| CTRI Number |
CTRI/2024/06/069326 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| 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
|
Comparing Two Treatments Myofascial arm line and Deep friction massage for Tennis elbow for 2 weeks on pain and functional performance |
|
Scientific Title of Study
|
Effect of Myofascial arm line manipulation vs Deep friction massage for 2 week on pain , grip strength and functional performance in patients of lateral elbow tendinopathy: A randomised control 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 |
Nidhi Joshi |
| Designation |
Post graduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College Physiotherapy |
| Address |
Room no.2 , first floor , Musculoskeletal department ,Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Thube park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
4111005
India |
| Phone |
9702407834 |
| Fax |
|
| Email |
nidhipiyushjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhanth Sawant |
| Designation |
Associate Professor |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College Physiotherapy |
| Address |
Room no. 2 , first floor , Musculoskeletal department,Sancheti Institute for Orthopaedics and Rehabilitation College Physiotherapy 11/12, Thube park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
4111005
India |
| Phone |
9833680079 |
| Fax |
|
| Email |
Sawantsiddhanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nidhi Joshi |
| Designation |
Post graduate |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College pf Physiotherapy |
| Address |
Room no.2 , first floor , Musculoskeletal department ,Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Thube park, Shivaji Nagar, Pune.
Pune
MAHARASHTRA
4111005
India |
| Phone |
9702407834 |
| Fax |
|
| Email |
Nidhipiyushjoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.2 , first floor , Musculoskeletal department ,Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Thube park, Shivaji Nagar, Pune.
pune-411005 |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation College Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College Physiotherapy11/12 Thube Park, Shivajinagar,
Pune – 411 005 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrNidhi Joshi |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy 11/12 Thube Park, Shivajinagar,
Pune – 411 005
Pune
MAHARASHTRA |
9702407834
nidhipiyushjoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M771||Lateral epicondylitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Deep friction massage |
ultrasound for 7mins (1:4 pulsed, 1MHz, 1.5watt) will be given for 2 weeks , 3 session per week followed by deep friction massage for 1 to 2 mins (total 5min) ,Stretching for 30 sec,3 repetitions (elbow extended, pronation and wrist extension)and
Strengthening of wrist ,finger and elbow according to patient compliance
|
| Intervention |
Myofascial arm line manipulation |
Before starting the treating subjects will be assessed according to arm line muscles. Then ultrasound for 7mins (1:4 pulsed, 1MHz, 1.5watt) will be given for 2 weeks ,3 session per week followed by following treatment
TREATMENT
1. Feel it –
a)Find it (perception, explorative and activation)
Hold the correct position for 30sec, relax for few seconds and repeat 4 more times
b)Flash activation (work on neuromyofascial activation) opening and closing of grip for 10-20 rep
2. Mobility-
a) Thoracic rotation– 10 repetitions
b) Spider women – 10 repetitions
(progression increase the range of angle, if tolerated hold the position for 5 sec for active static stretching)
3. Stretching –
a) Side way spider against the wall (move your head away, progress by increasing the angle) – hold for 3 sec and 10 repetitions
b) Swinging with weights (start in week two)- 10 repetitions
c) Post isometric relaxation (forearm pronation wrist neutral, contract wrist extensor for 5-7 sec and relaxation of 15-20 sec) – 3 repetitions
4. Energy –
a) Swinging end to end swinging angle variation – 10 repetitions
b) Gecko wall push up -10 repetitions
(progression swinging with weights)
5. Release –
a) Release of muscle according to the assessment earlier of myofascial muscles of arm line.
(Using tennis ball over arm line for 30 to 55 sec, 1 to 3 per session. teaching self-release for home).
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Pain over lateral epicondyle of elbow and gripping activities.
2. Palpation tenderness over or near the lateral epicondyle of elbow.
3. Cozen, Mills and Maudsley’s special test
(Any two out of three should be positive)
|
|
| ExclusionCriteria |
| Details |
1. Patients undergone any other treatment such as surgery in past 3 months.
2. Metal implants in the upper limb
3. Neurological impairments
4. Diabetic neuropathy, osteoarthritis, rheumatoid arthritis and tissue lesions (cutaneous ulcers of any aetiology) that are functionally limiting.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain – Numerical pain rating scale, Pressure pain Threshold
2. Grip strength – Handheld dynamometer
3. Functional performance- Quick Disabilities of arm shoulder and hand(qDASH), global rating scale
|
At baseline(0 week) and after intervention (after 4 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Global rating scale |
At baseline(0 week) and after intervention (after 2 weeks) |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
18/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Lateral elbow
tendinopathy can be source of lasting pain and disability for many people. Some
experience full resolution of symptoms with nonsurgical care, more than half of
patients seeking general medical care continue to report symptoms after 1 year.
Regardless of past treatments, up to 20% of individuals report persistent pain
for 3-5 years after care. Up to 55% of individuals with Lateral elbow
tendinopathy have been shown to have lingering pain and functional loss for
more than 2 years after the onset of symptoms . The recurrence
rate within 2 years is 8.5% . Single-muscle theory was
inefficient to reason how functional human movement can be performed by a
single muscle. There should be presence of a holistic approach For functional
pattern movement .Fascia
can be simply defined as a network of fibrous tissue pervading the entire body,
which surrounds, supports, suspends, protects, connects and divides muscular,
skeletal and visceral components of an
organism .Thus, it may be argued that treatment of
disorders affecting the musculoskeletal system may need to be focused on this
fascial network The reason of the study is to introduce Myofascial arm line
manipulation as a useful intervention method to the lateral elbow tendinopathy
and to find the effectiveness of the myofascial manipulation in the management
pain, grip strength and to improve the functional performance in subjects with
chronic lateral elbow tendinopathy .
|
Null Hypothesis
There will be a significant
difference between the outcome of myofascial arm line manipulation and Deep friction
massage on pain, grip strength and functional performance in lateral elbow tendinopathy.
Alternate
Hypothesis:
There won’t be a significant
difference between the outcome of myofascial arm line manipulation and Deep
friction massage on pain, grip strength and functional performance in lateral
elbow tendinopathy.
|
|