| CTRI Number |
CTRI/2024/12/078610 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| 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
|
Physiotherapy treatment for lateral elbow pain. |
|
Scientific Title of Study
|
comparison between blood flow restriction training and mulligan mobilization with movement in the management of 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 |
Vidhi Joshi |
| Designation |
Research scholar |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy,
Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
7599177720 |
| Fax |
|
| Email |
vidhijoshi2115@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida
UTTAR PRADESH
201313
India
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Health Allied Sciences Amity University Noida Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Vidhi Joshi |
| Address |
Department of Physiotherapy
Amity Institute of Health Allied Sciences, Amity University F1 LGF sector 125 Noida
Uttar Pradesh
201313 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sanjib Kumar Das |
Department of Physiotherapy
Amity Institute of Health Allied Sciences, Amity University F1 LGF sector 125 Noida
Uttar Pradesh
201313 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vidhi Joshi |
Amity Institute of Health Allied Sciences, Amity University |
Department of Physiotherapy
F1 LGF
Gautam Buddha Nagar
UTTAR PRADESH |
7599177720
vidhijoshi2115@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar PPradesh |
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 |
Blood flow restriction training |
Intervention: Participants will perform low-intensity resistance exercises (e.g., wrist extension, wrist flexion, grip exercises) with BFR cuffs applied to the affected arm over the biceps region. The exercises will be performed 3 times per week for 6 weeks.
Exercise protocol- Low intensity (20-40% of 1 RM) resistance training with blood flow restriction
Wrist flexion-extension
Radial and ulnar deviations
Grip exercises with ball and hand exerciser
BFR cuff application-
Load: 20-40% of 1 RM
Sets: Two per exercise
Rest periods: 30-60 seconds between sets (keep muscle wrapped/occluded during the rest periods for a single exercise, and release wrap for at least 1 minute before beginning a different exercise)
Occlusion time: 5-10 minutes total per exercise
The pressure of the cuff will be 50 mmgh.
Protocol:
30 -15-15-15 reps (30-sec rest break in between will be given each time)
Deflate the cuff for 1-minute before the next exercise
The sphygmomanometer will be used to apply occlusion to the arm.
The groups will also receive conventional therapy including ultrasound therapy, stretching exercises and deep friction massage. |
| Comparator Agent |
Mulligan mobilization with movement |
Mulligan mobilization with movement-
Patient position-Supine lying (forearm pronated, elbow extended)
Therapist position- walk standing (at the side of mobilizing forearm)
The belt will be applied at the forearm near the elbow joint of the patient and around the shoulder of the
therapist. The patient will be asked to make a fist and perform the active movement without experiencing
any pain while the therapist provides the lateral glide at the forearm using the belt. Mobilization will be provided 3 times a week for 6 weeks
Three sets of mobilization with movement of ten repetitions each will be given per session.
The groups will also receive conventional therapy including ultrasound therapy, stretching exercises and deep
friction massage. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of pain on the lateral epicondyle of the elbow.
2. Tenderness on palpation on the lateral epicondyle.
3. Positive cozens, mills, and maudsley’s test results.
4. Complaints persisting for at least 8 weeks.
5. There is an apparent decline in grip strength in the affected arm.
6. Informed consent form signed by participants. |
|
| ExclusionCriteria |
| Details |
1. Participants who had a history of surgery on the affected arm.
2. Participants with other upper extremity conditions (e.g. Carpal tunnel syndrome, rotator cuff pathology, biceps tear) that could interfere with the assessment of grip strength and function.
3. Participants who had received the corticosteroid injection around the affected elbow within the past 3 months.
4. Participants with systemic conditions, that may affect the healing or muscle performance (e.g. diabetes, rheumatoid arthritis, chronic inflammatory conditions, and hypertension both controlled and
uncontrolled).
5. Participants on blood thinners or anticoagulant therapy, as BFR training could increase the risk of complications.
6. Pregnant women will be excluded due to potential risks associated with BFR training.
7. Participants who will experience significant discomfort, pain, or any other adverse reactions during a trial session of BFR training.
8. Participants with mental or cognitive impairments that could prevent them from understanding the study procedure or following the exercise protocol. |
|
|
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 |
| Grip strength measurement, Pain intensity, and functional disability |
Baseline, 4th and 6th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
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)
|
20/01/2025 |
| 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="0"
Months="4"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vidhijoshi2115@gmail.com].
- For how long will this data be available start date provided 30-12-2024 and end date provided 11-05-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aims & Objectives – Aim: To evaluate the relative benefits of blood flow restriction training and mulligan mobilization with movement for alleviating pain, improving grip strength and functional disability in lateral epicondylitis patients. Objectives- To assess the difference in grip strength between lateral epicondylitis patients receiving blood flow restriction training and those receiving mulligan mobilization with movement. -To assess the impact of mulligan mobilization with movement and blood flow restriction training on the degree of pain and functional disability in lateral epicondylitis patients and comparison between both.
Hypothesis – Null hypothesis-Blood flow restriction training and mulligan mobilization with movement will not significantly vary in terms of improving grip strength, reducing pain, or improving functional outcomes in individuals with lateral epicondylitis. Alternate hypothesis- Blood flow restriction training and mulligan mobilization with movement will differ significantly in terms of improving grip strength, reducing pain, and improving functional outcomes in patients with lateral epicondylitis.
|