Investigation of the Efficacy of Blood Flow Restricted Training in Lateral Elbow Tendinopathy

NCT ID: NCT06001944

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-11

Study Completion Date

2024-04-11

Brief Summary

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The investigators believe that blood flow-restricted training can result in increased caste hypertrophy and strength without stressing the tendon in lateral elbow tendinopathy, and that changes in local metabolic activities can be effective in the process of tendon healing. The researchers' aim in the study is to investigate the effectiveness of blood flow restriction training in lateral elbow tendinopathy for 8 weeks, in addition to the 2 days a week multi-modal physiotherapy program, which will be applied by limiting blood flow by 40-50% occlusion recommended for the upper extremity using the patient's systolic pressure to the severity of 20-30% of 1 maximum repetition, 75 repetitions including 30-15-15-15 repetitions and 30 seconds rest period between sets, remaining attached to the recommended 10-15 minutes period for the top extremity.

Detailed Description

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Physiotherapy is the first step in the treatment algorithm for lateral elbow tendinopathy (LET), which is characterized by pain in the lateral epicondyl of the humerus during wrist extension and which limits hand-to-hand movements such as grabbing and thinning and consequently negatively affects hand functions. Extender carpi radialis brevis (ECRB) and extender digitorum, communis (EDC) are the muscles that contribute most to the onset of symptoms. Exercise, either alone or as part of a multimodal physiotherapy program, is central to the management of many patients with LDT. Exercise in patients with chronic LDT has been shown to result in more and faster relief of pain, less use of illness, less medical consultation, and increased working capacity. In literature, loading with recommended exercises is considered necessary to re-form the tendon, while on the other hand some patients may not tolerate this loading. For rehabilitation practitioners, it is quite difficult to design optimal exercise programs that facilitate musculo-skeletal system (MSK) adaptations while also enabling biological healing and safe loading of the injured body. In these cases, there has been a search for a new method that can generate physiological benefits associated with higher intensity training with exercise at lower loads. Increasing evidence supports the use of resistance training at a reduced load along with blood flow restriction (BFR) therapy to increase hypertrophic and force responses in skeletal muscle. The American Association of Sports Physicians (ACSM) recommends that at least 65% of the 1 maximum repetition, similar to exercising at high intensity with 8-12 repetition resistant weight lifting strength training, can be used in low loads such as 20% to 30% of 1 maximum repeat in the treatment to caste hypertrophy and strength. Effects of blood flow-restricted training on muscle lithium excitement, mechanical tension, metabolic stress, systemic and local hormones, vascular endothelial growth factor (VEGF) and oxidative stress mechanisms have been. There have been no randomized controlled studies in the literature on the effectiveness of BFR training in tendinopathies. However, case studies and series of cases have been included and no contraindications of BFR have been for patients with tendinopathy. The increasing number of studies on various diseases in the literature is a proof of this.

Conditions

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Lateral Epicondylitis Tennis Elbow Tendonitis Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Treating therapists and patient will be aware of treatment. Grip strength objective measure will be performed by a clinician blinded to the participant's treatment group. All other outcome measures are patient-reported on outcome forms.

Study Groups

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Control group

8 weeks, 2 days a week, a multi-model rehabilitation program is implemented.

Group Type ACTIVE_COMPARATOR

Multimodal rehabilitation

Intervention Type OTHER

Patients with LDT will be informed that the condition will be gradually resolved with adequate rest and time.

Exercise Training will consist of 3 phases.The goal is to protect the injured tissue from stress during the first phase of rehabilitation during the protective phase but not to restrict its function. In this phase, the use of counterforce breys, cold application, cyriax physiotherapy, Mill's manipulation, elbow mobilization and stretching to the wrist extensors will be applied. The program will be created taking into account the principle of proximal stability for distal mobility during the reinforcement phase. The rotator manchet will be added to the program. It will be active first in the exercise and then progresses resistantly according to the condition of the patient. After distal strengthening, the dress will be transferred to stabilization exercises where flexion and extension reveal simultaneous contraction.

Experimental group

8 weeks, 2 days a week, blood flow restriction during exercise will be applied in addition to the multi-model rehabilitation program. The elbow will be placed near the elbow and the patient's systolic pressure will be used to restrict the blood flow with the recommended 40%-50% occlusion for the upper extremity, and the exercise intensity will be performed 75 times at 20-30% of 1 maximum repetition, 30-15-15-15 repetition and 30 seconds rest between sets.

Group Type EXPERIMENTAL

Blood flow restriction

Intervention Type OTHER

The BFR training group will be given detailed information about the technique and discussed possible side effects.The American Association of Sports Physicians (ACSM) recommends that at least 65% of 1 maximum repetition, similar to high-intensity exercise, 8-12 repetitions of resistant weight lifting strength training, can be used with low loads such as 20% to 30% of the maximum 1 repetition in therapy to caste hypertrophy and strength.

Interventions

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Blood flow restriction

The BFR training group will be given detailed information about the technique and discussed possible side effects.The American Association of Sports Physicians (ACSM) recommends that at least 65% of 1 maximum repetition, similar to high-intensity exercise, 8-12 repetitions of resistant weight lifting strength training, can be used with low loads such as 20% to 30% of the maximum 1 repetition in therapy to caste hypertrophy and strength.

Intervention Type OTHER

Multimodal rehabilitation

Patients with LDT will be informed that the condition will be gradually resolved with adequate rest and time.

Exercise Training will consist of 3 phases.The goal is to protect the injured tissue from stress during the first phase of rehabilitation during the protective phase but not to restrict its function. In this phase, the use of counterforce breys, cold application, cyriax physiotherapy, Mill's manipulation, elbow mobilization and stretching to the wrist extensors will be applied. The program will be created taking into account the principle of proximal stability for distal mobility during the reinforcement phase. The rotator manchet will be added to the program. It will be active first in the exercise and then progresses resistantly according to the condition of the patient. After distal strengthening, the dress will be transferred to stabilization exercises where flexion and extension reveal simultaneous contraction.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 65 years of age,
* Lateral tendinopathy diagnosis,
* Have scored 33 or more out of 100 on the Patient Based Tennis elbow Assessment Test (PRTEE).

Exclusion Criteria

* Dysfunction in the shoulder, neck and/or chest area,
* Local or generalized arthritis.
* The neurological deficit.
* Radial dysfunction,
* Limitation of arm functions,
* A history of shoulder or upper extremity pathology requiring surgery or treatment;
* Venous thromboembolism
* Inflammation or other hematological disorders.
* Coronary artery disease,
* Peripheral arterial disease or hypertension (systolic/diastolic blood pressure \>140 mm Hg/90 mmHg),
* To be pregnant,
* Irritation of median nerves.
* Irritation of radial nerves.
* Irritation of the ulnar nerves,
* The pain score is less than 30 mm.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Fulya Demirhan

Clinical Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yıldız ANALAY AKBABA, Assoc. prof.

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Locations

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Istanbul University - Cerrahpasa

Istanbul, Büyükçekmece, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fulya DEMIRHAN, PHd Student

Role: CONTACT

+90-532-353-2208

Yıldız ANALAY AKBABA, Assoc.prof.

Role: CONTACT

+90-532-377-4013

Facility Contacts

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Fulya DEMIRHAN, PHd Student

Role: primary

+90-532-353-2208

References

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Kim YJ, Wood SM, Yoon AP, Howard JC, Yang LY, Chung KC. Efficacy of Nonoperative Treatments for Lateral Epicondylitis: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2021 Jan 1;147(1):112-125. doi: 10.1097/PRS.0000000000007440.

Reference Type BACKGROUND
PMID: 33002980 (View on PubMed)

Lenoir H, Mares O, Carlier Y. Management of lateral epicondylitis. Orthop Traumatol Surg Res. 2019 Dec;105(8S):S241-S246. doi: 10.1016/j.otsr.2019.09.004. Epub 2019 Sep 19.

Reference Type BACKGROUND
PMID: 31543413 (View on PubMed)

Karanasios S, Korakakis V, Moutzouri M, Xergia SA, Tsepis E, Gioftsos G. Low-Load Resistance Training With Blood Flow Restriction Is Effective for Managing Lateral Elbow Tendinopathy: A Randomized, Sham-Controlled Trial. J Orthop Sports Phys Ther. 2022 Dec;52(12):803-825. doi: 10.2519/jospt.2022.11211. Epub 2022 Sep 13.

Reference Type BACKGROUND
PMID: 36099170 (View on PubMed)

Coombes BK, Bisset L, Vicenzino B. Management of Lateral Elbow Tendinopathy: One Size Does Not Fit All. J Orthop Sports Phys Ther. 2015 Nov;45(11):938-49. doi: 10.2519/jospt.2015.5841. Epub 2015 Sep 17.

Reference Type BACKGROUND
PMID: 26381484 (View on PubMed)

Ozdincler AR, Baktir ZS, Mutlu EK, Kocyigit A. Chronic lateral elbow tendinopathy with a supervised graded exercise protocol. J Hand Ther. 2023 Oct-Dec;36(4):913-922. doi: 10.1016/j.jht.2022.11.005. Epub 2023 Mar 11.

Reference Type BACKGROUND
PMID: 36914496 (View on PubMed)

Other Identifiers

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665912

Identifier Type: -

Identifier Source: org_study_id

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