NCT06490692

Brief Summary

The goal of this randomized controlled clinical trial is to investigate the effects of blood flow restriction training on the parameters surrounding tennis elbow afflicted patients including pain, disability, and grip strength. The main question this study aims to answer is: 1- Does blood flow restriction training offer significantly better effects on pain, disability, and grip strength when compared to conventional strength training without blood flow restriction in patients afflicted with tennis elbow? Research will compare two groups with tennis elbow where both will perform the same rehabilitation program consisting of conventional physical therapy for tennis elbow as well as a strength training program with the only difference being that one group will undergo blood flow restriction training while the other will not.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

June 29, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

July 8, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 29, 2024

Last Update Submit

June 29, 2024

Conditions

Keywords

blood flow restriction traininglateral epicondylitistennis elbow

Outcome Measures

Primary Outcomes (1)

  • Hand Grip Strength

    The hand grip strength was tested using a Camry Dynamometer, which is a smedly spring type dynamomter, whose reliability and validity in measuring handgrip strength has been reported by available literature.

    Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).

Secondary Outcomes (2)

  • Patient Related Tennis Elbow Evaluation Scale (PRTEES)

    Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).

  • Numerical Pain Rating Scale (NPRS)

    Taken initially before intervention process and after the conclusion of the intervention period (6 weeks, 12 sessions).

Study Arms (2)

Blood Flow Restriction Training Group

EXPERIMENTAL

The experimental group will undergo conventional physical therapy including ultrasound, stretching, icing, heat, and deep friction massage applied at the extensor origin. In addition, the experimental group will undergo blood flow restriction strength training including the following: the weight of the dumbbell should be between 20-40% of their 1 rep max. The exercises were targeting the extensor muscles, applied by extending the wrist while holding the dumbbel and exercises targeting the supinator's and pronators while the participants were holding the dumbbell with forearm in neutral position, and were asked to supinate or pronate their forearm. The cuff will be placed proximally at the affected arm and inflated to achieve 40% limb occlusion depending on size attested using a a golden standard vascular dopler and all blood flow restriction activities were done with a licensed and experienced physical therapist.

Other: Blood Flow Restriction Training

Conventional Strength Training Group

ACTIVE COMPARATOR

The active comparator group will undergo the same interventions as the experimental group with the addition of conventional strength training including the same program as the experimental group but without blood flow restriction of any kind: the weight of the dumbbell should be between 20-40% of their 1 rep max. The exercises were targeting the extensor muscles, applied by extending the wrist while holding the dumbbell for 4 sets (35 repetitions, 15 repetitions,15 repetitions,15 repetitions) respectively, and exercises targeting the supinator's and pronators while the participants were holding the dumbbell with forearm in neutral position, and were asked to supinate or pronate their forearm.

Other: Conventional Strength Training

Interventions

The affected limb will have a cuff placed proximally and inflated to occlude the blood flow by 40% attested using a golden standard vascular doppler after which the individuals will perform the strengthening program set forth by the physical therapist. This is preceded by other tennis elbow interventions such as ultrasound, stretching, and deep friction massage at the extensor origin.

Blood Flow Restriction Training Group

The individuals in this group will undergo the same conventional physical therapy program as the other group including ultrasound, stretching, and deep friction massage. In addition, they will undergo the same strengthening program set forth by the physical therapist however with no blood flow restriction of any kind.

Conventional Strength Training Group

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients that were included in this study were diagnosed with lateral epicondylitis by a medical doctor for less than 3 months.
  • Dominant hand was diagnosed with lateral epicondylitis.
  • They were aged between 20 and 40 years old.
  • With decreased grip strength and wrist range of motion.
  • No history of physical therapy treatment for lateral epicondylitis for at least 6 months.

You may not qualify if:

  • Patients with chronic diabetes.
  • Any type of trauma or fracture in the upper extremities in the last 3 months.
  • Patients with any vestibular problems.
  • Patients with deep vein thrombosis (DVT).
  • Patients with hypertension.
  • Patients with cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beirut Arab University

Beirut, 0000, Lebanon

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: A randomized controlled clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

June 29, 2024

First Posted

July 8, 2024

Study Start

June 29, 2024

Primary Completion

October 25, 2024

Study Completion

November 1, 2024

Last Updated

July 8, 2024

Record last verified: 2024-06

Locations