| CTRI Number |
CTRI/2024/10/074756 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| 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
|
Effectiveness of active release and neuromobilization techniques on grip strength, discomfort, and functional performance in individuals suffering from chronic lateral epicondylitis |
|
Scientific Title of Study
|
Comparison of active release technique and neuromobilization technique on pain, grip strength & functional performance in patients with chronic lateral epicondylitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Rai |
| Designation |
Post graduation student |
| Affiliation |
Shri guru ram rai university school of paramedical & allied health sciences |
| Address |
Room No. 5, Department of Physiotherapy, North Block Basement,
Shri Mahant Indiresh Hospital. Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8755142862 |
| Fax |
|
| Email |
prai1798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Niraj Kumar |
| Designation |
Associate professor |
| Affiliation |
Shri guru ram rai university school of paramedical & allied health sciences |
| Address |
Room No. 5, Department of Physiotherapy, North Block Basement,
Shri Mahant Indiresh Hospital. Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895795277 |
| Fax |
|
| Email |
drnirajkumar25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Niraj Kumar |
| Designation |
Associate professor |
| Affiliation |
Shri guru ram rai university school of paramedical & allied health sciences |
| Address |
Room No. 5, Department of Physiotherapy, North Block Basement,
Shri Mahant Indiresh Hospital. Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895795277 |
| Fax |
|
| Email |
drnirajkumar25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University, School of Para Medical and Allied Health and Sciences,
Pathribag, Dehradun, Uttaranchal. 248001
|
|
|
Primary Sponsor
|
| Name |
Priya rai |
| Address |
Shri guru ram rai university school of paramedical & allied health sciences |
| 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 |
| Prof Dr Niraj Kumar |
Shri Mahant Indiresh Hospital |
Department of
Physiotherapy, North
Block Basement, Shri
Mahant Indiresh
Hospital, Dehradun, Uttaranchal
Dehradun
UTTARANCHAL |
7895795277
drnirajkumar25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Guru Ram Rai Institute of Medical & Health Sciences |
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 |
| Intervention |
Active relaese technique |
Active relaese technique is based on the principle of recognizing and treating cumulative injury disorder. ART can identify and reduce fibrous adhesions, microscopic tissue injury and inflammation. During this therapy, the clinician applies a combination of deep manual tension at the area of tenderness with the patient actively moving the targeted tissue from a shortened to a lengthened position.Total time duration of each treatment is 30 minutes a day |
| Comparator Agent |
Neuromobilization technique |
Neuromobilization techniques may facilitate neural gliding,reduce adhesions between the nerve and its surrounding tissue, enhance neural vascularity, and improve axoplasmic flow. Neuromobilization techniques have also been proposed to modulate central sensitization and peripheral pain mechanisms in musculoskeletal disorders. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age 25-55 years
history of elbow pain lateral side more than 3 months |
|
| ExclusionCriteria |
| Details |
History of trauma, surgery and acute infections malignancy
Systemic disorders
Acute lateral epicondylitis
Inability perform the techniques |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical Pain Rating Scale for Accessing Pain
Level and
Hand dynamometer |
1st day, 29th day, 58th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient- Rated Tennis Elbow Evaluation |
1st day, 29th day, 58th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Lateral epicondylitis, also commonly referred to as tennis elbow, describes an overuse injury secondary to an eccentric overload of the common extensor tendon at the origin of the extensor carpi radialis brevis (ECRB) tendon. Tennis elbow primarily results from the repetitive strain caused by activities that involve loaded and repeated gripping and/or wrist extension. It is common in individuals who play tennis, squash, badminton, or any activity involving repetitive wrist extension, radial deviation, and/or forearm supination. This condition is primarily a degenerative overuse process of the extensor carpi radialis brevis and the common extensor tendon. LE is a soft-tissue lesion affecting men and women equally, with a reported incidence of up to 3% in the population and a peak occurrence in the fifth decade [5].LE is most common in those aged 30-64, affects 1-3% of the population, has no gender bias, and usually affects the dominant upper Extremity |