basis of self-efficacy theory [34,36], as well as clinical resources and research on pain management [40][41][42][43][44][45][46] and opioid tapering [6,33,37,[47][48][49][50], members of the research group (MRM, AG, AGM, CEAJ, and PG) drafted content for the preliminary video script and texts. This content was drawn from digital and traditional written resources and included information about pain self-management education, cognitive behavioral therapy concepts, and informational and supportive content from previous chronic pain and tapering research [7,9,15,16,40,[42][43][44][45][47][48][49][50][51]. The researchers who developed the draft script and texts screened and adapted the information and resources to develop content that matched consumer-identified themes from formative research [29].…”

“…The video was designed to familiarize participants with information about chronic pain, provide a rationale for opioid tapering (eg, emphasizing long-term side effects and enhancing motivation to taper [29,30]), strengthen opioid tapering concepts (benefits of tapering on quality of life and functioning), and address common concerns about tapering (withdrawal management and information on pain intensity) [6,33,37,[47][48][49][50], while introducing various pain self-management strategies (including flare-up management, relaxation, sleep hygiene, thought management, and pacing) [40][41][42][43][44][45][46]. These psychological concepts were also linked to improving mood, and the association of tapering, mood, and pain was also included in the content [15,42,43,46,52].…”

“…Consistent with previous research [28,40], the proposed content of the mHealth intervention was next evaluated by patients with pain who had experienced tapering opioids (consumers) and clinicians with experience supporting patients with pain to taper opioid medications.…”