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

Primary Purpose

Myofascial Trigger Point Pain, Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High intensity laser treatment
sham HILT.
knee osteoarthritis conventional exercises program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Laser group

the sham group group( B)

Arm Description

1. Experimental group (A) the laser group (n=20) which received high intensity laser therapy(HILT) 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.

the Sham group (n= 20) which received sham HILT knee osteoarthritis conventional exercises program previously mentioned . 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 .

Full Information

First Posted
November 10, 2021
Last Updated
November 24, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05148416
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 13, 2021 (Actual)
Study Completion Date
April 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser group
Arm Type
Experimental
Arm Description
1. Experimental group (A) the laser group (n=20) which received high intensity laser therapy(HILT) 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.
Arm Title
the sham group group( B)
Arm Type
Sham Comparator
Arm Description
the Sham group (n= 20) which received sham HILT knee osteoarthritis conventional exercises program previously mentioned . 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.
Intervention Type
Radiation
Intervention Name(s)
High intensity laser treatment
Other Intervention Name(s)
Zimmer High power laser (with 810 and 980 nm and maximal output power of pmax 7 w cw , made in Germany) with serial number : IEC 60825-1:2007
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham HILT.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
knee osteoarthritis conventional exercises program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity: change of serum cortisol level was used in many research as pain blood biomarker
Description
For measuring serum cortisol level, Each patient was drawn two 5 ml blood samples from cubital vein two times.
Time Frame
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 Outcome Measure Information:
Title
Pressure pain threshold: The Commander Algometer (JTECH Medical, Midvale, Utah, USA) was used to measure the PPT.
Description
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 .
Time Frame
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 Pre-specified Outcome Measures:
Title
Knee Function: knee injury and osteoarthritis outcome score ( KOOS )Score was used to measure the changes of functional disability.
Description
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.
Time Frame
The first score was taken before the first day's treatment and the second score was taken after 4 weeks of treatment (1 month).
Title
Passive Knee range of motion ( ROM): measured by the digital electronic goniometer Halo device through a standard measuring procedure.
Description
the Electro Goniometer device is considered as standard, simple, portable, valid and reliable device for measuring joints range of motion
Time Frame
The first measure was obtained before the first day's treatment and the second measure was obtained after 4 weeks of treatment (1 month) .

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Ebrahim Morsy Elsayed, A. professor
Organizational Affiliation
Monamorsy_niles@yahoo.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shimaa Taha Abou El Kasem, Lecturer
Organizational Affiliation
dr.shymaelshazly@yahoo.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data obtained through this study may be provided to qualified researchers with academic interest in myofascial trigger points pain and application of high intensity laser therapy
IPD Sharing Time Frame
data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 2 months.
IPD Sharing Access Criteria
access to trial Individual participant Data can be requested by qualified researchers .
Citations:
PubMed Identifier
24487957
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.
Results Reference
result
PubMed Identifier
28078503
Citation
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. Erratum In: Lasers Med Sci. 2020 Oct;35(8):1875.
Results Reference
result
PubMed Identifier
27942148
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. doi: 10.1589/jpts.28.3197. Epub 2016 Nov 29.
Results Reference
result
PubMed Identifier
32147037
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. 2020 Mar;49:102295. doi: 10.1016/j.ctim.2019.102295. Epub 2020 Jan 3.
Results Reference
result
PubMed Identifier
21654616
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 Rehabil Med. 2011 Sep;47(3):367-73. Epub 2011 Jun 8.
Results Reference
result
PubMed Identifier
22220431
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.
Results Reference
result

Learn more about this trial

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

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