Text-Messaging Platform for Musculoskeletal Disorders

Overseen By Paul Tornetta III, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Limited readers, Incarcerated, No cell phone

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3000 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Memora Platform for PROMIS, Memora Health's Text-Messaging Platform, Memora Platform, Right-Size Clinic Visits for musculoskeletal disorders?

Research suggests that text message interventions can be effective in promoting healthy behavior and managing chronic diseases, including musculoskeletal pain. Although the effects on pain intensity and function are small and inconsistent, text messages have shown potential benefits in treatment adherence and quality of life when used as part of a multicomponent intervention. ^{1 2 3 4 5}

Is the text-messaging platform for musculoskeletal disorders safe for humans?

The research on text message interventions for musculoskeletal pain suggests they are generally safe, with some positive effects on treatment adherence and quality of life, but the studies were of limited quality and more research is needed to confirm these findings. ^{1 6 7 8 9}

How is the Right-Size Clinic Visits treatment for musculoskeletal disorders unique?

The Right-Size Clinic Visits treatment is unique because it uses a text-messaging platform to manage musculoskeletal disorders, which is a low-cost and accessible method that can improve treatment adherence and potentially enhance pain management and quality of life. This approach differs from traditional treatments by incorporating digital communication to support patient care. ^{1 4 10 11 12}

What is the purpose of this trial?

Developing novel methods of patient communication is crucial in providing value-based care to orthopedic patients. Healthcare technology platforms have been developed to improve patient communication methods particularly for the administration of patient-reported outcome measures (PROMs). However, the majority of these interventions rely on web-based platforms that require patients to have computer access. Among American households earning less than $30,000 per year, only 59% have access to a desktop or laptop and just 47% have broadband internet at home compared to mobile phone penetration which is estimated at 95% of which 93% regularly use text messages. The use of phone messaging may be the most effective means to have patients complete PROMs. The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH-funded, clinically validated method of tracking patient-reported outcomes to efficiently assess patient health status. PROMIS utilizes Item Response Theory (IRT) and computerized adaptive testing (CAT) to improve measurement precision and decrease survey time as compared to traditional PROMs. The purpose of this two-phase study is to utilize Memora Health's text-messaging platform to collect web-based PROMIS CAT surveys from patients (Phase 1) and use this information to right-size clinic visits (Phase 2).

Research Team

Paul Tornetta III, MD

Principal Investigator

Boston Medical Center

Eligibility Criteria

This trial is for orthopedic patients with specific conditions like lumbar fusion, ACL reconstruction, or rotator cuff repair. Participants must have a personal cell phone with internet and speak English primarily. It's not for incarcerated individuals, those who can't read well, or without a cell phone.

Inclusion Criteria

I have a broken ankle.

I have been diagnosed with lumbar stenosis.

I have had surgery to repair my rotator cuff.

Exclusion Criteria

Limited and non-readers

Vulnerable populations - incarcerated patients

Patients with no cell phone to use for scoring

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Participants complete PROMIS CAT questionnaires via SMS or secure weblink to assess health status and develop recovery curves

1 year

Standard follow-up clinic visits

Phase 2

Clinic visits are adjusted based on recovery curves; participants receive phone calls or in-person visits based on PROMs

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Memora Platform for PROMIS
• Right-Size Clinic Visits

Trial Overview The study tests the use of Memora Health's text-messaging platform to collect patient-reported outcomes via PROMIS CAT surveys and then tailor clinic visits accordingly. The goal is to improve communication and care efficiency in two phases.

Participant Groups

Group I: Phase 2 Experimental Treatment 1 Intervention

Participants in Phase 2 will have their clinic visits potentially revised based on the phase 1 recovery curves which may increase or decrease the number of clinic visits they receive based on the PROMs reported.

Group II: Phase 1 Active Control 1 Intervention

Participants in phase 1 will be observed and data about their recovery time will be collected from which recovery curves will be calculated for Phase 2

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Findings from Research

This systematic review analyzed 11 studies on the use of text message interventions for managing musculoskeletal pain, finding that while the overall quality of the studies was limited, there were some positive effects on treatment adherence and other outcomes like pain intensity and quality of life.

Text messages, when combined with usual care or multicomponent interventions, showed potential benefits in managing musculoskeletal pain, suggesting they could be a low-cost addition to treatment strategies, but further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of using text message interventions for the management of musculoskeletal pain: a systematic review. Fritsch, CG., Ferreira, PH., Prior, JL., et al.[2021]

A study involving 42 patients with chronic musculoskeletal conditions found that telehealth assessments showed substantial agreement (83.3%) with in-person assessments regarding recommended management pathways.

The agreement for clinical diagnostics and further investigations was also high (83.3% and 81% respectively), indicating that telehealth is a viable and effective option for assessing patients who cannot attend in person.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agreement between telehealth and in-person assessment of patients with chronic musculoskeletal conditions presenting to an advanced-practice physiotherapy screening clinic. Cottrell, MA., O'Leary, SP., Swete-Kelly, P., et al.[2019]

Digital physiotherapy assessments show acceptable to excellent validity and reliability for various components, such as clinical tests and patient-reported outcomes, based on a systematic review of 10 studies involving 193 participants.

Patients reported satisfaction with digital assessments, although they rated them lower than face-to-face assessments, indicating that while digital options are viable, they may not fully replace in-person evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital physiotherapy assessment vs conventional face-to-face physiotherapy assessment of patients with musculoskeletal disorders: A systematic review. Bernhardsson, S., Larsson, A., Bergenheim, A., et al.[2023]

This study aims to systematically review and map the existing literature on mobile messaging interventions for adults with musculoskeletal pain, focusing on their efficacy, effectiveness, and economic impact, based on both experimental and observational studies.

The review will help identify optimal configurations for mobile messaging systems, including content presentation and patient preferences, to enhance support for individuals suffering from acute or chronic musculoskeletal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and use of mobile messaging for individuals with musculoskeletal pain conditions: a scoping review protocol. Scotti Requena, S., Sterling, M., Elphinston, RA., et al.[2021]

Musculoskeletal (MSK) conditions are a major global health issue, and eHealth technologies can significantly improve the accessibility and integration of care models for these conditions.

The implementation of eHealth in MSK models of care can enhance system efficiency, sustainability, and reduce disparities in access to treatment, particularly for conditions like osteoarthritis and persistent MSK pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of eHealth technologies to enable the implementation of musculoskeletal Models of Care: Evidence and practice. Slater, H., Dear, BF., Merolli, MA., et al.[2022]

A study using electronic health records (EHR) from English general practices found that 31.9% of adults aged 35 and older with non-inflammatory musculoskeletal disorders experienced high impact chronic pain in 2016/17.

The research identified that women, older individuals, and those from deprived neighborhoods reported worse musculoskeletal health, highlighting the potential of EHR data to provide valuable insights into population health trends over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimating the population health burden of musculoskeletal conditions using primary care electronic health records. Yu, D., Peat, G., Jordan, KP., et al.[2021]

The study aims to rigorously test the usability of the Digital Assessment Routing Tool (DART) for musculoskeletal conditions, involving 20-30 participants over 4 months to ensure it meets usability standards before clinical trials.

By optimizing DART's user experience, the goal is to create a safe and effective mobile health solution that improves patient access to care and reduces the burden on healthcare services, setting a precedent for future mobile health innovations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool: Protocol for an Iterative Convergent Mixed Methods Study. Lowe, C., Hanuman Sing, H., Browne, M., et al.[2021]

This scoping review aims to identify and map existing literature on minimal clinical data sets for spine-related musculoskeletal disorders, focusing on their use in primary care and outpatient settings, which is crucial for improving healthcare quality.

The review will include a variety of study designs and languages, ensuring a comprehensive understanding of how these data sets can be utilized to measure and monitor health status in patients, ultimately benefiting clinicians and researchers in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal clinical data sets for spine-related musculoskeletal disorders in primary care and outpatient settings: a scoping review protocol. Mikhail, J., Hofstetter, L., Côté, P., et al.[2022]

From 1999 to 2005, there were 41,804 visits for musculoskeletal complaints, showing stable prescribing patterns for nonsteroidal anti-inflammatory drugs (NSAIDs), but a shift occurred as COX-2 inhibitors were initially used as substitutes for nonselective NSAIDs until safety concerns led to a decline in COX-2 prescriptions.

Following the withdrawal of some COX-2 inhibitors, there was a notable increase in the prescribing of nonselective NSAIDs and nonnarcotic analgesics, while opiate and adjuvant analgesics also saw increased usage, indicating a shift in pain management strategies without directly substituting for NSAIDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic prescribing for musculoskeletal complaints in the ambulatory care setting after the introduction and withdrawal of cyclooxygenase-2 inhibitors. Wilson, RD.[2015]

A cohort study involving 121 mining workers successfully used daily text messages to collect data on low back pain (LBP) over 5 weeks, achieving a high response rate of 93%.

The method allowed for effective clustering of LBP into subgroups based on pain intensity (low, medium, high) and helped characterize the episodic nature of LBP, demonstrating its potential for ongoing pain assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily text messages used as a method for assessing low back pain among workers. Burström, L., Jonsson, H., Björ, B., et al.[2016]

The musculoskeletal Digital Assessment Routing Tool (DART) was successfully developed and tested with 22 adult participants, resolving all serious usability issues and achieving a high mean satisfaction score of 84.3, indicating it is user-friendly and effective for self-assessment in musculoskeletal disorders.

The study demonstrated that DART can provide immediate care recommendations without errors, paving the way for future randomized controlled trials to evaluate its safety and effectiveness compared to traditional care methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool for Musculoskeletal Disorders: Iterative, Convergent Mixed Methods Study. Lowe, C., Browne, M., Marsh, W., et al.[2022]

The 'Relieve my back' smartphone application significantly reduced pain intensity and disability in office workers with chronic low back pain after six weeks of use, compared to a control group that received a placebo version.

Participants using the application also experienced a notable improvement in their quality of life, as measured by the Short-Form Health Survey, indicating its potential as an effective management tool for low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an innovative smartphone application for office workers with chronic non-specific low back pain: a pilot randomized controlled trial. Almhdawi, KA., Obeidat, DS., Kanaan, SF., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of using text message interventions for the management of musculoskeletal pain: a systematic review. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Agreement between telehealth and in-person assessment of patients with chronic musculoskeletal conditions presenting to an advanced-practice physiotherapy screening clinic. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Digital physiotherapy assessment vs conventional face-to-face physiotherapy assessment of patients with musculoskeletal disorders: A systematic review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Development and use of mobile messaging for individuals with musculoskeletal pain conditions: a scoping review protocol. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Use of eHealth technologies to enable the implementation of musculoskeletal Models of Care: Evidence and practice. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Estimating the population health burden of musculoskeletal conditions using primary care electronic health records. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool: Protocol for an Iterative Convergent Mixed Methods Study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Minimal clinical data sets for spine-related musculoskeletal disorders in primary care and outpatient settings: a scoping review protocol. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Analgesic prescribing for musculoskeletal complaints in the ambulatory care setting after the introduction and withdrawal of cyclooxygenase-2 inhibitors. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Daily text messages used as a method for assessing low back pain among workers. [2016]

11. Canada pubmed.ncbi.nlm.nih.gov

Usability Testing of a Digital Assessment Routing Tool for Musculoskeletal Disorders: Iterative, Convergent Mixed Methods Study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Efficacy of an innovative smartphone application for office workers with chronic non-specific low back pain: a pilot randomized controlled trial. [2022]