Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-02 @ 1:37 PM
Study NCT ID:
NCT06276192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care
Sponsor:
Region Östergötland
Organization:
Study Overview
Official Title:
Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Traditional Physiotherapy Treatment in Primary Care - a Non-Inferiority Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
diSAID
Brief 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. 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?
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: