Subacromial Pain SyndromediSAIDNCT06276192
Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care
A study testing Digital Physiotherapy (diSAID) and Traditional Physiotherapy in people with Subacromial Pain Syndrome and Shoulder Pain, run by Region Östergötland at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Pain Syndrome, Shoulder Pain, Rotator Cuff Syndrome
- What is being tested?
- Digital Physiotherapy (diSAID) and Traditional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 26 Feb 2024to 26 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- Pain duration >2 weeks
- Lateral shoulder pain (C5 dermatome)
- At least three positive tests as follows:
- Painful arc
- External rotation resistance test
Show all 9Show fewer
- Jobe's test
- Neer's impingement sign
- Hawkin's-Kennedy's impingement test
Who cannot join
- Symptoms are related to a traumatic event in the last 6 months with suspected rotator cuff tear, dislocation or fracture.
- Clinical features of cervical radiculopathy
- Clinical features of Adhesive capsulitis
- The patient does not understand or can not read Swedish
- The patient has no access to BankID
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Anna Petersson
Linköping, SE 58191
Anna Petersson, PhD student, +46101031053, anna.h.petersson@regionostergotland.se
Teresa Holmgren, PhD, +46101034158, Teresa.Holmgren@regionostergotland.se
About this study
Official title: Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Traditional Physiotherapy Treatment in Primary Care - a Non-Inferiority Randomised Controlled Trial
The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.
The main question this clinical trial aims to answer are:
- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care?
Read the detailed description
Subacromial pain is the most common shoulder complaints in the general population. The pathology is multifactorial and mainly explained by pain generated from structures in the space between the caput humeri and acromion, especially the bursa and tendons of the rotator cuff. Exercises have positive effects on shoulder function, pain and satisfaction in patients with subacromial pain and is according to current evidence the primary treatment for this condition. Surgery and exercise have been shown to have an equivalent positive effect and it is possible to avoid surgery with specific training. This means that the motive for surgery has become increasingly questionable. Despite this, many patients undergo surgery without having taken part in specific supervised training and the selection of patient's prior to surgery is still inadequate. One reason for this may be that resources in healthcare are limited. Supervised training with physical visits over a longer period of time can be difficult for the primary care to offer. This require demands on physiotherapists' skills, time and resources.
Clinical studies with digital solutions are increasing and occur in several areas of healthcare. Digital interventions have proven to be effective in several diseases and disorders and can increase access to health education in a cost-effective way.
This is a single-blind, prospective, non-inferiority randomised controlled trial, designed to evaluate the feasibility and efficacy of a digital physiotherapy treatment compared to traditional physiotherapy for patients with subacromial pain in a primary care setting. The hypothesis is that clinical outcomes of the digital physiotherapy intervention for patients with subacromial pain can be effective and non-inferior compared to traditional physiotherapy in primary care.
Further the study objective is to evaluate the cost-effectiveness and impact on the environment using a digital intervention.
Sample size calculation: The estimated sample size is based the primary outcome SPADI assuming α = 0.05, β = 0.2 with a given power of 80% and a standard deviation of 18. A non-inferiority margin is set to 10 points (δ = -10) in total SPADI scores. Consequently, 82 patients have to be included, 41 per treatment group. Due to drop outs an over recruitment is planned (Total achievement of 60 per group).
We will use unpaired t-tests to compare the effect of treatment between the different groups regarding the primary outcome shoulder function and pain evaluated with SPADI after 3 months. The H0 hypothesis will be rejected and the H1 hypothesis will be accepted if a significant difference is proven. H0 is also rejected if non-inferiority of digital physiotherapy to traditional physiotherapy is proven. This is declared when the upper confidence limit of the one-sided confidence interval for the mean change of SPADI is lower than the selected non-inferiority margin (δ = -10).
(H0 : μA - μB ≤ -δ; H1 : μA - μB ≥ -δ).
Method:
Patients with subacromial pain are recruited from five different physiotherapy units in county of Region Östergötland, in Sweden. All patients receives an in-person evaluation performed by physiotherapists in primary care to ensure that potential participants meet the eligibility criteria. Participants available for recruitment due to study criteria's are assigned randomly to 1) Digital physiotherapy group 2) Traditional physiotherapy group. All participants will be followed-up after three months, six months and two years after the received intervention.
- Being tested
- Digital Physiotherapy (diSAID), Traditional Physiotherapy
- Keywords
- Shoulder pain, Subacromial pain, Digital care, Digital health intervention, Physiotherapy, Primary care
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Physiotherapy (diSAID)Other
The diSAID is developed by the research group and is a modified version of a previously tested exercise program for patients with subacromial pain. The diSAID is distributed in three stages with; Information about subacromial pain, effects of exercise, pain management and ergonomics in everyday living and at work. The training includes exercises for the rotator cuff and scapular stabilizers as well as posterior shoulder stretch. The exercises are performed 1 time/day during twelve weeks with a progression of dose, load and complexity continuously. Pain while performing the exercise program is accepted up until NRS 5 out of 10.
During ongoing treatment, there is the opportunity for counselling, individualization of exercises, adjustment of dose and load based on stated instructions from the treating physiotherapist.
Adherence, levels of pain and function is reported continuously by the patient via the digital platform.
Traditional PhysiotherapyOther
Patients in the active control group are offered the usual treatment practice that is currently offered by physiotherapists in primary care. No predetermined directives for the active control group are defined prior to the study and can contain; home exercise programs, manual therapy and other techniques. The treating physiotherapists in this group are not involved in the digital treatment. The choice of interventions, amounts of visits and adherence is checked retrospectively via patient data and medical records.
| Study group | Role | What they receive |
|---|---|---|
| Digital Physiotherapy (diSAID) | Experimental | The digital physiotherapy group receives the digital Shoulder Aid (diSAID) strategy available via a web application. For three months, this group will complete a home-based rehabilitation programme containing education and evidence based exercises for patients with subacromial pain tutored by videos, images and instructions.The treatment is standardized but can be customized by a responsible physiotherapist during the whole treatment period. The Physiotherapist also deliver progression in the education and in the exercises during the whole treatment period and can support the patient via a messenger function in the web application. Receives: Other: Digital Physiotherapy (diSAID) |
| Traditional Physiotherapy | Active comparator | The traditional physiotherapy group receives current practice provided by physiotherapist in primary care with no predefined directives. The treating physiotherapist are instructed to treat their patient as they usually do. Receives: Other: Traditional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index has good psychometric properties with good reliability and validity. It consists of two sub-areas, the first area includes five questions for the estimation of pain and the second area includes eight questions about the impact on activity-related function of the upper extremity. Grading of pain or functional limitation goes from 0-10 where 0 indicates "no pain or disability" and 10 indicate "maximum pain or disability". The sub-areas generate individual scales as well as a common total score that is given as a percentage. Minimal Clinically Important Difference is 8 to 13 points and Minimal Detectible Change is 18 points.
Measured: Initial, 12 weeks, 6 months, 2 year
Secondary outcomes (4)
Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS)
Pain level is rated between 0-10, where 0 corresponds to "no pain" and 10 corresponds to "worst pain imaginable".
Measured: Initial, 12 weeks, 6 months, 2 year
Mean change in pain Self-Efficacy
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire assessing peoples capabilities and the confidence in performing activities while ongoing pain. Each task have an answer that range from "not at all confident" to "completely confident" on a 7-point scale. The questions includes capacity of specific functional tasks and beliefs of handling function demands. Added scores from all items gives a total score, ranging from 0 to 60. Higher scores reflect stronger self-efficacy. The PSEQ have good psychometric properties of reliability, validity, and internal consistency
Measured: Initial, 12 weeks, 6 months, 2 year
Mean change of self-reported rating of improvement
Patient Global Impression of Change (PGIC) is a self-report measure reflecting a patient's improvement and belief about the efficacy of treatment between two time points. In this version the patients rate their change as "Completely recovered" "Much improved" "Slightly improved" "Unchanged" or "Worse".
Measured: Initial, 12 weeks, 6 months, 2 year
Mean change of health-related quality of life
EuroQol Instrument (EQ5D index and EQ VAS) is a self-reported measure capturing five dimensions of health-related quality of life: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The questions are validated and reliable for a broad spectra of medical conditions. The instrument can also be used as a measure in Estimation of health utility and quality-adjusted life years (QALYs) and is a part of the economic evaluation of the digital treatment.
Measured: Initial, 12 weeks, 6 months, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start26 Feb 2024 (estimated)
- Primary completion26 Mar 2026 (estimated)
- Study completion26 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subacromial Pain SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-Inferiority Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Teresa Holmgren, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276192
- Sponsor's protocol ID
- 2023-01882-01
- Other IDs
- 2023
- Acronym
- diSAID
- Status last verified
- Jan 2024
- First submitted
- 18 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Vandvik PO, Lahdeoja T, Ardern C, Buchbinder R, Moro J, Brox JI, Burgers J, Hao Q, Karjalainen T, van den Bekerom M, Noorduyn J, Lytvyn L, Siemieniuk RAC, Albin A, Shunjie SC, Fisch F, Proulx L, Guyatt G, Agoritsas T, Poolman RW. Subacromial decompression surgery for adults with shoulder pain: a clinical practice guideline. BMJ. 2019 Feb 6;364:l294. doi: 10.1136/bmj.l294.
PubMed 30728120Holmgren 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 25213604Hallgren HC, Holmgren T, Oberg B, Johansson K, Adolfsson LE. A specific exercise strategy reduced the need for surgery in subacromial pain patients. Br J Sports Med. 2014 Oct;48(19):1431-6. doi: 10.1136/bjsports-2013-093233. Epub 2014 Jun 26.
PubMed 24970843Clausen MB, Merrild MB, Holm K, Pedersen MW, Andersen LL, Zebis MK, Jakobsen TL, Thorborg K. Less than half of patients in secondary care adheres to clinical guidelines for subacromial pain syndrome and have acceptable symptoms after treatment: A Danish nationwide cohort study of 3306 patients. Musculoskelet Sci Pract. 2021 Apr;52:102322. doi: 10.1016/j.msksp.2021.102322. Epub 2021 Jan 12.
PubMed 33485212
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Traditional Physiotherapy Treatment in Primary Care - a Non-Inferiority Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06276192
- Acronym / sponsor ID
- diSAID / 2023-01882-01
- Keywords
- Shoulder pain, Subacromial pain, Digital care, Digital health intervention, Physiotherapy, Primary care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 26 Feb 2024 (estimated)
- Primary completion
- 26 Mar 2026 (estimated)
- Study completion
- 26 Mar 2028 (estimated)
- First posted
- 23 Feb 2024 (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 goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.
The main question this clinical trial aims to answer are:
- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care?
Detailed description
Subacromial pain is the most common shoulder complaints in the general population. The pathology is multifactorial and mainly explained by pain generated from structures in the space between the caput humeri and acromion, especially the bursa and tendons of the rotator cuff. Exercises have positive effects on shoulder function, pain and satisfaction in patients with subacromial pain and is according to current evidence the primary treatment for this condition. Surgery and exercise have been shown to have an equivalent positive effect and it is possible to avoid surgery with specific training. This means that the motive for surgery has become increasingly questionable. Despite this, many patients undergo surgery without having taken part in specific supervised training and the selection of patient's prior to surgery is still inadequate. One reason for this may be that resources in healthcare are limited. Supervised training with physical visits over a longer period of time can be difficult for the primary care to offer. This require demands on physiotherapists' skills, time and resources.
Clinical studies with digital solutions are increasing and occur in several areas of healthcare. Digital interventions have proven to be effective in several diseases and disorders and can increase access to health education in a cost-effective way.
This is a single-blind, prospective, non-inferiority randomised controlled trial, designed to evaluate the feasibility and efficacy of a digital physiotherapy treatment compared to traditional physiotherapy for patients with subacromial pain in a primary care setting. The hypothesis is that clinical outcomes of the digital physiotherapy intervention for patients with subacromial pain can be effective and non-inferior compared to traditional physiotherapy in primary care.
Further the study objective is to evaluate the cost-effectiveness and impact on the environment using a digital intervention.
Sample size calculation: The estimated sample size is based the primary outcome SPADI assuming α = 0.05, β = 0.2 with a given power of 80% and a standard deviation of 18. A non-inferiority margin is set to 10 points (δ = -10) in total SPADI scores. Consequently, 82 patients have to be included, 41 per treatment group. Due to drop outs an over recruitment is planned (Total achievement of 60 per group).
We will use unpaired t-tests to compare the effect of treatment between the different groups regarding the primary outcome shoulder function and pain evaluated with SPADI after 3 months. The H0 hypothesis will be rejected and the H1 hypothesis will be accepted if a significant difference is proven. H0 is also rejected if non-inferiority of digital physiotherapy to traditional physiotherapy is proven. This is declared when the upper confidence limit of the one-sided confidence interval for the mean change of SPADI is lower than the selected non-inferiority margin (δ = -10).
(H0 : μA - μB ≤ -δ; H1 : μA - μB ≥ -δ).
Method:
Patients with subacromial pain are recruited from five different physiotherapy units in county of Region Östergötland, in Sweden. All patients receives an in-person evaluation performed by physiotherapists in primary care to ensure that potential participants meet the eligibility criteria. Participants available for recruitment due to study criteria's are assigned randomly to 1) Digital physiotherapy group 2) Traditional physiotherapy group. All participants will be followed-up after three months, six months and two years after the received intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-Inferiority Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Digital Physiotherapy (diSAID) | Experimental | Other: Digital Physiotherapy (diSAID)The digital physiotherapy group receives the digital Shoulder Aid (diSAID) strategy available via a web application. For three months, this group will complete a home-based rehabilitation programme containing education and evidence based exercises for patients with subacromial pain tutored by videos, images and instructions.The treatment is standardized but can be customized by a responsible physiotherapist during the whole treatment period. The Physiotherapist also deliver progression in the education and in the exercises during the whole treatment period and can support the patient via a messenger function in the web application. |
| Traditional Physiotherapy | Active comparator | Other: Traditional PhysiotherapyThe traditional physiotherapy group receives current practice provided by physiotherapist in primary care with no predefined directives. The treating physiotherapist are instructed to treat their patient as they usually do. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >18 years old
- Pain duration >2 weeks
- Lateral shoulder pain (C5 dermatome)
- Painful arc
- External rotation resistance test
Key exclusion criteria (5 listed)
- Symptoms are related to a traumatic event in the last 6 months with suspected rotator cuff tear, dislocation or fracture.
