NCT04875689

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

May 1, 2021

Last Update Submit

May 1, 2021

Conditions

Keywords

WOMACROMNPRSOA

Outcome Measures

Primary Outcomes (3)

  • 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.

    12th day

  • Goniometry

    knee ROM can be measured with this tool

    12th day

  • 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

    12th day

Study Arms (2)

Group A (Experimental)

EXPERIMENTAL

Patient receive laser therapy along with conventional therapy

Other: Group A (Experimental

Group B: Conventional treatment

OTHER

patient will receive conventional therapy

Diagnostic Test: Group B (Control)

Interventions

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 A (Experimental)
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).

Group B: Conventional treatment

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral,Pakistan, 440000, Pakistan

Location

Related Publications (11)

  • 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.

    PMID: 20522967BACKGROUND
  • 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.

    PMID: 19751691BACKGROUND
  • 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.

    PMID: 21907813BACKGROUND
  • 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.

    PMID: 11410174BACKGROUND
  • 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.

    PMID: 18067658BACKGROUND
  • 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.

    PMID: 24999112BACKGROUND
  • 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.

    PMID: 25261425BACKGROUND
  • 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.

    PMID: 24055922BACKGROUND
  • 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.

    PMID: 25914044BACKGROUND
  • 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.

    PMID: 24919587BACKGROUND
  • 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.

    PMID: 24418801BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Shafaq Shahid, MSPT(OMPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2021

First Posted

May 6, 2021

Study Start

August 13, 2020

Primary Completion

March 20, 2021

Study Completion

March 20, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations