NCT06267027

Brief Summary

Comparison of the effects of kinesiotaping and high intensity laser therapy in patients with lateral epicondylitis: a randomized controlled study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

February 9, 2024

Last Update Submit

February 16, 2024

Conditions

Keywords

Lateral epicondylitisKinesiotapingHigh intensity laser

Outcome Measures

Primary Outcomes (1)

  • Patient Rated Tennis Elbow Evaluation (PRTEE)

    It consists of pain and function subscales that assess the level of pain in the affected arm in the last 1 week and the degree of difficulty experienced during specific and daily activities. The pain assessment consists of 5 questions and the functional assessment consists of 10 questions, totaling 15 questions. The questions are evaluated with a 10-point Likert scale, as in the VAS, with numbers written side by side from 0 to 10. It is calculated by averaging the pain score and functional score. The total score ranges from 0-100, with a higher score indicating an increase in pain and functional loss. Validation of turkish version is available.

    Initial, Week 3, Week 7

Secondary Outcomes (3)

  • Visual Analogue Scale (VAS)

    Initial, Week 3, Week 7

  • Quick Disabilities of the Arm, Shoulder and Hand (qDASH)

    Initial, Week 3, Week 7

  • Jamar's handheld dynamometer

    Initial, Week 3, Week 7

Study Arms (3)

Exercise

ACTIVE COMPARATOR

All study groups will be trained on a home exercise program that includes stretching and eccentric strengthening exercises.

Behavioral: Exercise

Kinesiotaping and exercise

EXPERIMENTAL

This study groups will be trained on a home exercise program and kinesiotaping. Kinesiotaping, muscle inhibition and fascia correction techniques will be applied in the forearm as described by Kase et al.

Behavioral: ExerciseDevice: Kinesiotaping

High intensity laser therapy and exercise

EXPERIMENTAL

This study groups will be trained on a home exercise program and high intensity laser therapy.

Behavioral: ExerciseDevice: High intensity laser therapy

Interventions

ExerciseBEHAVIORAL

The aim of exercise therapy is to stretch and strengthen the wrist extensor and flexor muscles. All study groups were given a home exercise program including stretching and eccentric strengthening exercises. The patient was instructed to start with stretching, and the patient was informed to stretch for 30s by flexing the wrist with the other hand while the shoulder was flexed 90 degrees, the elbow was in extension and the forearm was pronated. When stretching exercises could be performed painlessly, the patient was instructed to move on to strengthening exercises. Eccentric strengthening exercises for wrist extensors and flexors were explained with a support under the forearm and each patient was given a written program supported with visuals. It was emphasized that the exercises should be performed within the pain limit and patients were told to stop if they had severe pain. The exercise program was told to be performed 2 times a day, in 3 sets, 10 repetitions.

ExerciseHigh intensity laser therapy and exerciseKinesiotaping and exercise

Area where the tape would be applied was clean and dry. If there is excessive hair in the application area, patients were asked to shave this area. It was explained that cream and similar substances should not be used. Muscle inhibition technique and fascia correction technique were used as the application technique. An X strip of approximately 25 cm and a Y strip of 10 cm in length are prepared as long as the distance between the lateral epicondyle and the wrist. The short arms of the X strip are adhered to the dorsal side of the hand without stretching and the crossed part of the strip is placed on the wrist with maximal stretching. The long arms of the X strip are adhered along the extensor carpi ulnaris and extensor carpi radialis to the lateral epicondyle without stretching. The Y strip was applied using the fascia correction method. The tails of the Y band were applied using an oscillating motion. The taping procedure was applied 2 times a week for 3 weeks for a total of 6 times.

Kinesiotaping and exercise

The elbow area was marked and then the epicondylitis protocol was selected. The epicondylitis protocol consists of 3 phases. Phase 1 and 2 consist of analgesic treatment and phase 3 consists of anti-inflammatory treatment. In phase 1 and phase 2 treatment protocol, 8 W was applied to a circular area with a radius of 1.0 cm for 3 min. In Phase 3 protocol, a dose of 80 J/cm2 at 8 W power was applied and the patient's treatment was completed.

