Mulligan Technique on Shoulder Dysfunction

Head and Neck Cancer Clinical Trial

Official title:

Effect of Mulligan Technique on Shoulder Dysfunction Post Neck Dissection Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915572
• Other study ID #: 752015
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: Mona Amin, Master
• Phone: 01151602624
• Email: monaamin028[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. 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.

2. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• 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 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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	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 weeks