Clinical trial NCT05148416: Effect of High Intensity Laser in Treatment of Myofascial Trigger Points in Symptomatic Knee Osteoarthritis
Official title: Effect of High Intensity Laser in Treatment of Myofascial Trigger Points in Symptomatic Knee Osteoarthritis : A Randomized Single-blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Trigger Point Pain
Knee Osteoarthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to investigate the effect of High intensity laser therapy( HILT) on pressure pain threshold, serum cortisol level, passive knee range of motion, and changes of functional disability in patients with active myofascial trigger points(MTrPs) pain associated wit knee osteoarthritis(OA) .

Detailed description: Osteoarthritis (OA) is the most common cause of musculoskeletal pain and disability. It is a chronic degenerative disorder of multifactorial etiology, including acute and/or chronic insults from normal wear and tear, age, obesity and joint injury. The true pathogenesis remains poorly understood. OA is characterized by a degradation of the articular cartilage, resulting in an alteration of its biomechanical properties, which in turn contributes to a focal loss of articular cartilage, loss of joint space, osteophyte formation, focal areas of synovitis, per articular bone remodeling and sub chondral cysts , OA presents with symptoms such as joint pain, stiffness, motion limitations, motor and sensory dysfunction and functional impairments, thus, preventing patients from participating in regular physical activities , The common sites of OA appear on the knees, hands, and hips, whereas knee OA is the most common .

Pain is the most frequent complaint for patients with knee OA to seek medical attention. If left untreated, pain and stiffness can result in a loss of physical function and independence during daily activities. The presence of OA-related knee pain has also been associated with increased risks of physical disability in the community .

Many studies have revealed a discrepancy between patients' reports of pain and their radiographic findings , a plausible option is that the pain originates from the myofascial trigger points (MTrPs) in the surrounding muscles (myofascial pain) and cannot be visualized by imaging.

The term myofascial pain is defined as "the complex of sensory, motor, and autonomic symptoms caused by MTrPs , MTrPs, hyperirritable spots found in the skeletal muscles, are associated with hypersensitive palpable nodules located in a taut band. The spots are painful on compression and may produce characteristic referred pain, referred tenderness, motor dysfunction, and autonomic phenomena.

All studies found a high prevalence of myofascial pain in knee OA patients . study of OA patients, MTrPs were found in all participants, especially in the medial head of the gastrocnemius (92%) and the vastus medialis muscle (67%).

The treatment of MPS includes:

In activation of trigger points, relaxation of taut bands, and breaking the pain-spasm-ischemia-pain cycle. The most widely used treatment methods for MPS are education, exercise, non steroidal anti-inflammatory drugs (NSAIDs), superficial and deep heat, electrotherapy, laser therapy, and local injections.

Laser treatment :

Is non- invasive and painless and can be easily administered in therapy units for a wide range of conditions .

Recently, high-intensity laser therapy (HILT) was introduced to the field of physical therapy. The advantage of HILT over Low level laser therapy(LLLT) is that HILT is able to reach and stimulate the large and/or deep joints that are difficult to reach in LLLT .

The use of HILT has been proven to significantly reduce pain . Previous studies describe the anti-inflammatory, anti-edematous, and analgesic effects of HILT, thus justifying its use in the therapy of pain .

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as II degree bilateral knee OA having active MTrP in vastus medialis and medial head of gastrocnemius muscles and over the calf muscle .
* The patients from both gender aged were ranged from 35 to 55 years.

Exclusion Criteria:

* Reactive synovitis, corticosteroids or hyaluronic acid application during the last six months
* Not indicated and no history of knee joint arthroplastic surgery.
* Malignant tumors and chronic infection.
* Not diagnosed with cushing's syndrome.

Primary outcomes:
measure: Pain Intensity: change of serum cortisol level was used in many research as pain blood biomarker
timeFrame: The first sample was obtained before the first day of treatment and the second sample was obtained after 4 weeks (1 month) of treatment
Secondary outcomes:
measure: Pressure pain threshold: The Commander Algometer (JTECH Medical, Midvale, Utah, USA) was used to measure the PPT.
timeFrame: The first measure was obtained before the first day's treatment and the second measure was obtained after 4 weeks of treatment (1 month).
Other outcomes:
measure: Knee Function: knee injury and osteoarthritis outcome score ( KOOS )Score was used to measure the changes of functional disability.
timeFrame: The first score was taken before the first day's treatment and the second score was taken after 4 weeks of treatment (1 month).
measure: Passive Knee range of motion ( ROM): measured by the digital electronic goniometer Halo device through a standard measuring procedure.
timeFrame: The first measure was obtained before the first day's treatment and the second measure was obtained after 4 weeks of treatment (1 month) .
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Monamorsy_niles@yahoo.com
name: Mona Ebrahim Morsy Elsayed, A. professor
role: PRINCIPAL_INVESTIGATOR
affiliation: dr.shymaelshazly@yahoo.com
name: Shimaa Taha Abou El Kasem, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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