Shoulder ImpingementNCT06587399
Comparison of Manual Therapy Versus Radial Shock Waves in the Shoulder Pain Treatment
A study testing Manual therapy treatment and Radial shock wave treatment in people with Shoulder Impingement and Shoulder Pain, run by University of Alcala at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Impingement, Shoulder Pain
- What is being tested?
- Manual therapy treatment and Radial shock wave treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2024to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Alcalá University
Alcalá de Henares, Madrid, 28871
Patricia Martinez-Merinero, Professor, ifyd@fgua.es
Rodrigo Martinez, Professor
About this study
Official title: Comparison of Manual Therapy Versus Low-medium Energy Radial Shock Waves in the Treatment of Subacromial Syndrome in a Randomized Clinical 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.
Read more
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
- Being tested
- Manual therapy treatment, Radial shock wave treatment
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy treatmentOther
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy treatment | Active comparator | Joint mobilization techniques in the shoulder together with the treatment of muscle trigger points using pressure release techniques Receives: 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 Receives: Other: Radial shock wave treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline pain at 12 month.
Secondary outcomes (4)
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
Measured: Change from Baseline pain at 12 month.
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
Measured: Change from Baseline pain at 12 month.
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.
Measured: Change from Baseline pain at 12 month.
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
Measured: Change from Baseline pain at 12 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ImpingementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587399
- Sponsor's protocol ID
- CEIM/2024/3/053
- Status last verified
- Jun 2025
- First submitted
- 4 Sep 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Therapy Versus Low-medium Energy Radial Shock Waves in the Treatment of Subacromial Syndrome in a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06587399
- Acronym / sponsor ID
- CEIM/2024/3/053
- Conditions
- Shoulder Impingement, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy treatment | Active comparator | Other: Manual therapy treatmentJoint mobilization techniques in the shoulder together with the treatment of muscle trigger points using pressure release techniques |
| Radial shock wave treatment | Experimental | Other: Radial shock wave treatmentLow-medium energy radial shock waves will be used to treat muscle trigger points and the insertion of the supraspinatus muscle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy treatmentJoint 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 | Manual therapy treatment |
| Radial shock wave treatmentThe 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. | Other | Radial shock wave treatment |
Primary outcome
Shoulder Pain
Time frame: Change from Baseline pain at 12 month.
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Shoulder Impingement
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy treatment and Radial shock wave treatment in people with Shoulder Impingement and Shoulder Pain, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Varillas Hernández, PhD (+34 918855142, davvarher@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain (time frame: Change from Baseline pain at 12 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.