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| Name | Class |
|---|---|
| Dokuz Eylul University | OTHER |
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This study compared three different treatment approaches for lateral epicondylitis (tennis elbow), a common condition that causes pain on the outside of the elbow.Twenty-seven patients diagnosed with lateral epicondylitis were randomly assigned to one of three treatment groups for 6 weeks:Group 1 - Blood Flow Restriction Exercise (BFRE): Patients performed wrist strengthening exercises using light weights (30% of their maximum capacity) while wearing a pressure cuff on the upper arm that partially restricted blood flow. Sessions were held twice per week under supervision, along with daily stretching exercises and a wrist orthosis.Group 2 - Eccentric Exercise: Patients performed slow lowering (eccentric) wrist exercises using heavier weights (70% of their maximum capacity) five times per week under supervision, along with daily stretching exercises and a wrist orthosis.Group 3 - Orthosis Only: Patients wore a wrist orthosis that held the wrist in a slightly extended position throughout the day and performed daily stretching exercises at home.The main goal was to determine whether blood flow restriction exercise could reduce pain and improve hand function more effectively than eccentric exercise or orthosis use alone. Pain levels, hand grip strength, finger pinch strength, and upper limb function were measured before and after the 6-week treatment period.The study was conducted at Dokuz Eylül University, Department of Orthopedics and Traumatology, İzmir, Turkey.
Lateral epicondylitis (tennis elbow) is a musculoskeletal disorder affecting approximately 1-3% of the general population. It is characterized by pain and tenderness at the lateral epicondyle of the elbow due to degenerative changes in the extensor carpi radialis brevis (ECRB) tendon caused by repetitive microtrauma. Conservative treatment options include rest, orthotic devices, physical therapy, and exercise programs.
Eccentric exercise has been widely recommended as a first-line conservative treatment for lateral epicondylitis. However, these programs typically require loading at 70% or more of one-repetition maximum (1-RM), which may not be tolerated by patients experiencing significant pain.
Blood flow restriction exercise (BFRE) is a training method in which a pneumatic cuff is applied to the proximal portion of a limb to partially restrict arterial blood flow and completely restrict venous return during low-load resistance exercise. BFRE has been shown to produce muscle strength and hypertrophy gains at loads as low as 20-40% of 1-RM, making it a potential alternative for patients who cannot tolerate heavy loading. Recent studies have demonstrated the effectiveness of BFRE in various musculoskeletal conditions including osteoarthritis, anterior cruciate ligament reconstruction, and patellar tendinopathy. However, evidence for its use in lateral epicondylitis is limited.
STUDY DESIGN:
This was a prospective, randomized controlled trial with three parallel groups. Patients were allocated using block randomization with blocks of nine.
INTERVENTION PROTOCOLS:
BFRE Group (n=9): Arterial occlusion pressure (AOP) was individually determined using a pneumatic cuff and pulse oximetry. Exercise was performed at 30% of AOP and 30% of 1-RM. Protocol: 3 sets of 15 repetitions with 1-minute rest intervals, twice weekly for 6 weeks. Stretching exercises (3 repetitions x 30 seconds) were performed before and after each session. On non-exercise days, home stretching was performed twice daily. A wrist extension orthosis (15-20 degrees) was worn throughout the study.
Eccentric Exercise Group (n=9): Slow eccentric wrist extensor exercises were performed with the elbow in full extension and forearm in pronation. The weight was lowered from wrist extension to flexion over approximately 30 seconds. Protocol: 3 sets of 10 repetitions with 1-minute rest intervals, five times weekly for 6 weeks, at 70% of 1-RM. Stretching and orthosis protocols were identical to the BFRE group.
Orthosis Group (n=9): Participants wore a wrist extension orthosis maintaining 15-20 degrees of extension throughout the day, removing it only during sleep, bathing, and stretching exercises. Stretching exercises were performed twice daily (3 repetitions x 30 seconds).
Exercise protocols were kept constant throughout the 6-week intervention period without progression. All supervised sessions were conducted at Dokuz Eylül University. Patients received illustrated exercise booklets and maintained exercise diaries to monitor home program adherence.
SAMPLE SIZE JUSTIFICATION:
Sample size was calculated using G*Power (version 3.1.9.4) with the following parameters: effect size 1.8, Type I error rate alpha = 0.05, and 95% statistical power, yielding a minimum of 9 participants per group (total N = 27).
STATISTICAL ANALYSIS:
Data were analyzed using SPSS version 20.0. Normality was assessed using the Shapiro-Wilk test. Baseline comparisons used one-way ANOVA. Within-group pre-post comparisons used paired t-tests. Between-group differences and time-by-group interactions were evaluated using mixed model ANOVA with post-hoc analyses. Significance was set at p < 0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eccentric exercise | Active Comparator | The eccentric exercise protocol involved slow eccentric wrist extensor exercises with the elbow in full extension and the forearm in pronation. From a wrist extension position, participants slowly lowered the weight into flexion over approximately 30 seconds. |
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| Blood flow restriction | Experimental | Participants in the Blood flow restriction group performed low-load wrist extensor strengthening exercises with blood flow restriction twice weekly for 6 weeks. Arterial occlusion pressure was individually determined using a pneumatic cuff and pulse oximetry. |
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| Orthosis | Active Comparator | The orthosis group served as the reference standard conservative treatment group. Participants wore a wrist extension orthosis maintaining 15-20° of extension throughout the day, removing it only during sleep, bathing, and stretching exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood flow restriction | Other | Participants in the BFRE group performed low-load wrist extensor strengthening exercises with blood flow restriction twice weekly for 6 weeks. Arterial occlusion pressure was individually determined using a pneumatic cuff and pulse oximetry. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity (Visual Analog Scale) | Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line where 0 represents "no pain" and 10 represents "worst imaginable pain." Patients marked the point corresponding to their current pain level. Change was calculated as the difference between baseline and post-treatment scores. A negative change indicates pain reduction. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hand Grip Strength | Hand grip strength was measured using a JAMAR hydraulic hand dynamometer (kg). Measurements were performed in a standardized position with the elbow at 90 degrees of flexion and the forearm in neutral position. The mean of three consecutive trials was recorded. A positive change indicates strength improvement. | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dokuz Eylül University | Izmir | 3500 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10846023 | Background | Takarada Y, Takazawa H, Sato Y, Takebayashi S, Tanaka Y, Ishii N. Effects of resistance exercise combined with moderate vascular occlusion on muscular function in humans. J Appl Physiol (1985). 2000 Jun;88(6):2097-106. doi: 10.1152/jappl.2000.88.6.2097. | |
| 18515912 | Background | Kohia M, Brackle J, Byrd K, Jennings A, Murray W, Wilfong E. Effectiveness of physical therapy treatments on lateral epicondylitis. J Sport Rehabil. 2008 May;17(2):119-36. doi: 10.1123/jsr.17.2.119. |
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Individual participant data will not be shared to protect participant privacy and confidentiality, in accordance with the institutional review board approval limitations.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2026 | May 21, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| D009989 | Orthotic Devices |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Randomized Controlled Trial
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| Eccentric Exercise | Other | The eccentric exercise protocol involved slow eccentric wrist extensor exercises with the elbow in full extension and the forearm in pronation. From a wrist extension position, participants slowly lowered the weight into flexion over approximately 30 seconds. |
|
| Orthosis | Other | The orthosis group served as the reference standard conservative treatment group. Participants wore a wrist extension orthosis maintaining 15-20° of extension throughout the day, removing it only during sleep, bathing, and stretching exercises. |
|
| Change in Pinch Strength | Pinch strength was measured using a pinch meter (kg). Three types of pinch grip were assessed: lateral pinch, palmar pinch, and tip-to-tip pinch. The mean of three trials across all pinch types was recorded. A positive change indicates strength improvement. | Baseline and 6 weeks |
| Change in Upper Extremity Functional Disability (DASH Score) | Upper extremity functional disability was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The DASH consists of 30 items scored from 0 (no disability) to 100 (maximum disability). A negative change indicates functional improvement. | Baseline and 6 weeks |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |