NCT05924360

Brief Summary

The shoulder joint in the human body has a broader range of motion and opening compared to other joints, resulting in a multitude of potential problems. The rotator cuff lesion is one such issue. The rotator cuff is found in the subacromial space of the shoulder and results from the compression of the subacromial bursa and the long head of the M.biceps muscle between the humerus and the coracoacromial arch. Upon reviewing the literature, therapeutic exercise and electrotherapy modalities are the most preferred and studied areas. Alongside these, we also observe the usage of Mulligan and Maitland techniques for the treatment of rotator cuff lesions. The Mulligan technique was developed by Brian Mulligan in 1980, who lent his name to it. Also known as mobilization with movement, this technique is often applied to the body's distal joints. The Maitland mobilization technique is used to treat the relevant joint with specific methods, particularly focusing on pain and stiffness in the joint. The technique's application is graded from 1 to 4. Grade 1 is a small oscillation created without loading throughout the joint movement. Grade 2 is performed with a slightly more oscillation from the beginning of the movement. Grades 1 and 2 aim to restrict the pain stimulus going to the central nervous system by stimulating the mechanoreceptor in the joint, thereby reducing the sensation of pain. Grade 3 is applied at a larger amplitude until a limitation is felt from the middle of the joint movement. Lastly, grade 4 is applied to the limited small amplitude until tissue resistance is felt. Grades 3 and 4 are used to alleviate joint stiffness by applying shorter oscillation stimuli to a shorter tissue. The results of the use of Mulligan and Maitland techniques have been demonstrated in different studies in the literature. However, as far as we know, no study in the literature compares these two techniques in individuals with rotator cuff lesions. Based on this gap in the literature, the purpose of this study is to investigate the effects of the Mulligan technique and the Maitland method on pain, range of joint motion, functionality, joint position sense, and quality of life in individuals with a rotator cuff problem.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 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

First Submitted

Initial submission to the registry

June 21, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

June 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

June 21, 2023

Last Update Submit

August 26, 2023

Conditions

Keywords

Rotator cuffMulligan mobilizationMaitland mobilizationExercise

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale

    Visual Analog Scale (VAS) The Visual Analog Scale is a commonly preferred evaluation method in clinical practice and literature studies for measuring pain intensity. Patients' pain levels are determined by numbering the range from 0 to 10. A score of 0 indicates no pain, while 10 represents the most intense pain felt.

    5 minutes

  • Range of Motion

    Range of Joint Motion Evaluating the range of joint motion (ROM) is an objective method frequently used in both clinical settings and academic studies. The universal goniometer, used for assessing ROM, is the most preferred tool. In addition to determining the limit of joint movement, it is also used to provide clinicians with data on the effectiveness of the treatment.

    10 minutes

  • Joint Postion Sense

    The joint position sense measurements of the individuals participating in the study will be evaluated using a goniometer. Participants will be asked to raise their shoulder to a certain degree, and then return it to the same angle with their eyes closed. The angular value formed when the eyes are closed and open will be recorded, and the difference between the shoulder angles will be calculated. The joint position sense will be applied at 30 and 60 degrees of flexion and abduction movements.

    5 minutes

Secondary Outcomes (2)

  • Disabilities of the Arm, Shoulder, and Hand Questionnaire

    10 minutes

  • Rotator cuff quality of life

    10 minutes

Study Arms (3)

Control Group

OTHER

The individuals in this group will undergo a conventional exercise program.

Other: conventional exercise programDevice: TENS

Mulligan Group

EXPERIMENTAL

In addition to the conventional treatment program, individuals in this group will receive the mobilization with movement technique in the directions of flexion, abduction, and external rotation, twice a week.

Other: conventional exercise programOther: Mulligan application

Maitland Group

EXPERIMENTAL

In addition to the conventional treatment program, The Maitland application will be administered in the anterior-posterior, posterior-anterior, and caudal directions. The Maitland application will be delivered at grades 2-3. Patients in this group will receive the application in five sets of 30 seconds, twice a week.

Other: conventional exercise programOther: Maitland application

Interventions

The conventional treatment program will be applied to all participants included in the study, consisting of wand, codman, active and passive stretching exercises. This program will be administered to all patients five days a week. Wand exercises will be applied in the directions of flexion, abduction, extension, internal and external rotation, and will consist of 10 repetitions. Codman exercises will be applied in the directions of flexion, abduction, and circular, and will also consist of 10 repetitions. Active and passive stretching exercises will be applied in the directions of flexion, abduction, and external rotation, and will consist of 10 repetitions.

Control GroupMaitland GroupMulligan Group

The mobilization with movement technique, a part of Mulligan applications, will be performed twice a week in the directions of flexion, abduction, and external rotation.

Mulligan Group

Maitland Group: The Maitland application will be applied in the anterior-posterior, posterior-anterior, and caudal directions. The Maitland application will be administered at grades 2-3. Patients in this group will receive the application in five sets of 30 seconds, twice a week.

Maitland Group
TENSDEVICE

TENS application will be administered for 20 minutes at 100Hz

Control Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 30 and 70
  • Not having undergone any previous shoulder surgery
  • Being diagnosed with a rotator cuff lesion
  • Not having any orthopedic or cardiac problems that could interfere with the study or evaluation

You may not qualify if:

  • Having a pathology affecting the shoulder region
  • Having undergone any shoulder surgery
  • Individuals who are not cooperative or have mental problems
  • Individuals with neurological, cardiac, and vascular problems
  • Individuals who have participated in any physiotherapy program targeting the shoulder in the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Bagcilar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesMotor Activity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Burak Menek, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 21, 2023

First Posted

June 29, 2023

Study Start

June 23, 2023

Primary Completion

August 23, 2023

Study Completion

August 26, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations