| CTRI Number |
CTRI/2026/01/101305 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Accuracy of the Resisted External Derotation Test for Detecting Gluteal Tendinopathy and Central Sensitization Using Ultrasound |
|
Scientific Title of Study
|
Diagnostic accuracy of the resisted external derotation test for gluteal tendinopathy and central sensitization: A musculoskeletal ultrasound validation study using a novel phenotypic classification scale |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudhansu Sekhar Lenka |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of Physiotherapy, Srinivas University, Pandeshwar,
Dakshina Kannada Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7894188995 |
| Fax |
|
| Email |
sudhansulenka40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijayakumar Palaniswamy |
| Designation |
Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of Physiotherapy, Srinivas University, Pandeshwar,
Dakshina Kannada Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8148745409 |
| Fax |
|
| Email |
Vijayakumarpalaniswamy.ipt@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sudhansu Sekhar Lenka |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of Physiotherapy, Srinivas University, Pandeshwar,
Dakshina Kannada Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7894188995 |
| Fax |
|
| Email |
sudhansulenka40@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Physiotherapy, Srinivas University, Pandeshwar,
Dakshina Kannada Mangalore |
|
|
Primary Sponsor
|
| Name |
Sudhansu Sekhar Lenka |
| Address |
Institute of Physiotherapy, Srinivas University, Pandeshwar,
Dakshina Kannada Mangalore, 575001 |
| 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 Sudhansu Sekhar Lenka |
Musculoskeletal Sciences and Sports Physiotherapy OPD |
Musculoskeletal Sciences and Sports Physiotherapy Department, Institute of
Physiotherapy, Srinivas University, City Campus- ground floor, Pandeshwar,
Dakshina Kannada, Mangalore
Dakshina Kannada
KARNATAKA |
7894188995
sudhansulenka40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD AND ETHICAL COMMITTEE (IRBEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Persistent pain in the lateral aspect of the hip for more than three months.
2. Tested positive and negative in the resisted external de-rotation test
3. Sitting, weight-bearing activities, or lying on the afflicted side can all cause lateral hip pain. |
|
| ExclusionCriteria |
| Details |
1.Any history of lower limb, hip, or spine surgery during the previous six months.
2.Diagnosed with neurological conditions (e.g., peripheral neuropathy)
3.Diagnosed with Systemic inflammatory diseases (e.g., fibromyalgia, rheumatoid arthritis)
4.Pregnancy
5.receiving a radiographic diagnosis of osteoarthritis in the knee or hip
6.During the last month, hip pain has been treated with analgesics or physical therapy.
7.Known case of cognitive impairment or psychiatric disease
8.Determined that sciatica and/or low back pain were the main sources of the symptoms after a physical examination. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pressure Pain Threshold, Central Sensitization Inventory |
Only at Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resisted External Derotation Test, Hip Strength Assessment, |
The patients will be assessed only at the baseline |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
02/02/2026 |
| 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="0"
Months="6"
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 evaluates the diagnostic accuracy of the Resisted External De-rotation test for identifying gluteal tendinopathy in individuals with lateral hip pain, using musculoskeletal ultrasound as the reference standard. It also examines how central sensitization influences the accuracy of this clinical test. Central sensitization is assessed using the Central Sensitization Inventory (CSI) and the Pressure Pain Threshold (PPT) test. A new phenotypic classification scale is proposed to distinguish true tendon pathology from pain driven mainly by central mechanisms. The study aims to reduce misdiagnosis, explain false-positive test results, and improve diagnostic precision. Findings are expected to support more personalized and mechanism-based management of greater trochanteric pain syndrome. |