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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05475639
Other study ID # P.T.REC/012/003719
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 25, 2023
Est. completion date October 5, 2023

Study information

Verified date February 2023
Source Cairo University
Contact Haytham M el-hafez, professor
Phone 01001909630
Email elhafez@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date October 5, 2023
Est. primary completion date June 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Axillary Diclofenac phonophoresis
axillary diclophenac phonophoresis (voltaren gel) will be received three times per week for four weeks
Post isometric facilitation
Post isometric facilitation exercise will be received three times per week for four weeks
Traditional physiotherapy
Traditional physiotherapy will be received three times per week for four weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary pain intensity numerical rating scale (NRS) will be used for assessment of pain intensity. the scale from 0 to 10 where 0 is no pain and 10 is the worst pain up to six weeks
Primary pressure pain threshold commander algometer will be used for measuring pressure pain threshold up to six weeks
Primary shoulder range of motion digital goniometer will be used for measuring range of motion up to six weeks
Primary shoulder functional activity Disability of the Arm, Shoulder, and Hand questionnaire (DASH) will be used for measuring shoulder function activity. it is a shortened version of the DASH questionnaire that uses 11 items to measure the degree of difficulty in performing various physical activities due to a shoulder, arm, or hand problem (6 items); the severity of pain and tingling (2 items); and the problem's effect on social activities, work, and sleep (3 items) up to six months
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