Comparison of Manual Therapy Versus Radial Shock Waves in the Shoulder Pain Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Manual therapy treatment, Radial shock wave treatment.
- Who it may be relevant to
- Registry conditions: Shoulder Impingement, Shoulder Pain. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Manual Therapy Versus Low-medium Energy Radial Shock Waves in the Treatment of Subacromial Syndrome in a Randomized Clinical Trial
Overview
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.
Interventions
- Other 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. - 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.
Primary outcome measures
- Shoulder Pain [Time frame: Change from Baseline pain at 12 month.]
Secondary outcome measures (4)
- Disability [Time frame: Change from Baseline pain at 12 month.]
- Muscle Force [Time frame: Change from Baseline pain at 12 month.]
- Graded Chronic Pain Scale (CPGS) [Time frame: Change from Baseline pain at 12 month.]
- Shoulder range of movement (ROM) [Time frame: Change from Baseline pain at 12 month.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Alcalá University — Alcalá de Henares
Identifiers
NCT: NCT06587399 · CEIM/2024/3/053