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.

Read the detailed 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.

Conditions: Knee Osteoarthritis
Being tested: Laser Treatment
Keywords: Osteoarthritis, Intra-articular injection, PRP (Platelet-rich plasma), Physiotherapy, Laser Treatment
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laser TreatmentOther
Also called conventional 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.

Study groups in NCT06432842
Study group	Role	What they receive
Conventional treatment	Active comparator	Within the scope of conventional treatment, individuals were given Transcutaneous Electrical Nerve Stimulation (TENS), infrared, US and exercise therapy. Receives: 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. Receives: Other: Laser Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 2 weeks post-intervention
MUSCLE STRENGTH
Hip, knee flexor and extensor muscle strengths will be measured using a manual dynamometer.
Measured: Baseline and 2 weeks post-intervention
BALANCE
Dynamic balance of individuals through the Modified Star Balance Test will be evaluated.
Measured: Baseline and 2 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202330 Jun 2024

First posted29 May 2024
Study start1 Jul 2023
Primary completion1 Dec 2023
Study completion30 Jun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06432842
Sponsor's protocol ID: Karabuk-80
Status last verified: May 2024
First submitted: 25 Mar 2024
Last updated: 29 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 15593258
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.
PubMed 26405113
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.
PubMed 11846032
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.
PubMed 21683600
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.
PubMed 21560257
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.
PubMed 13610976
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.
PubMed 24462672
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.
PubMed 18081143
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.
PubMed 25624776

Want to know more?

Sevde Nur AKTAŞ, MsC

05438760764

sevdenur9880@icloud.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Knee Osteoarthritis and Lazer Therapy
ClinicalTrials.gov ID: NCT06432842
Acronym / sponsor ID: Karabuk-80
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis, Intra-articular injection, PRP (Platelet-rich plasma), Physiotherapy, Laser Treatment
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Karabuk UniversityUniversity, hospital or other
Study start: 1 Jul 2023 (actual)
Primary completion: 1 Dec 2023 (actual)
Study completion: 30 Jun 2024 (estimated)
First posted: 29 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Conventional treatment	Active comparator	Other: Laser TreatmentWithin the scope of conventional treatment, individuals were given Transcutaneous Electrical Nerve Stimulation (TENS), infrared, US and exercise therapy.
Laser treatment	Active comparator	Other: Laser TreatmentIn 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laser TreatmentAlso: conventional treatmentIn 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	Conventional treatment, Laser treatment

Primary outcome

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.
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.
MUSCLE STRENGTH
Time frame: Baseline and 2 weeks post-intervention
Hip, knee flexor and extensor muscle strengths will be measured using a manual dynamometer.
BALANCE
Time frame: Baseline and 2 weeks post-intervention
Dynamic balance of individuals through the Modified Star Balance Test will be evaluated.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
Background: PubMed 15593258Fitzgerald 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.
Background: PubMed 26405113Fransen 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.
Background: PubMed 11846032Hedbom 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.
Background: PubMed 21683600Citaker 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.
Background: PubMed 21560257Chapple 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.
Background: PubMed 13610976MILLER 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.
Background: PubMed 24462672McAlindon 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.
Background: PubMed 18081143Hagiwara 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.
Background: PubMed 25624776Raeissadat 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.
Individual participant dataSharing planned: No

Related trials for Knee Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sevde Nur AKTAŞ, MsC contact

05438760764

sevdenur9880@icloud.com

Metehan YANA, PhD contact

05072665522

metehanyana@karabuk.edu.tr

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Laser Treatment in people with Knee Osteoarthritis, run by Karabuk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sevde Nur AKTAŞ, MsC (05438760764, sevdenur9880@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain severity (time frame: Baseline and 2 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06432842, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.