- Clinical features of cervical radiculopathy
- Clinical features of Adhesive capsulitis
- The patient does not understand or can not read Swedish
- The patient has no access to BankID
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 |
|---|---|---|
| Digital Physiotherapy (diSAID)The diSAID is developed by the research group and is a modified version of a previously tested exercise program for patients with subacromial pain. The diSAID is distributed in three stages with; Information about subacromial pain, effects of exercise, pain management and ergonomics in everyday living and at work. The training includes exercises for the rotator cuff and scapular stabilizers as well as posterior shoulder stretch. The exercises are performed 1 time/day during twelve weeks with a progression of dose, load and complexity continuously. Pain while performing the exercise program is accepted up until NRS 5 out of 10. During ongoing treatment, there is the opportunity for counselling, individualization of exercises, adjustment of dose and load based on stated instructions from the treating physiotherapist. Adherence, levels of pain and function is reported continuously by the patient via the digital platform. | Other | Digital Physiotherapy (diSAID) |
| Traditional PhysiotherapyPatients in the active control group are offered the usual treatment practice that is currently offered by physiotherapists in primary care. No predetermined directives for the active control group are defined prior to the study and can contain; home exercise programs, manual therapy and other techniques. The treating physiotherapists in this group are not involved in the digital treatment. The choice of interventions, amounts of visits and adherence is checked retrospectively via patient data and medical records. | Other | Traditional Physiotherapy |
Primary outcome
Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI)
Time frame: Initial, 12 weeks, 6 months, 2 year
The Shoulder Pain and Disability Index has good psychometric properties with good reliability and validity. It consists of two sub-areas, the first area includes five questions for the estimation of pain and the second area includes eight questions about the impact on activity-related function of the upper extremity. Grading of pain or functional limitation goes from 0-10 where 0 indicates "no pain or disability" and 10 indicate "maximum pain or disability". The sub-areas generate individual scales as well as a common total score that is given as a percentage. Minimal Clinically Important Difference is 8 to 13 points and Minimal Detectible Change is 18 points.
4 secondary outcomes
Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS)
Time frame: Initial, 12 weeks, 6 months, 2 year
Mean change in pain Self-Efficacy
Time frame: Initial, 12 weeks, 6 months, 2 year
Mean change of self-reported rating of improvement
Time frame: Initial, 12 weeks, 6 months, 2 year
Mean change of health-related quality of life
Time frame: Initial, 12 weeks, 6 months, 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 30728120Vandvik PO, Lahdeoja T, Ardern C, Buchbinder R, Moro J, Brox JI, Burgers J, Hao Q, Karjalainen T, van den Bekerom M, Noorduyn J, Lytvyn L, Siemieniuk RAC, Albin A, Shunjie SC, Fisch F, Proulx L, Guyatt G, Agoritsas T, Poolman RW. Subacromial decompression surgery for adults with shoulder pain: a clinical practice guideline. BMJ. 2019 Feb 6;364:l294. doi: 10.1136/bmj.l294.
- 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 24970843Hallgren HC, Holmgren T, Oberg B, Johansson K, Adolfsson LE. A specific exercise strategy reduced the need for surgery in subacromial pain patients. Br J Sports Med. 2014 Oct;48(19):1431-6. doi: 10.1136/bjsports-2013-093233. Epub 2014 Jun 26.
- Background: PubMed 33485212Clausen MB, Merrild MB, Holm K, Pedersen MW, Andersen LL, Zebis MK, Jakobsen TL, Thorborg K. Less than half of patients in secondary care adheres to clinical guidelines for subacromial pain syndrome and have acceptable symptoms after treatment: A Danish nationwide cohort study of 3306 patients. Musculoskelet Sci Pract. 2021 Apr;52:102322. doi: 10.1016/j.msksp.2021.102322. Epub 2021 Jan 12.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Physiotherapy (diSAID) and Traditional Physiotherapy in people with Subacromial Pain Syndrome and Shoulder Pain, run by Region Östergötland 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 9 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Petersson, PhD student (+46101031053, anna.h.petersson@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI) (time frame: Initial, 12 weeks, 6 months, 2 year). 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 NCT06276192, which also lists 4 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 23 Feb 2024.