NCT05475639

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

February 25, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

July 20, 2022

Last Update Submit

February 8, 2023

Conditions

Keywords

adhesive capsulitispost isometric facilitationaxillary phonophoresis

Outcome Measures

Primary Outcomes (4)

  • 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

  • pressure pain threshold

    commander algometer will be used for measuring pressure pain threshold

    up to six weeks

  • shoulder range of motion

    digital goniometer will be used for measuring range of motion

    up to six weeks

  • 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

Study Arms (3)

axillary diclophenac phonophoresis ( diclophen gel "voltaren gel")

EXPERIMENTAL

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.

Other: Axillary Diclofenac phonophoresis

Post isometric Facilitation Techniques.

EXPERIMENTAL

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.

Other: Post isometric facilitation

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

ACTIVE COMPARATOR

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.

Other: Traditional physiotherapy

Interventions

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

axillary diclophenac phonophoresis ( diclophen gel "voltaren gel")

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

Post isometric Facilitation Techniques.

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

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

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • All patients will sign the informed consent before joining the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Marwa El-sayed, Bachlore

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haytham M el-hafez, professor

CONTACT

Marwa El-sayed, Bachlore

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: this trial has three group; two experimental and one control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 20, 2022

First Posted

July 27, 2022

Study Start

February 25, 2023

Primary Completion

June 5, 2023

Study Completion

October 5, 2023

Last Updated

February 10, 2023

Record last verified: 2023-02