Study Title:

Long-Term Benefits of Phonophoresis with Glyceryl Trinitrate (GTN) and repetitive peripheral magnetic stimulation (rPMS) for Lateral Epicondylitis: A Research Study Utilizing Musculoskeletal Ultrasound Imaging. 

Type of study

Interventional Clinical Trial

Study Design

Randomized Controlled Trial (RCT)

Objective

To Evaluate Long-Term Pain Reduction: Compare the ability of phonophoresis with GTN and rPMS to achieve sustained pain reduction in patients with lateral epicondylitis over an extended period (long-term assessment).

Duration of study

1 year

Study    population             and sample size

90

Eligibility criteria

Inclusion criteria:

a.       Age group between 30-45 years.

b.      Both males and females.

c.       Unilateral limb involvement.

d.      Pain and tenderness over the elbow at the lateral epicondyle area including the region 5cm proximal and 5cm distal to it.

e.       Patient diagnosed by medical practitioner as LE.

Exclusion criteria:         

a)      Cervical radiculopathy / Myelopathy

b)      Subjects with any other neurological disorders, tumor

c)      Subjects with any other musculoskeletal disorders at or around the elbow such as recent fractures, subluxation or dislocation, blunt trauma, ligament injury (ruled out by Valgus and Varus test.

d)        Patient is under blood thinner medication

Study Procedures

1.       Eligibility Assessment: Initially, potential participants who meet the inclusion criteria and do not violate any exclusion criteria will be identified from the pool of individuals with lateral epicondylitis.

2.       Informed Consent: Prior to randomization, all eligible participants will be provided with detailed information about the study, its objectives, the treatment modalities involved (phonophoresis with GTN and repetitive peripheral magnetic stimulation - rPMS), and potential risks and benefits. Informed consent will be obtained from each participant, ensuring they are willing to participate in the study.

3.       Randomization Procedure: The randomization process will be conducted using a computer-generated random sequence or a randomization table. This process will be overseen by an independent researcher not directly involved in the study. Participants will be assigned a unique study identification number.

4.       Treatment Groups: Participants will be randomly allocated to one of the two treatment groups:

•         Group A: Phonophoresis with GTN

•         Group B: Repetitive Peripheral Magnetic Stimulation (rPMS)

5.       Blinding: Both primary and secondary investigators or blinded.

6.       Treatment Implementation: Following randomization, participants will undergo the assigned treatment modality. For Group A -Patients under topical nitroglycerin treatment receive 1 g of 2% nitroglycerin ointment (containing 20 mg nitroglycerin) 20 minutes before phonophoresis. Then, they receive pulsatile ultrasound with a 2:1 frequency of 0.8 MHz and intensity of 1.5 W/CM for 10 minutes in sessions every other day ⁽³⁷⁾. For Group B - The stimulation coil was fixed with a coil holder, and the coil was in contact with the skin during stimulation. The stimulus protocol used a frequency of 10 Hz and 10 pulses per train (i.e., train duration of 1 s) and an interval of 5 sec. One-hundred trains were applied, leading to a total treatment time of 600 s (10 min). The intensity was 10% above supra threshold stimulation, which was determined by observing visible hand muscle contraction. Five sessions of magnetic stimulation were performed over a period of 2 weeks, with three sessions in the first week and two sessions in the second week ⁽⁴³⁾. For both groups will receive eccentric exercise followed by the respective treatments.  The treatments will be administered by qualified healthcare professionals to ensure consistency.

7.       Follow-up: Participants will be regularly assessed and followed up according before the treatment, at 4th week and 12th week. The outcomes are recorded for both treatment groups. The outcomes are 1. VAS. 2. GRIP STRENGTH. 3. ULTRASOUND FINDINGS like detecting hypoechogenicity of the common extensor origin in elbows, Tendon thickness, Bone changes on the lateral epicondyle, Neovascularity, cortical irregularities, 4. GROC scale.