Sub Acromial Impingement SyndromePhase 3NCT05951322
Extra Corporeal Shock Wave Versus Phonophoresis in Sub Acromial Impingement Syndrome.
A Phase 3 study testing Shockwave therapy and Phonophoresis in people with Sub Acromial Impingement Syndrome, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
shoulder sub acromial impingement syndrome is an encroachment of subacrormial tissues, rotator cuff, subacrormial bursa, and the long head of the biceps tendon, as a result of narrowing of the subacrormial space. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Sub Acromial Impingement Syndrome
- What is being tested?
- Shockwave therapy and Phonophoresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 8 Jan 2023to 8 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient reported a positive "Neer sign" and" Hawkins sign".
- The patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and over head playing athletes).
- The patient reported pain with palpation of the rotator cuff tendons.
- The patient reported pain with resisted isometric abduction.
Who cannot join
- Frozen shoulder.
- Rotator cuff tear.
- Glenohumeral or acromioclavicular arthritis.
- Implented pace maker.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Extra Corporeal Shock Wave Versus Phonophoresis on Pain Severity and Functional Disability in Patients With Sub Acromial Impingement Syndrome. A Randomized Clinical Trial.
shoulder sub acromial impingement syndrome is an encroachment of subacrormial tissues, rotator cuff, subacrormial bursa, and the long head of the biceps tendon, as a result of narrowing of the subacrormial space. Activities requiring repetitive or sustained use of the arms over head often predispose the rotator cuff tendon to injury. Hence the objective of the study is to examine the influence of extra corporeal Shock wave versus phonophoresis on pain severity and functional disability in patients with sub acromial impingement syndrome.
Read the detailed description
Background: shoulder sub acromial impingement syndrome is an encroachment of subacrormial tissues, rotator cuff, subacrormial bursa, and the long head of the biceps tendon, as a result of narrowing of the subacrormial space. Activities requiring repetitive or sustained use of the arms over head often predispose the rotator cuff tendon to injury. Objective of the study: To examine the influence of extra corporeal Shock wave versus phonophoresis on pain severity and functional disability in patients with sub acromial impingement syndrome. Subjects and Methods: Thirty patients diagnosed as shoulder impingement syndrome stage II Neer classification due to mechanical causes. Patients were randomly distributed into two equal groups. The first group consisted of 15 patients with a mean age of 45.46 (+ 8.64) received therapeutic exercises( stretching exercise of posterior shoulder capsule and strengthening exercises of shoulder muscles) and shockwave therapy (6000 shock, 2000/session, 3 sessions, 2 weeks a part, 0.22mJ/mm2) years. The second group consisted of 15 patients with a mean age of 46.26 (+ 8.05) received same therapeutic exercises and phonophoresis (3 times per week, each other day, for 4 consecutive weeks). Patients were evaluated pretreatment and post treatment for shoulder pain severity, shoulder functional disability, shoulder flexion, abduction and internal rotation motions.
- Conditions
- Sub Acromial Impingement Syndrome
- Being tested
- Shockwave therapy, Phonophoresis
- Keywords
- Extra corporeal shock wave, phonophoresis, sub acromial impingement syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave therapyDevice
Radial extracorporeal shock wave device, it is serial number (1107394), medispec and connected to electrical supply 115/220 A C frequency.
PhonophoresisDevice
Pagani ultrasound apparatus 200 cosistts of multi frequency head(1 and 3 MHz), surface area 4 cm², continuous and pulsed mode, main voltages: 100-240-VAC.50/60Hz.
| Study group | Role | What they receive |
|---|---|---|
| Shockwave therapy | Experimental | All patients were received (ESWT) at sitting position, exposed the affected shoulder, the shoulder adducted and elbow extended and the shock wave applicator was directed in most tender point near the insertion of rotator cuff at greater tuberosity under the acromion [23].
The treatment area was prepared with a coupling gel to minimize the loss of shockwave at the interface between applicator tip and skin.
