| CTRI Number |
CTRI/2023/05/052643 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The aim of this study is to find out the Effect of Maitland and Mulligan Mobilization on Pain,
Range of Motion and functional Disability in patients with Rotator Cuff Syndrome:
Randomized Clinical Trial |
|
Scientific Title of Study
|
EFFECT OF MAITLAND AND MULLIGAN MOBILIZATION ON PAIN, RANGE
OF MOTION AND FUNCTIONAL DISABILITY IN PATIENTS WITH ROTATOR
CUFF SYNDROME: RANDOMIZED CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samiksha V Sonone |
| Designation |
PG student |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8983204947 |
| Fax |
|
| Email |
samikshasonone12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Patil |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975453662 |
| Fax |
|
| Email |
dvjphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samiksha V Sonone |
| Designation |
PG student |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8983204947 |
| Fax |
|
| Email |
samikshasonone12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of
Higher Education and Research (Deemed to be University), Sawangi (Meghe) Wardha,
Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy
College, Datta Meghe Institute of Higher Education and Research
(Deemed to be University), Sawangi(Meghe) Wardha. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Samiksha V Sonone |
Acharya Vinoba Bhave Rural Hospital and Musculoskeletal Physiotherapy OPD of RNPC |
Department of Musculoskeletal
Physiotherapy, Ravi
Nair Physiotherapy
College, Datta Meghe
Institute of Higher
Education and
Research (Deemed to
be University), Sawangi
(Meghe) Wardha
Wardha
MAHARASHTRA |
8983204947
samikshasonone12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maitland Mobilization |
Patient was in supine lying with arm abducted to 30 degrees and therapist was in walk
standing position holding proximal end of the humerus and maintaining a lateral
humeral distraction in its midrange position.
Duration: Glenohumeral caudal glide mobilization was given at the rate of 2-3 glides
per second for 30 seconds for each 6 weeks glide, given for 5 sets
 Conventional Therapy
1. Wand exercises
2. Codman exercises
3. Shoulder capsule stretching exercises.
4. Stretching exercises
5. Strengthening exercises
6. Finger stairs
7. Shoulder hand wheel
8. Ultrasound of 1.5 MHz in 6 minutes
9. TENS of 100 Hz in 20 minutes
These Exercises will be performed for 10 repetitions and gradually will be progressed.
Patients in group A will need 60 minutes of overall treatment which will include 20 minutes
of Mulligan mobilization, 40 minutes of conventional physiotherapy (6 minutes US, 20
minutes TENS and 15 minutes exercises) |
| Comparator Agent |
Mulligans mobilization |
The participants in this group will receive traditional physiotherapy applications, and active
accessory mobilizations of the humeral head using the MWM technique were carried out in
flexion, abduction, and external and internal rotation directions. For this technique, participants
were seated on a stretcher, and the physical therapist was standing opposite of the upper
extremity that would be treated. The internal hand of the physical therapist stabilized
participants’ shoulder girdle and, with the thenar eminence of the other hand, performed a
glide of the humeral head (this direction is the most suitable for treating such shoulder
limitations). Participants were asked to flex the affected shoulder until the pain started while
the physical therapist sustained the gliding force to the humeral head. The physical therapist
tried to maintain the glide at right angles to the plane of movement throughout the entire
range while participants were requested to perform an active movement. Participants were
instructed that MWM, including shoulder movement, must be pain-free and should be
immediately stopped if any pain was experienced during the treatment.
Duration: The MWM technique lasted around 20 minutes, in 3 sequences of 10 repetitions
with a rest interval of 30 seconds between each sequence.
 CONVENTIONAL THERAPY
1. Wand exercises
2. Codman exercises
3. Shoulder capsule stretching exercises.
4. Stretching exercises
5. Strengthening exercises
6. Finger stairs
7. Shoulder hand wheel
8. Ultrasound of 1.5 MHz in 6 minutes
9. TENS of 100 Hz in 20 minutes
These Exercises will be performed for 10 repetitions and gradually will be progressed.
Patients in group B will need 60 minutes of overall treatment which will include 20 minutes
of Mulligan mobilization, 40 minutes of conventional physiotherapy (6 minutes US, 20
minutes TENS and 15 minutes exercises) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having limited ROM of the shoulder joint
2. Partial rupture and suffering from Rotator cuff syndrome
3. No shoulder surgery
4. Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. A recent myocardial infarction or major shoulder trauma
2. Patient with osteoporosis
3. Not willing to participate in the study
4. Tumours/malignancies/infections associated with the shoulder joint and upper limb metallic implants. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. VAS
2. ROM
3. DASH |
Outcomes will be assessed at baseline and after
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. SF-36 |
Outcomes will be assessed at baseline and after
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 06-09-2024 and end date provided 06-09-2050?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
AIMS The aim of this study is to find out the Effect of Maitland and Mulligan Mobilization on Pain,
Range of Motion, and Functional Disability in patients with Rotator Cuff Syndrome:
Randomized Clinical Trial
OBJECTIVES • To evaluate the effect of Maitland mobilization on pain in individuals with Rotator
Cuff Syndrome • To evaluate the effect of Mulligan Mobilization on Pain, Range of Motion, and
Functional Disability in Individuals with Rotator Cuff Syndrome • To compare the effects of Maitland and Mulligan Mobilization in a patient with Rotator
Cuff Syndrome. |