Comparison of Manual Therapy Versus Radial Shock Waves in the Shoulder Pain Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Alcala
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Presence of red flags.
Diagnosis of shoulder instability.
Diagnosis of frozen shoulder.
Diagnosis of complete rupture of the common rotator cuff tendon.
Trial design
Design model
Parallel
Treatments tested in this trial
Manual therapy treatment
Other interventionJoint 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
Other interventionThe 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.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Manual therapy treatmentActive comparator 1 intervention
Group B: Radial shock wave treatmentExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Change from Baseline pain at 12 month.Secondary outcomes
1
Disability
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
Time frame
Change from Baseline pain at 12 month.2
Muscle Force
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
Time frame
Change from Baseline pain at 12 month.3
Graded Chronic Pain Scale (CPGS)
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.
Time frame
Change from Baseline pain at 12 month.4
Shoulder range of movement (ROM)
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
Time frame
Change from Baseline pain at 12 month.Sponsors and contacts
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Source ClinicalTrials.gov