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

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Axillary Diclofenac phonophoresis
Post isometric facilitation
Traditional physiotherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder focused on measuring adhesive capsulitis, post isometric facilitation, axillary phonophoresis

Eligibility Criteria

30 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    axillary diclophenac phonophoresis ( diclophen gel "voltaren gel")

    Post isometric Facilitation Techniques.

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

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    pressure pain threshold
    commander algometer will be used for measuring pressure pain threshold
    shoulder range of motion
    digital goniometer will be used for measuring range of motion
    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 20, 2022
    Last Updated
    February 8, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05475639
    Brief Title
    Axillary Phonophoresis Versus Post Isometric Facilitation in the Treatment of Shoulder Adhesive Capsulitis
    Official Title
    Axillary Phonophoresis Versus Post Isometric Facilitation in the Treatment of Shoulder Adhesive Capsulitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 25, 2023 (Anticipated)
    Primary Completion Date
    June 5, 2023 (Anticipated)
    Study Completion Date
    October 5, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adhesive Capsulitis of Shoulder
    Keywords
    adhesive capsulitis, post isometric facilitation, axillary phonophoresis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    this trial has three group; two experimental and one control
    Masking
    Participant
    Masking Description
    opaque sealed envelope
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    axillary diclophenac phonophoresis ( diclophen gel "voltaren gel")
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Post isometric Facilitation Techniques.
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    traditional physiotherapy (infrared, supervised exercise program, home exercise program)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Axillary Diclofenac phonophoresis
    Intervention Description
    axillary diclophenac phonophoresis (voltaren gel) will be received three times per week for four weeks
    Intervention Type
    Other
    Intervention Name(s)
    Post isometric facilitation
    Intervention Description
    Post isometric facilitation exercise will be received three times per week for four weeks
    Intervention Type
    Other
    Intervention Name(s)
    Traditional physiotherapy
    Intervention Description
    Traditional physiotherapy will be received three times per week for four weeks
    Primary Outcome Measure Information:
    Title
    pain intensity
    Description
    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
    Time Frame
    up to six weeks
    Title
    pressure pain threshold
    Description
    commander algometer will be used for measuring pressure pain threshold
    Time Frame
    up to six weeks
    Title
    shoulder range of motion
    Description
    digital goniometer will be used for measuring range of motion
    Time Frame
    up to six weeks
    Title
    shoulder functional activity
    Description
    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)
    Time Frame
    up to six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haytham M el-hafez, professor
    Phone
    01001909630
    Email
    elhafez@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marwa El-sayed, Bachlore
    Phone
    01117150486
    Email
    marwabasit55@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marwa El-sayed, Bachlore
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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