NCT04219488

Brief Summary

This study aimed to determine the effects of neuromobilization techniques and conservative rehabilitation therapy on pain, grip strength, and functional status in patients with lateral epicondylitis (LE). A total of 40 patients (26 females and 14 males; age: 42.80 ± 8.91 years) with a history of LE participated in the study. The patients were randomly assigned to two groups: the neuromobilization group and the control group. The neuromobilization group completed a 6-week conservative rehabilitation and radial nerve mobilization program, whereas the control group received conservative rehabilitation therapy only. Both groups underwent a 7-day weekly conservative home rehabilitation program. Pain severity, grip strength, pinch strength, joint mobility, and upper extremity functional level were assessed before treatment, at the third week, after treatment, and at the sixth week after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

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

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2014

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2015

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

December 31, 2019

Last Update Submit

January 3, 2020

Conditions

Tennis ElbowLateral Epicondylitis

Keywords

eccentric exerciseradial nerve mobilization

Outcome Measures

Primary Outcomes (12)

  • Pain severity

    Pain severity was measured using a 10-cm visual analog scale, labeled from 0 (no pain) to 10 (the worst pain), at rest, at night, and during daily activities

    at the beginning of treatment

  • Pain severity

    Pain severity was measured using a 10-cm visual analog scale, labeled from 0 (no pain) to 10 (the worst pain), at rest, at night, and during daily activities

    3 weeks later

  • Pain severity

    Pain severity was measured using a 10-cm visual analog scale, labeled from 0 (no pain) to 10 (the worst pain), at rest, at night, and during daily activities

    6 weeks later

  • Pain severity

    Pain severity was measured using a 10-cm visual analog scale, labeled from 0 (no pain) to 10 (the worst pain), at rest, at night, and during daily activities

    12 weeks later

  • Grip strength

    Grip strength was measured using two different test methods: pain-free grip strength and maximum grip strength. Both tests were performed in the sitting position with the elbow flexed at 90° and in the standing position with the elbow extended at 0°. Both tests were performed using a calibrated hydraulic hand dynamometer® (Jamar, Bolingbrook IL).The measurements of both extremities were repeated 3 times with a resting interval of 30 s between each measurement. The average of the three trials was recorded in kilograms (kg).

    at the beginning of treatment

  • Grip strength

    Grip strength was measured using two different test methods: pain-free grip strength and maximum grip strength. Both tests were performed in the sitting position with the elbow flexed at 90° and in the standing position with the elbow extended at 0°. Both tests were performed using a calibrated hydraulic hand dynamometer® (Jamar, Bolingbrook IL).The measurements of both extremities were repeated 3 times with a resting interval of 30 s between each measurement. The average of the three trials was recorded in kilograms (kg).

    3 weeks later

  • Grip strength

    Grip strength was measured using two different test methods: pain-free grip strength and maximum grip strength. Both tests were performed in the sitting position with the elbow flexed at 90° and in the standing position with the elbow extended at 0°. Both tests were performed using a calibrated hydraulic hand dynamometer® (Jamar, Bolingbrook IL).The measurements of both extremities were repeated 3 times with a resting interval of 30 s between each measurement. The average of the three trials was recorded in kilograms (kg).

    6 weeks later

  • Grip strength

    Grip strength was measured using two different test methods: pain-free grip strength and maximum grip strength. Both tests were performed in the sitting position with the elbow flexed at 90° and in the standing position with the elbow extended at 0°. Both tests were performed using a calibrated hydraulic hand dynamometer® (Jamar, Bolingbrook IL).The measurements of both extremities were repeated 3 times with a resting interval of 30 s between each measurement. The average of the three trials was recorded in kilograms (kg).

    12 weeks later

  • Tip pinch and key pinch

    Tip pinch and key pinch were measured using the "Baseline Mechanical Pinch Gauge" (FEI, White Plains, NY). Measurements were repeated 3 times with a resting interval of 30 s between each measurement. The average of the three trials was recorded in kg.

    at the beginning of treatment

  • Tip pinch and key pinch

    Tip pinch and key pinch were measured using the "Baseline Mechanical Pinch Gauge" (FEI, White Plains, NY). Measurements were repeated 3 times with a resting interval of 30 s between each measurement. The average of the three trials was recorded in kg.

    3 weeks later

  • Tip pinch and key pinch

    Tip pinch and key pinch were measured using the "Baseline Mechanical Pinch Gauge" (FEI, White Plains, NY). Measurements were repeated 3 times with a resting interval of 30 s between each measurement. The average of the three trials was recorded in kg.

    6 weeks later

  • Tip pinch and key pinch

    Tip pinch and key pinch were measured using the "Baseline Mechanical Pinch Gauge" (FEI, White Plains, NY). Measurements were repeated 3 times with a resting interval of 30 s between each measurement. The average of the three trials was recorded in kg.

    12 weeks later

Secondary Outcomes (8)

  • Wrist active range of motion (ROM)'s

    at the beginning of treatment

  • Wrist active range of motion (ROM)'s

    3 weeks later

  • Wrist active range of motion (ROM)'s

    6 weeks later

  • Wrist active range of motion (ROM)'s

    12 weeks later

  • The functional status of the upper extremity

    at the beginning of treatment

  • +3 more secondary outcomes

Study Arms (2)

Neuromobilization group

EXPERIMENTAL

The neuromobilization group received a supervised home program plus radial nerve mobilization. Radial nerve mobilization exercises were performed by the physiotherapist for 3 days a week for 3 weeks. The patients in the neuromobilization group also performed self-neuromobilization exercises at home for 6 weeks. Supervised home program including patient education and eccentric exercises was administered three times daily for 6 weeks.

Other: Radial nerve mobilizationOther: Supervised home program

Control group

ACTIVE COMPARATOR

The control group received a supervised home program. Supervised home program including patient education and eccentric exercises was administered 3 times a day for 6 weeks.

Other: Supervised home program

Interventions

Radial nerve mobilizationOTHER
Neuromobilization group
Supervised home programOTHER
Control groupNeuromobilization group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged \>18 years
  • A symptom duration of \>3 months

You may not qualify if:

  • Bilateral symptoms
  • Rheumatologic diseases affecting the elbow and the wrist
  • Musculoskeletal disorders due to connective tissue diseases
  • Diffuse pain syndrome
  • Cervical radiculopathy
  • Nerve compression syndromes involving upper extremity
  • Undergone surgery at the affected arm
  • Received an LE treatment in the last 6 months
  • An inability to perform the exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Kamil Yılmaz, 1

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double Blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2019

First Posted

January 7, 2020

Study Start

May 1, 2014

Primary Completion

December 15, 2014

Study Completion

January 5, 2015

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

TU(1)