A Pilot Study on App-based Treatment Combining Physical Exercise, Graded Activity, and Pain Journaling for Patients with Spinal Complaints

NCT06896812 | Not Yet Recruiting DMC

• 1 other identifier: Z2024093
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: The prevalence of spinal complaints such as low back pain is rising due to factors like aging, sedentary lifestyle, and obesity. Traditional conservative treatments include physical therapy and lifestyle modifications. The digital revolution in healthcare has introduced app-based interventions as a promising alternative. Rationale: Given the high burden of spinal complaints and the associated economic impact, there is need for effective and efficient treatment modalities. This is especially evident in Western healthcare systems with growing demands and limited resources due to the changing demographic of the population. An app-based approach offers a viable solution by combining evidence-based conservative treatments. Moreover, an app-based treatment could offer personalized treatment, real-time feedback, and enhanced patient engagement at lower costs, presents as a viable solution. Objective: This pilot study aims to evaluate the efficacy of an app-based treatment method combining physical exercise, graded activity, and pain journaling for patients with spinal complaints who will otherwise receive physical therapy, general lifestyle advice, or an expectant treatment in current practice. Study design: Single center prospective study. Study population: A total of 30 patients over 18 years old suffering from spinal complaints for which in current practice physical therapy, general lifestyle advice, or an expectant treatment will be advised. Intervention: An app-based treatment consisting of a combination of physical exercise, graded activity, and pain journaling. Main study parameters/endpoints: Primary endpoint: Patients' experience and satisfaction qualitatively, measured using semi-structured face-to-face interviews after three months of treatment. Secondary endpoints: Quality of Life (Qol) measured with the EuroQol 5 dimensions (EQ-5D-5L) at baseline, one, two and three months after starting the intervention. Change in back- and leg-pain, measured with the Visual Analogue Scale (VAS). Change in disability, measured with the Oswestry Disability Index (ODI). Change in catastrophizing of pain, measured with the Pain Catastrophizing Scale (PCS). Change in lost productivity, measured with patient reported missed working days. Healthcare consumption, measured with number of visits to doctor or paramedic. Change in Body Mass Index, measured using patients' input on length and weight. Adherence of participants measured using frequency of patients' input in the mobile application. Safety measured using the (serious) adverse events ((S)AE). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The nature and extent of the burden associated with participation in the app-based treatment program primarily involve adherence to recommended activities and inputting relevant health data. Given that the investigators are integrating existing treatment modalities, such as physical exercise, graded activity, and pain journaling, the risks associated with participation are minimal, as these interventions are already deemed safe and widely practiced. The responsibility for determining each patient's suitability for participation in this study lies with the referring physician. Participants can expect benefits such as improved pain management, enhanced physical function, and better overall well-being.

Conditions

Back Pain; Spinal Disease; Spinal Condition

Keywords

conservative; app; spine; ehealth; e-health; back pain; graded activity

Outcome Measures

Primary Outcomes (1)

• The primary outcome is qualitative information on the viability, feasibility, effectiveness, and safety.

  The data used is gathered by evaluating the patients' experience and satisfaction qualitatively, using semi-structured face-to-face interviews at three months follow-up.

  3 months

Secondary Outcomes (8)

• Secondary outcome, Quality of Life

  3 months

• Secondary outcome, pain

  3 months

• Secondary outcome, disablity

  3 months

• Secondary outcome, productivity

  3 months

• Secondary outcome, BMI

  3 months

Study Arms (1)

App-based treatment consisting of physical exercise, graded activity, and pain journaling

EXPERIMENTAL

An app-based treatment consisting of a combination of physical exercise, graded activity, and pain journaling.

Device: The app-based treatment consists of a combination of physical exercise, graded activity, and pain journaling.

Interventions

The app-based treatment consists of a combination of physical exercise, graded activity, and pain journaling. DEVICE

The app-based treatment consists of a combination of physical exercise, graded activity, and pain journaling. The app will be installed on the participant's mobile device. The app will be used anonymously, and patients use their unique study code to activate the app. The content and user-interface of the app-based treatment were developed in collaboration with healthcare professionals for relevant medical specialties, including orthopedic surgery, neurosurgery, neurology, physiotherapy, and rehabilitation. The content is based on expert opinion from these fields. Additionally, there is scientific evidence indicating that the treatments used within the app are safe and effective. The app has been tested for usability and functionality by both professionals and laypersons, including individuals with back pain.

App-based treatment consisting of physical exercise, graded activity, and pain journaling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients visiting the spine-centre at Zuyderland Medical Centre.
• Suffering from spinal complaints for which in current practice physical therapy, general lifestyle advice, or an expectant treatment would be advised.
• Minimum age of 18 years.
• Psychosocially, mentally, and physically able to fully comply with this study protocol.
• Informed consent prior to this study.

You may not qualify if:

• Requiring a specific intervention (e.g., surgery, pain treatment, rehabilitation, bracing)
• Inadequate command of the Dutch language.
• Digitally illiterate or otherwise unable to use an application on a mobile phone.
• Active spinal infection.
• Immature bone (ongoing growth).
• Active malignancy.
• Pregnancy.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• The eHealth Project B.V.: collaborator

Related Publications (20)

• Nordstoga AL, Aasdahl L, Sandal LF, Dalager T, Kongsvold A, Mork PJ, Nilsen TIL. The Role of Pain Duration and Pain Intensity on the Effectiveness of App-Delivered Self-Management for Low Back Pain (selfBACK): Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Aug 31;11:e40422. doi: 10.2196/40422.

  PMID: 37656023 BACKGROUND

• Bardal EM, Sandal LF, Nilsen TIL, Nicholl BI, Mork PJ, Sogaard K. Do age, gender, and education modify the effectiveness of app-delivered and tailored self-management support among adults with low back pain?-Secondary analysis of the selfBACK randomised controlled trial. PLOS Digit Health. 2023 Sep 22;2(9):e0000302. doi: 10.1371/journal.pdig.0000302. eCollection 2023 Sep.

  PMID: 37738237 BACKGROUND

• Friese, S., Qualitative data analysis with ATLAS. ti. 2019.

  BACKGROUND

• Hasenohrl T, Windschnurer T, Dorotka R, Ambrozy C, Crevenna R. Prescription of individual therapeutic exercises via smartphone app for patients suffering from non-specific back pain : A qualitative feasibility and quantitative pilot study. Wien Klin Wochenschr. 2020 Mar;132(5-6):115-123. doi: 10.1007/s00508-020-01616-x. Epub 2020 Feb 14.

  PMID: 32060724 BACKGROUND

• Lau AY, Piper K, Bokor D, Martin P, Lau VS, Coiera E. Challenges During Implementation of a Patient-Facing Mobile App for Surgical Rehabilitation: Feasibility Study. JMIR Hum Factors. 2017 Dec 7;4(4):e31. doi: 10.2196/humanfactors.8096.

  PMID: 29217504 BACKGROUND

• Meinert E, Rahman E, Potter A, Lawrence W, Van Velthoven M. Acceptability and Usability of the Mobile Digital Health App NoObesity for Families and Health Care Professionals: Protocol for a Feasibility Study. JMIR Res Protoc. 2020 Jul 22;9(7):e18068. doi: 10.2196/18068.

  PMID: 32706703 BACKGROUND

• Sandal LF, Bach K, Overas CK, Svendsen MJ, Dalager T, Stejnicher Drongstrup Jensen J, Kongsvold A, Nordstoga AL, Bardal EM, Ashikhmin I, Wood K, Rasmussen CDN, Stochkendahl MJ, Nicholl BI, Wiratunga N, Cooper K, Hartvigsen J, Kjaer P, Sjogaard G, Nilsen TIL, Mair FS, Sogaard K, Mork PJ. Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1288-1296. doi: 10.1001/jamainternmed.2021.4097.

