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

NCT ID: NCT06587399

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-09-15

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.

Conditions

Shoulder Impingement; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Manual therapy treatment

Joint mobilization techniques in the shoulder together with the treatment of muscle trigger points using pressure release techniques

Group Type: ACTIVE_COMPARATOR

Manual therapy treatment

Intervention Type: OTHER

Joint mobilization techniques will be applied to the shoulder joint complex, adapted to the subjects' degree of irritability.

The muscular trigger points of the shoulder muscles will be treated using a pressure release technique applied for 60 seconds.

In addition, the subjects will carry out a 12-week home-based therapeutic exercise program.

Radial shock wave treatment

Low-medium energy radial shock waves will be used to treat muscle trigger points and the insertion of the supraspinatus muscle

Group Type: EXPERIMENTAL

Radial shock wave treatment

Intervention Type: OTHER

The treatment will be carried out with 1 session per week for 6 weeks. For this purpose, a radial shock wave generator will be used, at a frequency of 8 to 12 Hz, 2000 pulses/session and with a pressure of 2.5 to 4.0 bar.

Between 3 and 5 points will be treated per session: insertion of the supraspinatus muscle, dorsolateral area under the acromion and a maximum of 3 trigger points of the rotator cuff muscles.

In addition, the subjects will carry out a 12-week home therapeutic exercise program.

Interventions

Manual therapy treatment

Joint mobilization techniques will be applied to the shoulder joint complex, adapted to the subjects' degree of irritability.

The muscular trigger points of the shoulder muscles will be treated using a pressure release technique applied for 60 seconds.

In addition, the subjects will carry out a 12-week home-based therapeutic exercise program.

Intervention Type: OTHER

Radial shock wave treatment

The treatment will be carried out with 1 session per week for 6 weeks. For this purpose, a radial shock wave generator will be used, at a frequency of 8 to 12 Hz, 2000 pulses/session and with a pressure of 2.5 to 4.0 bar.

Between 3 and 5 points will be treated per session: insertion of the supraspinatus muscle, dorsolateral area under the acromion and a maximum of 3 trigger points of the rotator cuff muscles.

In addition, the subjects will carry out a 12-week home therapeutic exercise program.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Daniel Pecos Martín

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alcalá University

Alcalá de Henares, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

David Varillas Hernández, PhD

Role: CONTACT

davvarher@gmail.com

+34 918855142

Facility Contacts

Patricia Martinez-Merinero, Professor

Role: primary

ifyd@fgua.es

Other Identifiers

CEIM/2024/3/053

Identifier Type: -

Identifier Source: org_study_id