Evaluation of the Effectiveness of Manual Therapy in Patients With Knee Osteoarthritis

NCT06329128 | Not Yet Recruiting DMC

• 1 other identifier: 2022/04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of three different applications (Manual therapy, electrotherapy and home program) on long-term pain, joint range of motion and, secondarily, the functional level of the knee.

Conditions

Osteoarthritis, Knee

Keywords

Manual therapy; Exercise; Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• The pain

  Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

  through of the study, average 5 weeks and 3 months later

• Functional status

  Western Ontario ve McMaster Universities (WOMAC) index will used to determine the knee osteoarthritis functional status. The questionnaire, developed at Western Ontario and McMaster University in 1982, includes a total of 24 items consisting of the subparameters Pain (5), Stiffness (2), and Physical function (17). Scoring of the items is done according to the Likert scale. The degree of pain and strain is indicated by giving points from 0 to 4 on the Likert scale. The total score is calculated as a percentage by multiplying the score by 100 and dividing by 96, which is the maximum total score.

  through of the study, average 5 weeks and 3 months later

• The quality of Life

  Nothingham Health Profile will used to determine the quality of life. Hunt et al. NHP, which was developed in 1981 and used to evaluate the quality of life, consists of 2 subsections. Part 1 includes the subparameters of Pain, Emotional Reactions, Sleep, Social Isolation, Physical Activity and Energy, and Part 2 measures the frequency of health-related problems in work and home life, hobbies, social and sexual life. Part 1 is measured between 0-600 points, and Part 2 is measured between 0-7 points. As the score increases, the quality of life decreases

  through of the study, average 5 weeks and 3 months later

• Lower extremity functional strength and balance test

  Sit to stand test will used to determine Lower extremity strength and balance. The sit to stand test, which evaluates lower extremity muscle strength and endurance and is frequently used in osteoarthritis patients, is performed on a chair without armrests with a height of approximately 44 cm. The patient sits in the middle of the chair with his back straight. Feet touch the ground approximately shoulder-width apart, with one foot slightly in front of the other to help maintain balance. Arms are crossed on the shoulders and the patient is asked to stand up and sit like this for 30 seconds. Sitting and standing for less than 10 repetitions after 30 seconds indicates lower extremity weakness.

  through of the study, average 5 weeks and 3 months later

• Functional mobility

  Time up and go test will used to determine functional mobility. Time up and go test was developed by Podsiadlo et al. in 1991. It was developed by Mathias et al. as a modification of the Get-Up and Go Test. For performance measurement that evaluates fall risk and functional mobility, a 3-meter area is determined in front of the chair. The patient is asked to get up from the chair, walk a distance of 3 meters, and then come back and sit on the chair. Time is measured in seconds with a stopwatch. It is determined that there is a risk of falling when the test is completed in more than 12 seconds.

  through of the study, average 5 weeks and 3 months later

Study Arms (2)

Study Group

EXPERIMENTAL

This group will get manuel therapy that combinated electroterapy and hm programme (exercise).

Other: Experimental: Study Group

Control Group

ACTIVE COMPARATOR

This group will get traditional therapy (electrotherapy and exercise)

Other: Active Comparator: Control Group

Interventions

Experimental: Study Group OTHER

A 15-session (5 days a week / 3 weeks) physiotherapy and rehabilitation (electrotherapy and home program) program will be applied to both groups. Electrotherapy application; It will consist of Hotpack (15 minutes), TENS (20 minutes), Ultrasound (10 minutes) applications. For the home program, a program consisting of isometric and isotonic exercises will be given to the muscles around the knee. The home program will be followed with an exercise diary. In the manual therapy group, in addition to the above treatment, manual therapy will be given 3 days a week. The content of the manual therapy program is as follows; * Patellofemoral joint superior-inferior mobilization * Medial-lateral mobilization with active knee flexion * Tibiofemoral joint ventral (anterior-posterior) mobilization * Tibiofemoral traction mobilization

Study Group

Active Comparator: Control Group OTHER

A 15-session (5 days a week / 3 weeks) physiotherapy and rehabilitation (electrotherapy and home program) program will be applied to both groups. Electrotherapy application; It will consist of Hotpack (15 minutes), TENS (20 minutes), Ultrasound (10 minutes) applications. For the home program, a program consisting of isometric and isotonic exercises will be given to the muscles around the knee. The home program will be followed with an exercise diary.

Control Group

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Male and female individuals who agree to participate in the study will be included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of knee osteoarthritis according to the clinical and radiological diagnostic criteria of the American College of Rheumatology
• Patients with osteoarthritis stage II or III according to the Kellgren-Lawrence classification

You may not qualify if:

• Having had knee surgery or lower extremity surgery
• Those who have received any physical therapy program in the last week
• Those with serious arrhythmia or a pacemaker
• Inflammatory arthritis or neuromuscular
• Having a history of malignancy
• Pregnant
• Those with open wounds and infections in the knee area
• Those with severe hypoesthesia or neurological disease
• Those with bleeding conditions and thrombophlebitis

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Şahinbey, 27100, Turkey (Türkiye)

Location

Related Publications (9)

• Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.

  PMID: 24387819 BACKGROUND

• 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: 24999112 BACKGROUND

• Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.

  PMID: 22563589 BACKGROUND

• 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.

  PMID: 24462672 BACKGROUND

• Rutjes AW, Nuesch E, Sterchi R, Kalichman L, Hendriks E, Osiri M, Brosseau L, Reichenbach S, Juni P. Transcutaneous electrostimulation for osteoarthritis of the knee. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD002823. doi: 10.1002/14651858.CD002823.pub2.

  PMID: 19821296 BACKGROUND

• Conaghan PG, Kloppenburg M, Schett G, Bijlsma JW; EULAR osteoarthritis ad hoc committee. Osteoarthritis research priorities: a report from a EULAR ad hoc expert committee. Ann Rheum Dis. 2014 Aug;73(8):1442-5. doi: 10.1136/annrheumdis-2013-204660. Epub 2014 Mar 13.

  PMID: 24625626 BACKGROUND

• Zasadzka E, Borowicz AM, Roszak M, Pawlaczyk M. Assessment of the risk of falling with the use of timed up and go test in the elderly with lower extremity osteoarthritis. Clin Interv Aging. 2015 Aug 7;10:1289-98. doi: 10.2147/CIA.S86001. eCollection 2015.

  PMID: 26300633 BACKGROUND

• Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.

  PMID: 23680877 BACKGROUND

• Courtney CA, Witte PO, Chmell SJ, Hornby TG. Heightened flexor withdrawal response in individuals with knee osteoarthritis is modulated by joint compression and joint mobilization. J Pain. 2010 Feb;11(2):179-85. doi: 10.1016/j.jpain.2009.07.005. Epub 2009 Nov 27.

  PMID: 19945353 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Central Study Contacts

Tuğba GÖNEN, Asst. Prof.

CONTACT

05050905846; tugba.badat@hku.edu.tr

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were divided in two groups. One groups will get electrotherapy, exercise(home programme) and manuel therapy intervention. One group will be the control group. Control group will get electrotherapy and exercise (home programme).

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: March 25, 2024
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)