| CTRI Number |
CTRI/2025/04/085350 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| 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
|
How Blood Flow Restriction Therapy Helps Improve Pain, Ankle Movement, Foot Position, and Overall Foot Health in People with Achilles Tendonitis |
|
Scientific Title of Study
|
EFFECTIVENESS OF BLOOD FLOW RESTRICTION THERAPY ON TENDERNESS DORSIFEXION OF ANKLE JOINT FOOT PRONATION PLANTER ARCHES FOOT POSTURE and SEVERITY OF CONDITIONS IN PATIENTS WITH ACHILLES TENDINITIS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AAYUSHI JAIN |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SGT UNIVERSITY |
| Address |
D-Block, SGT UNIVERSITY, GURUGRAM, HARYANA
Gurgaon
HARYANA
122505
India |
| Phone |
9039522514 |
| Fax |
|
| Email |
aayushijainn007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SIDDHARTHA SEN |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SGT UNIVERSITY |
| Address |
D-Block, SGT UNIVERSITY, GURUGRAM, HARYANA
SGT UNIVERSITY, GURUGRAM, HARYANA
Gurgaon
HARYANA
122505
India |
| Phone |
9958389234 |
| Fax |
|
| Email |
siddhartha_FPHY@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
AAYUSHI JAIN |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SGT UNIVERSITY |
| Address |
ROOM NO 13,SGT HOSPITAL, PHYSIOTHERAPY OPD,GURUGRAM, HARYANA
Gurgaon
HARYANA
122505
India |
| Phone |
9039522514 |
| Fax |
|
| Email |
aayushijainn007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Physiotherapy, SGT University, Gurugram, 122505 |
|
|
Primary Sponsor
|
| Name |
AAYUSHI |
| Address |
FACULTY OF PHYSIOTHERAPY,SGT UNIVERSITY,122505 |
| 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 Aayushi Jain |
SGT University |
Physiotherapy OPD, Room no-13,SGT hospital
Gurgaon
HARYANA |
9039522514
aayushijainn007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 1(EXPERIMENTAL GROUP)
BFRT WITH OCCLUSION |
Patient will perform exercises with occlusion of cuff
[ROM of ankle joint using resistance band (dorsiflexion + plantar flexion), toe standing, lunges, squats]
3 times/week for 4 weeks |
| Comparator Agent |
GROUP 2 (CONTROL GROUP)
BFRT WITHOUT OCCLUSION |
Patient will perform exercises without occlusion of cuff
[ROM of ankle joint using resistance band (dorsiflexion + plantar flexion), toe standing, lunges, squats]
3 times/week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Age of 18 years-40 years
2. Pain and tenderness over the tendon achilles and calcaneum
3. Palpable tendon thickening and Crepitus
4. A characteristic history of pain over achilles tendon during or after activities
5. Pain intensity between 3 and 7 on a Numerical pain rating scale
6. Positive Royal London Hospital Test
7. Positive Arc Sign
8. Positive Hop Test
9. A score below 80 on the Victorian Institute of Sports Assessment for PT (VISA-A) questionnaire
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. Vertigo, dizziness, arterial hyper/hypo tension
3. Neurological alterations
4. Any history of lower limb bone fracture & surgery in past 6 months
5. Recent ankle sprain
6. Deep vein thrombosis,
7. Cardiovascular condition
|
|
|
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 |
• Tenderness (algometer)
• Dorsiflexion of ankle joint(inclinometer)
• Foot pronation (FPI)
• Planter arches (navicular drop test)
• Severity of condition (VISA-A)
|
Baseline - At starting of 1st week
Post Data- At the end of 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Severity of condition (VISA-A) |
Baseline - At starting of 1st week
Post Data- At the end of 4 wee |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
02/05/2025 |
| 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
|
|
Brief Summary
|
Achilles tendinopathy (AT) is a common lower limb condition characterized by localized tendon pain and swelling due to mechanical loading. It often affects the midportion or insertional part of the tendon and is typically diagnosed clinically, with pain on tendon-loading and palpation as key criteria.
Conventional treatments for AT include eccentric exercises and heavy slow resistance training, which are effective in reducing symptoms and improving tendon structure. However, blood flow restriction training (BFRT)—a method combining low-load resistance training with restricted blood flow—has emerged as a promising alternative, particularly for individuals unable to perform high-load exercises.
BFRT enhances muscle hypertrophy and strength through physiological mechanisms like hypoxia, metabolite accumulation, and fast-twitch muscle recruitment, offering comparable outcomes to high-intensity training with less joint stress.
Despite its increasing use in rehabilitation, research on BFRT’s effects specifically on Achilles tendinopathy is limited. Therefore, this study aims to evaluate the effectiveness of BFRT on tenderness, ankle dorsiflexion, foot pronation, and plantar arches in individuals with AT |