NCT07365033

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 15, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

Lateral EpicondylitisBlood Flow Restriction TherapyEccentric TrainingResistance Training,

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity (Numeric Pain Rating Scale)

    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 Outcomes (1)

  • Patient-Specific Functional Performance (PSFS)

    Baseline, 4 weeks, and 8 weeks

Study Arms (2)

interventional group A

EXPERIMENTAL

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

Control group B

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: blood flow resistance training
interventional group A
control group bBEHAVIORAL

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.

Also known as: resistance training
Control group B

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lahore Teaching Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Nimra Rafiq, MS MSK

    The University of Lahore, Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Montiha Azeem, MSPTN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

January 30, 2026

Primary Completion

March 30, 2026

Study Completion

March 31, 2026

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations