Shoulder PainNCT05402514
Digitally Delivered Exercise and Education Treatment for Shoulder Pain: 3 Months Follow-up
An observational study of Shoulder Pain and Subacromial Pain Syndrome, run by Joint Academy at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Subacromial Pain Syndrome
- What is being tested?
- Digitally delivered exercise and education treatment Joint Academy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 682 participants
- Where
- 1 siteSweden
- Study dates
- 5 Oct 2021to 24 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Subacute or long term subacromial pain
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Musculoskeletal conditions are identified by the Global Burden of Disease Study as a leading cause of global morbidity. Estimates of the need for rehabilitation services show that at least one in every three people in the world needs rehabilitation at some point in their life course. As disability becomes an increasingly large component of disease burden and health expenditure, greater research and development investment is needed to identify new, more effective intervention strategies.
Traditional face-to-face interventions present barriers, such as limited access and lack of flexibility, which may limit the patients' adherence with the interventions. Digital delivery of the management program may be one way of overcoming such barriers. Telerehabilitation has been successfully implemented and compared to conventional treatments, where adherence to digital treatment has been shown to be associated with an improvement in function and pain in a variety of musculoskeletal(MSK) conditions. The evidence for digital delivered rehabilitation for shoulder pain indicates that it may be a promising way of delivering treatment for the patient group but is still at an early stage and more research is needed.
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. A further aim is to compare changes in outcomes between patients with different demographics, and health- and treatment related factors.
The study will be an observational, registry-based longitudinal study with consecutively recruited participants. Socio-demographic data will be collected at baseline including variables such as age, sex, weight, height, highest level of education reached and current job status. All data will be collected through digitally delivered questionnaires in the app at baseline and 3 months besides pain levels, which will be reported weekly until treatment week 6. All outcomes will be self-assessed through the digital program interface. The study will be presented in accordance to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
- Conditions
- Shoulder Pain, Subacromial Pain Syndrome
- Being tested
- Digitally delivered exercise and education treatment Joint Academy
- Keywords
- Shoulder pain, Rehabilitation, Physical Therapy Modalities, Telerehabilitation, Exercise therapy, Patient education as Topic
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally delivered exercise and education treatment Joint AcademyBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly changes and baseline to 3 month follow-up
Secondary outcomes (1)
Shoulder Pain and Disability Index (SPADI)
The self administered Shoulder Pain and Disability Index (SPADI) will be collected at baseline and at 3 months to assess shoulder function. The questionnaire contains 13 items and the score is expressed as percentage where 0 is the best score and 100 the worst score. A higher score means more disability.
Measured: Baseline and follow-up after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start5 Oct 2021
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Academy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Leif E Dahlberg, Professor, Study director, Arthro Therapeutics /Joint Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402514
- Sponsor's protocol ID
- Shoulder3months
- Status last verified
- Nov 2023
- First submitted
- 30 May 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25213604Lee 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.
PubMed 32343836Gohir 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.
PubMed 33620447Pieters 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.
PubMed 31726927Haik 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.
PubMed 27288517Bjornsson 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.
PubMed 28812398Dahlberg 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.
PubMed 32130276Cottrell 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.
PubMed 27141087Seron 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.
PubMed 33561280Gava 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.
PubMed 35230167Janela 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.
PubMed 35035234Cieza 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.
PubMed 33275908Worner 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.
PubMed 38835146
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally Delivered Exercise and Education Treatment for Shoulder Pain: 3 Months Follow-up
- ClinicalTrials.gov ID
- NCT05402514
- Acronym / sponsor ID
- Shoulder3months
- Conditions
- Shoulder Pain, Subacromial Pain Syndrome
- Keywords
- Shoulder pain, Rehabilitation, Physical Therapy Modalities, Telerehabilitation, Exercise therapy, Patient education as Topic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Joint AcademyIndustry (pharma, biotech, devices)
- Collaborators
- Lund University
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Musculoskeletal conditions are identified by the Global Burden of Disease Study as a leading cause of global morbidity. Estimates of the need for rehabilitation services show that at least one in every three people in the world needs rehabilitation at some point in their life course. As disability becomes an increasingly large component of disease burden and health expenditure, greater research and development investment is needed to identify new, more effective intervention strategies.
Traditional face-to-face interventions present barriers, such as limited access and lack of flexibility, which may limit the patients' adherence with the interventions. Digital delivery of the management program may be one way of overcoming such barriers. Telerehabilitation has been successfully implemented and compared to conventional treatments, where adherence to digital treatment has been shown to be associated with an improvement in function and pain in a variety of musculoskeletal(MSK) conditions. The evidence for digital delivered rehabilitation for shoulder pain indicates that it may be a promising way of delivering treatment for the patient group but is still at an early stage and more research is needed.
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. A further aim is to compare changes in outcomes between patients with different demographics, and health- and treatment related factors.
The study will be an observational, registry-based longitudinal study with consecutively recruited participants. Socio-demographic data will be collected at baseline including variables such as age, sex, weight, height, highest level of education reached and current job status. All data will be collected through digitally delivered questionnaires in the app at baseline and 3 months besides pain levels, which will be reported weekly until treatment week 6. All outcomes will be self-assessed through the digital program interface. The study will be presented in accordance to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Subacute or long term subacromial pain
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digitally delivered exercise and education treatment Joint AcademyThe 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. | Behavioural | – |
Primary outcome
Pain Numeric Rating Scale (NRS)
Time frame: Weekly changes and baseline to 3 month follow-up
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.
1 secondary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline and follow-up after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Background: PubMed 25213604Holmgren 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.
- Background: PubMed 32343836Lee 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.
- Background: PubMed 33620447Gohir 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.
- Background: PubMed 31726927Pieters 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.
- Background: PubMed 27288517Haik 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.
- Background: PubMed 28812398Bjornsson 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.
- Background: PubMed 32130276Dahlberg 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.
- Background: PubMed 27141087Cottrell 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.
- Background: PubMed 33561280Seron 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.
- Background: PubMed 35230167Gava 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.
- Background: PubMed 35035234Janela 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.
- Background: PubMed 33275908Cieza 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif E Dahlberg, Professor study director
Arthro Therapeutics /Joint Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Subacromial Pain Syndrome, run by Joint Academy at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numeric Rating Scale (NRS) (time frame: Weekly changes and baseline to 3 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402514, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.