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Investigating the Effects of Neuromobilization in Lateral Epicondylitis

Primary Purpose

Tennis Elbow, Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Radial nerve mobilization
Supervised home program
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring eccentric exercise, radial nerve mobilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromobilization group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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).
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).
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).
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).
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.
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.
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.
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.

Secondary Outcome Measures

Wrist active range of motion (ROM)'s
Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
Wrist active range of motion (ROM)'s
Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
Wrist active range of motion (ROM)'s
Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
Wrist active range of motion (ROM)'s
Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
The functional status of the upper extremity
The functional status of the upper extremity was evaluated using the Turkish version of the disabilities of the arm, shoulder and hand (DASH) questionnaire. The DASH questionnaire includes 30 items related to symptoms and activities of daily living. The total score is 100, and a higher score indicates a higher degree of disability.
The functional status of the upper extremity
The functional status of the upper extremity was evaluated using the Turkish version of the disabilities of the arm, shoulder and hand (DASH) questionnaire. The DASH questionnaire includes 30 items related to symptoms and activities of daily living. The total score is 100, and a higher score indicates a higher degree of disability.
The functional status of the upper extremity
The functional status of the upper extremity was evaluated using the Turkish version of the disabilities of the arm, shoulder and hand (DASH) questionnaire. The DASH questionnaire includes 30 items related to symptoms and activities of daily living. The total score is 100, and a higher score indicates a higher degree of disability.
The functional status of the upper extremity
The functional status of the upper extremity was evaluated using the Turkish version of the disabilities of the arm, shoulder and hand (DASH) questionnaire. The DASH questionnaire includes 30 items related to symptoms and activities of daily living. The total score is 100, and a higher score indicates a higher degree of disability.

Full Information

First Posted
December 31, 2019
Last Updated
January 3, 2020
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT04219488
Brief Title
Investigating the Effects of Neuromobilization in Lateral Epicondylitis
Official Title
Comparison of the Effects of Neuromobilization and Conservative Rehabilitation Therapy on Pain, Grip Strength and Functional Status in Lateral Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
December 15, 2014 (Actual)
Study Completion Date
January 5, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Lateral epicondylitis (LE) is a painful situation, which usually occurs due to the overuse of the wrist extensor muscles. The prevalence of LE is 1%-3% in both men and women, and it is highest in individuals aged >40 years. Pain and tenderness over the lateral epicondyle of the humerus at the origin of the common extensor tendon are the main characteristics. Different conservative treatment methods have been used for treating LE; however, no standard protocol has been documented in the literature. Physiotherapy programs have focused on relieving pain, controlling inflammation, and increasing muscle strength and endurance. The use of eccentric strengthening programs has been supported by current research. Eccentric exercises have been demonstrated to reduce pain and increase function in patients with LE. Recently, neuromobilization techniques have been employed in treating musculoskeletal problems and various compression syndromes. These techniques aimed to provide nerve gliding via joint movements wherein a therapist extends the nerve length in one joint while shortening the same in the adjacent joint. This tensioning technique increases the distance between each end of the nerve, and this neural elongation ability significantly decreases in patients with LE. Neuromobilization techniques have been also proposed to modulate central sensitization and peripheral pain mechanisms in musculoskeletal disorders. Given that central sensitization plays an important role in the increased nociceptive reflex and hyperalgesia in LE, inducing hypoalgesia via neuromobilization techniques may provide pain relief in the long term.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Lateral Epicondylitis
Keywords
eccentric exercise, radial nerve mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double Blinded
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromobilization group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Radial nerve mobilization
Intervention Type
Other
Intervention Name(s)
Supervised home program
Primary Outcome Measure Information:
Title
Pain severity
Description
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
Time Frame
at the beginning of treatment
Title
Pain severity
Description
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
Time Frame
3 weeks later
Title
Pain severity
Description
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
Time Frame
6 weeks later
Title
Pain severity
Description
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
Time Frame
12 weeks later
Title
Grip strength
Description
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).
Time Frame
at the beginning of treatment
Title
Grip strength
Description
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).
Time Frame
3 weeks later
Title
Grip strength
Description
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).
Time Frame
6 weeks later
Title
Grip strength
Description
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).
Time Frame
12 weeks later
Title
Tip pinch and key pinch
Description
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.
Time Frame
at the beginning of treatment
Title
Tip pinch and key pinch
Description
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.
Time Frame
3 weeks later
Title
Tip pinch and key pinch
Description
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.
Time Frame
6 weeks later
Title
Tip pinch and key pinch
Description
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.
Time Frame
12 weeks later
Secondary Outcome Measure Information:
Title
Wrist active range of motion (ROM)'s
Description
Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
Time Frame
at the beginning of treatment
Title
Wrist active range of motion (ROM)'s
Description
Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
Time Frame
3 weeks later
Title
Wrist active range of motion (ROM)'s
Description
Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
Time Frame
6 weeks later
Title
Wrist active range of motion (ROM)'s
Description
Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
Time Frame
12 weeks later
Title
The functional status of the upper extremity
Description
The functional status of the upper extremity was evaluated using the Turkish version of the disabilities of the arm, shoulder and hand (DASH) questionnaire. The DASH questionnaire includes 30 items related to symptoms and activities of daily living. The total score is 100, and a higher score indicates a higher degree of disability.
Time Frame
at the beginning of treatment
Title
The functional status of the upper extremity
Description
The functional status of the upper extremity was evaluated using the Turkish version of the disabilities of the arm, shoulder and hand (DASH) questionnaire. The DASH questionnaire includes 30 items related to symptoms and activities of daily living. The total score is 100, and a higher score indicates a higher degree of disability.
Time Frame
3 weeks later
Title
The functional status of the upper extremity
Description
The functional status of the upper extremity was evaluated using the Turkish version of the disabilities of the arm, shoulder and hand (DASH) questionnaire. The DASH questionnaire includes 30 items related to symptoms and activities of daily living. The total score is 100, and a higher score indicates a higher degree of disability.
Time Frame
6 weeks later
Title
The functional status of the upper extremity
Description
The functional status of the upper extremity was evaluated using the Turkish version of the disabilities of the arm, shoulder and hand (DASH) questionnaire. The DASH questionnaire includes 30 items related to symptoms and activities of daily living. The total score is 100, and a higher score indicates a higher degree of disability.
Time Frame
12 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged >18 years A symptom duration of >3 months Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamil Yılmaz, 1
Organizational Affiliation
KTO Karatay University
Official's Role
Principal Investigator
Facility Information:
Facility Name
KTO Karatay University
City
Konya
ZIP/Postal Code
42020
Country
Turkey

12. IPD Sharing Statement

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Investigating the Effects of Neuromobilization in Lateral Epicondylitis

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