Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2028-03-26

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Subacromial Pain Syndrome Shoulder Pain Rotator Cuff Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non-Inferiority Randomised Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Digital Physiotherapy (diSAID)

Intervention Type 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 Physiotherapy

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.

Group Type ACTIVE_COMPARATOR

Traditional Physiotherapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Traditional Physiotherapy

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>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
* Jobe's test
* Neer's impingement sign
* Hawkin's-Kennedy's impingement test

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No