Using Gait Modification to Treat Knee Osteoarthritis in Saudi Arabia: Possibilities and Acceptability.

Pain Clinical Trial

Official title:

The Possibilities and Acceptability of Applying Gait Modification to the Treatment of Knee Osteoarthritis in Saudi Arabia Based on the Perceptions of Patients and Physiotherapists. A Mixed-methods Feasibility Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06306079
• Other study ID #: KKUMC
• Secondary ID: Abdullah Al Assi
• Status: Completed
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2024
• Source: King Khalid University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A variety of biomechanical gait modification interventions can elevate knee loading and improve knee symptoms in knee osteoarthritis patients. However, there was a lack of acceptability and adherence regarding modification interventions without any explanation. Thus, this study investigates the feasibility and acceptability of foot insoles as a gait modification tool among Saudi Arabian knee osteoarthritis patients and physiotherapists. This study aims to answer the following: - Which gait modification intervention is most likely to be implemented in Saudi Arabia (SA) clinical practice, taking context, patients' clinical and research evidence into consideration? - In Saudi Arabia, can this proposed foot-insole intervention be implemented? Is there sufficient experience among physiotherapists regarding gait modification to deliver it, and will patients engage with it? How can KOA rehabilitation outcomes be evaluated in the future? The participants will be conducted over three phases: 1. The patients' interview and therapists' focus group discussion will be used to examine KOA patients' and clinicians' perspectives on enabling and accepting gait modifications in phase 1. 2. The feasibility study will explore how a small number of KOA patients tolerate gait modifications and consider the most relevant outcome measures, such as pain and function, in phase (2). 3. A small group of knee osteoarthritis patients and their physiotherapists who participated in phase (2) will be asked to participate in a descriptive survey in phase (3). To examine the acceptability and feasibility of the study intervention in phase (2).

Description:

Since several different types of gait modifications have been studied, it has been challenging to determine which are most likely to be used by patients and healthcare professionals. A notable number of Saudi Arabians suffer from knee osteoarthritis (KOA), which reported a 29.5% prevalence of KOA; another recent study reported a 24.5% prevalence of KOA among the elderly. A 2002 study found that 30.8% of those aged 46-55 and 60.6% aged 66-75 were affected. Thus, KOA is roughly equally distributed between genders and is more prevalent among elderly and overweight individuals, so policymakers should focus on raising awareness to prevent and treat affected individuals. The healthcare system in SA is publicly funded and accessible; 79% of patients use the public system, and the rest obtain private care. In most cases, private patients have insurance coverage. The public healthcare system has three primary, secondary, and tertiary care levels. Rehabilitation and gait modification investigations are not available at the primary level. This snapshot of the literary review raises questions about the viability of the long-term use of learned/assistive gait modifications. The studies reported dissatisfaction with the gait modification approach but gave no reasons. Since most studies focus on results in a short time or a specific area, pre-training courses measuring acceptability and commitment can fill the gaps in previous studies. After determining the importance of gait modification, the question becomes, should it be integrated into the therapy strategy or other rehabilitative methods to increase the treatment's clinical efficacy? It is essential to understand the practices, views and expectations of KOA patients and health professionals concerning gait modifications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 30, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

KOA Patient participants:

• Adults aged above 45 years old.
• Both Male & Female.
• Radiographically or KOA participants meet any diagnostic classification guidelines/criteria (American College of Rheumatology classification criteria) or any eligible diagnostic guidelines.
• Typical knee pain while walking > 3 on an 11-point scale (0-10) in at least one knee pain or tenderness, primarily in the medial knee.

Exclusion Criteria:

• Severe KOA subjects (on the waiting list for knee arthroplasty).
• Knee post-operation or corticosteroid intra-articular injection last 6 months.
• Inability to walk for longer than 20 minutes without experiencing severe pain.
• Painful treadmill walking or unable to walk without heavy assistance, such as a lifting belt or walker frame.
• Significant knee effusion, musculoskeletal or neurological diseases that influence gait parameters.
• It is presently undergoing physiotherapy treatment.
• Rheumatoid Arthritis (RA), gout, one or both knees replaced, low back pain, hip OA, any serious knee or lower limb injuries in the past 24 months.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Device:
• Lateral Wedge insole
Insoles with lateral wedges are placed in patients' shoes to control biomechanical knee loading on the medial side of the knee. Insoles with lateral wedges are designed to be thinner on the inside (medially of the foot) and thicker on the outside (laterally of the foot) to relieve knee biomechanical loading parameters.

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital & Research Centre	Jeddah	Western

Sponsors (2)

Lead Sponsor	Collaborator
King Khalid University	University of Nottingham

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (10)

Al-Arfaj A, Al-Boukai AA. Prevalence of radiographic knee osteoarthritis in Saudi Arabia. Clin Rheumatol. 2002 May;21(2):142-5. doi: 10.1007/s10067-002-8273-8. — View Citation

Al-Modeer MA, Hassanien NS, Jabloun CM. Profile of morbidity among elderly at home health care service in Southern Saudi Arabia. J Family Community Med. 2013 Jan;20(1):53-7. doi: 10.4103/2230-8229.108187. — View Citation

Almalki M, Fitzgerald G, Clark M. Health care system in Saudi Arabia: an overview. East Mediterr Health J. 2011 Oct;17(10):784-93. doi: 10.26719/2011.17.10.784. — View Citation

Butler RJ, Marchesi S, Royer T, Davis IS. The effect of a subject-specific amount of lateral wedge on knee mechanics in patients with medial knee osteoarthritis. J Orthop Res. 2007 Sep;25(9):1121-7. doi: 10.1002/jor.20423. — View Citation

Fantini Pagani CH, Hinrichs M, Bruggemann GP. Kinetic and kinematic changes with the use of valgus knee brace and lateral wedge insoles in patients with medial knee osteoarthritis. J Orthop Res. 2012 Jul;30(7):1125-32. doi: 10.1002/jor.22032. Epub 2011 De — View Citation

Jones RK, Zhang M, Laxton P, Findlow AH, Liu A. The biomechanical effects of a new design of lateral wedge insole on the knee and ankle during walking. Hum Mov Sci. 2013 Aug;32(4):596-604. doi: 10.1016/j.humov.2012.12.012. Epub 2013 Jul 17. — View Citation

Khalid W. AlKuwaity, Tasneem N. Mohammad, Malik A. Hussain, Annas Alkhanani, A. M. . A. (2018) 'Prevalence and Determinant Factors of Osteoarthritis of the Knee Joint among Elderly in Arar, KSA', The Egyptian Journal of Hospital Medicine, 72(9).

Kutzner I, Damm P, Heinlein B, Dymke J, Graichen F, Bergmann G. The effect of laterally wedged shoes on the loading of the medial knee compartment-in vivo measurements with instrumented knee implants. J Orthop Res. 2011 Dec;29(12):1910-5. doi: 10.1002/jor — View Citation

Moyer RF, Birmingham TB, Dombroski CE, Walsh RF, Leitch KM, Jenkyn TR, Giffin JR. Combined effects of a valgus knee brace and lateral wedge foot orthotic on the external knee adduction moment in patients with varus gonarthrosis. Arch Phys Med Rehabil. 201 — View Citation

Pollo FE, Otis JC, Backus SI, Warren RF, Wickiewicz TL. Reduction of medial compartment loads with valgus bracing of the osteoarthritic knee. Am J Sports Med. 2002 May-Jun;30(3):414-21. doi: 10.1177/03635465020300031801. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	The change from baseline pain intensity level at 6-weeks, based on the nine points of a visual analogue scale, where 0 represents (no pain) and 9 represents (worst pain).	6 weeks post-intervention.
Primary	Western Ontario and McMaster Universities Arthritis Index-total	The change from baseline pain, stiffness and physical activity levels at 6-weeks.; Each question is scored from 0 to 4, which are: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).; Scores are summed for each subscale, ranging from 0-20 for pain, 0-8 for stiffness, and 0-68 for Physical Function.; A higher WOMAC score indicates worse pain, stiffness, and functional limitations.	6 weeks post-intervention.
Primary	Likert scale	Measuring knee osteoarthritic subjects' satisfaction based on the 5 point Likert scale survey.	6 weeks post-intervention.
Primary	Likert scale	Measuring therapists' agreement based on the 5-point Likert scale survey.	6 weeks post-intervention supervision.