search
Back to results

Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
first physiotherapy
second physiotherapy
third physiotherapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring tennis elbow, pain, shock wave, kinesio taping

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed with tennis elbow,
  • and the duration of symptoms was between 8 and 10 weeks,
  • and pain over the lateral epicondyle, pain during grip strength testing, and pain with one of the following tests: extensor carpi radialis test (i.e., resisted middle-finger extension), resisted wrist extension, or passive stretch of the wrist extensors.
  • Furthermore, the participants had to agree to abstain from any other form of treatment during their involvement in this study

Exclusion Criteria:

  • patients with inflammatory, autoimmune, endocrine or kidney diseases, cubital tunnel syndrome, carpal tunnel syndrome, radiculopathies due to cervical disc pathologies, additional shoulder-hand-wrist pathologies, inflammatory arthritis, upper extremity operations or traumas,
  • allergies to adhesive tape,
  • and the patients who received corticosteroid injection due to lateral epicondylitis within the last 3 months

Sites / Locations

  • Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

first physiotherapy

second physiotherapy

third physiotherapy

Arm Description

cold pack, TENS, exercise

cold pack, TENS, exercise, kinesiotaping

cold pack, TENS, ESWT, exercise

Outcomes

Primary Outcome Measures

pain assessment
pain intensity will de assessed by using Visual Analog Scale at rest, activity and at night. All assessment will be recorded at baseline and at the end of the three week treatment sessions

Secondary Outcome Measures

functional assessment
functional status will be assessed by using Patient-Rated Tennis Elbow Evaluation Scale (PRTEE). All assessment will be recorded at baseline and at the end of the three week treatment sessions
maximum grip strength evaluation
maximum grip strength will be assessed with hand dynamometer both elbow flexion and extension position. All assessment will be recorded at baseline and at the end of the three week treatment sessions

Full Information

First Posted
October 2, 2016
Last Updated
April 11, 2018
Sponsor
Hacettepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT02930304
Brief Title
Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial
Official Title
Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi. The aim of this study is to The compare the short-term effects of different physiotherapy approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.
Detailed Description
Lateral epicondylitis (tennis elbow) is a painful musculoskeletal condition, which is considered to be due to overuse, over-stress or over-exertion of the wrist extensors of the forearm, especially extensor carpi radialis brevi. Different treatment approaches are described in the literature. The primary aim of the treatment approaches are decrease the pain and improve the functional level in patients with lateral epicondylitis. Thus, decreasing pain and regaining the functional performance in the daily living activity is essential in early diagnosed patients. The aim of this study is to compare the short-term effects of different treatment approaches on pain, function and grip strength in the rehabilitation of patients with lateral epicondylitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
tennis elbow, pain, shock wave, kinesio taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
first physiotherapy
Arm Type
Experimental
Arm Description
cold pack, TENS, exercise
Arm Title
second physiotherapy
Arm Type
Experimental
Arm Description
cold pack, TENS, exercise, kinesiotaping
Arm Title
third physiotherapy
Arm Type
Experimental
Arm Description
cold pack, TENS, ESWT, exercise
Intervention Type
Other
Intervention Name(s)
first physiotherapy
Other Intervention Name(s)
physiotherapy
Intervention Description
physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions
Intervention Type
Other
Intervention Name(s)
second physiotherapy
Other Intervention Name(s)
kinesiotaping
Intervention Description
physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Kinesio taping will be applied two times per week total six times in addition to conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
third physiotherapy
Other Intervention Name(s)
Extracorporeal shockwave therapy (ESWT)
Intervention Description
physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Extracorporeal shockwave therapy (ESWT) will be applied one times per week total three session.
Primary Outcome Measure Information:
Title
pain assessment
Description
pain intensity will de assessed by using Visual Analog Scale at rest, activity and at night. All assessment will be recorded at baseline and at the end of the three week treatment sessions
Time Frame
from baseline to third week after treatment sessions
Secondary Outcome Measure Information:
Title
functional assessment
Description
functional status will be assessed by using Patient-Rated Tennis Elbow Evaluation Scale (PRTEE). All assessment will be recorded at baseline and at the end of the three week treatment sessions
Time Frame
from baseline to third week after treatment sessions
Title
maximum grip strength evaluation
Description
maximum grip strength will be assessed with hand dynamometer both elbow flexion and extension position. All assessment will be recorded at baseline and at the end of the three week treatment sessions
Time Frame
from baseline to third week after treatment sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with tennis elbow, and the duration of symptoms was between 8 and 10 weeks, and pain over the lateral epicondyle, pain during grip strength testing, and pain with one of the following tests: extensor carpi radialis test (i.e., resisted middle-finger extension), resisted wrist extension, or passive stretch of the wrist extensors. Furthermore, the participants had to agree to abstain from any other form of treatment during their involvement in this study Exclusion Criteria: patients with inflammatory, autoimmune, endocrine or kidney diseases, cubital tunnel syndrome, carpal tunnel syndrome, radiculopathies due to cervical disc pathologies, additional shoulder-hand-wrist pathologies, inflammatory arthritis, upper extremity operations or traumas, allergies to adhesive tape, and the patients who received corticosteroid injection due to lateral epicondylitis within the last 3 months
Facility Information:
Facility Name
Hacettepe University, Faculty of Health Sciences, Dept. of Physiotherapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non-Surgical Treatment Approaches in Patients With Newly Diagnosed Lateral Epicondylitis: A Randomized Clinical Trial

We'll reach out to this number within 24 hrs