| CTRI Number |
CTRI/2025/06/089184 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Find Out How Mills Manipulation and Muscle Energy Technique Can Help Reduce Pain, Improve Arm Movement, and Make Daily Activities Easier for People with Tennis Elbow. |
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Scientific Title of Study
|
To Study the Effect of Mills Manipulation and Muscle Energy Technique on Pain, Range of Motion and Functional Activities in Patients with Tennis Elbow: An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vedanti Ashok Bhure |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9730267586 |
| Fax |
|
| Email |
vedantibhure06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Deshmukh |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8888826093 |
| Fax |
|
| Email |
nehadeshmukh57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vedanti Ashok Bhure |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe College of Physiotherapy |
| Address |
Department of Musculoskeletal Physiotherapy, Shri Datta Meghe Polytechnic Campus Wanadongri, Hingna Road, Nagpur
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9730267586 |
| Fax |
|
| Email |
vedantibhure06@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy |
| Address |
Datta Meghe College of Physiotherapy Shri Datta Meghe polytechnic campus Wanadongri, Hingna road Nagpur 441110 Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vedanti Bhure |
Datta Meghe College of physiotherapy and Shalinitai Meghe Hospital and Research Centre |
Musculoskeletal OPD no. 1 Ground Floor of Datta Meghe College of Physiotherapy and Shalinitai Meghe Hospital and Research Centre ,Shri Datta Meghe Polytechnic Campus Wanadongri, hingna road Nagpur 441110
Nagpur
MAHARASHTRA |
9730267586
vedantibhure06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nagar Yuvak Sanstha, Datta Meghe College of Physiotherapy, Nagpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mills Manipulation |
Mills manipulation is a manual therapy technique commonly used to treat tennis elbow.
The patient is seated comfortably with the olecranon facing up and the affected extremity in a 90° abduction with internal rotation
The patient is seated with the therapist behind them.
Place the thumb of your other hand in the web space fully flex the patients wrist and pronate the forearm while the other hand is placed on the olecranon. At the end of the elbow extension range the therapist should perform a high-velocity low-amplitude push while assuming full wrist flexion and pronation. TREATMENT DURATION: Single application 3 times a week for 2 weeks i.e 6 sessions
|
| Comparator Agent |
Muscle Energy Technique |
he patient is seated on a treatment table in a comfortable and relaxed position. The affected arm is positioned in 90° elbow
flexion with the forearm in a neutral position. The wrist and hand are relaxed allowing the therapist to guide the movement.
The therapist stands beside or in front of the patient depending on comfort and ease of applying the technique.
Placed on the distal part of the patients forearm.
This hand guides the supination movement. The therapist gradually supinates the forearm until resistance is felt. When the position is taken, the patient actively pronates the forearm against resistance for 5 seconds immediately after supination is slightly increased until resistance is encountered once more.
TREATMENT DURATION: 5 times in one session 3 times a week for 2 weeks i.e 6 sessions |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Tenderness and pain over the lateral epicondyle of the humerus.
2 Either one of the tests positive: Cozens test Mills test or Maudsley test.
3 Able to provide informed consent and participate in the study.
4 Pain on NPRS 4-7
5 Chronic Patients |
|
| ExclusionCriteria |
| Details |
1 Any history of previous trauma fracture subluxation dislocation surgery or bony abnormalities around the elbow.
2 Soft tissue injuries other than lateral epicondylitis.
3 Elbow pain due to neck or shoulder complication.
4 Systemic inflammatory diseases.
5 Neurological impairments.
6 Presence of any joint pathologies.
7 History of Neoplasm.
8 Any congenital or acquired deformity of upper limb.
9 Use of steroids injection during last 3 months.
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|
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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 |
Numerical pain rating scale
Patient rated tennis elbow evaluation
Goniometer
|
Baseline and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/07/2025 |
| 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
|
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Brief Summary
|
Tennis Elbow is commonly known as Lateral Epicondylitis which is one of the most frequently found musculoskeletal disorders of the upper extremity. Dominant extremity is affected more as compared to non-dominant. Tennis elbow can affect individuals across all age groups; however, it is most commonly observed in those aged between 30 to 60 years. Both men and women are equally susceptible to this condition. Pain and tenderness on the lateral epicondyle of the humerus are typical symptoms of tennis elbow. The lateral side of the elbow becomes painful and tender as a result of overuse and repetitive movements that damage the forearm muscles and tendons. This condition results from non-specific inflammation at the start of the forearms extensor muscles, particularly the extensor carpi radialis brevis. MET is a gentle manual therapy technique that targets the soft tissues. It is a combination of isometric contraction and stretching which helps to stimulate the receptors that are responsible for stretching from the muscle spindle to move to adjust the maximum muscle length. MET targets soft tissues such as muscles, fascia, tendons, and ligaments that aim to improve musculoskeletal function and reduce pain. MET can have an impact in increasing tissue elasticity, reducing pain, releasing adhesions, accelerating tissue healing, elongating the muscle to the maximum, and increasing ROM so that functional abilities will increase and disability in the arm will decrease Whereas Mills Manipulation is a high-velocity, low-amplitude thrust technique that aims to break adhesions, restore mobility, and provide immediate pain relief. The purpose of the study is to compare the effect of Mills Manipulation and Muscle Energy Technique in reducing pain, improving range of motion, and enhancing functional activities in patients with tennis elbow using various outcome measures like pain scales and patient rated tennis elbow evaluation scale .Both groups will also receive conventional exercise interventions over a 2-week period.
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