High intensity laser therapy and exercise

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Volunteer patients diagnosed with unilateral lateral epicondylitis

You may not qualify if:

  • Those who have previously received treatment for lateral epicondylitis
  • Current extremity fracture or surgical history
  • Presence of congenital deformity in the upper extremity
  • Cervical radiculopathy, myelopathy, plexopathy, entrapment neuropathies
  • Presence of neurological disease such as stroke, Parkinson's, multiple sclerosis, epilepsy and muscle disease
  • Presence of skin lesion, infection and open wound on the affected extremity
  • Presence of metal implant in the affected extremity
  • Rheumatological disease
  • Pregnancy
  • Pacemaker presence
  • Malignancy
  • Cognitive dysfunction
  • Presence of psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BakirkoySadiKonuk

Bakırköy, Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (8)

  • Cho YT, Hsu WY, Lin LF, Lin YN. Kinesio taping reduces elbow pain during resisted wrist extension in patients with chronic lateral epicondylitis: a randomized, double-blinded, cross-over study. BMC Musculoskelet Disord. 2018 Jun 19;19(1):193. doi: 10.1186/s12891-018-2118-3.

    PMID: 29921250BACKGROUND
  • Kaydok E, Ordahan B, Solum S, Karahan AY. Short-term Efficacy Comparison of High-intensity and Low-intensity Laser Therapy in the Treatment of Lateral Epicondylitis: A Randomized Double-blind Clinical Study. Arch Rheumatol. 2019 Apr 24;35(1):60-67. doi: 10.5606/ArchRheumatol.2020.7347. eCollection 2020 Mar.

    PMID: 32637921BACKGROUND
  • Shechtman O, Gestewitz L, Kimble C. Reliability and validity of the DynEx dynamometer. J Hand Ther. 2005 Jul-Sep;18(3):339-47. doi: 10.1197/j.jht.2005.04.002.

    PMID: 16059855BACKGROUND
  • Haidar SG, Kumar D, Bassi RS, Deshmukh SC. Average versus maximum grip strength: which is more consistent? J Hand Surg Br. 2004 Feb;29(1):82-4. doi: 10.1016/j.jhsb.2003.09.012.

    PMID: 14734079BACKGROUND
  • Halpern CA, Fernandez JE. The effect of wrist and arm postures on peak pinch strength. J Hum Ergol (Tokyo). 1996 Dec;25(2):115-30.

    PMID: 9735592BACKGROUND
  • Angst F, Schwyzer HK, Aeschlimann A, Simmen BR, Goldhahn J. Measures of adult shoulder function: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) and its short version (QuickDASH), Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form, Constant (Murley) Score (CS), Simple Shoulder Test (SST), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ), and Western Ontario Shoulder Instability Index (WOSI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S174-88. doi: 10.1002/acr.20630. No abstract available.

    PMID: 22588743BACKGROUND
  • Overend TJ, Wuori-Fearn JL, Kramer JF, MacDermid JC. Reliability of a patient-rated forearm evaluation questionnaire for patients with lateral epicondylitis. J Hand Ther. 1999 Jan-Mar;12(1):31-7. doi: 10.1016/s0894-1130(99)80031-3.

    PMID: 10192633BACKGROUND
  • Altan L, Ercan I, Konur S. Reliability and validity of Turkish version of the patient rated tennis elbow evaluation. Rheumatol Int. 2010 Jun;30(8):1049-54. doi: 10.1007/s00296-009-1101-6. Epub 2009 Aug 26.

    PMID: 19707766BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Exercise

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sibel CAGLAR

    Bakırkoy Dr. Sadi Konuk Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Hasan YUKSEL

    Bakırkoy Dr. Sadi Konuk Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RANDOMIZED CONTROLLED STUDY
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 20, 2024

Study Start

February 7, 2023

Primary Completion

September 15, 2023

Study Completion

December 15, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations