NCT05402514

Brief Summary

The overall aim of this project is to describe changes in pain and perceived shoulder dysfunction in patients with subacromial shoulder pain, following 3 months of digitally delivered first-line treatment containing exercise and patient education with support of a licensed physical therapist. The intervention, a digital first-line treatment for subacromial shoulder pain is a part of the public healthcare system in Sweden and all residents in the country can access the treatment. The treatment program is based on the existing evidence for treating subacromial shoulder pain and is inspired by specific exercises that have been documented to reduce the need for surgery in the patient group. The program focuses on strengthening the rotator cuff and the muscles stabilizing the scapula. The intervention procedure is similar to previous digital treatments by the same digital care provider and is thoroughly described in previous studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
682

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

May 30, 2022

Last Update Submit

November 20, 2023

Conditions

Keywords

Shoulder painRehabilitationPhysical Therapy ModalitiesTelerehabilitationExercise therapyPatient education as Topic

Outcome Measures

Primary Outcomes (1)

  • Pain Numeric Rating Scale (NRS)

    Shoulder pain will be assessed using NRS with the instructions "Mark on the scale your average pain from your shoulder in the past week", followed by a 0-10 scale where 0 is described as "No pain" and 10 described as "Unbearable". Higher scores means worse outcome.

    Weekly changes and baseline to 3 month follow-up

Secondary Outcomes (1)

  • Shoulder Pain and Disability Index (SPADI)

    Baseline and follow-up after 3 months

Interventions

The Joint Academy® (www.jointacademy.com) program for people with subacromial shoulder pain consist of two daily distributed and progressively adaptable exercises there are delivered through the app as videos with subtitles. Patient education is provided 2-3 times per week as short lessons in the app with a quiz following the text to ensure that the information is properly understood by the patients. An individual physical therapist is assigned to each patient with compulsory telephone or video consultations at the start of the treatment, at 6 weeks and at 3 months. An asynchronous chat function with the physical therapist is available during the treatment period as well as a peer support chat.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients eligible for the digital first-line treatment program for subacromial shoulder pain with given informed consent will be included in the study. General marketing through different media channels, the company website and word of mouth will be used to recruit patients for the treatment. Patients will not be required to have a doctor or physical therapist referral to enter the treatment. Patients without a prior diagnosis will be assessed and diagnosed by a physical therapist per phone or video call.

You may qualify if:

  • Subacute or long term subacromial pain

You may not qualify if:

  • acute pain caused by trauma within the past 3 months that has not yet been physically examined
  • signs of acute infection
  • suspected undiagnosed malignancy
  • radiculopathy from the neck
  • shortness of breath or chest pain combined with shoulder pain
  • Patients excluded from the program will be welcomed back into the treatment after a physical visit if medical professional conclude that they are eligible for physical therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Academy

Malmo, Skåne County, Sweden

Location

Related Publications (13)

  • Holmgren T, Hallgren HB, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. Br J Sports Med. 2014 Oct;48(19):1456-7. doi: 10.1136/bjsports-2014-e787rep.

    PMID: 25213604BACKGROUND
  • Lee AC. COVID-19 and the Advancement of Digital Physical Therapist Practice and Telehealth. Phys Ther. 2020 Jul 19;100(7):1054-1057. doi: 10.1093/ptj/pzaa079. No abstract available.

    PMID: 32343836BACKGROUND
  • Gohir SA, Eek F, Kelly A, Abhishek A, Valdes AM. Effectiveness of Internet-Based Exercises Aimed at Treating Knee Osteoarthritis: The iBEAT-OA Randomized Clinical Trial. JAMA Netw Open. 2021 Feb 1;4(2):e210012. doi: 10.1001/jamanetworkopen.2021.0012.

    PMID: 33620447BACKGROUND
  • Pieters L, Lewis J, Kuppens K, Jochems J, Bruijstens T, Joossens L, Struyf F. An Update of Systematic Reviews Examining the Effectiveness of Conservative Physical Therapy Interventions for Subacromial Shoulder Pain. J Orthop Sports Phys Ther. 2020 Mar;50(3):131-141. doi: 10.2519/jospt.2020.8498. Epub 2019 Nov 15.

    PMID: 31726927BACKGROUND
  • Haik MN, Alburquerque-Sendin F, Moreira RF, Pires ED, Camargo PR. Effectiveness of physical therapy treatment of clearly defined subacromial pain: a systematic review of randomised controlled trials. Br J Sports Med. 2016 Sep;50(18):1124-34. doi: 10.1136/bjsports-2015-095771. Epub 2016 Jun 10.

    PMID: 27288517BACKGROUND
  • Bjornsson Hallgren HC, Adolfsson LE, Johansson K, Oberg B, Peterson A, Holmgren TM. Specific exercises for subacromial pain. Acta Orthop. 2017 Dec;88(6):600-605. doi: 10.1080/17453674.2017.1364069. Epub 2017 Aug 16.

    PMID: 28812398BACKGROUND
  • Dahlberg LE, Dell'Isola A, Lohmander LS, Nero H. Improving osteoarthritis care by digital means - Effects of a digital self-management program after 24- or 48-weeks of treatment. PLoS One. 2020 Mar 4;15(3):e0229783. doi: 10.1371/journal.pone.0229783. eCollection 2020.

    PMID: 32130276BACKGROUND
  • Cottrell MA, Galea OA, O'Leary SP, Hill AJ, Russell TG. Real-time telerehabilitation for the treatment of musculoskeletal conditions is effective and comparable to standard practice: a systematic review and meta-analysis. Clin Rehabil. 2017 May;31(5):625-638. doi: 10.1177/0269215516645148. Epub 2016 May 2.

    PMID: 27141087BACKGROUND
  • Seron P, Oliveros MJ, Gutierrez-Arias R, Fuentes-Aspe R, Torres-Castro RC, Merino-Osorio C, Nahuelhual P, Inostroza J, Jalil Y, Solano R, Marzuca-Nassr GN, Aguilera-Eguia R, Lavados-Romo P, Soto-Rodriguez FJ, Sabelle C, Villarroel-Silva G, Gomolan P, Huaiquilaf S, Sanchez P. Effectiveness of Telerehabilitation in Physical Therapy: A Rapid Overview. Phys Ther. 2021 Jun 1;101(6):pzab053. doi: 10.1093/ptj/pzab053.

    PMID: 33561280BACKGROUND
  • Gava V, Ribeiro LP, Barreto RPG, Camargo PR. Effectiveness of physical therapy given by telerehabilitation on pain and disability of individuals with shoulder pain: A systematic review. Clin Rehabil. 2022 Jun;36(6):715-725. doi: 10.1177/02692155221083496. Epub 2022 Mar 1.

    PMID: 35230167BACKGROUND
  • Janela D, Costa F, Molinos M, Moulder RG, Lains J, Francisco GE, Bento V, Cohen SP, Correia FD. Asynchronous and Tailored Digital Rehabilitation of Chronic Shoulder Pain: A Prospective Longitudinal Cohort Study. J Pain Res. 2022 Jan 8;15:53-66. doi: 10.2147/JPR.S343308. eCollection 2022.

    PMID: 35035234BACKGROUND
  • Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.

    PMID: 33275908BACKGROUND
  • Worner T, Sirard P, Nero H, Horder H, Misini Ignjatovic M, Eek F. Changes in pain and disability in patients with shoulder pain after three months of digitally delivered exercise and patient education. J Rehabil Med. 2023 Nov 14;55:jrm9415. doi: 10.2340/jrm.v55.9415.

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leif E Dahlberg, Professor

    Arthro Therapeutics /Joint Academy

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2022

First Posted

June 2, 2022

Study Start

October 5, 2021

Primary Completion

June 24, 2022

Study Completion

June 24, 2022

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations