Clinical trial NCT06587399: Comparison of Manual Therapy Versus Radial Shock Waves in the Shoulder Pain Treatment
Official title: Comparison of Manual Therapy Versus Low-medium Energy Radial Shock Waves in the Treatment of Subacromial Syndrome in a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Impingement
Shoulder Pain
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Shoulder Pain
timeFrame: Change from Baseline pain at 12 month.
Secondary outcomes:
measure: Disability
timeFrame: Change from Baseline pain at 12 month.
measure: Muscle Force
timeFrame: Change from Baseline pain at 12 month.
measure: Graded Chronic Pain Scale (CPGS)
timeFrame: Change from Baseline pain at 12 month.
measure: Shoulder range of movement (ROM)
timeFrame: Change from Baseline pain at 12 month.
Other outcomes:
Locations:
city: Alcala de Henares
country: Spain
facility: Alcalá University
state: Madrid
Study officials:
References: