- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04219488
Investigating the Effects of Neuromobilization in Lateral Epicondylitis
January 3, 2020 updated by: KTO Karatay University
Comparison of the Effects of Neuromobilization and Conservative Rehabilitation Therapy on Pain, Grip Strength and Functional Status in Lateral Epicondylitis
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.
Study Overview
Status
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Konya, Turkey, 42020
- KTO Karatay University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Neuromobilization group
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.
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ACTIVE_COMPARATOR: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain severity
Time Frame: at the beginning of treatment
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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
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at the beginning of treatment
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Pain severity
Time Frame: 3 weeks later
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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
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3 weeks later
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Pain severity
Time Frame: 6 weeks later
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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
Time Frame: 12 weeks later
|
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
Time Frame: at the beginning of treatment
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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).
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at the beginning of treatment
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Grip strength
Time Frame: 3 weeks later
|
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
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Grip strength
Time Frame: 6 weeks later
|
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
Time Frame: 12 weeks later
|
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
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Tip pinch and key pinch
Time Frame: at the beginning of treatment
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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.
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at the beginning of treatment
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Tip pinch and key pinch
Time Frame: 3 weeks later
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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.
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3 weeks later
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Tip pinch and key pinch
Time Frame: 6 weeks later
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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.
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6 weeks later
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Tip pinch and key pinch
Time Frame: 12 weeks later
|
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.
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12 weeks later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wrist active range of motion (ROM)'s
Time Frame: at the beginning of treatment
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Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
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at the beginning of treatment
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Wrist active range of motion (ROM)'s
Time Frame: 3 weeks later
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Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
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3 weeks later
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Wrist active range of motion (ROM)'s
Time Frame: 6 weeks later
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Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
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6 weeks later
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Wrist active range of motion (ROM)'s
Time Frame: 12 weeks later
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Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.
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12 weeks later
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The functional status of the upper extremity
Time Frame: at the beginning of treatment
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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.
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at the beginning of treatment
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The functional status of the upper extremity
Time Frame: 3 weeks later
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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.
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3 weeks later
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The functional status of the upper extremity
Time Frame: 6 weeks later
|
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.
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6 weeks later
|
The functional status of the upper extremity
Time Frame: 12 weeks later
|
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.
|
12 weeks later
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2014
Primary Completion (ACTUAL)
December 15, 2014
Study Completion (ACTUAL)
January 5, 2015
Study Registration Dates
First Submitted
December 31, 2019
First Submitted That Met QC Criteria
January 3, 2020
First Posted (ACTUAL)
January 7, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 7, 2020
Last Update Submitted That Met QC Criteria
January 3, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KaratayUK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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