  PMID: 34338710 BACKGROUND

• Snoswell CL, Chelberg G, De Guzman KR, Haydon HH, Thomas EE, Caffery LJ, Smith AC. The clinical effectiveness of telehealth: A systematic review of meta-analyses from 2010 to 2019. J Telemed Telecare. 2023 Oct;29(9):669-684. doi: 10.1177/1357633X211022907. Epub 2021 Jun 29.

  PMID: 34184580 BACKGROUND

• Loohuis AMM, Van Der Worp H, Wessels NJ, Dekker JH, Slieker-Ten Hove MCP, Berger MY, Vermeulen KM, Blanker MH. Cost-effectiveness of an app-based treatment for urinary incontinence in comparison with care-as-usual in Dutch general practice: a pragmatic randomised controlled trial over 12 months. BJOG. 2022 Aug;129(9):1538-1545. doi: 10.1111/1471-0528.17191. Epub 2022 May 31.

  PMID: 35460163 BACKGROUND

• Mahtta D, Daher M, Lee MT, Sayani S, Shishehbor M, Virani SS. Promise and Perils of Telehealth in the Current Era. Curr Cardiol Rep. 2021 Jul 16;23(9):115. doi: 10.1007/s11886-021-01544-w.

  PMID: 34269884 BACKGROUND

• Krebs P, Duncan DT. Health App Use Among US Mobile Phone Owners: A National Survey. JMIR Mhealth Uhealth. 2015 Nov 4;3(4):e101. doi: 10.2196/mhealth.4924.

  PMID: 26537656 BACKGROUND

• van Tulder MW, Koes BW, Bouter LM. Conservative treatment of acute and chronic nonspecific low back pain. A systematic review of randomized controlled trials of the most common interventions. Spine (Phila Pa 1976). 1997 Sep 15;22(18):2128-56. doi: 10.1097/00007632-199709150-00012.

  PMID: 9322325 BACKGROUND

• Bredow J, Bloess K, Oppermann J, Boese CK, Lohrer L, Eysel P. [Conservative treatment of nonspecific, chronic low back pain : Evidence of the efficacy - a systematic literature review]. Orthopade. 2016 Jul;45(7):573-8. doi: 10.1007/s00132-016-3248-7. German.

  PMID: 27075679 BACKGROUND

• Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 10.7326/M16-2459. Epub 2017 Feb 14.

  PMID: 28192793 BACKGROUND

• Weiner DK, Kim YS, Bonino P, Wang T. Low back pain in older adults: are we utilizing healthcare resources wisely? Pain Med. 2006 Mar-Apr;7(2):143-50. doi: 10.1111/j.1526-4637.2006.00112.x.

  PMID: 16634727 BACKGROUND

• Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA. 2008 Feb 13;299(6):656-64. doi: 10.1001/jama.299.6.656.

  PMID: 18270354 BACKGROUND

• Smith E, Hoy DG, Cross M, Vos T, Naghavi M, Buchbinder R, Woolf AD, March L. The global burden of other musculoskeletal disorders: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Aug;73(8):1462-9. doi: 10.1136/annrheumdis-2013-204680. Epub 2014 Mar 3.

  PMID: 24590181 BACKGROUND

• Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.

  PMID: 29573870 BACKGROUND

• Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.

  PMID: 22231424 BACKGROUND

• Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

  PMID: 24665116 BACKGROUND

MeSH Terms

Conditions

Back Pain; Spinal Diseases; Alzheimer Disease

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ruud Droeghaag, MD, PhD

CONTACT

088 459 7777; r.droeghaag@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study design: Single center prospective study. Study population: A total of 30 patients over 18 years old suffering from spinal complaints for which in current practice physical therapy, general lifestyle advice, or an expectant treatment will be advised.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03