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

NCT06001944 | Unknown DMC

• 1 other identifier: 665912
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lateral Epicondylitis; Tennis Elbow; Tendonitis Elbow

Keywords

lateral elbow tendinopathy; blood flow restriction; exercise

Outcome Measures

Primary Outcomes (3)

• Visual Analog Scale

  In the resting position, a 100 mm long line will be drawn and patients will be asked to mark the area where they express the severity of the pain on that line.

  Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up

• Painless Grip Strength

  Average values of 3 repeated measurements with the Baseline dynamometer will be recorded while the patient is sitting upright, at shoulder adduction, at 90 degree flexion of the elbow, supported at the middle rotation of the front arm and while the wrist is in a neutral position.

  Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up

• Patient-rated tennis elbow evaluation (PRTEE)

  It consists of two subheadings, pain and function. Function subheadings include specific activities and general activities, and each subgroup takes a value from 0 to 10. For the total score, the average of individual and general activity scores is collected with the total pain score. The result is a value between 0 and 100.

  Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up

Secondary Outcomes (5)

• SF-12 Quality of Life Questionnaire

  Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up

• Global Rating of Change

  Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up

• Range of Motion

  Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up

• Manual Muscle Testing

  Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up

• Pressure-Pain Threshold Measurement

  Evaluation should be carried out at baseline, at the end of four weeks of the treatment, at the end of eight weeks of the treatment, and at the end of four weeks of follow-up

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Multimodal rehabilitation

Experimental group

EXPERIMENTAL

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.

Other: Blood flow restriction

Interventions

Blood flow restriction 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.

Experimental group

Multimodal rehabilitation 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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, Büyükçekmece, No:5/9/1, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 33002980 BACKGROUND

• 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.

  PMID: 31543413 BACKGROUND

• 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.

  PMID: 36099170 BACKGROUND

• 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.

  PMID: 26381484 BACKGROUND

• 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.

  PMID: 36914496 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow; Motor Activity

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Yıldız ANALAY AKBABA, Assoc. prof.

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Fulya DEMIRHAN, PHd Student

CONTACT

+90-532-353-2208; f.gurcenan@hotmail.com

Yıldız ANALAY AKBABA, Assoc.prof.

CONTACT

+90-532-377-4013; yildizanalay@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: August 21, 2023
• Study Start: April 11, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)