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Knee OsteoarthritisNCT04875689

Laser Therapy on Chronic Knee Joint Osteoarthritis Patients PATIENTS

A study testing Group A (Experimental in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Knee osteoarthritis is the most common condition presented in physiotherapy OPD.LASER therapy is new treatment option and to find out its effects in knee osteoarthritis is need of the hour. Read more about this study

Who is it for?
Ages 45 to 65 years, women only
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Group A (Experimental
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 sitePakistan
Study dates
13 Aug 2020to 20 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • The study includes female patients with chronic knee OA
  • The study includes patients from the age of 40 years and 65 years
  • The study includes patients with Grade II and III OA of knee
  • Patients having no other physical and mental issues

Who cannot join

  • • The study excludes male patients
  • Patients with lab results abnormal (inflammatory and infectious disease, malignant tumor)
  • Patients with arterial coagulation blockage in lower limbs.
  • Usual contraindication for laser therapy
  • Patient's undergone surgery of knee

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah International University

    Islamabad, Fedral,Pakistan, 440000

Other trials in Pakistan

About this study

Official title: Effects of Laser Therapy on Chronic Knee Joint Osteoarthritis Patients

Knee osteoarthritis is the most common condition presented in physiotherapy OPD.LASER therapy is new treatment option and to find out its effects in knee osteoarthritis is need of the hour. With this research one can find out best treatment program for knee osteoarthritis patients which can be shared with other community members. If there will be added effect of LASER treatment in reducing the visits or stays it will be a cost effective option. this study will help to find better management option for patients with knee osteoarthritis.

This study will address the scarcity of research on this topic in Pakistan and will help to raise awareness among patients about the effects of LASER THERAY.

Read the detailed description

Osteoarthritis (OA) is a degenerative joint disease characterized by the loss of articular cartilage, subchondral bone remodeling, joint space narrowing and the formation of bone spurs. The initiation of cartilage breakdown is stimulated by mechanical stress or injury and the degenerative process progresses slowly over many years. In the advanced stage of OA, the abnormal remodeling of cartilage and subchondral bone results in the formation of osteophytes at the joint surface and margins, which irreversibly destroys the affected joint. Obesity, previous trauma, female gender and older age are considered the most common risk factors for knee OA. The prevalence of radiographic KOA for all age groups and found a value of 27.3 % for women and 21.0 % for men.Clinical manifestations include joint pain, stiffness, decreased range of motion (ROM), muscle weakness, proprioceptive changes, difficulties in activities of daily living (ADL) such as walking, climbing / descending stairs and housekeeping[5]Many physical therapy agents such as ultrasound[6], electrical stimulation, strengthening exercise[8]and thermal therapy[9] have been introduced.

Because of the non-invasiveness and advantage of inciting nearly no adverse side effects, low-level laser therapy (LLLT) has been widely used to relieve pain in different musculoskeletal disorder. It also promotes fibroblasts, collagen synthesis, cell oxygen recovery, and bone remodeling. Laser efficacy depends on 4 factors of wavelength, duration of treatment, dose, and areas of the application.Low level laser therapy induces photochemical physiological actions in living tissues at the cellular level. Some of these effects include cellular oxygenation, release of neurotransmitters associated with pain modulation and release of anti-inflammatory, endogenous mediators. LLLT consists of a monochromatic light source without any thermal effect that stimulates reparative properties in human cartilage. Moreover, it has an analgesic effect, although the mechanisms through which this occurs remain uncertain. The suggested mechanisms include: increased mitochondrial ATP and tissue oxygenation, increased levels of neurotransmitters implicated in pain modulation (such as serotonin) and anti-inflammatory effects. Study stated that the reduction in pain through using LLLT might be due to mechanisms such as physiological effects mediated by photochemical actions at cellular level in animal or human tissue, and through increased levels of the neurotransmitters implicated in pain modulation, such as serotonin. Some researchers have also concluded that LLLT has an effect on joint cartilage regeneration, achieved through proliferation of chondrocytes and synthesis and secretion of extracellular matrix.

A study on "Effect of laser therapy on chronic osteoarthritis of the knee in older subjects" showed that there was a significant reduction in VAS and pain intensity, an increase in isometric muscle strength and range of motion of the knee as well as increase in physical functional ability in three treatment groups.

A study on "Efficacy of low-level laser therapy on pain and disability in knee osteoarthritis: systematic review and meta-analysis of randomized placebo-controlled trials" showed that LLLT reduces pain and disability in KOA at 4-8 J with 785-860 nm wavelength and at 1-3 J with 904 nm wavelength per treatment spot.

A study on "effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis" this study indicated that low level laser therapy has neither early nor later benefits in reducing pain or improving function in patients with KOA.

A study on "The Effect of Low Level Laser Therapy on Pain and Range of Motion of Patients With Knee Osteoarthritis" showed that the effectiveness of low-power laser in reducing pain and improving the range of motion in patients with knee osteoarthritis is similar to the effectiveness of the placebo laser. Low-power laser is recognized as an appropriate medical modality to treat knee osteoarthritis in animals and humans and can be used along with acupuncture or exercise.

A study on Effect of low level laser therapy (904nm) and static stretching in patients with knee osteoarthritis: a protocol of randomized controlled trial showed that the The European League Against Rheumatism (EULAR) recommendations indicate stretching exercises as an adjunctive treatment.

Being tested
Group A (Experimental, Group B (Control)
Keywords
WOMAC, ROM, NPRS, OA
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • Group A (ExperimentalOther

    Laser therapy is performed on patients in supine lying position. Treatments will be delivered with a diode laser (wavelength 830 nm, continuous wave, power 50 mW) in skin contact at a dose of 6 J/point. Treatment times per point are in the range of 30 seconds to 1 minute. eight points were irradiated per session.

    Conventional therapy will include:

    • TENS for 15 minutes
    • Hot pack for 15 minutes
    • Hamstrings muscle stretching and calf muscle stretching. Strengthening exercises ,straight leg raising exercise in crook lying position
    • Joint mobilizations
  • Group B (Control)Diagnostic test

    1. Participants of this group will receive only conventional therapy which will include;
    • TENS for 15 minutes
    • Hot pack for 15 minutes
    • Hamstrings muscle stretching and calf muscle stretching.Each stretch was sustained for 30 seconds, with 10-second rest intervals.
    • Strengthening exercises include quadricep drills(full knee extension maintained for 5 seconds, followed by a 5-second rest) 20 repetitions per session,straight leg raising exercise in crook lying position(the patients were asked to tense the quadriceps muscle, elevate the limb to 45° and maintain it for 6 seconds, and lower the limb slowly and then relax for 6 seconds; the exercise was performed for three sets of 10 repetitions per session).
    • Joint mobilizations (tibiofemoral extension and flexion; patellofemoral medial-lateral and inferior glide).
Study groups in NCT04875689
Study groupRoleWhat they receive
Group A (Experimental)ExperimentalPatient receive laser therapy along with conventional therapy
Receives: Other: Group A (Experimental
Group B: Conventional treatmentOtherpatient will receive conventional therapy
Receives: Diagnostic Test: Group B (Control)

What is being measured

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

  1. WOMAC questionnaire

    It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.

    • Test-retest reliability of pain,stiffness and physical function was satisfactory with ICCs(intraclass correlation coefficients) of 0.86, 0.68, and 0.89, respectively.

    Measured: 12th day

  2. Goniometry

    knee ROM can be measured with this tool

    Measured: 12th day

  3. NPRS

    • Numeric pain rating scale: numeric pain rating scale (NPRS) is ascale for pain measurement, ranging from "0" representing no pain :10" representing the worst or severe pain

    Measured: 12th day

Timeline

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

  1. First posted6 May 2021
  2. Study start13 Aug 2020
  3. Primary completion20 Mar 2021
  4. Study completion20 Mar 2021

Resources

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
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875689
Sponsor's protocol ID
REC/Letter-00767Mahnoor Hanif
Status last verified
May 2021
First submitted
1 May 2021
Last updated
6 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim JK, Kim TH, Park SW, Kim HY, Kim Sh, Lee Sy, Lee SM. Protective effects of human placenta extract on cartilage degradation in experimental osteoarthritis. Biol Pharm Bull. 2010;33(6):1004-10. doi: 10.1248/bpb.33.1004.

    PubMed 20522967
  • Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.

    PubMed 19751691
  • Pereira D, Peleteiro B, Araujo J, Branco J, Santos RA, Ramos E. The effect of osteoarthritis definition on prevalence and incidence estimates: a systematic review. Osteoarthritis Cartilage. 2011 Nov;19(11):1270-85. doi: 10.1016/j.joca.2011.08.009. Epub 2011 Aug 24.

    PubMed 21907813
  • Kaufman KR, Hughes C, Morrey BF, Morrey M, An KN. Gait characteristics of patients with knee osteoarthritis. J Biomech. 2001 Jul;34(7):907-15. doi: 10.1016/s0021-9290(01)00036-7.

    PubMed 11410174
  • Bennell KL, Hunt MA, Wrigley TV, Hunter DJ, Hinman RS. The effects of hip muscle strengthening on knee load, pain, and function in people with knee osteoarthritis: a protocol for a randomised, single-blind controlled trial. BMC Musculoskelet Disord. 2007 Dec 7;8:121. doi: 10.1186/1471-2474-8-121.

    PubMed 18067658
  • Zeng C, Li H, Yang T, Deng ZH, Yang Y, Zhang Y, Ding X, Lei GH. Effectiveness of continuous and pulsed ultrasound for the management of knee osteoarthritis: a systematic review and network meta-analysis. Osteoarthritis Cartilage. 2014 Aug;22(8):1090-9. doi: 10.1016/j.joca.2014.06.028. Epub 2014 Jul 4.

    PubMed 24999112
  • Melo Mde O, Pompeo KD, Brodt GA, Baroni BM, da Silva Junior DP, Vaz MA. Effects of neuromuscular electrical stimulation and low-level laser therapy on the muscle architecture and functional capacity in elderly patients with knee osteoarthritis: a randomized controlled trial. Clin Rehabil. 2015 Jun;29(6):570-80. doi: 10.1177/0269215514552082. Epub 2014 Sep 26.

    PubMed 25261425
  • Uthman OA, van der Windt DA, Jordan JL, Dziedzic KS, Healey EL, Peat GM, Foster NE. Exercise for lower limb osteoarthritis: systematic review incorporating trial sequential analysis and network meta-analysis. BMJ. 2013 Sep 20;347:f5555. doi: 10.1136/bmj.f5555.

    PubMed 24055922
  • Huang Z, Chen J, Ma J, Shen B, Pei F, Kraus VB. Effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Sep;23(9):1437-1444. doi: 10.1016/j.joca.2015.04.005. Epub 2015 Apr 23.

    PubMed 25914044
  • Coelho Cde F, Leal-Junior EC, Biasotto-Gonzalez DA, Bley AS, de Carvalho Pde T, Politti F, Gonzalez Tde O, de Oliveira AR, Frigero M, Garcia MB, Dibai-Filho AV, Gomes CA. Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial. Trials. 2014 Jun 11;15:221. doi: 10.1186/1745-6215-15-221.

    PubMed 24919587
  • Al Rashoud AS, Abboud RJ, Wang W, Wigderowitz C. Efficacy of low-level laser therapy applied at acupuncture points in knee osteoarthritis: a randomised double-blind comparative trial. Physiotherapy. 2014 Sep;100(3):242-8. doi: 10.1016/j.physio.2013.09.007. Epub 2013 Nov 15.

    PubMed 24418801

Questions about this trial

What is this clinical trial studying?

A study testing Group A (Experimental in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 6 May 2021. 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 Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC questionnaire (time frame: 12th day). The study lists 3 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 NCT04875689, which also lists 11 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 6 May 2021.

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