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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06010381
Other study ID # P.T.REC/012/003370
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date September 13, 2023

Study information

Verified date April 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effect of muscle energy technique versus Maitland's mobilization on shoulder pain and disability after neck dissection surgeries.


Description:

Thirty patients with shoulder pain and limited ROM post-neck dissection surgeries participated in this study. Patients were subdivided into two groups, fifteen patients in each group. Group A received the muscle energy technique and group B received Maitland's mobilization. Data obtained from both groups regarding the Visual Analogue Scale, it has a 100-mm-long horizontal line labeled ''no pain' (with or without related facial expressions) at one extreme and ''worst pain ever' at the other. Pain intensity is determined by the length of the line as measured from the left-hand side to the point marked, The Shoulder Pain and Disability Index, it has two subscales; The pain subscale includes five questions about pain intensity. The disability subscale includes eight questions about difficulty in different orders. Each question of both pain and disability subscale was scaled in numeric ratings ranging from 0 to 10. Each score was summed up and transformed into percentages. Finally, the average score between pain and disability subscale comprised the total SPADI scores ranging from 0 (the best) to 100 (the worst), and shoulder flexion, abduction, and external ROM were statistically analyzed and compared.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 13, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 25 Years to 70 Years
Eligibility Inclusion Criteria: - Age range between 25-70 years. - Male and female patients participated in the study. - All patients had shoulder pain following different NDS - All patients had no previous shoulder pain. - All patients enrolled in the study had their informed consent. Exclusion Criteria: - Previous shoulder pain from any other causes. - Pregnancy. - Epileptics. - Radiotherapy. - Chemotherapy.

Study Design


Intervention

Other:
Muscle energy technique
It was applied on the shoulder flexion and the external rotation. An isometric contraction of the agonist muscle (the muscle which requires stretching) for 7 seconds with gentle muscle contraction to avoid the risk of increasing the muscle tone. This contraction started just short of the restrictive barrier. After that, the patient is asked to relax for 2-3 seconds and then the therapist stretches the contracted muscle in the opposite direction for 30 seconds. This is repeated three repetitions for each muscle.
Maitland mobilization
At the start of each session, the physical therapist examined the patient's ROM in all directions to obtain information about the end-range position and the end feel of the glenohumeral joint. Start with rhythmic mid-range mobilization with the patient in a supine position. The therapist's hands are placed close to the glenohumeral joint, and the humerus is brought into a position of maximal flexion in the sagittal plane. After 10 to 15 repetitions of intensive mobilization techniques in this end-range position, the direction of mobilization will be altered by varying the plane of elevation or by varying the degree of rotation. When alternating the direction of mobilization, other movements such as gliding techniques and distraction in that joint position were (inferior gliding, anterior gliding, and posterior gliding).
Traditional shoulder exercise
Traditional shoulder exercises in the form of shoulder range of motion exercises, stretching exercises and, scapular stabilization.

Locations

Country Name City State
Egypt Shaimaa Mohamed Ahmed El Sayeh Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue scale A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiology and clinical research to measure the intensity or frequency of various symptoms. It has a 100-mm-long horizontal line labeled ''no pain' (with or without related facial expressions) at one extreme and ''worst pain ever' at the other. Pain intensity is determined by the length of the line as measured from the left-hand side to the point marked. Change from baseline at four weeks after the intervention
Primary Shoulder Pain and Disability Index It is a self-reported questionnaire consisting of 13 items divided in two parts: pain and disability sub-scale. The pain subscale includes five questions about pain intensity. The disability subscale includes eight questions about difficulty in different orders. Each question of both pain and disability subscale was scaled in numeric ratings ranging from 0 to 10. Each score was summed up and transformed into percentages. Finally, the average score between pain and disability subscale comprised the total SPADI scores ranging from 0 (the best) to 100 (the worst). Change from baseline at four weeks after the intervention
Primary Shoulder active range of motion Through using the universal goniometer to measure the shoulder flexion, abduction and, external rotation. Change from baseline at four weeks after the intervention
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