Knee Osteoarthritis and Rehabilitation

NCT06432842 | Recruiting

• 1 other identifier: Karabuk-80
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Intra-articular injection; PRP (Platelet-rich plasma); Physiotherapy; Laser Treatment

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• MUSCLE STRENGTH

  Hip, knee flexor and extensor muscle strengths will be measured using a manual dynamometer.

  Baseline and 2 weeks post-intervention

• BALANCE

  Dynamic balance of individuals through the Modified Star Balance Test will be evaluated.

  Baseline and 2 weeks post-intervention

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Within the scope of conventional treatment, individuals were given Transcutaneous Electrical Nerve Stimulation (TENS), infrared, US and exercise therapy.

Other: Laser Treatment

Laser treatment

ACTIVE COMPARATOR

In the study group, low-dose laser treatment was applied in addition to conventional treatment. 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.

Other: Laser Treatment

Interventions

Laser Treatment OTHER

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.

Also known as: conventional treatment

Conventional treatment; Laser treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead

Study Sites (1)

Karabük University

Karabük, 78000, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• 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.

  PMID: 15593258 BACKGROUND

• 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.

  PMID: 26405113 BACKGROUND

• 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.

  PMID: 11846032 BACKGROUND

• 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.

  PMID: 21683600 BACKGROUND

• 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.

  PMID: 21560257 BACKGROUND

• 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.

  PMID: 13610976 BACKGROUND

• 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.

  PMID: 24462672 BACKGROUND

• 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.

  PMID: 18081143 BACKGROUND

• 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.

  PMID: 25624776 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Sevde Nur AKTAŞ, MsC

CONTACT

05438760764; sevdenur9880@icloud.com

Metehan YANA, PhD

CONTACT

05072665522; metehanyana@karabuk.edu.tr

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: Director

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: May 29, 2024
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 30, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)