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NCT Number: NCT05832866

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

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Obafemi Awolowo University,

Ile-Ife, Osun State, 220005, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Based Isometric contraction strengthening Exercises using Thera band

Other

Patients did isometric contraction exercises using thera band in the clinic physically. They did not need to be monitored by telephone

Other names: Clinical Based intervention

Telemonitored Home based Isometric Cntraction strengthening exercises using Thera band

Other

Patients did isometric contraction exercises using thera band at home, they were monitored by telephone three times in a week for 8 weeks

Other names: Telemonitores Home based Intervention

Primary outcomes

  1. Quadruple Visual Analog Scale (QVAS)

    Time frame: 1-8 weeks

    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

Secondary outcomes

  1. The Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: 1-8 weeks

    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

Sponsors and collaborators

Lead sponsor

Obafemi Awolowo University

Other

Registry information

Official study title

Effect of Clinic-based and Tele-monitored Home-based Intervention on Pain Intensity, Function and Quality of Life in Patients With Knee Osteoarthritis

Acronym: CB&HMInKOA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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