Each patient was received (6000 shocks,21000 shock/ session, 3 session 2 weeks apart, energy flux density 0.22 mJ/mm2, energy level 5-7, pulse rate 160/min., 2-3Hz) Receives: Device: Shockwave therapy |
| Phonophoresis | Active comparator | Pagani ultrasound apparatus 200 cosistts of multi frequency head(1 and 3 MHz), surface area 4 cm², continuous and pulsed mode, main voltages: 100-240-VAC.50/60Hz. Receives: Device: Phonophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain assessed by (Visual analog scale (VAS). VAS is a scale that allows continuous data analysis and uses a 10cm line with 0 (no pain) and 10 (worst pain) on the other end .Patients were asked to place a mark a long the line to denote their level of pain.
Measured: Baseline
Pain intensity
Pain assessed by (Visual analog scale (VAS). VAS is a scale that allows continuous data analysis and uses a 10cm line with 0 (no pain) and 10 (worst pain) on the other end .Patients were asked to place a mark a long the line to denote their level of pain.
Measured: 6 weeks
Secondary outcomes (4)
Functional disability
It was assessed by using the shoulder pain and disability index (SPADI) which is a valid and reliable index for measuring shoulder pain and disability. It consists of two parts, part one which assesses pain and part two which assesses functional disability. Scores were calculated as follow, in part one pain scores in all questions were added, and the mean value was chosen. In part two functional score of all questions were added and the mean value was chosen for the purpose of data analysis. Final score for each part was statistically analyzed separately.
Measured: Baseline
Functional disability
It was assessed by using the shoulder pain and disability index (SPADI) which is a valid and reliable index for measuring shoulder pain and disability. It consists of two parts, part one which assesses pain and part two which assesses functional disability. Scores were calculated as follow, in part one pain scores in all questions were added, and the mean value was chosen. In part two functional score of all questions were added and the mean value was chosen for the purpose of data analysis. Final score for each part was statistically analyzed separately.
Measured: 6 weeks
Range of motion
In this study the shoulder flexion, abduction and internal rotation were measured by using(Model 01129 Guymon goniometer). It is an electrogoniometer which eliminates the need of manually score each measurement by storing the information internally, it reduces time. It measure any joint angle quickly and accurately. It has range of 0 to 360 and stores up to 80 data points. The validity and reliability of electrogoniometer for shoulder assessment was tested and well documented.
Measured: Baseline
Range of motion
In this study the shoulder flexion, abduction and internal rotation were measured by using(Model 01129 Guymon goniometer). It is an electrogoniometer which eliminates the need of manually score each measurement by storing the information internally, it reduces time. It measure any joint angle quickly and accurately. It has range of 0 to 360 and stores up to 80 data points. The validity and reliability of electrogoniometer for shoulder assessment was tested and well documented.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start8 Jan 2023
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sub Acromial Impingement SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were identified and recruited over 5-month period. Thirty-six patients diagnosed clinically with shoulder impingement syndrome (according to location of trigger points at rotator cuff muscles and aggravation of pain with overhead activities) were randomly assigned in two groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gopal Nambi, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951322
- Sponsor's protocol ID
- ECM#2023-1102
- Status last verified
- Jul 2023
- First submitted
- 9 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Extra Corporeal Shock Wave Versus Phonophoresis on Pain Severity and Functional Disability in Patients With Sub Acromial Impingement Syndrome. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05951322
- Acronym / sponsor ID
- ECM#2023-1102
- Conditions
- Sub Acromial Impingement Syndrome
- Keywords
- Extra corporeal shock wave, phonophoresis, sub acromial impingement syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 19 Jul 2023 (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.
shoulder sub acromial impingement syndrome is an encroachment of subacrormial tissues, rotator cuff, subacrormial bursa, and the long head of the biceps tendon, as a result of narrowing of the subacrormial space. Activities requiring repetitive or sustained use of the arms over head often predispose the rotator cuff tendon to injury. Hence the objective of the study is to examine the influence of extra corporeal Shock wave versus phonophoresis on pain severity and functional disability in patients with sub acromial impingement syndrome.
Detailed description
Background: shoulder sub acromial impingement syndrome is an encroachment of subacrormial tissues, rotator cuff, subacrormial bursa, and the long head of the biceps tendon, as a result of narrowing of the subacrormial space. Activities requiring repetitive or sustained use of the arms over head often predispose the rotator cuff tendon to injury. Objective of the study: To examine the influence of extra corporeal Shock wave versus phonophoresis on pain severity and functional disability in patients with sub acromial impingement syndrome. Subjects and Methods: Thirty patients diagnosed as shoulder impingement syndrome stage II Neer classification due to mechanical causes. Patients were randomly distributed into two equal groups. The first group consisted of 15 patients with a mean age of 45.46 (+ 8.64) received therapeutic exercises( stretching exercise of posterior shoulder capsule and strengthening exercises of shoulder muscles) and shockwave therapy (6000 shock, 2000/session, 3 sessions, 2 weeks a part, 0.22mJ/mm2) years. The second group consisted of 15 patients with a mean age of 46.26 (+ 8.05) received same therapeutic exercises and phonophoresis (3 times per week, each other day, for 4 consecutive weeks). Patients were evaluated pretreatment and post treatment for shoulder pain severity, shoulder functional disability, shoulder flexion, abduction and internal rotation motions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were identified and recruited over 5-month period. Thirty-six patients diagnosed clinically with shoulder impingement syndrome (according to location of trigger points at rotator cuff muscles and aggravation of pain with overhead activities) were randomly assigned in two groups.
| Arm | Type | Receives |
|---|---|---|
| Shockwave therapy | Experimental | Device: Shockwave therapyAll patients were received (ESWT) at sitting position, exposed the affected shoulder, the shoulder adducted and elbow extended and the shock wave applicator was directed in most tender point near the insertion of rotator cuff at greater tuberosity under the acromion [23]. The treatment area was prepared with a coupling gel to minimize the loss of shockwave at the interface between applicator tip and skin. Each patient was received (6000 shocks,21000 shock/ session, 3 session 2 weeks apart, energy flux density 0.22 mJ/mm2, energy level 5-7, pulse rate 160/min., 2-3Hz) |
| Phonophoresis | Active comparator | Device: PhonophoresisPagani ultrasound apparatus 200 cosistts of multi frequency head(1 and 3 MHz), surface area 4 cm², continuous and pulsed mode, main voltages: 100-240-VAC.50/60Hz. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patient reported a positive "Neer sign" and" Hawkins sign".
- The patient reported pain with active shoulder elevation in the scapular plane (eg: welders, plate workers, slaughterhouse workers and over head playing athletes).
- The patient reported pain with palpation of the rotator cuff tendons.
- The patient reported pain with resisted isometric abduction.
Key exclusion criteria (5 listed)
- Frozen shoulder.
- Rotator cuff tear.
- Glenohumeral or acromioclavicular arthritis.
- Implented pace maker.
- Pregnancy
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 |
|---|---|---|
| Shockwave therapyRadial extracorporeal shock wave device, it is serial number (1107394), medispec and connected to electrical supply 115/220 A C frequency. | Device | Shockwave therapy |
| PhonophoresisPagani ultrasound apparatus 200 cosistts of multi frequency head(1 and 3 MHz), surface area 4 cm², continuous and pulsed mode, main voltages: 100-240-VAC.50/60Hz. | Device | Phonophoresis |
Primary outcome
Pain intensity
Time frame: Baseline
Pain assessed by (Visual analog scale (VAS). VAS is a scale that allows continuous data analysis and uses a 10cm line with 0 (no pain) and 10 (worst pain) on the other end .Patients were asked to place a mark a long the line to denote their level of pain.
Pain intensity
Time frame: 6 weeks
Pain assessed by (Visual analog scale (VAS). VAS is a scale that allows continuous data analysis and uses a 10cm line with 0 (no pain) and 10 (worst pain) on the other end .Patients were asked to place a mark a long the line to denote their level of pain.
4 secondary outcomes
Functional disability
Time frame: Baseline
Functional disability
Time frame: 6 weeks
Range of motion
Time frame: Baseline
Range of motion
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: Yes
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shockwave therapy and Phonophoresis in people with Sub Acromial Impingement Syndrome, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 19 Jul 2023. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline). The study lists 2 primary outcomes in all. 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 19 Jul 2023.