Clinical trial NCT05832866: Clinic-based and Tele-monitored Home-based Intervention in Patients With Knee OA
Official title: Effect of Clinic-based and Tele-monitored Home-based Intervention on Pain Intensity, Function and Quality of Life in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Pain intensity
Functioning
Health Related Quality of Life
Tele-monitoring
Lead sponsor: Obafemi Awolowo University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There were two groups, one with clinical based and the other with telemonitored home based. The two groups received thera band exercises of isometric contractions. The clinical based at the hospital, and the home based at home but being monitored by researcher with phone call.
Primary purpose: TREATMENT

Brief summary: This study assessed and compared the effects of clinic-based and telemonitored home-based interventions on pain intensity, function and quality of life in patients with knee osteoarthritis (KOA). This was with a view to providing evidence for the validation of the effectiveness of home-based intervention on knee osteoarthritis

Detailed description: This study was a quasi-experiment involving forty two patients with KOA. They were randomly allocated into two groups equally; clinic-based group (CBG) and telemonitored home-based group (THG).

The CBG received exercises to strengthen the quadriceps and hamstring muscles using thera band while THG received same treatment regimen but at home and were monitored on phone by the researcher. The subjects performed four sets of eight repetitions for each of the exercises three days in a week for eight weeks. Pain intensity was assessed with Quadruple Visual Analog Scale, function was assessed with the Western Ontario and McMaster University Osteoarthritis Index and quality of life was assessed with WHO Quality of Life-BREF at pretreatment, 3rd week, 6th week and 8th week of intervention. Data was analysed with descriptive and inferential statistics. Repeated measure ANOVA was used to compare the mean value of variables within the group and between the groups. Alpha level was set at 0.05.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with osteoarthritis of the knee of not less than six weeks.
* Patients that have means of communication via mobile telephone.
* Patients who understands English or Yoruba Language.

Exclusion Criteria:

Participants that have any other knee joint diseases.

* Participants with history of knee joint trauma.
* Participants with history of knee surgery or arthroplasty

Primary outcomes:
measure: Quadruple Visual Analog Scale (QVAS)
timeFrame: 1-8 weeks
Secondary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 1-8 weeks
Other outcomes:
Locations:
city: Ile Ife
country: Nigeria
facility: Obafemi Awolowo University,
state: Osun
Study officials:
References:
citation: Russell TG, Buttrum P, Wootton R, Jull GA. Internet-based outpatient telerehabilitation for patients following total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2011 Jan 19;93(2):113-20. doi: 10.2106/JBJS.I.01375.
citation: Runhaar J, Koes BW, Clockaerts S, Bierma-Zeinstra SM. A systematic review on changed biomechanics of lower extremities in obese individuals: a possible role in development of osteoarthritis. Obes Rev. 2011 Dec;12(12):1071-82. doi: 10.1111/j.1467-789X.2011.00916.x. Epub 2011 Aug 3.
citation: Ojoawo AO, Malomo EO, Olusegun EO, Olaogun BMO. Effects of pulse ultrasound and kneading massage in managing individual with incessant pain at lower region of back using random allocation. J Exerc Rehabil. 2018 Jun 30;14(3):516-522. doi: 10.12965/jer.1836126.063. eCollection 2018 Jun.