Lateral Epicondylitis Extracorporeal Shock Wave Therapy, Ultrasound Iontophoresis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

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.
    

Detailed description: 
      This is a prospective randomized single blind clinical study. A total of 78 patients age
      between 18-65 who were diagnosed with lateral epicondylitis between June 2023 and December
      2023 were included in our study. The study was approved by the University Ethics Committee
      (2023-77) and written informed consent was obtained from all the patients. The study was
      carried out in accordance with the principles of the Declaration of Helsinki.

      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.
      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 fibromyalgia have been excluded.

      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 transcutaneus electrical
      nerve stimulation (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).

      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).

      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).

      Evaluations were conducted at before treatment and one month after treatment in all groups by
      the same researchers who were blind in treatment groups.

      The clinical and demographic data of the patients were recorded. 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). It has been shown that a composite scoring system including best,
      worse, and current level of pain over the last 24 hours was sufficient to pick up changes in
      pain intensity with maximal reliability(Jensen et al 1999).

      The hand grip strength (HGS) was measured with a Jamar hydraulic hand dynamometer (Saehan,
      SH5001)) in kilograms. This instrument has a closed hydraulic system that measures the amount
      of grip strength produced by an isometric contraction applied to the handles and the grip
      strength of the hand is registered in kilograms Hand and pinch strength were measured by
      hydraulic pinch gauge (Saehan, SH5005) This instrument has also a closed hydraulic system
      that measures the amount of grip strength produced by an isometric contraction applied to the
      handles and the pinc strength of the hand is registered in kilograms Upper extremity
      disability levels were assessed with Quick Disabilities of the Arm, Shoulder and Hand
      (QuickDASH). 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 totalscore 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). 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. The validity and
      reliability of the Turkish version of the test was evaluated.

      In the study power analysis performed by examining the related studies in the literature and
      the sample size required to obtain a significant result was calculated as totally 76
      patients, 26 patients in each group (G-Power v3.1.9.7). All data were analysed using the
      Windows 15.0 Statistical Package for Social Sciences (SPSS Inc., Chicago, IL, USA). Fisher
      Exact and Chi-square tests were used to determine the differences between proportions or
      relationships between categorical variables. Paired Sample T-test was used to compare
      measurements at multiple different times in the same individuals. The Student's t-test was
      used when the data were normally distributed, the Wilcoxon signed rank test was used for
      intragroup comparisons and the Mann Whitney U test was used for intergroup comparisons when
      the data were not normally distributed.
    

Intervention name(s): Extracorporeal shock wave group; ultrasound group; dexamethasone iontophoresis group
Intervention type(s): Other; Other; Other
Intervention description(s): 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).; 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).; 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).
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment