Comparison of Different Physical Therapy Modalities in Lateral Epicondylitis

NCT ID: NCT06267027

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2023-12-15

Brief Summary

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

Detailed Description

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In this study, it was aimed to compare the effects of exercise therapy, kinesiology taping and high-intensity laser therapy on pain, muscle strength and functional status in patients with LE. Patients who applied to the outpatient clinic of the Sadi Konuk Training and Research Hospital Physical Medicine and Rehabilitation clinic due to elbow pain and were diagnosed with unilateral LE will be included. The study was planned as randomized, prospective and controlled. Patients will be randomized using a random (randomized) numbers table and distributed equally to the groups. Only exercise will be applied to the first group, high-intensity laser therapy and exercise to the second group, and kinesiology taping and exercise treatments to the third group. Sixty people will be included in the study. Patients will be evaluated before treatment, immediately after treatment, and at 4 weeks post-treatment. In the evaluation of the patients, the severity of pain during rest and activity measured with the Visual Analogue Scale (VAS), Quick Disability of the Arm, Shoulder and Hand (QuickDASH), Patient Based Lateral Epicondylitis Evaluation Test - Patient Rated Tennis Elbow Evaluation (PRTEE), Jamar' Hand grip strength will be evaluated with the hand dynamometer.

Conditions

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Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RANDOMIZED CONTROLLED STUDY
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Exercise

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

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

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.

Kinesiotaping and exercise

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

Kinesiotaping

Intervention Type DEVICE

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.

High intensity laser therapy and exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

High intensity laser therapy

Intervention Type DEVICE

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.

Interventions

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Exercise

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.

Intervention Type BEHAVIORAL

Kinesiotaping

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.

Intervention Type DEVICE

High intensity laser therapy

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Volunteer patients diagnosed with unilateral lateral epicondylitis

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sibel Caglar Okur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sibel CAGLAR

Role: PRINCIPAL_INVESTIGATOR

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Hasan YUKSEL

Role: STUDY_CHAIR

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Locations

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BakirkoySadiKonuk

Bakırköy, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29921250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32637921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16059855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14734079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9735592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22588743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10192633 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19707766 (View on PubMed)

Other Identifiers

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2022/125

Identifier Type: -

Identifier Source: org_study_id

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