Investigating the Effects of Neuromobilization in Lateral Epicondylitis

Sponsor
KTO Karatay University (Other)
Overall Status
Completed
CT.gov ID
NCT04219488
Collaborator
(none)
40
1
2
8.2
4.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Radial nerve mobilization
  • Other: Supervised home program
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double Blinded
Primary Purpose:
Treatment
Official Title:
Comparison of the Effects of Neuromobilization and Conservative Rehabilitation Therapy on Pain, Grip Strength and Functional Status in Lateral Epicondylitis
Actual Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Dec 15, 2014
Actual Study Completion Date :
Jan 5, 2015

Arms and Interventions

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.

Other: Radial nerve mobilization

Other: Supervised home program

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.

Other: Supervised home program

Outcome Measures

Primary Outcome Measures

  1. Pain severity [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KTO Karatay University Konya Turkey 42020

Sponsors and Collaborators

  • KTO Karatay University

Investigators

  • Principal Investigator: Kamil Yılmaz, 1, KTO Karatay University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
KTO Karatay University
ClinicalTrials.gov Identifier:
NCT04219488
Other Study ID Numbers:
  • KaratayUK
First Posted:
Jan 7, 2020
Last Update Posted:
Jan 7, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by KTO Karatay University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 7, 2020