NCT05354167

Brief Summary

Lateral epicondylitis (LE) is a painful musculoskeletal condition caused by overuse. The condition is also called tennis elbow because it affects 50% of tennis players, notably beginners learning the one-handed backhand. Nonetheless, only 10% of all patients with LE play tennis. Lateral Epicondylitis (LE) or tennis elbow affects about 1-3% of general population. Muscle energy technique was developed by osteopathic physician, Fred Mitchell, Sr. It was refined and systematized by Fred Mitchell, Jr., and has continued to evolve with contributions from many individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

April 25, 2022

Last Update Submit

September 15, 2022

Conditions

Keywords

lateral epicondylitisMuscle energy techniqueOscillating manual energy therapygrip strengthpain

Outcome Measures

Primary Outcomes (3)

  • Numerical rating scale

    The Verbal Numerical Rating Scale is the most commonly used self-report measure of pain intensity. Patients are instructed to choose a single number from the scale that best indicates their level of pain.1-4 Mild pain,5-6 Moderate,7-10 severe. assessment to be done on baseline and after every week

    four weeks

  • Hand dynamometer(Grip strength)

    Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength. Assessment to be done on baseline and after every week.

    for four weeks

  • Patient rated tennis elbow evaluation (functional status)

    The Patient-rated Tennis Elbow Evaluation (PRTEE) enables quantitative rating by the patient of pain and functional impairment associated with tennis elbow or lateral elbow tendinopathy. It takes the form of a 15-item questionnaire, with five items addressing pain and 10 concerned with functional deficit. Assessment to be done on baseline and after every week.

    for four weeks

Study Arms (2)

muscle energy technique

EXPERIMENTAL

the subject to sit comfortably and then stabilize the subject's distal humerus with one hand, then the forearm was supinated with the therapist another hand until resistance appeared. Holding the position the subject was asked to slowly pronate the forearm that is Isometric contraction against resistance for a period of 6-10 seconds with inhale and exhale, followed by slightly increasing supination until resistance was met once again. After 5 seconds of relaxation, the procedure was repeated 5 times during a single treatment session.

Other: muscle energy technique

oscillating manual energy therapy

EXPERIMENTAL

It is also known as V-spread .The subject was asked to sit on a chair with the affected painful arm resting on the treatment table. Tender points were palpated. Then the therapist places the index and middle fingers of one hand in a V-shape around the tender point and placed the index finger of the other hand in the medial side of the elbow, diagonally across the located tender point. Gentle pressure was applied a few times using fingertips to the tissues alternatively from the medial and lateral sides to start the oscillations. On the initiation of oscillations, the application of pressure should be stopped and allow the oscillations to continue between the two points of contact on the subject's elbow. This technique was repeated until there were no tender points on palpation. The duration varied from 30 seconds to 2 minutes.

Other: oscillating manual energy therapy

Interventions

the subject to sit comfortably and then stabilize the subject's distal humerus with one hand, then the forearm was supinated with the therapist another hand until resistance appeared. Holding the position the subject was asked to slowly pronate the forearm that is Isometric contraction against resistance for a period of 6-10 seconds with inhale and exhale, followed by slightly increasing supination until resistance was met once again. After 5 seconds of relaxation, the procedure was repeated 5 times during a single treatment session; this technique was applied in 2 sessions for a week for 4 weeks.

muscle energy technique

It is also known as V-spread .The subject was asked to sit on a chair with the affected painful arm resting on the treatment table. Tender points were palpated. Then the therapist places the index and middle fingers of one hand in a V-shape around the tender point and placed the index finger of the other hand in the medial side of the elbow, diagonally across the located tender point. Gentle pressure was applied a few times using fingertips to the tissues alternatively from the medial and lateral sides to start the oscillations. On the initiation of oscillations, the application of pressure should be stopped and allow the oscillations to continue between the two points of contact on the subject's elbow.

oscillating manual energy therapy

Eligibility Criteria

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

You may qualify if:

  • Presence of tenderness point on lateral epicondyle.
  • Positive cozen test, mills test, Maudsley's test
  • Negative Radial nerve test

You may not qualify if:

  • Cervical spine disorder
  • Peripheral neuropathy
  • Fractures
  • Major upper limb surgery
  • Steroid injections in last 6 months
  • Tumor or wound
  • take any kind of physiotherapy treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Rehabilitation Medicine,

Islamabad, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Tennis ElbowPain

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

April 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 5, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations