| CTRI Number |
CTRI/2025/01/079063 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effect of two different techniques for the tretament of frozen shoulder. |
|
Scientific Title of Study
|
Effect of Niel Asher technique vs Spencer technique on Pain Range of Motion and Functional Disability in Frozen shoulder A Randomized clinical 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 Apeksha Hungund |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39 department of Orthopedic Manual Therapy room no 13, Sagar floor, Belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8310725829 |
| Fax |
|
| Email |
apeksha_hungund@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha Hungund |
| Designation |
Assistant Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39 department of Orthopedic Manual Therapy room no 13, Sagar floor, Belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8310725829 |
| Fax |
|
| Email |
apeksha_hungund@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kavya S Bharbhari |
| Designation |
Post graduate |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39 department of Orthopedic Manual Therapy room no 13, Sagar floor, Belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9632247826 |
| Fax |
|
| Email |
ksbharbhari152001@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Institute of Physiotherapy, Nehru nagar Belagavi Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Kavya S Bharbhari |
| Address |
KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi KARNATAKA -
590010
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Apeksha Hungund |
KAHERs Institute of Physiotherapy |
KAHERs Prabhakar
Kore Hospital and
Research centre,
Physiotherapy OPD no
39 sagar wards,
Orthopedic Manual
Therapy OPD NO 13.
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
8310725829
apeksha_hungund@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher education and researc |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M258||Other specified joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Niel Asher technique
|
Participants of this group will receive Neil Asher technique which will be carried out for 10 sessions over 2 weeks , they will be given hot moist pack in the beginning of the intervention for 10-15 minutes followed by the 5 steps regimen of Neil Asher technique , where the patient will be
made to lie sideways and several deep strokes with your hand, from
elbow to humeral head will be applied. Apply sustained pressure over
the embedded nodules or over the fibrous band which you may
feel when you move upwards. Apply deep sustained pressure on
the tender point over the posterior joint capsule area (teres minor).
Perform circumduction of shoulder with bent elbow repeatedly
several times from small to large complete circles. Release the fascia
up the long head biceps tendon and move upwards only. Pause on
the nodules along the tendon; these are fascial tetherings and may
be inflamed. As you approach the shoulder, near biceps tendon
joins the capsule, hold the trigger point for upto three minutes until it
is completely pain free. In supine lying position, the middle fingers of
your hand, presses deeply on the trigger point in the middle of the
shoulder blade (infraspinatus)
After the technique the patient will be given conventional physiotherapy ,exercises like finger ladder, shoulder wheel, wand exercises and capsular stretching . |
| Comparator Agent |
Spencer technique |
Participants of this group will receive Spencer technique which will be carried out for 10 sessions over 2 weeks , they will be given hot moist pack in the beginning of the intervention for 10-15 minutes followed by the Spencer technique.
Step 1: Shoulder extension with elbow flexion
Step 2: Shoulder flexion with elbow extension
Step 3: Circumduction with compression
Step 4: Circumduction with distraction
Step 5: Shoulder abduction and internal rotation with elbow flexion
Step 6: Shoulder adduction and external rotation with elbow flexion
Step 7: Stretching tissue and pumping fluids with the arm extended repeated this 5-10 times.
It will be administered for two sets of 10 repetitions with a one-minute break in
between.
After the technique the patient will be given conventional physiotherapy ,exercises like finger ladder, shoulder wheel, wand exercises and capsular stretching .
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age40 to 65 years
Gender both male and female
Individuals diagnosed with stage 2 and 3 of frozen shoulder
Shoulder pain limited range of motion both active and passive
•Capsular motion restriction, including external rotation, abduction, flexion and internal rotation.
|
|
| ExclusionCriteria |
| Details |
Post traumatic shoulder discomfort and stiffness
A history of a shoulder complex fracture within the last 6 months
Diagnosed case of rib fracture rotator cuff pathology
A recent history of surgery on a specific shoulder
Diagnosed case of tendon calcification
Diagnosed case of malignancies in the shoulder region
Subjects with neurological disorders
Coronary Artery Bypass surgery
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Range of Motion |
Range of Motion will be assessed at the baseline day 1 and post tretament after 10 sessions after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| visual Analogue scale & Shoulder Pain & Disability index |
Visual Analogue scale & Shoulder Pain & Disability index will be assessed at the baseline day 1 & after 10 sessions after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2025 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Effect of Niel Asher technique vs Spencer technique on pain, range of motion and functional disability in frozen shoulder - A Randomized clinical trial. Objective: To determine the effectiveness of Niel Asher technique v/s Spencer
technique on pain using visual analogue scale (VAS), ROM using a universal goniometer
and functional disability in frozen shoulder using The Shoulder Pain and
Disability Index (SPADI).
Inclusion criteria : - Age-40 to 65 years
- Gender -both male and female.
- Individuals diagnosed with stage 2 and 3 of frozen shoulder.
- Shoulder pain, limited range of motion (both active and passive).
- Capsular motion restriction, including external rotation, abduction, flexion and internal rotation.
Exclusion criteria: - Post-traumatic shoulder discomfort and stiffness.
- A history of a shoulder complex fracture within the last 6 months.
- Diagnosed case of rib fracture, rotator cuff pathology.
- A recent history of surgery on a specific shoulder.
- Diagnosed case of tendon calcification.
- Subjects with neurological disorders.
- Coronary Artery Bypass surgery.
Outcome measures 1. Visual Analogue Scale 2. Shoulder Pain and Disability Index (SPADI) 3. Range of Motion
Procedure Both groups will receive a Hot moist pack for 10 -15 minutes before the treatment Group 1: Participants of this group will receive Neil Asher technique + Conventional Physiotherapy which will be carried out in 10 sessions over 2 weeks. Group 2 : Participants of this group will receive Spencer technique + Conventional Physiotherapy which will be carried out in 10 sessions for 2 weeks. The pre and post data will be the collected, tabulated and analysed. O |