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Mulligan Technique on Shoulder Dysfunction

Primary Purpose

Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mulligan Mobilization Technique
Traditional Physical Therapy Program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Mulligan Technique, Shoulder Dysfunction, Neck Dissection Surgeries

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients' age will be between 30-50 years old. Both gender 76 patients will participate in this study. Patients with stage I, II adhesive capsulitis post neck dissection surgeries. Frozen shoulder patients with painful, stiff shoulder for at least 3 months. Frozen Shoulder with at least 25% restricted shoulder range of motion. All patients have from moderate to severe pain (VAS score > 4). Patients who are able to comprehend command and willing to participate in the study. All patients enrolled to the study had their informed consent. Exclusion Criteria: Patients with rotator cuff tears and other shoulder ligament injuries or tendon calcification. Rheumatoid arthritis shoulder secondary to fracture, dislocation. Musculoskeletal injuries of glenohumeral joint like fracture and dislocation. Malignancies in the shoulder region, neurological disorders, thoracic outlet syndrome and peripheral nerve injuries Epilepsy or any psychological disorders. Cervical disk lesion, cervical radiculopathy. Cervical spine fracture or spondylolisthesis.

Sites / Locations

  • Faculty of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mulligan Mobilization Technique Plus Traditional Physical Therapy Program

Traditional Physical Therapy Program

Arm Description

Mulligan Mobilization Technique in addition to traditional physical therapy program (myofascial release, capsular stretching ex. strengthening ex. and ROM ex.) 3 sessions per week for 6 weeks. The therapist applied passive accessory glide to increase shoulder flexion, abduction, external rotation as the patient moved the arm actively in the desired direction with in a pain free range with dosage: 3 sets for 10 repetitions with 1 minute rest between sets. 3 times a week for 6 weeks. Traditional physical therapy will include chin tucks, shoulder shrugs, shoulder circle, scapular retraction/adduction and shoulder ROM exercises, including shoulder flexion and abduction to improve glenohumeral & scapulothoracic motion and shoulder extension & adduction with moderate resistance and shoulder internal/external rotation with approximately two sets of 15 repetitions.

Traditional physical therapy program (myofascial release, capsular stretching ex. strengthening ex. and ROM ex.) 3 sessions per week for 6 weeks. Traditional physical therapy will include chin tucks, shoulder shrugs, shoulder circle, scapular retraction/adduction and shoulder ROM exercises, including shoulder flexion and abduction to improve glenohumeral & scapulothoracic motion and shoulder extension & adduction with moderate resistance and shoulder internal/external rotation with approximately two sets of 15 repetitions.

Outcomes

Primary Outcome Measures

Digital Goniometer:
Digital Goniometer is a device which measures joint ranges, together with velocity and acceleration variables, with a high level of precision and at a relatively low-cost, practically similar to current analogical tools. The digital goniometer is a device specifically designed for the measurement of angles of movement of the human body with a resolution of 1°, representing an ideal substitute to traditional goniometers, which are usually based on a scale of 5° increments. For measuring the selected shoulder movements (flexion, abduction, external rotation), the position used as the supine position, in which the participant was asked to lie down restfully on his back.

Secondary Outcome Measures

Shoulder Pain and Disability Index:
The SPADI is a self-reported questionnaire consisting of 13 items divided in two parts: pain and disability subscale. The pain subscale includes five questions about pain intensity at its worst and when lying on the involved side, reaching for something on a high shelf, touching the back of the neck and pushing with the involved arm. The disability subscale includes eight questions about difficulty when washing the hair, washing the back, putting on an undershirt or jumper, putting on a shirt that buttons down the front, putting on your pants, placing an object on a high shelf, carrying an object of 10 pounds (4.5 kilograms) and removing something from your back pocket. Each question of both pain and disability subscale was scaled in 11-numeric ratings ranging from 0 to 10. Each score was summed and transformed to percentage. Finally, the average score between pain and disability subscale comprised the total SPADI scores ranging from 0 (the best) to 100 (the worst).

Full Information

First Posted
June 14, 2023
Last Updated
October 8, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05915572
Brief Title
Mulligan Technique on Shoulder Dysfunction
Official Title
Effect of Mulligan Technique on Shoulder Dysfunction Post Neck Dissection Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (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
Seventy six patients of both genders with age 30 - 50 year old suffering from shoulder dysfunction after neck dissection surgeries will participate in this study. The participants will be selected from Damanhur Oncology Center and randomly will be distributed into two groups equal in number. Group (A): 38 patients will receive mulligan mobilization technique in addition to traditional physical therapy program (myofascial release, capsular stretching ex. strengthening ex. and ROM ex.) 3 sessions per week for 6 weeks. Group (B): 38 patients will receive traditional physical therapy program (myofascial release, capsular stretching ex. strengthening ex. and ROM ex.) 3 sessions per week for 6 weeks.
Detailed Description
Subjects: Seventy six patients of both genders with age 30 - 50 year old suffering from shoulder dysfunction after neck dissection surgeries will participate in this study. The participants will be selected from Damanhur Oncology Center and randomly will be distributed into two groups equal in number. Group (A): 38 patients will receive mulligan mobilization technique in addition to traditional physical therapy program (myofascial release, capsular stretching ex. strengthening ex. and ROM ex.) 3 sessions per week for 6 weeks. Group (B): 38 patients will receive traditional physical therapy program (myofascial release, capsular stretching ex. strengthening ex. and ROM ex.) 3 sessions per week for 6 weeks. Equipment: Therapeutic equipment: Mulligan Mobilization Technique: the therapist applied passive accessory glide to increase shoulder flexion, abduction, external rotation as the patient moved the arm actively in the desired direction with in a pain free range with dosage: 3 sets for 10 repetitions with 1 minute rest between sets. 3 times a week for 6 weeks. Traditional physical therapy program: (myofascial release, capsular stretching ex. Strengthening ex. And ROM ex.) 3 sessions per week for 6 weeks. Traditional physical therapy will include chin tucks, shoulder shrugs, shoulder circle, scapular retraction/adduction and shoulder ROM exercises, including shoulder flexion and abduction to improve glenohumeral & scapulothoracic motion and shoulder extension & adduction with moderate resistance and shoulder internal/external rotation with approximately two sets of 15 repetitions. Measurement equipment: Digital Goniometer: It's a device which measures joint ranges, together with velocity and acceleration variables, with a high level of precision and at a relatively low-cost, practically similar to current analogical tools. The digital goniometer is a device specifically designed for the measurement of angles of movement of the human body with a resolution of 1°, representing an ideal substitute to traditional goniometers, which are usually based on a scale of 5° increments. For measuring the selected shoulder movements (flexion, abduction, external rotation), the position used as the supine position, in which the participant was asked to lie down restfully on his back. Shoulder Pain and Disability Index: The SPADI is a self-reported questionnaire consisting of 13 items divided in two parts: pain and disability subscale. The pain subscale includes five questions about pain intensity at its worst and when lying on the involved side, reaching for something on a high shelf, touching the back of the neck and pushing with the involved arm. The disability subscale includes eight questions about difficulty when washing the hair, washing the back, putting on an undershirt or jumper, putting on a shirt that buttons down the front, putting on your pants, placing an object on a high shelf, carrying an object of 10 pounds (4.5 kilograms) and removing something from your back pocket. Each question of both pain and disability subscale was scaled in 11-numeric ratings ranging from 0 to 10. Each score was summed and transformed to percentage. Finally, the average score between pain and disability subscale comprised the total SPADI scores ranging from 0 (the best) to 100 (the worst).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Mulligan Technique, Shoulder Dysfunction, Neck Dissection Surgeries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mulligan Mobilization Technique Plus Traditional Physical Therapy Program
Arm Type
Experimental
Arm Description
Mulligan Mobilization Technique in addition to traditional physical therapy program (myofascial release, capsular stretching ex. strengthening ex. and ROM ex.) 3 sessions per week for 6 weeks. The therapist applied passive accessory glide to increase shoulder flexion, abduction, external rotation as the patient moved the arm actively in the desired direction with in a pain free range with dosage: 3 sets for 10 repetitions with 1 minute rest between sets. 3 times a week for 6 weeks. Traditional physical therapy will include chin tucks, shoulder shrugs, shoulder circle, scapular retraction/adduction and shoulder ROM exercises, including shoulder flexion and abduction to improve glenohumeral & scapulothoracic motion and shoulder extension & adduction with moderate resistance and shoulder internal/external rotation with approximately two sets of 15 repetitions.
Arm Title
Traditional Physical Therapy Program
Arm Type
Experimental
Arm Description
Traditional physical therapy program (myofascial release, capsular stretching ex. strengthening ex. and ROM ex.) 3 sessions per week for 6 weeks. Traditional physical therapy will include chin tucks, shoulder shrugs, shoulder circle, scapular retraction/adduction and shoulder ROM exercises, including shoulder flexion and abduction to improve glenohumeral & scapulothoracic motion and shoulder extension & adduction with moderate resistance and shoulder internal/external rotation with approximately two sets of 15 repetitions.
Intervention Type
Other
Intervention Name(s)
Mulligan Mobilization Technique
Intervention Description
The therapist applied passive accessory glide to increase shoulder flexion, abduction, external rotation as the patient moved the arm actively in the desired direction with in a pain free range with dosage: 3 sets for 10 repetitions with 1 minute rest between sets. 3 times a week for 6 weeks. Traditional physical therapy will include chin tucks, shoulder shrugs, shoulder circle, scapular retraction/adduction and shoulder ROM exercises, including shoulder flexion and abduction to improve glenohumeral & scapulothoracic motion and shoulder extension & adduction with moderate resistance and shoulder internal/external rotation with approximately two sets of 15 repetitions.
Intervention Type
Other
Intervention Name(s)
Traditional Physical Therapy Program
Intervention Description
Myofascial release, capsular stretching ex. strengthening ex. and ROM ex. 3 sessions per week for 6 weeks. Traditional physical therapy will include chin tucks, shoulder shrugs, shoulder circle, scapular retraction/adduction and shoulder ROM exercises, including shoulder flexion and abduction to improve glenohumeral & scapulothoracic motion and shoulder extension & adduction with moderate resistance and shoulder internal/external rotation with approximately two sets of 15 repetitions.
Primary Outcome Measure Information:
Title
Digital Goniometer:
Description
Digital Goniometer is a device which measures joint ranges, together with velocity and acceleration variables, with a high level of precision and at a relatively low-cost, practically similar to current analogical tools. The digital goniometer is a device specifically designed for the measurement of angles of movement of the human body with a resolution of 1°, representing an ideal substitute to traditional goniometers, which are usually based on a scale of 5° increments. For measuring the selected shoulder movements (flexion, abduction, external rotation), the position used as the supine position, in which the participant was asked to lie down restfully on his back.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Shoulder Pain and Disability Index:
Description
The SPADI is a self-reported questionnaire consisting of 13 items divided in two parts: pain and disability subscale. The pain subscale includes five questions about pain intensity at its worst and when lying on the involved side, reaching for something on a high shelf, touching the back of the neck and pushing with the involved arm. The disability subscale includes eight questions about difficulty when washing the hair, washing the back, putting on an undershirt or jumper, putting on a shirt that buttons down the front, putting on your pants, placing an object on a high shelf, carrying an object of 10 pounds (4.5 kilograms) and removing something from your back pocket. Each question of both pain and disability subscale was scaled in 11-numeric ratings ranging from 0 to 10. Each score was summed and transformed to percentage. Finally, the average score between pain and disability subscale comprised the total SPADI scores ranging from 0 (the best) to 100 (the worst).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients' age will be between 30-50 years old. Both gender 76 patients will participate in this study. Patients with stage I, II adhesive capsulitis post neck dissection surgeries. Frozen shoulder patients with painful, stiff shoulder for at least 3 months. Frozen Shoulder with at least 25% restricted shoulder range of motion. All patients have from moderate to severe pain (VAS score > 4). Patients who are able to comprehend command and willing to participate in the study. All patients enrolled to the study had their informed consent. Exclusion Criteria: Patients with rotator cuff tears and other shoulder ligament injuries or tendon calcification. Rheumatoid arthritis shoulder secondary to fracture, dislocation. Musculoskeletal injuries of glenohumeral joint like fracture and dislocation. Malignancies in the shoulder region, neurological disorders, thoracic outlet syndrome and peripheral nerve injuries Epilepsy or any psychological disorders. Cervical disk lesion, cervical radiculopathy. Cervical spine fracture or spondylolisthesis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Amin, Master
Phone
01151602624
Email
monaamin028@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Research Ethical Committee Faculty of Physical Therapy
Phone
01151312322
Email
eth.com@pt.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Research Ethical Committee Faculty of Physical Therapy
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faculty of Physical Therapy
Phone
01151312322
Email
eth.com@pt.cu.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Mulligan Technique on Shoulder Dysfunction

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