Comparison of Mobilization and Ozone Therapy in Impingement Syndrome

June 25, 2024 updated by: Songül Bağlan Yentür, Firat University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 8-65 years
  • Patients with shoulder impingement syndrome

Exclusion Criteria:

  • Shoulder surgery
  • History of scoliosis
  • Infection
  • Cardiac pacemaker
  • Recent myocardial infarction
  • Malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ozone therapy group
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.
Other: Ozone therapy
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.
Experimental: Mobilization group
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.
Other: Mulligan Mobilization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion assessment
Time Frame: 1 minute
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.
1 minute
Function assessment
Time Frame: 2 minutes
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.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 21, 2024

Primary Completion (Estimated)

August 20, 2024

Study Completion (Estimated)

September 20, 2024

Study Registration Dates

First Submitted

June 20, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/06-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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