- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06432842
Knee Osteoarthritis and Rehabilitation
Knee Osteoarthritis and Lazer Therapy
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.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sevde Nur AKTAŞ, MsC
- Phone Number: 05438760764
- Email: sevdenur9880@icloud.com
Study Contact Backup
- Name: Metehan Yana, PhD
- Phone Number: 05072665522
- Email: metehanyana@karabuk.edu.tr
Study Locations
-
-
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Karabük, Turkey, 78000
- Recruiting
- Karabuk University
-
Contact:
- Metehan YANA Phd
- Phone Number: 05072665522
- Email: metehanyana@karabuk.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional treatment
Within the scope of conventional treatment, individuals were given Transcutaneous Electrical Nerve Stimulation (TENS), infrared, US and exercise therapy.
|
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.
Other Names:
|
|
Active Comparator: Laser treatment
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain severity
Time Frame: Baseline and 2 weeks post-intervention
|
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
Time Frame: 2 weeks post-intervention
|
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.
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2 weeks post-intervention
|
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MUSCLE STRENGTH
Time Frame: Baseline and 2 weeks post-intervention
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Hip, knee flexor and extensor muscle strengths will be measured using a manual dynamometer.
|
Baseline and 2 weeks post-intervention
|
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BALANCE
Time Frame: Baseline and 2 weeks post-intervention
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Dynamic balance of individuals through the Modified Star Balance Test will be evaluated.
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Baseline and 2 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Karabuk-80
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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