Comparison of Manual Therapy Versus Radial Shock Waves in the Shoulder Pain Treatment

Not Applicable

Recruiting

• Conditions: Shoulder Impingement; Shoulder Pain

• Registration Number: NCT06587399
• Lead Sponsor: University of Alcala

Brief Summary

Subacromial syndrome represents the third leading cause of pain in the general population. There is no clear pathophysiological explanation, nor a specific treatment. Manual therapy stands out as one of the reference treatments for this disease, however, it is complex to develop a specific protocol. On the other hand, shock waves have still not received adequate attention in the treatment of this pathology. The aim of this study will focus on using manual treatment using ischemic pressure, joint mobilizations and myofascial techniques in comparison to shock wave therapy to determine which is more effective.

This study will be a randomized, single-blind clinical trial with third-party evaluation. In it 88 subjects suffering from subacromial syndrome will participate. 44 patients will receive treatment through manual therapy over 6 weeks and other 44 patients through low-med energy radial shock waves for 6 weeks.

All subjects will complete their treatment with a 12-week home-based therapeutic exercise program.

The main endpoint of the study will be pain measured using the visual analogue scale (VAS) in motion. Pain will also be assessed using the VAS scale at rest and overnight. The Spadi Spanish version questionnaire will be used, shoulder strength will be measured using a handheld dynamometer and the ranges of motion will be measured.

Data will be measured before and one year after treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-19
• Study Start: 2024-09-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-01
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-09-15
• Study Completion: 2026-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Unilateral shoulder pain with no history of trauma.
• Pain of at least 4/10 on the Visual Analogue Scale for a minimum period of 3 months.
• Be positive in at least 3 of the following 5 tests: painful arc test, Neer impingement test, Hawkins-Kennedy test, Jobe test, external rotation test against resistance for the infraspinatus tendon.

Exclusion Criteria

• Presence of red flags.
• Diagnosis of shoulder instability.
• Diagnosis of frozen shoulder.
• Diagnosis of complete rupture of the common rotator cuff tendon.
• Diagnosis of cervical radiculopathy.
• Diagnosis of whiplash.
• Diagnosis of degenerative disease of the glenohumeral joint.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Shoulder Pain	Change from Baseline pain at 12 month.	Pain intensity will be measured using the Visual Analog Scale (VAS) for pain. The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.

Secondary Outcome Measures

Name	Time	Method
Disability	Change from Baseline pain at 12 month.	Disability will be measured by Shoulder Pain and Disability Index (SPADI).The Spanish version of SPADI has high test-retest reliability (ICC 0.89-0.93).The clinically important minimum difference varies between 8 and 13.2. The minimum value is 0 and de maximum value is 100
Muscle Force	Change from Baseline pain at 12 month.	Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of external rotation and abduction of both shoulders.; Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in external rotation of the shoulder, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98). The minimum value is 0 and de Maximum values is 55
Graded Chronic Pain Scale (CPGS)	Change from Baseline pain at 12 month.	The CPGS is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. It is suitable for use in all chronic pain conditions.The 3 subscale scores (characteristic pain intensity, disability score, and the disability points score) are used to classify subjects into 1 of the 5 pain severity grades: grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting.
Shoulder range of movement (ROM)	Change from Baseline pain at 12 month.	Active range of motion of glenohumeral joint will be measured using a Standard BASELINE ® 12-inch plastic goniometer following previous guidelines. The 0 degrees of movement is worse and 180 degrees is the better

Trial Locations

Locations (1)

Alcalá University; 🇪🇸 Alcala de Henares, Madrid, Spain