Effect of High Intensity Laser in Treatment of Myofascial Trigger Points in Symptomatic Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Effect of High Intensity Laser in Treatment of Myofascial Trigger Points in Symptomatic Knee Osteoarthritis : A Randomized Single-blinded Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148416
• Other study ID #: High Intensity laser knee
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: April 13, 2021

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 13, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Radiation:
• High intensity laser treatment
20 patients received high power laser therapy . Zimmer High power laser applied by laser probe perpendicular to and in slight contact with the skin around knee joint , the total energy was delivered to the patient during one session was 1060 j in 3 phases of treatment.

Device:
• sham HILT.
20 patients received placebo laser " sham laser . The same treatment protocol of HILT was given to the sham group, but the laser instrument was switched off during applications. All laser applications were performed by the same physiotherapist.

Other:
• knee osteoarthritis conventional exercises program
knee osteoarthritis conventional exercises program in form of stretching exercises for both vastus medialis and gastrocnemius muscles , ROM exercises for knee flexion and extension , and isometric strengthening exercise of previously mentioned muscles . all interventions were done under the supervision of physiotherapist for 30 minutes once a day for 3 days per week during a period of 4 weeks.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Alayat MSM, Aly THA, Elsayed AEM, Fadil ASM. Efficacy of pulsed Nd:YAG laser in the treatment of patients with knee osteoarthritis: a randomized controlled trial. Lasers Med Sci. 2017 Apr;32(3):503-511. doi: 10.1007/s10103-017-2141-x. Epub 2017 Jan 11. Er — View Citation

Fiore P, Panza F, Cassatella G, Russo A, Frisardi V, Solfrizzi V, Ranieri M, Di Teo L, Santamato A. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of low back pain: a randomized controlled trial. Eur J Phys R — View Citation

Kheshie AR, Alayat MS, Ali MM. High-intensity versus low-level laser therapy in the treatment of patients with knee osteoarthritis: a randomized controlled trial. Lasers Med Sci. 2014 Jul;29(4):1371-6. doi: 10.1007/s10103-014-1529-0. Epub 2014 Feb 1. — View Citation

Kim GJ, Choi J, Lee S, Jeon C, Lee K. The effects of high intensity laser therapy on pain and function in patients with knee osteoarthritis. J Phys Ther Sci. 2016 Nov;28(11):3197-3199. Epub 2016 Nov 29. — View Citation

Stiglic-Rogoznica N, Stamenkovic D, Frlan-Vrgoc L, Avancini-Dobrovic V, Vrbanic TS. Analgesic effect of high intensity laser therapy in knee osteoarthritis. Coll Antropol. 2011 Sep;35 Suppl 2:183-5. — View Citation

Yilmaz M, Tarakci D, Tarakci E. Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation on cervical pain associated with cervical disc herniation: A randomized trial. Complement Ther Med. 202 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee Function: knee injury and osteoarthritis outcome score ( KOOS )Score was used to measure the changes of functional disability.	KOOS is a valid, and reliable questionnaire used for assessing the functional status and quality of life (QoL) of patients with any type of knee injuries and osteoarthritis .It assesses five outcomes: pain , symptoms , activities of daily living , sport and recreation function and knee related quality of life . It is a 42-itemself-reported, joint-specific questionnaire which comprises five subscales: Pain (nine items), Symptoms (seven items), Activities of daily life (ADL) (17 items), Function in Sport and Recreation (Sport/Rec) (five items) and Knee-related quality of life (QoL) (four items). Each item is scored from 0 (no problems) to 4 (extreme problems). For each subscale, the score was normalized to a 0-100 scale with higher scores indicating better status.	The first score was taken before the first day's treatment and the second score was taken after 4 weeks of treatment (1 month).
Other	Passive Knee range of motion ( ROM): measured by the digital electronic goniometer Halo device through a standard measuring procedure.	the Electro Goniometer device is considered as standard, simple, portable, valid and reliable device for measuring joints range of motion	The first measure was obtained before the first day's treatment and the second measure was obtained after 4 weeks of treatment (1 month) .
Primary	Pain Intensity: change of serum cortisol level was used in many research as pain blood biomarker	For measuring serum cortisol level, Each patient was drawn two 5 ml blood samples from cubital vein two times.	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	Pressure pain threshold: The Commander Algometer (JTECH Medical, Midvale, Utah, USA) was used to measure the PPT.	It's a hand-held tool that uses manual pressure to test pain sensitivity in deeper structures. It's a valid tool that's been widely used. The algometer's tip was positioned on the trigger area, and pressure was increased at a rate of 1 kg per second.; When the patient expressed discomfort and verified it verbally, the pressure measurement was recorded as kg/cm2, the technique was done three times at 60-second intervals and the average was taken .	The first measure was obtained before the first day's treatment and the second measure was obtained after 4 weeks of treatment (1 month).