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

NCT06587399 | Recruiting

• 1 other identifier: CEIM/2024/3/053
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain

  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.

  Change from Baseline pain at 12 month.

Secondary Outcomes (4)

• Disability

  Change from Baseline pain at 12 month.

• Muscle Force

  Change from Baseline pain at 12 month.

• Graded Chronic Pain Scale (CPGS)

  Change from Baseline pain at 12 month.

• Shoulder range of movement (ROM)

  Change from Baseline pain at 12 month.

Study Arms (2)

Manual therapy treatment

ACTIVE COMPARATOR

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

Other: Manual therapy treatment

Radial shock wave treatment

EXPERIMENTAL

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

Other: Radial shock wave treatment

Interventions

Manual therapy treatment 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.

Manual therapy treatment

Radial shock wave treatment 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.

Radial shock wave treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Alcalá University

Alcalá de Henares, Madrid, 28871, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

David Varillas Hernández, PhD

CONTACT

+34 918855142; davvarher@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)