Axillary Phonophoresis Versus Post Isometric Facilitation in the Treatment of Shoulder Adhesive Capsulitis

NCT ID: NCT05475639

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-25
• Study Completion Date: 2023-10-05

Brief Summary

the aim of this study is to compare the effect of Axillary Phonophoresis versus Post isometric facilitation in subjects with Adhesive capsulitis

Detailed Description

Adhesive Capsulitis is a common cause of shoulder pain and disability and also a condition involving glen humeral pain and loss of motion. It is characterized by significant restriction of both active and passive motion that occurs in the absence of a known intrinsic shoulder disorder. The intervention strategies for AC include a trial of conservative therapy followed by more invasive procedures.it may be primary-onset is generally idiopathic or Secondary- results from known cause. Clinically, patients may present with pain and mild restriction of movement which can lead to a gross loss of function predisposing factor or surgical event . it is most frequent in women, diabetic population and patient older than 40 years .It is described as having 3 stages. Stage Ⅰ involves pain (freezing or painful stage) and lasts from 3 to 9 months and is characterized by an acute synovitis of the glen humeral joint. Stage Ⅱ (frozen or transitional stage) includes pain and restricted movement and lasts from 4 to 12 months. Stage Ⅲ (thawing stage) involves painless restriction and lasts from 12 to 42 months. Contributing factors include diabetes mellitus, stroke, thyroid disorder, dupuytren disease, complex regional pain syndrome and metabolic syndrome.

Axillary Phonophoresis and Post isometric facilitation play a major role in the treatment of adhesive capsulitis so this trial was conducted to determine which one has superiority. this trial has three groups. two experimental and one control group. pain ,function, pressure pain threshold will be measured.

Conditions

Adhesive Capsulitis of Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

axillary diclophenac phonophoresis ( diclophen gel "voltaren gel")

the subject in the axillary diclophenac phonophoresis group will receive axillary diclophenac phonophoresis using ultrasound 1 MHz to increases the absorbtion. Diclofenac phonophoresis will be applied beside conventional therapy program ,Apply the diclophen gel (voltaren gel) on the head of the US in the axillary pouch of the capsule at 1.5 W\\cm2 for 10 minutes as pulsed U.S. the group will be treated for 4weeks, 3 sessions per week and all patients will be assessed pre and post intervention.

Group Type: EXPERIMENTAL

Axillary Diclofenac phonophoresis

Intervention Type: OTHER

axillary diclophenac phonophoresis (voltaren gel) will be received three times per week for four weeks

Post isometric Facilitation Techniques.

the subject in the Post isometric Facilitation Techniques group will be treated by applying isometric contraction followed by isometric relaxation followed by stretching to the target muscle .when performing isometric facilitation with the shoulder in flexion , the patient was seated with his\\her back supported and the therapist standing facing the patient's painful shoulder .the patient's shoulder joint was flexed to the maximum available range with the elbow completely flexed .the patient performed isometric contraction of the shoulder extensors against maximum resistance provided by the therapist .this contraction will last for 10 seconds followed by relaxation for 5 seconds .this contraction will allow the shortened shoulder extensors to relax and permit easier stretching.the group will be treated for 4weeks, 3 sessions per week and all patients will be assessed pre and post intervention.

Group Type: EXPERIMENTAL

Post isometric facilitation

Intervention Type: OTHER

Post isometric facilitation exercise will be received three times per week for four weeks

traditional physiotherapy (infrared, supervised exercise program, home exercise program)

The traditional physical therapy program, which includes Infrared (IR) lambs apply heat to deep joints such as shoulder joint. Avoid deltoid muscle; apply over thin, bony areas for maximum penetration.

supervised exercise program are self-exercise included: 1-Codmans or pendulum exercise (circumduction): It should be done 5 times daily in 5 to 10 minute sessions Passive stretching exercise (for shoulder extensors, abductors, and internal rotator) home exercise program includes the same exercise as in supervised exercise program. The participant will instruct to perform exercises1-2 times/day within pain -free ROM.

the group will be 4weeks, 3 sessions per week and all patients will be assessed pre and post intervention.

Group Type: ACTIVE_COMPARATOR

Traditional physiotherapy

Intervention Type: OTHER

Traditional physiotherapy will be received three times per week for four weeks

Interventions

Axillary Diclofenac phonophoresis

axillary diclophenac phonophoresis (voltaren gel) will be received three times per week for four weeks

Intervention Type: OTHER

Post isometric facilitation

Post isometric facilitation exercise will be received three times per week for four weeks

Intervention Type: OTHER

Traditional physiotherapy

Traditional physiotherapy will be received three times per week for four weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The patient age will range from 30to 40years old from both sexes (male and female).
• All recruited subjects in the 2nd stage of adhesive capsulitis (transitional stage).
• The patient will be diagnosed and referred by orthopedist as Adhesive capsulitis.
• The diagnosis will be confirmed by shoulder MRI.
• The diagnosis will be confirmed by shrug test.
• The patient will be referred by anterior shoulder pain or anterolateral shoulder pain.
• Inclusion requirement include two or more of the following pain complaints: Grooming ones hair, Scratching your back and getting dressed, Overhead activities or Difficulty in the action of throwing the ball and giving a high -five.
• All patients will sign the informed consent before joining the study.

Exclusion Criteria

• Previous fracture with or without internal fixation in the shoulder joint
• Any previous surgery in the shoulder joint and patient with tendon calcification
• Local corticosteroid injection to the affected shoulder within the last three months or recent ones (Michener et al, 2004).
• Neuromuscular disease
• Rotator cuff tear
• History of metastatic cancer or diagnosis of cancer within 12 months
• Unstable angina

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Abdel Basset Ali Elsayed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa El-sayed, Bachlore

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

Haytham M el-hafez, professor

Role: CONTACT

elhafez@yahoo.com

01001909630

Marwa El-sayed, Bachlore

Role: CONTACT

marwabasit55@gmail.com

01117150486

Other Identifiers

P.T.REC/012/003719

Identifier Type: -

Identifier Source: org_study_id