| CTRI Number |
CTRI/2025/06/088977 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare The Effect Of Two Combined techniques - Scapular PNF With Maitland Mobilization Versus Scapular PNF With Kaltenborn Mobilization On Pain, Range of motion And Function In Adhesive Capsulitis. |
|
Scientific Title of Study
|
Effectiveness Of Scapular Proprioceptive Neuromuscular Facilitation Technique Along With Maitland Mobilization Versus Scapular Proprioceptive Neuromuscular Facilitation Technique Along With Kaltenborn Mobilization in Adhesive Capsulitis A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujata Nair |
| Designation |
PG Student |
| Affiliation |
Maharashtra University of Health Sciences |
| Address |
Sector 4, Institutional area, YMT College of Physiotherpy, Kharghar.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8356094457 |
| Fax |
|
| Email |
sujatanair2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ambulkar |
| Designation |
Associate Professor |
| Affiliation |
Maharashtra University of Health Sciences |
| Address |
Sector 4, Institutional area, Dr G.D.POL Foundation YMT College of Physiotherapy, Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8356094457 |
| Fax |
|
| Email |
ambulkaramit444@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Nair |
| Designation |
PG Student |
| Affiliation |
Maharahtra University Of Health Sciences |
| Address |
Sector 4, Institutional area, YMT College of Physiotherpy, Kharghar.
Raigarh
MAHARASHTRA
41010
India |
| Phone |
8356094457 |
| Fax |
|
| Email |
sujatanair2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sector 4, Dr G.D.POL Foundation YMT College of Physiotherapy, Kharghar. |
|
|
Primary Sponsor
|
| Name |
Dr GDPOL Foundation Ymt college of physiotherapy PG Institute |
| Address |
Sector 4, Institutional area, YMT College of Physiotherpy, Kharghar,421210,Maharashtra,India. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Amit Ambulkar |
Kharghar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujata Nair |
YMT College of Physiotherapy |
Musculoskeletal department, Institutional Area, sector 4 ,kharghar,Navi Mumbai
Thane
MAHARASHTRA |
8356094457
sujatanair2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr G.D.POL Foundation YMT Physiotherapy College PG Institute 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, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A - Scapular PNF and Conventional Physiotherapy
|
1.Scapular PNF- 20 repetitions of each diagonal and rest interval between repetitions will be 20 seconds.
2.Conventional Physiotherapy-
1.Hot packs –
A moist heat pack will be applied to both the groups for
15 minutes. Hot packs consisting of bentonite crystals enclosed in canvas cover and wrapped in terry vinyl cover and towel with three to four folds, that were preheated
for 30 min to 75–800C in the hydrocollator unit3
2) Each exercise will be performed for 10 repetitions with 2
minutes of rest interval in between
1) Codman pendulum exercises
2) Finger ladder exercise
3) Capsular stretching – Anterior, posterior and inferior
capsular stretch
4) Active Range of motion exercises – flexion,
abduction, extension, internal and external rotation |
| Intervention |
Group B- Scapular PNF and Maitland Glenohumeral Mobilization and Conventional physiotherapy. |
1.Scapular PNF- 20 repetitions of each diagonal and rest interval between repetitions will be 20 seconds.
2. Maitland Glenohumeral Mobilization-
For Group A Scapular PNF will be followed by Maitland
glenohumeral caudal glide and posteroant8erior glides.
Dosage and rate of application- Passive oscillatory movements will
be performed at the rate of 2-3 glides per second for 30 seconds
of each glide. 5 sets of each glide will be applied1
.
Grades
Grade 1- Small–amplitude rhythmic oscillations are performed at
the beginning of the range. They are usually rapid oscillations, like
manual vibrations.
Grade 2- Large amplitude rhythmic oscillations are performed
within the range,not reaching the limit.
Grade 3- Large amplitude rhythmic oscillations are performed up
to the limit of the available motion and are stressed into the tissue
resistance.
Grade 4- Small – amplitude rhythmic oscillations are performed at the limit of the available motion and stressed into the tissue
resistance.They are usually rapid oscillations like manual
vibrations.
3.Conventional Physiotherapy-
1.Hot packs – A moist heat pack will be applied to both the groups for 15 minutes. Hot packs consisting of bentonite crystals enclosed in canvas cover and wrapped in terry vinyl cover and towel with three to four folds, that were preheated for 30 min to 75–800C in the hydrocollator unit3 2) Each exercise will be performed for 10 repetitions with 2 minutes of rest interval in between 1) Codman pendulum exercises 2) Finger ladder exercise 3) Capsular stretching – Anterior, posterior and inferior capsular stretch 4) Active Range of motion exercises – flexion, abduction, extension, internal and external rotation |
| Intervention |
Group c-Scapular PNF and Kaltenborn Glenohumeral Mobilization and Conventional Physiotherapy. |
1.Scapular PNF- 20 repetitions of each diagonal and rest interval between repetitions will be 20 seconds.
2.Kaltenborn Mobilization technique
For Group B, Scapular PNF will be followed by Kaltenborn
Glenohumeral mobilization
Dosage and rate of application- A sustained distraction will be
applied grade-wise for 15 seconds for 10 repetitions. 3 sets of this
technique will be applied with a time interval of 10 second in
between4
.
Grades
Grade 1 (loosen)- Small amplitude distraction is applied when no
stress is placed on the capsule. It equalizes cohesive forces,
muscle tension, and atmospheric pressure acting on the joint.
Grade 2 (tighten)- Enough distraction is applied to tighten the
tissues around the joint
Grade 3 (stretch)- A distraction or glide is applied with an
amplitude large enough to place stretch on the joint capsule and
surrounding periarticular structures.
3. Conventional Physiotherapy- 1.Hot packs – A moist heat pack will be applied to both the groups for 15 minutes. Hot packs consisting of bentonite crystals enclosed in canvas cover and wrapped in terry vinyl cover and towel with three to four folds, that were preheated for 30 min to 75–800C in the hydrocollator unit3 2) Each exercise will be performed for 10 repetitions with 2 minutes of rest interval in between 1) Codman pendulum exercises 2) Finger ladder exercise 3) Capsular stretching – Anterior, posterior and inferior capsular stretch 4) Active Range of motion exercises – flexion, abduction, extension, internal and external rotation |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Prediagnosed cases of adhesive capsulitis.
Inflammatory and freezing stages of adhesive capsulitis.
Unilateral adhesive capsulitis.
Adhesive capsulitis of primary and secondary origin.
Diabetic patients on medications.
Both males and females of the age group 40 to 60 years.
|
|
| ExclusionCriteria |
| Details |
History of shoulder surgery or manipulation under general anaesthesia to the affected shoulder within last 3months.
Any neurological deficit affecting the shoulder functioning during daily activities. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS, Range of motion and DASH Disability questionnaire |
At baseline, post 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/06/2025 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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 - Data are available indefinitely at (Link to be included YES).
- For how long will this data be available start date provided 07-01-2026 and end date provided 07-12-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
According to the literature review, A study compared two scapular techniques – scapular PNF and scapular mobilization combined with Maitland Glenohumeral mobilization, and found that Scapular PNF with Maitland had better results in improving symptoms.But there have been no comparative study on two different Glenohumeral mobilization techniques combined with scapular PNF. This study compares two different glenohumeral mobilization techniques – Maitland and Kaltenborn – with different work mechanisms, in combination with the Scapular PNF technique to address both scapulothoracic joint and glenohumeral joint. Therefore, this study aims to discover which combined technique is more clinically effective, to incorporate into the rehabilitation program of Adhesive Capsulitis. |