NCT06010381

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2023

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

August 21, 2023

Last Update Submit

April 15, 2024

Conditions

Keywords

Muscle energy techniqueMaitland's mobilizationshoulder pain and disabilityneck dissection surgeries

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Muscle energy technique

ACTIVE COMPARATOR

This group includes 15 patients who received muscle energy technique post-surgery in addition to traditional shoulder exercise, 3 sessions/week for four weeks.

Other: Muscle energy techniqueOther: Traditional shoulder exercise

Maitland mobilization

ACTIVE COMPARATOR

This group includes 15 patients who received mobilization in addition to traditional shoulder exercise, 3 sessions/week for four weeks.

Other: Maitland mobilizationOther: Traditional shoulder exercise

Interventions

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.

Muscle energy technique

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).

Maitland mobilization

Traditional shoulder exercises in the form of shoulder range of motion exercises, stretching exercises and, scapular stabilization.

Maitland mobilizationMuscle energy technique

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous shoulder pain from any other causes.
  • Pregnancy.
  • Epileptics.
  • Radiotherapy.
  • Chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaimaa Mohamed Ahmed El Sayeh

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMobility LimitationSomatoform DisordersShoulder Pain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic Manifestations

Study Officials

  • Shaimaa MA El Sayeh, PhD

    Lecturer at Faculty of Physical Therapy, Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 24, 2023

Study Start

November 1, 2021

Primary Completion

August 30, 2023

Study Completion

September 13, 2023

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations