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

NCT06276192 | Not Yet Recruiting

• 1 other identifier: 2023-01882-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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?

Conditions

Subacromial Pain Syndrome; Shoulder Pain; Rotator Cuff Syndrome

Keywords

Shoulder pain; Subacromial pain; Digital care; Digital health intervention; Physiotherapy; Primary care

Outcome Measures

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.

  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)

  Initial, 12 weeks, 6 months, 2 year

• Mean change in pain Self-Efficacy

  Initial, 12 weeks, 6 months, 2 year

• Mean change of self-reported rating of improvement

  Initial, 12 weeks, 6 months, 2 year

• Mean change of health-related quality of life

  Initial, 12 weeks, 6 months, 2 year

Other Outcomes (4)

• Patients treatment expectancies

  Initial

• Patients self-reported rating of pain sensitivity

  Initail

• Costs and cost-effectiveness direct and indirect

  3 months and 2 year

Study Arms (2)

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.

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.

Other: Traditional Physiotherapy

Interventions

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.

Digital Physiotherapy (diSAID)

Traditional Physiotherapy 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.

Traditional Physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Östergötland: lead
• Linkoeping University: collaborator

Study Sites (1)

Anna Petersson

Linköping, SE 58191, Sweden

Location

Related Publications (4)

• 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.

  PMID: 30728120 BACKGROUND

• 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.

  PMID: 25213604 BACKGROUND

• 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.

  PMID: 24970843 BACKGROUND

• 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.

  PMID: 33485212 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Petersson, PhD student

CONTACT

+46101031053; anna.h.petersson@regionostergotland.se

Teresa Holmgren, PhD

CONTACT

+46101034158; Teresa.Holmgren@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Physical therapist

Model Details: Non-Inferiority Randomised Controlled Trial

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: February 23, 2024
• Study Start: February 26, 2024
• Primary Completion: March 26, 2026
• Study Completion (Estimated): March 26, 2028
• Last Updated: February 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: A statistical analysis plan will be available at Clinicaltrials.gov prior to the start of data analysis.

Locations

SE (1)