Clinic-based and Tele-monitored Home-based Intervention in Patients With Knee OA

Knee Osteoarthritis Clinical Trial

— CB&HMInKOA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05832866
• Other study ID #: Ojoawo23/01
• Status: Completed
• Phase: N/A
• Start date: February 12, 2021
• Est. completion date: October 23, 2021

Study information

• Verified date: April 2023
• Source: Obafemi Awolowo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 23, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Clinical Based Isometric contraction strengthening Exercises using Thera band
Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone
• Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band
Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks

Locations

Country	Name	City	State
Nigeria	Obafemi Awolowo University,	Ile Ife	Osun

Sponsors (1)

Lead Sponsor	Collaborator
Obafemi Awolowo University

Country where clinical trial is conducted

Nigeria, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadruple Visual Analog Scale (QVAS)	This was used to assess pain intensity experienced by the participants at the time of assessment, typical or average pain, pain at its best, and pain at its worst, respectively (Von Korff et al, 1993).It consists of 4 items with each item numbered 0 to 10. With 0 indicating no pain and 10 is worst possible pain. A Yoruba translated version of the QVAS was used for participants who had preference for the Yoruba language	1-8 weeks
Secondary	The Western Ontario and McMaster Universities Osteoarthritis Index	WOMAC is a self-administered health-status instrument for patients with KOA, consists of 24 items within three subscales: pain (5 items), stiffness (2 items) and physical function (17 items). The Yoruba version of WOMAC translated was used for participants who do not understand English. Minimum is 0 and maxmum is 4	1-8 weeks