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Completed

NCT Number: NCT04219488

Investigating the Effects of Neuromobilization 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.

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Key information

Conditions

Tennis Elbow Arm Injuries Elbow Injuries Elbow Tendinopathy Lateral Epicondylitis Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KTO Karatay University

Konya, 42020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radial nerve mobilization

Other

Supervised home program

Other

Primary outcomes

  1. Pain severity

    Time frame: at the beginning of treatment

    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

  2. Pain severity

    Time frame: 3 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

  3. Pain severity

    Time frame: 6 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

  4. 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

  5. Grip strength

    Time frame: at the beginning of treatment

    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. 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).

  7. 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).

  8. 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).

  9. Tip pinch and key pinch

    Time frame: at the beginning of treatment

    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.

  10. Tip pinch and key pinch

    Time frame: 3 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.

  11. Tip pinch and key pinch

    Time frame: 6 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.

  12. 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.

Secondary outcomes

  1. Wrist active range of motion (ROM)'s

    Time frame: at the beginning of treatment

    Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.

  2. Wrist active range of motion (ROM)'s

    Time frame: 3 weeks later

    Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.

  3. Wrist active range of motion (ROM)'s

    Time frame: 6 weeks later

    Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.

  4. Wrist active range of motion (ROM)'s

    Time frame: 12 weeks later

    Wrist active ROMs, including flexion, extension, and radial and ulnar deviation were recorded in degrees by using a universal goniometer for each group.

  5. The functional status of the upper extremity

    Time frame: at the beginning of treatment

    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. The functional status of the upper extremity

    Time frame: 3 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

Comparison of the Effects of Neuromobilization and Conservative Rehabilitation Therapy on Pain, Grip Strength and Functional Status in Lateral Epicondylitis

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 7, 2020
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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