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Comparison of the acceptance and effectiveness of two exercise therapies for shoulder pain: a randomized controlled trial

Comparison of the acceptance and effectiveness of two exercise therapies for shoulder pain: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037987
Enrollment
40
Registered
2025-10-02
Start date
2026-02-17
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rotator cuff-related shoulder pain

Interventions

Group 1: Exercise Training The active exercise training intervention, termed the "Self-managed loaded shoulder rehabilitation program", will involve progressive exercises designed to restore muscle fu

Sponsors

Deutsche Sporthochschule Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Unilateral shoulder pain of atraumatic origin. Scoring at least 3 out of 10 on a numeric pain rating scale with movement. Symptoms lasting more than 6 weeks. Pain on active shoulder movement. Pain provoked by at least three of the following tests: Hawkins-Kennedy, Neer, Painful arc, Empty/full can and resisted external rotation in neutral. Participants referred by a shoulder specialist with diagnosis of rotator cuff injury (tendinitis/tendinosis), subacromial impingement syndrome, bursitis, subacromial pain, that fulfill the criteria above. Able to read, communicate in and understand German.

Exclusion criteria

Exclusion criteria: Shoulder pain following a traumatic event. History and clinical presentation compatible with complete rotator cuff and/or biceps brachii rupture. Frozen Shoulder (Adhesive capsulitis). Restricted external rotation of 50% compared to the opposite side and/or 30 degrees absolute restriction of external rotation of the shoulder. History of dislocation. Known diagnosis of glenohumeral osteoarthritis. Known diagnosis of Cancer. Known diagnosis of ssystemic, local or auto-immune inflammatory conditions. Previous shoulder or neck surgery or fracture. Shoulder pain provoked by neck movements. Presence of radicular signs. Use of corticosteroids over the past six months. Known diagnosis of fibromyalgia. Known diagnosis of clinical depression. Participants who have received exercise therapy treatment for their shoulder condition within the last 3 months.

Design outcomes

Primary

MeasureTime frame
Treatment Credibility Modified Credibility/Expectancy Questionnaire: 3 questions, scale 0–10 (0 = not at all, 10 = very much). Total score: 0–30 points. German Version of the Helping Alliance Questionnaire: 11 items, 6-point scale (strongly disagree to strongly agree). Two subscales: Satisfaction with treatment (sum of items 4, 5, 11, 12). Quality of the therapeutic relationship (sum of items 1, 6, 7, 8, 9, 10).

Secondary

MeasureTime frame
Pain SPADI Pain Subscale: 5 items, scored 0–11 (0 = no pain, 10 = worst pain imaginable). Total: 0–55 points. Visual Analogue Scale (VAS): 0–100 points (0 = no pain, 100 = worst pain imaginable). Measures average pain intensity over the past week. Function SPADI Function Subscale: 8 items, scored 0–11 (0 = no difficulties, 10 = activity not feasible). Total: 0–88 points. Global Rating of Improvement Global Rating of Change (GRC) Scale: 11-point scale, -5 (very much worse) to 0 (unchanged) to +5 (completely recovered). Adverse Events Captured via questionnaires, including a dedicated adverse event questionnaire. Categorized as serious (life-threatening, results in death, or requires hospitalization) or non-serious. Treatment-related if linked to the intervention, as determined by the investigator. Emotional Wellbeing DASS-21 (Depression, Anxiety, Stress Scales): 21 items across 3 subscales, scored 0–3 (0 = did not apply, 3 = applied very much). Participation (Recreation and Work) Quick-DASH: 11 mandatory items + optional work/occupation and sports/music modules (4 items each). Scored 1–5 (1 = no difficulties, 5 = impossible). Normed 0–100 points (0 = no restrictions, 100 = severe restrictions). Sleep Pittsburgh Sleep Quality Index (PSQI): 7 components, global score 0–21 (higher scores = poorer sleep quality, >5 = clinically significant disturbance). Pathophysiological Manifestations Isometric Strength (Handheld Dynamometer): Measures pain-free and maximum isometric strength in shoulder flexion, extension, internal, and external rotation. Recovery and Treatment Expectations General Recovery Expectations: Rated 0–10 (0 = no improvement, 10 = complete recovery). Treatment-Specific Expectations: Rated 0–10 (0 = not at all helpful, 10 = extremely helpful). Kinesiophobia Tampa Scale for Kinesiophobia (TSK-GV): 11 items, 4-point Likert scale (strongly disagree to strongly agree). Higher scores = greater kinesiophobia. ICC: 0.91. Pain Cat

Countries

Germany

Contacts

Public ContactTobias Saueressig

Deutsche Sporthochschule Köln

t.saueressig@gmx.de0049-(0)157-71142590

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026