Lateral Epicondylitis Extracorporeal Shock Wave Therapy, Ultrasound Iontophoresis

NCT06189521 | Completed

• 1 other identifier: 2023-77
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis (LE) is one of the most common causes of non-traumatic elbow pain, which develops as a result of repetitive stresses due to overuse of the forearm muscles, and is also called tennis elbow.Conservative treatment options include electrotherapy, exercises, extracorporeal shock wave therapy (ESWT), steroid injections, platelet rich plasma, hyaluronic acid injections. As our knowledge this is the first study comparing the three different treatment modalities ESWT, Us and Iontophoresis on lateral epicondylitis The aim of our study; to evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments against each other.

Conditions

Lateral Epicondylitis

Outcome Measures

Primary Outcomes (2)

• Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in term of pain

  Investigators aimed to evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of pain, grip strength, functionality and quality of life in patients with lateral epicondylitis. Numerical Rating Scale (NRS) was used for the pain assessment The NRS is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  6 months from June 2023 to December 2023

• Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of disability

  Upper extremity disability levels were assessed with Quick Disabilities of the Arm, Shoulder and Hand questionnaire The Quick-DASH is an 11-item that measures upper extremity activity limitation and symptoms . Items were scored from 1: indicating no functional limitation and no symptoms, to 5: indicating functional inability and extreme symptoms. The tota lscore was computed by transforming the mean items score to a scale from 0 to 100, where 0 indicates the best upper extremity function and no symptoms. Turkish version of the test was evaluated. Quality of life was measured by notthingham health profile (NHP) questionaireQuality of life was measured by notthingham health profile (NHP). Scale, 6 dimensions, total It consists of 38 items. Sub-dimensions: Energy (3 items), pain (8 items), emotional status (9 items), sleep (5 items),social isolation (5 items) and physical activity (8 items). Its range is 0-100is scored. As the score increases health status gets worse.

  6 months from June 2023 to December 2023

Secondary Outcomes (1)

• Evaluate the efficacy of ESWT, ultrasound and iontophoresis treatments in terms of strength

  6 months from June 2023 to December 2023

Study Arms (3)

Extracorporeal shock wave group

ACTIVE COMPARATOR

Patients were randomized into three groups by a physiotherapist with sealed envelopes. The researchers were blinded to the patient's groups. The same physiotherapy program was applied to all groups. The physiotherapy program consisted of hot packs and TENS for 10 minutes and stretching and eccentric strengthening exercises were given to all groups. All exercises were done under the supervision of the same physiotherapist. In addition to the ten-day of physiotherapy program, in the first group one day for a week a total of 3 sessions of ESWT was applied at 1.8 bar, 10.0 Hz, 2000 beats (Elmed Vibrolith Ortho).

Other: Extracorporeal shock wave group

ultrasound group

ACTIVE COMPARATOR

In addition to the ten-day of physiotherapy program, in the second group, ten days of ultrasound applied at 1.5 watt/cm2, continuous mode to the painful area for 5 minutes, 5 days a week for two weeks (Chattanooga Intelect Advanced).

Other: ultrasound group

dexamethasone iontophoresis group

ACTIVE COMPARATOR

In addition to the ten-day of physiotherapy program, in the third group ten days of dexamethasone iontophoresis therapy was applied. 10 days for 10 minutes. 0,1% dexamethasone ophthalmic pomade was applied to the anodal electrode and placed on the lateral epicondyle and 0.1-0.2 milliampere/cm2 galvanic current was applied in each session (ES-522; ITO Physiotherapy and Rehabilitation).

Other: dexamethasone iontophoresis group

Interventions

Extracorporeal shock wave group OTHER

In addition to the ten-day of physiotherapy program, in the first group one day for a week a total of 3 sessions of ESWT was applied at 1.8 bar, 10.0 Hz, 2000 beats (Elmed Vibrolith Ortho).

Extracorporeal shock wave group

ultrasound group OTHER

In addition to the ten-day of physiotherapy program,In the second group, ten days of ultrasound applied at 1.5 watt/cm2 continuous mode to the painful area for 5 minutes, 5 days a week for two weeks (Chattanooga Intelect Advanced).

ultrasound group

dexamethasone iontophoresis group OTHER

In addition to the ten-day of physiotherapy program, In the third group ten days of dexamethasone iontophoresis therapy was applied. 10 days for 10 minutes. 0,1% dexamethasone ophthalmic pomade was applied to the anodal electrode and placed on the lateral epicondyle and 0.1-0.2 milliampere/cm2 galvanic current was applied in each session (ES-522; ITO Physiotherapy and Rehabilitation).

dexamethasone iontophoresis group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who had pain at the lateral epicondyle at least for four weeks,
• detection of sensitivity by palpation on the lateral epicondyle and
• having positivity in at least two of the special tests (Cozen test, Maudsley test and Mills test) were included in the study

You may not qualify if:

• Physical therapy, ESWT or local injections for lateral epicondylitis within the last 3 months,
• the presence of cervical radiculopathy, carpal tunnel syndrome, other neuropathic diseases, neurologic diseases, medial epicondylitis, systemic inflammatory diseases, --
• tenderness or swelling at the ipsilateral extremity and
• patients with fibromyalgia have been excluded.

Sponsors & Collaborators

• Pınar Özge Başaran: lead

Study Sites (1)

Hitit University

Çorum, 19040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• MUSTAFA KESER, MD

  HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 1. Participant : patients with lateral epicondylitis 2. Care provider: physiotherapist who applied the treatment (ESWT,US,iontophoresis) 3. Investigator: examine the patients and evaluates the results of the study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This single-blind prospective randomized study. Patients were randomized into three groups by a physiotherapist with sealed envelopes. The researchers were blinded to the patient's groups.

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: January 3, 2024
• Study Start: June 14, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)