Telerehabilitation for Lower Back Pain
(ARBOR-Th Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Recent lumbar surgery, Pregnancy, Serious pathology, Neurological disorder, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Physical therapy is the first line of treatment for patients with low back pain (LBP) and has been shown to be a cost-effective method for improving pain and disability in patients with chronic LBP; however, despite this effectiveness, only 7-13% of patients go on to receive physical therapy services with patients in rural communities being especially limited to do lack of provider availability, transportation, and missed work time leading to greater rates of LBP-related disability and opioid consumption. With the rapid emergence of digital treatment approaches to physical therapy (i.e., telerehabilitation), access could be improved by reducing or eliminating many barriers that patients report; however, it is unclear how to appropriately incorporate digital treatment approaches into existing health care models. The investigators propose a single-masked prospective randomized clinical trial conducted at a health system serving rural communities to determine the effectiveness of innovative risk-stratified telerehabilitation versus standard educational control for patients with chronic LBP that will match individual patients with specific physical therapy delivery (physical therapy telehealth visits or psychologically informed physical therapy telehealth visits) based on the patient's psychosocial risk of poor outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Telerehabilitation for Lower Back Pain?
Research shows that telerehabilitation can effectively manage chronic low back pain by providing remote access to therapy, which is especially beneficial for those in low-resource areas. Studies indicate that telerehabilitation is as effective as traditional clinic-based therapy in reducing pain and improving health outcomes.
12345Is telerehabilitation safe for humans?
Telerehabilitation is generally considered safe for humans, as it allows remote access to medical treatments and ongoing monitoring, which can be beneficial for patients, especially those in remote areas.
12367How does the treatment Telerehabilitation differ from other treatments for lower back pain?
Telerehabilitation is unique because it allows patients to receive treatment remotely, making it accessible for those who are physically or economically disadvantaged. It facilitates multidisciplinary management and provides the opportunity for early intervention, ongoing monitoring, and cost savings, especially in low-resource areas.
12578Eligibility Criteria
This trial is for people with chronic lower back pain (LBP) who live in rural areas and have trouble accessing physical therapy due to provider availability, transportation issues, or work conflicts. Participants should be willing to engage in telerehabilitation.Inclusion Criteria
I have been diagnosed with chronic lower back pain.
I am 18 years old or older.
I experience moderate to severe pain and disability.
Exclusion Criteria
I had lumbar spine surgery in the last 6 months.
I have a severe movement disorder or a serious mental health condition like schizophrenia.
Participant Groups
The study tests the effectiveness of telerehabilitation—a way to do physical therapy over the internet—against standard educational materials for managing chronic LBP. It will also see if matching patients with specific types of telehealth visits based on their psychological risk improves outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: TelerehabilitationExperimental Treatment1 Intervention
Based on prior STarT Back Tool (SBTS) screening risk stratification, participants in the risk-informed telerehabilitation group will receive subsequent care using an evidence-based treatment protocol designed for video visits to be informed by a participant's baseline risk score with elements ranging from standard physical therapy telehealth visits (low-to-medium risk) to psychological informed physical therapy (PIPT) telehealth visits (high-risk).
The SBTS is a short questionnaire that assesses an individual's physical, psychosocial, and psychological risk factors for chronic back pain that can be improved with treatment.
Group II: Educational ControlActive Control1 Intervention
Patients randomized to the educational control group will receive registered access to a study website with access to evidence-based education for patients with chronic LBP. Each participant will have unique login credentials to allow for tracking of individual patient use. The website will include important education on the etiology of chronic LBP and evidence-based suggestions for self-management of symptoms. Education will focus on the importance of maintaining healthy levels of physical activity and avoiding bedrest. To promote increased physical activity levels, the website will also include pictures and videos of common exercises targeting the lumbopelvic region that patients can perform independently without the need for exercise equipment.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Johns Hopkins University School of MedicineBaltimore, MD
TidalhealthSalisbury, MD
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
Tidalhealth, Inc.Collaborator
Maryland Rural Health AssociationCollaborator
Medstar Health Research InstituteCollaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Collaborator
References
Virtually Administered Intervention Through Telerehabilitation for Chronic Non-specific Low Back Pain: A Review of Literature. [2023]The most frequent reason for individuals to seek medical attention in both primary care settings and immediate care centers is low back pain (LBP). Over a duration of time, the disability caused by lower back pain has risen enough, particularly in countries with low or moderate incomes. In the coming years, there may be an increase in LBP-related impairment and expenses in countries with low or medium incomes, particularly when fragile medical systems are unable to handle this growing load. Hence, this review focuses on the effectiveness of telerehabilitation (TR) on LBP. The significant advantages of TR may include greater interaction and remote accessibility to medical treatments. The exchange of knowledge and health information is made possible through a more effective interaction, which benefits patients, families, carers, physicians, and researchers. People who live in distant places now have the opportunity to get medical attention assisting families in caring for patients with poor responsiveness. In addition, it provides the potential for prompt detection, the beginning of treatment in the midst of an emergency, a shorter stay in the hospital, ongoing monitoring of those at risk, and overall time and expense savings. Therefore, this study supports the application of TR in conditions of LBP for early management and relief of pain for patients in low-resource areas.
The Clinical and Cost-Effectiveness of Telerehabilitation for People With Nonspecific Chronic Low Back Pain: Randomized Controlled Trial. [2023]Telerehabilitation can facilitate multidisciplinary management for people with nonspecific chronic low back pain (NCLBP). It provides health care access to individuals who are physically and economically disadvantaged.
Physical Therapists' Opinion of E-Health Treatment of Chronic Low Back Pain. [2021](1) Background: Using new technologies to manage home exercise programmes is an approach that allows more patients to benefit from therapy. The objective of this study is to explore physical therapists' opinions of the efficacy and disadvantages of implementing a web-based telerehabilitation programme for treating chronic low back pain (CLBP). (2) Methods: Nineteen physical therapists from academic and healthcare fields in both the public and private sector participated in the qualitative study. Texts extracted from a transcript of semi-structured, individual, in-depth interviews with each consenting participant were analysed to obtain the participants' prevailing opinions. The interviews lasted approximately 40 min each. The participants' responses were recorded. (3) Results: The results suggest that telerehabilitation can only be successful if patients become actively involved in their own treatment. However, exercise programmes for LBP are not always adapted to patient preferences. New technologies allow physical therapists to provide their patients with the follow-up and remote contact they demand, but long-term adherence to treatment stems from knowledge of the exercises and the correct techniques employed by the patients themselves. (4) Conclusions: Physical therapists treating patients with chronic non-specific low back pain believe that new technologies can provide highly effective means of reaching a greater number of patients and achieving significant savings in healthcare costs, despite the limitations of a telerehabilitation approach in developing an appropriate and effective patient-based physiotherapy programme.
Comparative Efficacy of Clinic-Based and Telerehabilitation Application of Mckenzie Therapy in Chronic Low-Back Pain. [2020]Studies on validation of telerehabilitation as an effective platform to help manage as well as reduce burden of care for Low-Back Pain (LBP) are sparse. This study compared the effects of Telerehabilitation-Based McKenzie Therapy (TBMT) and Clinic-Based McKenzie Therapy (CBMT) among patients with LBP. Forty-seven consenting patients with chronic LBP who demonstrated 'directional preference' for McKenzie Extension Protocol (MEP) completed this quasi experimental study. The participants were assigned into either the CBMT or TBMT group using block permuted randomization. Participants in the CBMT and TBMT groups received MEP involving a specific sequence of lumbosacral repeated movements in extension aimed to centralize, decrease, or abolish symptoms, thrice weekly for eight weeks. TBMT is a comparable version of CBMT performed in the home with the assistance of a mobile phone app. Outcomes were assessed at the 4th and 8th weeks of the study in terms of Pain Intensity (PI), Back Extensors Muscles' Endurance (BEME), Activity Limitation (AL), Participation Restriction (PR), and General Health Status (GHS). Data were analyzed using descriptive and inferential statistics. Alpha level was set at p< 0.05. Within-group comparison across baseline, 4th and 8th weeks indicate that both CBMT and TBMT had significant effects on PI (p=0.001), BEME (p=0.001), AL (p=0.001), PR (p=0.001) and GHS (p=0.001) respectively. However, there were no significant differences (p>0.05) in the treatment effects between TBMT and CBMT, except for 'vitality' (p=0.011) scale in the GHS where TBMT led to significantly higher mean score. Mobile-app platform of the McKenzie extension protocol has comparable clinical outcomes with the traditional clinic-based McKenzie Therapy, and thus is an effective supplementary platform for care of patients with low-back pain.
The effect of video exercise-based telerehabilitation on clinical outcomes, expectation, satisfaction, and motivation in patients with chronic low back pain. [2022]The efficacy of exercise-based telerehabilitation in chronic low back pain (CLBP) has not been well studied. To our knowledge, no other studies have investigated the efficacy of video exercise-based telerehabilitation software in the remote management of home exercises in patients with CLBP.
Remote Versus in-Person Exercise Instruction for Chronic Nonspecific Low Back Pain Lasting 12 Weeks or Longer: A Randomized Clinical Trial. [2021]Low back pain is a common health problem. We compared the effects of a remote exercise instruction with in-person exercise instruction on the pain and disability of people with nonspecific low back pain for more than 12 weeks.
In non-specific low back pain, is an exercise program carried out through telerehabilitation as effective as one carried out in a physiotherapy center? A controlled randomized trial. [2023]s:The effectiveness of telerehabilitation (TLRH) in patients with non-specific low back pain (NLBP) remains unknown. No study till date has investigated the efficacy of a mobile-based TLRH in patients with NLBP.
Telerehabilitation for the treatment in chronic low back pain: A randomized controlled trial. [2023]Although there is growth in the approach to telerehabilitation (TLRH) in different pathologies, research on TLRH for the management of low back pain is scarce and controversial. Thus, the purpose of this study was to analyze whether a TLRH program is as effective as a clinical exercise program in improving pain and different functional variables in patients with nonspecific low back pain (NLBP).