Low Level Laser Therapy in Knee Osteoarthritis

NCT04682171 | Completed

• 1 other identifier: REC/RCRS/20/1040 Abeel Ashraf
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be Randomized Controlled Trial. It will be conducted in Allied Hospital Faisalabad. The study will be completed in four months duration. Consecutive sampling technique will be used for data collection. A sample size of 40 patients will be taken in this study. Participants will be divided into two groups. Group A will be treated by LLLT and conventional exercises. Group B will perform conventional exercises only. Numeric Pain Rating Scale will be used to measure pain. Western Ontario McMaster Universities Osteoarthritis Index Score (WOMAC) and Sit to stand test will be used to measure knee function. Goniometry will be used to measure ROM of knee. The participants will fill numeric pain rating scale and WOMAC as subjective measurements. Knee flexion ROM will be measured with universal Goniometer. Total 12 sessions will be given with three sessions per week. Post treatment readings will be taken at the end of 4th week. Data will be analyzed on SPSS 25.

Conditions

Knee Osteoarthritis

Keywords

Knee pain; Knee function; Degenerative knee disease

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale (NPRS)

  NPRS is a segmented version of Visual Analogue Scale (VAS). It consists of number from 0 to 10. Patient selects a number that best reflects his/her pain intensity where 0 is no pain and 10 is maximum pain. For construct validity, NPRS was highly correlated to Visual Analogue Scale (VAS) (0.86-0.95).The test-retest reliability of this scale is recorded to be 0.96

  4th week

• Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)

  WOMAC is a valid and reliable outcome measuring tool for evaluating patients with hip and knee osteoarthritis. It measures degree of pain (5 questions), severity of joint stiffness (2 questions) and physical functions (17 questions). WOMAC score was recorded on five points Likert Scale ranging from 0-4 where 0 shows no pain/limitation and 4 shows extreme pain/limitation. Maximum score for pain, joint stiffness and physical function are 28, 8 and 68 respectively with total of 96 scores indicating severe disease.

  4th week

Secondary Outcomes (1)

• Knee Rang of Motion (Flexion and Extension)

  4th Week

Study Arms (2)

Low level Laser Therapy

EXPERIMENTAL

Low Level Laser Therapy and Conventional Exercise therapy

Other: Low level laser therapy; Other: Conventional Exercise Therapy

Conventional ExerciseTherapy

ACTIVE COMPARATOR

Conventional ExerciseTherapy

Other: Conventional Exercise Therapy

Interventions

Low level laser therapy OTHER

* Gallium aluminium arsenide laser device will be used with wavelength of 850nm, power 100 mW, spot size of 1.0 mm and energy of 6J/point for 60seconds. Total 8 points will be irradiated. It will take 20 minutes. * Patient will receive treatment in supine position with the affected knee(s) slightly flexed supported by the pillow or rolled towel. * On the affected knee the laser probe will placed with full contact with skin at 8 points. Three points at medial side of the knee, three points at lateral side and two points at the medial edge of the bicep femoris muscle tendon and semitendinosus muscle tendon in the popliteal fossa

Low level Laser Therapy

Conventional Exercise Therapy OTHER

1. Quadriceps isometric strengthening exercises. 2. Range of motion and active stretching exercises applied to hamstring and quadriceps muscle. 3. Hamstring muscle isometric exercises 4. Active ankle pump. 5. Short arc terminal extension exercises for the knee joint. 6. Static and dynamic strengthening exercises for the hip abductors, adductors and extensor group of muscles. 7. Non-weight bearing progressive resistance exercises with weighted cuffs, with progression to closed chain exercises as patient's pain allows. 8. Isometric exercises were applied with 6 second contractions and rest period of 2 seconds. Isotonic exercises were started as 10 repetitions with half of weight of 10 RM, 10 repetitions with three fourth of this weight and 10 repetitions with whole 10 RM

Conventional ExerciseTherapy; Low level Laser Therapy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both males and females
• Patients with age 45-65 years
• Patients with knee OA of grade II or III according to Kellgren-Lawrence grade.
• Pain intensity ranging between\> 5 measured by Numeric Pain Rating Scale.
• Patients who had minimum score of 25 on the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) total score.
• Patients having knee pain for at least 3 months.

You may not qualify if:

• Patients with pain in other lower limb joints.
• Patients with symptomatic hip osteoarthritis.
• Patients with knee surgery in last 6 months.
• Patients with complaint of cancer, diabetes, neurological deficit or uncontrolled hypertension

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Allied Hospital

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related Publications (14)

• Johnson VL, Hunter DJ. The epidemiology of osteoarthritis. Best Pract Res Clin Rheumatol. 2014 Feb;28(1):5-15. doi: 10.1016/j.berh.2014.01.004.

  PMID: 24792942 BACKGROUND

• Alghadir A, Omar MT, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014 Mar;29(2):749-55. doi: 10.1007/s10103-013-1393-3. Epub 2013 Aug 3.

  PMID: 23912778 BACKGROUND

• Akhter E, Bilal S, Kiani A, Haque U. Prevalence of arthritis in India and Pakistan: a review. Rheumatol Int. 2011 Jul;31(7):849-55. doi: 10.1007/s00296-011-1820-3. Epub 2011 Feb 18.

  PMID: 21331574 BACKGROUND

• Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.

  PMID: 18163497 BACKGROUND

• Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.

  PMID: 17216685 BACKGROUND

• Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.

  PMID: 26872913 BACKGROUND

• Jackson BD, Wluka AE, Teichtahl AJ, Morris ME, Cicuttini FM. Reviewing knee osteoarthritis--a biomechanical perspective. J Sci Med Sport. 2004 Sep;7(3):347-57. doi: 10.1016/s1440-2440(04)80030-6.

  PMID: 15518300 BACKGROUND

• Jarvholm B, Lewold S, Malchau H, Vingard E. Age, bodyweight, smoking habits and the risk of severe osteoarthritis in the hip and knee in men. Eur J Epidemiol. 2005;20(6):537-42. doi: 10.1007/s10654-005-4263-x.

  PMID: 16121763 BACKGROUND

• Christensen R, Bartels EM, Astrup A, Bliddal H. Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta-analysis. Ann Rheum Dis. 2007 Apr;66(4):433-9. doi: 10.1136/ard.2006.065904. Epub 2007 Jan 4.

  PMID: 17204567 BACKGROUND

• Rosemann T, Kuehlein T, Laux G, Szecsenyi J. Osteoarthritis of the knee and hip: a comparison of factors associated with physical activity. Clin Rheumatol. 2007 Nov;26(11):1811-7. doi: 10.1007/s10067-007-0579-0. Epub 2007 Mar 2.

  PMID: 17332977 BACKGROUND

• 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: 25914044 BACKGROUND

• Alqualo-Costa R, Thome GR, Perracini MR, Liebano RE. Low-level laser therapy and interferential current in patients with knee osteoarthritis: a randomized controlled trial protocol. Pain Manag. 2018 May;8(3):157-166. doi: 10.2217/pmt-2017-0057. Epub 2018 May 3.

  PMID: 29722602 BACKGROUND

• Alfredo PP, Bjordal JM, Dreyer SH, Meneses SR, Zaguetti G, Ovanessian V, Fukuda TY, Junior WS, Lopes Martins RA, Casarotto RA, Marques AP. Efficacy of low level laser therapy associated with exercises in knee osteoarthritis: a randomized double-blind study. Clin Rehabil. 2012 Jun;26(6):523-33. doi: 10.1177/0269215511425962. Epub 2011 Dec 14.

  PMID: 22169831 BACKGROUND

• Esser S, Bailey A. Effects of exercise and physical activity on knee osteoarthritis. Curr Pain Headache Rep. 2011 Dec;15(6):423-30. doi: 10.1007/s11916-011-0225-z.

  PMID: 21956792 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Saima Zahid, PhD*

  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: December 21, 2020
• First Posted: December 23, 2020
• Study Start: December 30, 2020
• Primary Completion: June 25, 2021
• Study Completion: June 30, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)