| CTRI Number |
CTRI/2025/09/095298 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| 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
|
Comparing the Effect of Spencer Muscle Energy Technique and Kaltenborn Mobilization on Pain, Movement, and Disability in Frozen Shoulder |
|
Scientific Title of Study
|
Effect of Spencer Muscle Energy Technique versus Kalternborn Mobilization on Pain,Range of Motion and Disability in patients with Frozen Shoulder: 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 Pratiksha Kadam PT |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. G. D. Pol Foundation YMT College of Physiotherapy |
| Address |
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9967957205 |
| Fax |
|
| Email |
ambulkaramit444@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ambulkar PT |
| Designation |
Thesis Guide |
| Affiliation |
Dr. G. D. Pol Foundation YMT College of Physiotherapy |
| Address |
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9730831186 |
| Fax |
|
| Email |
ambulkaramit444@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratiksha Kadam PT |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. G. D. Pol Foundation YMT College of Physiotherapy |
| Address |
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9967957205 |
| Fax |
|
| Email |
ambulkaramit444@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pratiksha Kadam PT |
| Address |
Dr. G.D. Pol Foundation YMT College of Physiotherapy, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra, 410210 |
| 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 |
| DrPratiksha KadamPT |
YMT College Of Physiotherapy |
Room number 305,Third floor,Musculoskeletal OPD,YMT College Of Physiotherapy,Dr.G.D.Pol Foundation,Kharghar
Raigarh
MAHARASHTRA |
9967957205
prati1201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.G.D. Pol Foundation YMT College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kalternborn Mobilization Technique |
The intervention will be given for 4 Weeks. It will consist of AP glide PA glide and caudal glide |
| Comparator Agent |
Spencer Muscle Energy Technique |
The intervention will be given for 4 weeks. It will consist of 7 steps of Spencer Muscle Energy Technique. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnosed cases of Frozen Shoulder.
Participants within the age group of 40-60 yrs.
Participants with Shoulder Pain for 2-6 months .
Participants with Unilateral Frozen Shoulder.
|
|
| ExclusionCriteria |
| Details |
Participants with recent history of surgery on affected shoulder.
Participants with recent history of any trauma or fracture around shoulder complex.
Participants with Stage 3 of Frozen Shoulder.
Osteoporosis and malignancies in shoulder region.
Neurological deficits affecting shoulder function.
Pain or Disorders of cervical spine,elbow,wrist or hand on affected side.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain using Numerical pain Rating Scale
Range of Motion using Universal Goniometer.
Shoulder Disability Using Shoulder pain and disability Index Questionnaire |
It will be assessed at the baseline and at the end of four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 3 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="1"
Months="0"
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 - NO
|
|
Brief Summary
|
This study is a single-blinded randomized clinical trial designed to compare the effectiveness of the Spencer Muscle Energy Technique (MET) and the Kalternborn Mobilization Technique (KMT) in the treatment of frozen shoulder, also known as adhesive capsulitis. Frozen shoulder is a painful condition characterized by stiffness and restricted shoulder movement, most commonly affecting adults between 40 and 60 years of age, with higher prevalence in women and individuals with diabetes. The trial will recruit 52 participants with stage 1 and 2 frozen shoulder, who will be randomly divided into two groups: one receiving Spencer MET with conventional physiotherapy and the other receiving Kalternborn mobilization with conventional physiotherapy. Both groups will undergo treatment for four weeks, three times per week. Pain, range of motion, and disability will be assessed using the Numerical Pain Rating Scale (NPRS), the Shoulder Pain and Disability Index (SPADI), and a universal goniometer before and after the intervention. Data will be analyzed statistically to determine which technique is more effective. This research aims to provide evidence-based guidance for physiotherapists in selecting the most beneficial manual therapy approach for managing frozen shoulder. |