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

NCT05148416 | Completed

• 1 other identifier: High Intensity laser knee
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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) .

Conditions

Myofascial Trigger Point Pain; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pressure pain threshold: The Commander Algometer (JTECH Medical, Midvale, Utah, USA) was used to measure the PPT.

  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 (2)

• Knee Function: knee injury and osteoarthritis outcome score ( KOOS )Score was used to measure the changes of functional disability.

  The first score was taken before the first day's treatment and the second score was taken after 4 weeks of treatment (1 month).

• Passive Knee range of motion ( ROM): measured by the digital electronic goniometer Halo device through a standard measuring procedure.

  The first measure was obtained before the first day's treatment and the second measure was obtained after 4 weeks of treatment (1 month) .

Study Arms (2)

Laser group

EXPERIMENTAL

1\. Experimental group (A) the laser group (n=20) which received 1. high intensity laser therapy(HILT) 2. 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.

Radiation: High intensity laser treatment; Other: knee osteoarthritis conventional exercises program

the sham group group( B)

SHAM COMPARATOR

the Sham group (n= 20) which received 1. sham HILT 2. 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.

Device: sham HILT.; Other: knee osteoarthritis conventional exercises program

Interventions

High intensity laser treatment RADIATION

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.

Also known as: 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

Laser group

sham HILT. DEVICE

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.

the sham group group( B)

knee osteoarthritis conventional exercises program OTHER

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.

Laser group; the sham group group( B)

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

Related Publications (6)

• 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.

  PMID: 24487957 RESULT

• 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.

  PMID: 28078503 RESULT

• 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.

  PMID: 27942148 RESULT

• 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.

  PMID: 32147037 RESULT

• 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.

  PMID: 21654616 RESULT

• 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.

  PMID: 22220431 RESULT

MeSH Terms

Conditions

Myofascial Pain Syndromes; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Study Officials

• Mona Ebrahim Morsy Elsayed, A. professor

  Monamorsy_niles@yahoo.com

  PRINCIPAL INVESTIGATOR

• Shimaa Taha Abou El Kasem, Lecturer

  dr.shymaelshazly@yahoo.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 8, 2021
• Study Start: February 1, 2021
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: access to trial Individual participant Data can be requested by qualified researchers .

Locations

EG (1)