Impingement SyndromeNCT06474897
Comparison of Mobilization and Ozone Therapy in Impingement Syndrome
A study testing Ozone therapy and Mulligan Mobilization in people with Impingement Syndrome, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Studies investigating the efficacy of the Mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. The aim of this study was to compare the effectiveness of Mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Impingement Syndrome
- What is being tested?
- Ozone therapy and Mulligan Mobilization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2024to 20 Sep 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 8-65 years
- Patients with shoulder impingement syndrome
Who cannot join
- Shoulder surgery
- History of scoliosis
- Infection
- Cardiac pacemaker
- Recent myocardial infarction
- Malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul Baglan Yentur
Elâzığ, 23100
Songul Baglan Yentur, 04242370000, songulbaglan23@hotmail.com
Songul Baglan Yentur, songulbaglan23@hotmail.com
About this study
Official title: Comparison of the Efficacy of Mulligan Mobilization and Ozone Therapy in Patients With Subacromial Impingement Syndrome
Studies investigating the efficacy of the Mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. The aim of this study was to compare the effectiveness of Mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. Ozone therapy will be practiced to study group. Mulligan mobilization will be practiced to control group. Pain, range of motion and function will be assessed before and after treatment.
Read the detailed description
The subacromial bursa and rotator cuff muscles are compressed between the acromion and the proximal humerus. If the subacromial surface volume decreases, degeneration and tears of the soft structures may occur during forward extension and rotation. Studies investigating the efficacy of the Mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. The aim of this study was to compare the effectiveness of Mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. Ozone therapy will be practiced to study group. Inject 10 ml of ozone gas (O2-O3) at a concentration of 10 µg/ml 3 times at one week intervals. All injections will be performed by the same experienced specialist doctor. Mulligan mobilization will be practiced to control group. Mobilizations will be performed once a week for 3 consecutive weeks. The first one is a seated position with the patient's arm in approximately 90° abduction. The patient will be asked to abduct the arm and at the same time the physiotherapist will perform posterio/lateral gliding of the shoulder head with the left hand. Pain, range of motion and function will be assessed before and after treatment.
- Conditions
- Impingement Syndrome
- Being tested
- Ozone therapy, Mulligan Mobilization
- Keywords
- Impingement Syndrome, Ozone therapy, Mulligan mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozone therapyOther
Ozone therapy will be practiced to study group. Inject 10 ml of ozone gas (O2-O3) at a concentration of 10 µg/ml 3 times at one week intervals. All injections will be performed by the same experienced specialist doctor.
Mulligan MobilizationOther
Mulligan mobilization will be practiced to control group. Mobilizations will be performed once a week for 3 consecutive weeks. The first one is a seated position with the patient's arm in approximately 90° abduction. The patient will be asked to abduct the arm and at the same time the physiotherapist will perform posterio/lateral gliding of the shoulder head with the left hand.
| Study group | Role | What they receive |
|---|---|---|
| Ozone therapy group | Experimental | Ozone therapy will be practiced to study group. Inject 10 ml of ozone gas (O2-O3) at a concentration of 10 µg/ml 3 times at one week intervals. All injections will be performed by the same experienced specialist doctor. Receives: Other: Ozone therapy |
| Mobilization group | Experimental | Mulligan mobilization will be practiced to control group. Mobilizations will be performed once a week for 3 consecutive weeks. The first one is a seated position with the patient's arm in approximately 90° abduction. The patient will be asked to abduct the arm and at the same time the physiotherapist will perform posterio/lateral gliding of the shoulder head with the left hand. Receives: Other: Mulligan Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
The Visual Analog Scale (VAS), which quantifies parameter values that cannot be measured numerically, will be used to assess the pain intensity of the participants. VAS is a simple and commonly used scale that numerically indicates the severity of pain. A 10 cm line is divided into 10 equal parts and numbered from 0 to 10. The two extremes are defined as the minimum and maximum pain intensity.
Measured: 1 minute
Secondary outcomes (2)
Range of motion assessment
n order to evaluate the active and passive range of motion of the participants, measurements will be made with a goniometer, which gives an objective and numerical value.
Measured: 1 minute
Function assessment
The Shoulder Arm and Hand Problems Questionnaire (DASH) will be used to assess shoulder function. It is one of the most validated questionnaires used to assess functionality after upper extremity injuries.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start21 Jun 2024 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474897
- Sponsor's protocol ID
- 2024/06-38
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Mulligan Mobilization and Ozone Therapy in Patients With Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06474897
- Acronym / sponsor ID
- 2024/06-38
- Conditions
- Impingement Syndrome
- Keywords
- Impingement Syndrome, Ozone therapy, Mulligan mobilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 21 Jun 2024 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 26 Jun 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.
Studies investigating the efficacy of the Mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. The aim of this study was to compare the effectiveness of Mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. Ozone therapy will be practiced to study group. Mulligan mobilization will be practiced to control group. Pain, range of motion and function will be assessed before and after treatment.
Detailed description
The subacromial bursa and rotator cuff muscles are compressed between the acromion and the proximal humerus. If the subacromial surface volume decreases, degeneration and tears of the soft structures may occur during forward extension and rotation. Studies investigating the efficacy of the Mulligan technique and ozone therapy in patients with shoulder impingement syndrome are limited in the literature. The aim of this study was to compare the effectiveness of Mulligan mobilization method and ozone therapy in patients with shoulder impingement syndrome. Ozone therapy will be practiced to study group. Inject 10 ml of ozone gas (O2-O3) at a concentration of 10 µg/ml 3 times at one week intervals. All injections will be performed by the same experienced specialist doctor. Mulligan mobilization will be practiced to control group. Mobilizations will be performed once a week for 3 consecutive weeks. The first one is a seated position with the patient's arm in approximately 90° abduction. The patient will be asked to abduct the arm and at the same time the physiotherapist will perform posterio/lateral gliding of the shoulder head with the left hand. Pain, range of motion and function will be assessed before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone therapy group | Experimental | Other: Ozone therapyOzone therapy will be practiced to study group. Inject 10 ml of ozone gas (O2-O3) at a concentration of 10 µg/ml 3 times at one week intervals. All injections will be performed by the same experienced specialist doctor. |
| Mobilization group | Experimental | Other: Mulligan MobilizationMulligan mobilization will be practiced to control group. Mobilizations will be performed once a week for 3 consecutive weeks. The first one is a seated position with the patient's arm in approximately 90° abduction. The patient will be asked to abduct the arm and at the same time the physiotherapist will perform posterio/lateral gliding of the shoulder head with the left hand. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 8-65 years
- Patients with shoulder impingement syndrome
Key exclusion criteria (6 listed)
- Shoulder surgery
- History of scoliosis
- Infection
- Cardiac pacemaker
- Recent myocardial infarction
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 |
|---|---|---|
| Ozone therapyOzone therapy will be practiced to study group. Inject 10 ml of ozone gas (O2-O3) at a concentration of 10 µg/ml 3 times at one week intervals. All injections will be performed by the same experienced specialist doctor. | Other | Ozone therapy group |
| Mulligan MobilizationMulligan mobilization will be practiced to control group. Mobilizations will be performed once a week for 3 consecutive weeks. The first one is a seated position with the patient's arm in approximately 90° abduction. The patient will be asked to abduct the arm and at the same time the physiotherapist will perform posterio/lateral gliding of the shoulder head with the left hand. | Other | Mobilization group |
Primary outcome
Pain assessment
Time frame: 1 minute
The Visual Analog Scale (VAS), which quantifies parameter values that cannot be measured numerically, will be used to assess the pain intensity of the participants. VAS is a simple and commonly used scale that numerically indicates the severity of pain. A 10 cm line is divided into 10 equal parts and numbered from 0 to 10. The two extremes are defined as the minimum and maximum pain intensity.
2 secondary outcomes
Range of motion assessment
Time frame: 1 minute
Function assessment
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone therapy and Mulligan Mobilization in people with Impingement Syndrome, run by Firat University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Songul Baglan Yentur (+90 424 2370000, songulbaglan23@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: 1 minute). 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 26 Jun 2024.