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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04219488
Other study ID # KaratayUK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2014
Est. completion date January 5, 2015

Study information

Verified date January 2020
Source KTO Karatay University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 5, 2015
Est. primary completion date December 15, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Radial nerve mobilization

Supervised home program


Locations

Country Name City State
Turkey KTO Karatay University Konya

Sponsors (1)

Lead Sponsor Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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. at the beginning of treatment
Secondary 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. 3 weeks later
Secondary 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. 6 weeks later
Secondary 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. 12 weeks later
Secondary 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. at the beginning of treatment
Secondary 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. 3 weeks later
Secondary 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. 6 weeks later
Secondary 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. 12 weeks later
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