Effect of Ozonated Gel Phonophoresis on Pain and Functional Disability in Patients With Chronic Supraspinatus Tendinitis

Cairo University (CU)

Status: Not yet enrolling

Conditions: Supraspinatus Tendinitis

Treatments: Other: ozonated gel phonophoresis; Other: conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07316738

P.T.REC/012/006041

Details and patient eligibility

About

This study will be conducted to investigate the effect of ozonated gel phonophoresis on pain intensity, shoulder joint range of motion, and functional disability in patients with chronic supraspinatus tendinitis grades I and II.

Full description

Tendinopathy is a condition in which pain arises on tendon near origin or insertion due to repetitive activities and reduced functional level, it occurs when the tendon does not properly heal.

Thirty percentages of tendinopathies in musculoskeletal conditions are shoulder pain related where supraspinatus tendinitis is the third most prevalent problem.

The primary function of the supraspinatus muscle is shoulder abduction, particularly movements that elevate the arm overhead. During these motions, the supraspinatus tendon repeatedly passes beneath the acromion process of the scapula, which can result in impingement and subsequent inflammation. If this condition progresses, an unexpected force or trauma may cause partial or complete rupture of the tendon.

Phonophoresis was first used to treat polyarthritis of hand by driving hydrocortisone ointment into inflamed areas in 1994. Since then it has been used in the treatment of various dermatological and musculoskeletal disorders.

The major medications used today with phonophoresis include the anti-inflammatories (cortisol, dexamethasone, salicylates) and local anaesthetics (lidocaine). Cameroy reports success using Carbocaine phonophoresis before closed reduction of Colles fractures.

The main purpose of phonophoresis is to achieve a suitable and fast concentration of drug in the tissue without inactivating the drug molecules with no side effects. In this efficient method, this has had wide utility in physical therapy and sports medicine. The drug is applied locally at the target site and messaged with a therapeutic ultrasound applicator.

Ozone therapy is a potential minimally invasive, conservative treatment that can be used alone or in conjunction with other therapies to help people with musculoskeletal diseases perform better and experience less pain. According to various studies, the effectiveness and safety of ozone therapy have primarily been researched in cases of knee osteoarthritis and on back pain.

Several papers suggested relevant medical features of O3, including inflammatory modulation and circulatory stimulation, with multiple applications in several medical fields including wound healing, ischemic disorders, infections and chronic inflammatory conditions like musculoskeletal disorders.

In the available literature there is no studies were done to identify the effect of ozonated gel phonophoresis in management of patients with chronic supraspinatus tendinitis grade I & II.

So this study may add a piece of information to the therapists in the governmental hospitals and private clinics to be aware about the efficacy of this approach during dealing with patients of chronic supraspinatus tendinitis grade I & II.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients from 30-60 years old from both genders.
• The patients will be assigned to the study will be diagnosed with grade I or II supraspinatus tendinitis based on Neer's classification.
• The patients suffered from supraspinatus tendinitis for more than 3 months and taking non-steroidal anti-inflammatory drugs suggested by orthopedist.
• All patients have body mass index between 18.5 and 29.9 kg/m2.

Exclusion criteria

• Grades III of supraspinatus tendinitis. (Bone spurs and tendon rapture)
• Any past shoulder surgical interventions. (Rotator cuff repair, labrum tear and open reduction internal fixation)
• Shoulder joint instability
• Shoulder fracture.
• Non-cooperative subjects.
• Neuromuscular diseases (spinal muscular atrophy, whiplash injury)
• Cardiovascular disease.
• History of cancer.
• Systemic diseases such as rheumatoid arthritis, Reiter's syndrome, or diabetes.
• Severe medical and neurological or psychiatric disorders.
• Pregnant and lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

ozonated gel phonophoresis + conventional treatment

Experimental group

Description:

Twenty patients will receive ozonated gel phonophoresis in addition to conventional treatment, three times per week for four weeks.

Treatment:

Other: conventional treatment

Other: ozonated gel phonophoresis

conventional treatment

Active Comparator group

Description:

Twenty patients will receive conventional treatment consisting of hot pack application and stretching exercises targeting the upper trapezius and pectoralis minor muscles. Stretching will be performed for three repetitions, each held for 30 seconds with 30 seconds of rest between repetitions. This will be followed by strengthening exercises for the external shoulder rotators, lower trapezius, and serratus anterior muscles using color-coded elastic resistance bands, performed as three sets of ten repetitions for each muscle group. In addition, ultrasound therapy will be applied at a frequency of 1 MHz and an intensity of 0.8 W/cm² for 7 minutes. Treatment sessions will be conducted three times per week for four weeks.

Treatment:

Other: conventional treatment