Knee Osteoarthritis and Rehabilitation

Knee Osteoarthritis Clinical Trial

Official title:

Knee Osteoarthritis and Lazer Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432842
• Other study ID #: Karabuk-80
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Karabuk University
• Contact: Sevde Nur AKTAS, MsC
• Phone: 05438760764
• Email: sevdenur9880[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Osteoarthritis (OA) is a chronic degenerative disease of articular cartilage that causes hypertrophic changes in bone. OA is a non-inflammatory progressive musculoskeletal disease and is one of the most common degenerative diseases in the general population. OA is characterized by progressive cartilage destruction in load-bearing joints, subchondral sclerosis, osteophyte formation, and some biochemical and morphological changes in the synovial membrane and joint capsule. Common symptoms of knee osteoarthritis are; Knee pain that increases with activity, limitation of normal joint movement of the knee, edema, and knee pain that begins with prolonged sitting.

The aim of this study is to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received PRP.

Description:

OA is a non-inflammatory progressive musculoskeletal disease; damage begins in the cartilage and causes changes in the joint structure over time. Although intra-articular injection approaches have been frequently used in the treatment of OA recently, intra-articular injections known as Platelet Rich Plasma (PRP) have also started to be used frequently. Today, the areas of use of laser therapy have increased. When the laser beam is applied, it is absorbed by the tissue or scattered back. Laser has photochemical, thermal and ionizing effects on tissues. Laser has an analgesic effect by increasing endorphin synthesis and reducing C nerve fiber activation. Laser indirectly increases microcirculation by increasing temperature in the tissue. Although there are various studies on treatment options for OA in the literature, no studies have been found to investigate the effectiveness of laser treatment applied in addition to conventional treatment after PRP. In our study, we aimed to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received PRP.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Volunteering to participate in the study

• Being diagnosed with knee OA by a specialist physician

• Having had PRP injection applied by a specialist physician

• Having unilateral knee OA

• Being stage I-stage III in the Kellgren-Lawrence OA classification

• Being between the ages of 18-65

Exclusion Criteria:

• Being stage IV in the Kellgren-Lawrence OA classification

• BMI being more than 40 kg/m2

• Patients who do not cooperate well

• Patients with neurological or neuromuscular disease

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Laser Treatment
In the study group, low-dose laser treatment was applied in addition to conventional treatment. Chattanoga Group Therapeutic Laser device was used for laser treatment. Laser treatment was applied to 8 sensitive points around the knee for 1 minute, for a total of 8 minutes. Laser treatment was applied continuously, with a wavelength of 830nm and a power of 6J.

Locations

Country	Name	City	State
Turkey	Karabük University	Karabük

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Chapple CM, Nicholson H, Baxter GD, Abbott JH. Patient characteristics that predict progression of knee osteoarthritis: a systematic review of prognostic studies. Arthritis Care Res (Hoboken). 2011 Aug;63(8):1115-25. doi: 10.1002/acr.20492. — View Citation

Citaker S, Gunduz AG, Guclu MB, Nazliel B, Irkec C, Kaya D. Relationship between foot sensation and standing balance in patients with multiple sclerosis. Gait Posture. 2011 Jun;34(2):275-8. doi: 10.1016/j.gaitpost.2011.05.015. Epub 2011 Jun 16. — View Citation

Fitzgerald GK, Piva SR, Irrgang JJ. Reports of joint instability in knee osteoarthritis: its prevalence and relationship to physical function. Arthritis Rheum. 2004 Dec 15;51(6):941-6. doi: 10.1002/art.20825. — View Citation

Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015 Dec;49(24):1554-7. doi: 10.1136/bjsports-2015-095424. Epub 2015 Sep 24. — View Citation

Hagiwara S, Iwasaka H, Okuda K, Noguchi T. GaAlAs (830 nm) low-level laser enhances peripheral endogenous opioid analgesia in rats. Lasers Surg Med. 2007 Dec;39(10):797-802. doi: 10.1002/lsm.20583. — View Citation

Hedbom E, Hauselmann HJ. Molecular aspects of pathogenesis in osteoarthritis: the role of inflammation. Cell Mol Life Sci. 2002 Jan;59(1):45-53. doi: 10.1007/s00018-002-8404-z. — View Citation

McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24. — View Citation

MILLER JH, WHITE J, NORTON TH. The value of intra-articular injections in osteoarthritis of the knee. J Bone Joint Surg Br. 1958 Nov;40-B(4):636-43. doi: 10.1302/0301-620X.40B4.636. No abstract available. — View Citation

Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain severity	Knee pain severity will measured using the Visual Analog Scale. Scale (VAS). The VAS is a 10 cm scale, where 0 represented no pain and 10 represented unbearable pain. Pain intensity was recorded by measuring the point marked between 0- 10.	Baseline and 2 weeks post-intervention
Primary	Function	WOMAC will be used to evaluate the degree of physical function. This scale has a total of 24 questions and 5 answers between 0-4 for each question. A high score indicates that the symptoms are severe.	2 weeks post-intervention
Primary	MUSCLE STRENGTH	Hip, knee flexor and extensor muscle strengths will be measured using a manual dynamometer.	Baseline and 2 weeks post-intervention
Primary	BALANCE	Dynamic balance of individuals through the Modified Star Balance Test will be evaluated.	Baseline and 2 weeks post-intervention