Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Östergötland
About this 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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>18 years old
Pain duration >2 weeks
Lateral shoulder pain (C5 dermatome)
Painful arc
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Physiotherapy (diSAID)
Other interventionThe 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
Other interventionPatients 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Digital Physiotherapy (diSAID)Experimental treatment 1 intervention
Group B: Traditional PhysiotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Initial, 12 weeks, 6 months, 2 yearSecondary outcomes
1
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".
Time frame
Initial, 12 weeks, 6 months, 2 year2
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
Time frame
Initial, 12 weeks, 6 months, 2 year3
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".
Time frame
Initial, 12 weeks, 6 months, 2 year4
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.
Time frame
Initial, 12 weeks, 6 months, 2 yearOther outcomes
1
Patients treatment expectancies
Stanford Expectations of Treatment Scale (SETS) is used to assess expectancy effects. Patients rate their expectations before treatment on a 7-point scale with two sub-categories: negative and positive treatment expectancies. The instrument can be used to improve statistical sensitivity for detecting treatment differences or to identify patients with poor treatment expectancies.
Time frame
Initial2
Patients self-reported rating of pain sensitivity
2\. The Pain Sensitivity Questionnaire (PSQ) is a 17-item questionnaire that assesses a patient's perception to different fictional physical stimuli that might be experienced in daily life. The patient rate their imagined pain intensity of each item on an 11-point scale with 0 meaning "not painful at all" and 10 meaning "worst pain imaginable." The PSQ is a reliable and valid measure and can be expressed in PSQ-total score or PSQ-minor score. The Pain Sensitivity Questionnaire (PSQ) is a 17-item questionnaire that assesses a patient's perception to different fictional physical stimuli that might be experienced in daily life. The patient rate their imagined pain intensity of each item on an 11-point scale with 0 meaning "not painful at all" and 10 meaning "worst pain imaginable." The PSQ is a reliable and valid measure and can be expressed in PSQ-total score or PSQ-minor score.
Time frame
Initail3
Costs and cost-effectiveness direct and indirect
The economic evaluation will primary be based on the time and amounts of visits causing cost for the health sector during the treatment. An economic analysis of QALYS, reduced remittance to specialised care and surgery will be analysed in a longer perspective.
Time frame
3 months and 2 year4
Impact on the environment
Evaluation will we based on emission of CO2 connected to the treatments. The climate impact will primary be linked to the direct emissions per passenger kilometers (ie emissions from the fuel used in transport to care visits)
Time frame
2 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Östergötland
Lead sponsor
Linkoeping University
Collaborator
Source ClinicalTrials.gov
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