Clinical trial NCT06276192: Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care
Official title: Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Traditional Physiotherapy Treatment in Primary Care - a Non-Inferiority Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subacromial Pain Syndrome
Shoulder Pain
Rotator Cuff Syndrome
Keywords: Shoulder pain
Subacromial pain
Digital care
Digital health intervention
Physiotherapy
Primary care
Lead sponsor: Region Östergötland
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2024-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-Inferiority Randomised Controlled Trial
Primary purpose: TREATMENT

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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in shoulder function and pain after 12 weeks using The Shoulder Pain and Disability Index (SPADI)
timeFrame: Initial, 12 weeks, 6 months, 2 year
Secondary outcomes:
measure: Mean change in shoulder pain intensity at rest, arm activity and at night measured by numeric rating scale (NRS)
timeFrame: Initial, 12 weeks, 6 months, 2 year
measure: Mean change in pain Self-Efficacy
timeFrame: Initial, 12 weeks, 6 months, 2 year
measure: Mean change of self-reported rating of improvement
timeFrame: Initial, 12 weeks, 6 months, 2 year
measure: Mean change of health-related quality of life
timeFrame: Initial, 12 weeks, 6 months, 2 year
Other outcomes:
measure: Patients treatment expectancies
timeFrame: Initial
measure: Patients self-reported rating of pain sensitivity
timeFrame: Initail
measure: Costs and cost-effectiveness direct and indirect
timeFrame: 3 months and 2 year
measure: Impact on the environment
timeFrame: 2 year
Locations:
city: Linköping
country: Sweden
facility: Anna Petersson
Study officials:
References:
citation: 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.
citation: 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.
citation: Hallgren 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.
citation: Clausen 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.