- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06010381
Muscle Energy Technique Versus Maitland Mobilization on Shoulder Pain and Disability
Muscle Energy Technique Versus Maitland Mobilization on Shoulder Pain and Disability After Neck Dissection Surgeries.
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 02
- Shaimaa Mohamed Ahmed El Sayeh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Muscle energy technique
This group includes 15 patients who received muscle energy technique post-surgery in addition to traditional shoulder exercise, 3 sessions/week for four weeks.
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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.
Traditional shoulder exercises in the form of shoulder range of motion exercises, stretching exercises and, scapular stabilization.
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Active Comparator: Maitland mobilization
This group includes 15 patients who received mobilization in addition to traditional shoulder exercise, 3 sessions/week for four weeks.
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Traditional shoulder exercises in the form of shoulder range of motion exercises, stretching exercises and, scapular stabilization.
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Shoulder active range of motion
Time Frame: Change from baseline at four weeks after the intervention
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Through using the universal goniometer to measure the shoulder flexion, abduction and, external rotation.
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Change from baseline at four weeks after the intervention
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Visual analogue scale
Time Frame: Change from baseline at four weeks after the intervention
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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.
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Change from baseline at four weeks after the intervention
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Shoulder Pain and Disability Index
Time Frame: Change from baseline at four weeks after the intervention
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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).
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Change from baseline at four weeks after the intervention
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shaimaa MA El Sayeh, PhD, Lecturer at Faculty of Physical Therapy, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003370
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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