UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063635 |
|---|---|
| Receipt number | R000072830 |
| Scientific Title | Effects of low-load blood flow restriction training at different occlusion pressures on pain and peritendinous microcirculation around the common extensor tendon in patients with lateral elbow tendinopathy: a randomized controlled trial |
| Date of disclosure of the study information | 2026/11/15 |
| Last modified on | 2026/11/15 16:29:58 |
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Basic information
Public title
Effects of low-load blood flow restriction training at different occlusion pressures on pain and peritendinous microcirculation around the common extensor tendon in patients with lateral elbow tendinopathy: a randomized controlled trial
Acronym
A comparative trial of blood flow restriction training at different occlusion pressures in lateral elbow tendinopathy
Scientific Title
Effects of low-load blood flow restriction training at different occlusion pressures on pain and peritendinous microcirculation around the common extensor tendon in patients with lateral elbow tendinopathy: a randomized controlled trial
Scientific Title:Acronym
A comparative trial of blood flow restriction training at different occlusion pressures in lateral elbow tendinopathy
Region
| Japan |
Condition
Condition
lateral elbow tendinopathy
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this sutdy is to investigate the effects of low-load blood flow restriction training at different levels of arterial occlusion pressure on pain and microcirculation around the common extensor tendon in patients with lateral elbow tendinopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical Pain Rating Scale (NRS) scores at baseline, 4 weeks, and 8 weeks.
Key secondary outcomes
Disabilities of the Arm, Shoulder, and Hand (DASH) score at baseline, 4 weeks, and 8 weeks.
Pain-free grip strength (PFGS) at baseline, 4 weeks, and 8 weeks.
Microcirculatory parameters around the CET, including oxygenated hemoglobin (O2Hb), deoxygenated hemoglobin (HHb), total hemoglobin (cHb), and tissue oxygenation index (TOI), measured by near-infrared spectroscopy (NIRS) at baseline, 4 weeks, and 8 weeks. Recovery rates during the first minute after cuff release will be calculated.
CET fiber orientation at baseline, 4 weeks, and 8 weeks.
Peak systolic velocity (PSV) of the radial recurrent artery (RRA) at baseline, 4 weeks, and 8 weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Participants in the 80% AOP-BFRT group will perform low-load blood flow restriction training at 80% of their individually determined arterial occlusion pressure (AOP).
The exercise will consist of wrist extension using a dumbbell at 30% of one-repetition maximum (1RM), performed in four sets of 30, 15, 15, and 15 repetitions. Each repetition will consist of a 1-second contraction and a 2-second relaxation, with 30 seconds of rest between sets.
Exercise-induced pain will be maintained below 2/10 on the Numerical Pain Rating Scale (NRS). The load will be increased by 0.5-1.0 kg per week depending on pain tolerance. AOP will be reassessed every 4 weeks.
Physical therapy will be provided once or twice weekly for 40-60 minutes per session over 8 weeks.
All participants will also receive standard physical therapy, including elbow soft tissue mobilization, elbow joint mobilization, scapular muscle training, activity modification education, and home exercise instruction.
Interventions/Control_2
Participants in the 40% AOP-BFRT group will perform low-load blood flow restriction training at 40% of their individually determined arterial occlusion pressure (AOP).
The exercise protocol, including exercise type, intensity, sets, repetitions, contraction and relaxation times, rest intervals, treatment frequency, intervention duration, and standard physical therapy, will be identical to that used in the 80% AOP-BFRT group.
The only difference between groups will be the relative arterial occlusion pressure applied during blood flow restriction training (80% versus 40% AOP).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with lateral elbow tendinopathy who meet all of the following criteria:
1. Tenderness on palpation over the lateral epicondyle.
2. A positive Thomsen test or middle finger extension test.
3. Grip strength measured with the elbow extended is at least 10% lower than that measured with the elbow flexed.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
1. History of upper extremity surgery.
2. History of upper extremity trauma.
3. History of cardiac surgery.
4. History of deep vein thrombosis.
5. Presence of medical conditions such as cardiac disease.
6. Symptomatic cervical radiculopathy.
7. Rheumatoid arthritis.
8. Treatment for lateral elbow tendinopathy within the previous 6 months.
9. Pregnancy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya University of Medical Sciences
Division name
Inclusive Medical Sciences Research Institute
Zip code
559-8611
Address
1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka
TEL
0666166911
kudo@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidemi |
| Middle name | |
| Last name | Sakai |
Organization
Morinomiya University of Medical Sciences
Division name
research support center
Zip code
559-8611
Address
1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka
TEL
0666166911
Homepage URL
kenkyu@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Shintarou Kudo
Funding Source
Organization
Morinomiya University of Medical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
AR-Ex Oyamadai Orthopedic Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Morinomiya University of Medical Sciences
Address
1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka
Tel
0666166911
kudo@morinomiya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
AR-Ex尾山台整形外科（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 15 | Day |
Last modified on
| 2026 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072830
