Eccentric Exercise With Blood Flow Restriction vs Resistance Training for Lateral Epicondylitis (BFR-ET LE)

February 4, 2026 updated by: Nimra Rafiq

Effectiveness of Eccentric Training With Blood Flow Restriction Therapy Versus Resistance Training in Patients With Lateral Epicondylitis

This randomized controlled trial aims to compare the effectiveness of eccentric training combined with blood flow restriction (ECC+BFR) versus heavy slow resistance (HSR) training in patients with chronic lateral epicondylitis. The study will recruit 40 participants (accounting for 10% attrition), aged 25-45 years, from Sakina Memorial Hospital Sheikhupura and University of Lahore Teaching Hospital using convenience sampling. Participants will be randomly allocated into two groups: an interventional group receiving ECC+BFR and a control group undergoing HSR training. Both interventions will be administered three times per week for 8 weeks under professional supervision. Outcome measures including pain intensity (NPRS), patient-specific functional performance (PSFS), muscle strength, and hypertrophy will be assessed at baseline, 4 weeks, and 8 weeks. Data will be analyzed using SPSS, with appropriate parametric or non-parametric tests applied after checking data normality. Ethical approval will be obtained, informed consent will be secured, and participant confidentiality will be strictly maintained.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single-blinded randomized controlled trial designed to evaluate and compare the therapeutic effectiveness of eccentric training with blood flow restriction (ECC+BFR) and heavy slow resistance (HSR) training in individuals diagnosed with chronic unilateral lateral epicondylitis. The study will be conducted at Sakina Memorial Hospital Sheikhupura and University of Lahore Teaching Hospital over a duration of 9 months following synopsis approval.

A total sample size of 40 participants (20 per group) has been determined using Epitool software, based on the Patient-Specific Functional Scale (PSFS), with a confidence level of 95%, power of 80%, and a 10% attrition allowance. Participants aged 25-45 years, of both genders, with clinically confirmed chronic lateral epicondylitis (positive Cozen's and Mill's tests) and symptom duration exceeding 12 months, will be included. Individuals with prior surgery, recent injections, systemic inflammatory conditions, vascular or clotting disorders, contraindications to BFR, pregnancy, or psychological illness will be excluded.

Eligible participants will be enrolled after providing written informed consent and randomized using a computer-generated block randomization method, with allocation concealment ensured through sealed opaque envelopes. Outcome assessors will be blinded to group allocation to minimize assessment bias.

The interventional group will receive eccentric wrist extensor exercises combined with blood flow restriction therapy, using a pneumatic cuff inflated to 50-60% limb occlusion pressure. Exercises will be performed at 20-30% 1-RM using a 30-15-15-15 repetition protocol, emphasizing slow controlled eccentric contractions. Sessions will be conducted three times weekly for 8 weeks, totaling 24 supervised sessions.

The control group will undergo a heavy slow resistance training protocol, involving wrist extensor exercises performed at 70-85% of 1-RM, with slow concentric and eccentric phases (3 seconds each). Participants will complete 3-4 sets of 6-8 repetitions, with adequate rest intervals, following the same session frequency and duration as the intervention group.

Primary and secondary outcome measures include pain intensity (Numeric Pain Rating Scale), patient-specific functional performance (PSFS), muscle strength, and muscle hypertrophy, assessed at baseline, 4 weeks, and 8 weeks post-intervention. Data will be analyzed using SPSS (version 25/27). Descriptive statistics will summarize participant characteristics, while inferential statistics will be applied based on data distribution, with significance determined accordingly.

Ethical considerations will strictly adhere to the guidelines of the Institutional Research Ethics Board (IREB), University of Lahore. Participant confidentiality, voluntary participation, right to withdraw, and safety monitoring will be ensured throughout the study. No serious adverse effects are anticipated.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • University of Lahore Teaching Hospital, Lahore
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nimra Rafiq, MS MSK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patient aged between 25 and 45 years. Both male and female participants with unilateral symptoms only. Clinically diagnosed unilateral lateral epicondylitis (LE), confirmed by positive Cozen's and Mills' tests. Symptom duration exceeding 12 months, indicating chronic LE.

Exclusion Criteria:

Previous history of surgery or injection therapy for LE within the past 6 months.

Coexisting conditions (e.g., rheumatoid arthritis, cervical radiculopathy, significant tendon tears). Contraindications to BFR (e.g., DVT, vascular disease, uncontrolled hypertension, clotting disorders).

Use of anticoagulants or long-term pain medications. Pregnant or psychological person.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interventional group A
The interventional group will receive eccentric wrist extensor exercises combined with blood flow restriction therapy, using a pneumatic cuff inflated to 50-60% limb occlusion pressure. Exercises will be performed at 20-30% 1-RM using a 30-15-15-15 repetition protocol, emphasizing slow controlled eccentric contractions. Sessions will be conducted three times weekly for 8 weeks, totaling 24 supervised sessions.
Behavioral: interventional group A
The interventional group will receive eccentric wrist extensor exercises combined with blood flow restriction therapy, using a pneumatic cuff inflated to 50-60% limb occlusion pressure. Exercises will be performed at 20-30% 1-RM using a 30-15-15-15 repetition protocol, emphasizing slow controlled eccentric contractions. Sessions will be conducted three times weekly for 8 weeks, totaling 24 supervised sessions.
Other Names:
  • blood flow resistance training
Active Comparator: Control group B
The control group will undergo a heavy slow resistance training protocol, involving wrist extensor exercises performed at 70-85% of 1-RM, with slow concentric and eccentric phases (3 seconds each). Participants will complete 3-4 sets of 6-8 repetitions, with adequate rest intervals, following the same session frequency and duration as the intervention group.
Behavioral: control group b
The control group will undergo a heavy slow resistance training protocol, involving wrist extensor exercises performed at 70-85% of 1-RM, with slow concentric and eccentric phases (3 seconds each). Participants will complete 3-4 sets of 6-8 repetitions, with adequate rest intervals, following the same session frequency and duration as the intervention group.
Other Names:
  • resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (Numeric Pain Rating Scale)
Time Frame: Baseline, 4 weeks, and 8 weeks
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their average elbow pain during daily activities involving the affected upper limb.
Baseline, 4 weeks, and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Specific Functional Performance (PSFS)
Time Frame: Baseline, 4 weeks, and 8 weeks
Functional performance will be assessed using the Patient-Specific Functional Scale (PSFS). Participants will identify activities affected by lateral epicondylitis and rate their ability to perform each activity on an 11-point scale ranging from 0 (unable to perform) to 10 (able to perform at pre-injury level). Higher scores indicate improved functional ability.
Baseline, 4 weeks, and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nimra Rafiq

Investigators

  • Principal Investigator: Nimra Rafiq, MS MSK, The University of Lahore, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOL/IREB/25/15/03/28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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