NCT04505215

Brief Summary

In this study, the effects of mulligan and muscle energy techniques on pain, grip strength and functionality will be investigated in a randomized controlled manner in individuals with lateral epicondylitis. Various treatments have been tried in patients with lateral epicondylitis whose daily activities are restricted in order to reduce pain and increase functions. Among them, conservative and physical therapy agents have an important place. There are many studies in the literature evaluating the effects of mobilization in LE treatment. However, there are no definitive data on the long-term efficacy and benefits of all these treatment methods. Mulligan and muscle energy techniques can be used in lateral epicondylitis due to many positive reasons such as being effective in a short time, giving fast results, high success rate, risk-free and painless in the case of specialists. Thanks to the findings obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

August 14, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2020

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

July 23, 2020

Last Update Submit

September 7, 2021

Conditions

Keywords

Tennis ElbowExerciseMusculoskeletal Manipulations

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Hand Grip Strenght at 6 weeks

    The maximum grip force measurements of the patients were made with "Baseline Hydraulic Hand Dynamometer". The patient's measurements were carried out in two positions. While the patient was in a sitting position, measurements were made in shoulder adduction, elbow 90˚ flexion, forearm in neutral position, wrist in 0-30˚ extension and 0-15˚ in ulnar deviation position. While the patient was standing, measurement was performed with shoulder adduction, elbow extension, forearm in neutral position. For maximum grip, patients should be able to hold the dynamometer for a maximum of 3 seconds. it was said to tighten with all its might. Measurements were repeated 3 times at 30-second intervals on the affected limb, and the measurements were averaged. Values are noted in kilograms (kg) - force

    Baseline and 4 weeks

  • Change from baseline in Pain Score at 6 weeks

    Visual Analogue Scale was used to determine the severity of rest, activity and night pain in patients with lateral epicondylitis. Patients were asked to mark their pain levels on a 10 cm scale before starting treatment and after 4 weeks of treatment. The value "0" means that there is no pain, and the value "10" means unbearable pain. The marked points are measured and recorded in centimeters

    Baseline and 4 weeks

Secondary Outcomes (1)

  • Change from baseline in Functionality at 6 weeks

    Baseline and 4 weeks

Study Arms (3)

Mulligan Technique

EXPERIMENTAL

In addition to the exercises applied to the participants in the control group, the participants in this group used Mobilization with movement, which was performed with the principle of painless movement 3 times a week for a total of 12 times a week for 4 weeks. Mobilization with movement has been performed by a certified physiotherapist who has been practicing this technique for 10 years.

Other: Mulligan Technique

Muscle Energy Technique

EXPERIMENTAL

In addition to the exercises applied to the participants in the control group, the Janda method (Post Isometric Relaxation Technique) from Muscle Energy Technique (3 times a week) was used 3 times a week for 4 weeks.

Other: Muscle Energy Technique

Only Exercise (Control)

ACTIVE COMPARATOR

Stretching and strengthening exercises for the forearm extensors were shown to the participants in the control group for 4 weeks every day of the week.

Other: Only Exercise (Control)

Interventions

First, the painless application angle was determined for each patient. The lateral condyle of the humerus was fixed by the web range of the physiotherapist. The elbow joint was glided until the elbow joint and the hand tightening position were not able to cause pain. The patients were asked to repeat the motion of the elbow joint and the ball squeezing motion given to their hands 10 times without pain. For pain control, the same procedure was performed with three sets, each containing 10 repetitions of the exercise. The interval between sets was 15 to 20 seconds, and the interval between repetitions within each set was 30 seconds.

Mulligan Technique

Firstly, 5-7 sec opposite isometric muscle contraction was requested from the patient in the barrier by passively stretching by the physiotherapist until the barrier of the related muscle or dysfunctional joint. After a short rest period of 2-3 seconds, the physiotherapist continued to stretch passively until the second barrier. The application continued until the tension of the muscle or dysfunction of the joint disappeared.

Muscle Energy Technique

Eccentric training for the extensor Carpi Radialis Brevis (ECRB) muscle, the most affected wrist extensor tendon, and static stretching exercise for the EKRB muscle were given as home exercise program. The best stretching position for the EKRB tendon is provided when the elbow joint is in extension, forearm pronation, when the wrist is flexed with ulnar deviation (Mills maneuver). Each exercise was taught to patients in 10 repetitions and 10 seconds, and one day of the week, participants in the control group performed their exercises under the supervision of a physiotherapist.

Only Exercise (Control)

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosing lateral epicondylitis
  • Age between 30 and 60 years
  • Willingness to comply with treatment and follow-up assessments

You may not qualify if:

  • Treatment of elbow complaints with surgical intervention
  • Physiotherapy or CSIs in the past 6 months
  • Duration of \<3 months
  • Severe neck or shoulder problems likely to cause or maintain the elbow complaints
  • Posterior interosseous nerve compression
  • Congenital or acquired deformities of the elbow
  • Systemic musculoskeletal or neurologic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis ElbowMotor Activity

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesBehavior

Study Officials

  • Bayram Sönmez ÜNÜVAR

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2020

First Posted

August 10, 2020

Study Start

August 14, 2020

Primary Completion

November 7, 2020

Study Completion

November 14, 2020

Last Updated

September 8, 2021

Record last verified: 2020-08

Locations