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NCT Number: NCT04165187

Effects of Body Awareness Therapy in Knee Osteoarthritis

The aim of this study is to investigate the effect of Body Awareness Therapy (BAT) on pain, balance and functional capacity in patients with knee osteoarthritis.

Individuals will divided into two groups: training group and control group. Both groups will receive exercise training as a home program. Individuals in study group will participate in BAT training 3 days for 6 weeks. Assessments will be made before and after the 6-week study program.

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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

45 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Eyup, Turkey (Türkiye)

About this study

Symptoms such as pain, morning stiffness, and decreased muscle strength lead to a decrease in functional capacity and quality of life in knee osteoarthritis. It is estimated that 80% of patients with osteoarthritis have movement limitation and 25% are unable to perform significant daily activities. It is also stated that increases the risk of falls due to decrease proprioception in patients with knee osteoarthritis. In addition to physical symptoms, it is reported in the literature that symptoms such as sleep disturbance, depression and anxiety are seen and play a role in pain experience.

It is stated in the literature that hypersensitivity of the central nervous system causes painful perception of normal body functions in chronic osteoarthritis, which leads patients to compensatory and dysfunctional movement strategies.

Body Awareness Therapy (BAT) is a mind-body treatment approach directed towards awareness of body senses and how the body is used. The aim is to integrate the body and soul in the individual's experiences and to restructure body awareness and control.

The aim of this study is to investigate the effect of BAT on pain, balance and functional capacity in patients with knee osteoarthritis.

The study will consist of patients with stage 2-3 knee osteoarthritis according to Kellgren-Lawrence classification.

The individuals included in the study will be divided into two groups as training and control groups using a computer-based randomization program.

Both groups will be given a home program consisting of joint range of motion, stretching, strengthening and proprioceptive exercises. The control group will perform home exercise program and follow up will be made at once a week. The training group will participate in BAT for 3 days/week for 6 weeks in addition to home exercise program. Assessments will be made before and after the 6-week study program.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary knee Osteoarthritis
  • Stage 2 -3 according to Kellgren - Lawrence Classification

Exclusion criteria

  • Previous surgery in the lower extremity
  • Neuromuscular disease
  • Vestibular pathology
  • Physiotherapy intervention or intra-articular injection within the last 6 months

Treatment and study plan

Body Awareness Therapy

Other

Body scanning, stretch-release movements, centralization, contact with the ground, postural stability, movement flow and free breathing will be performed during sessions in lying, sitting and standing positions.

Home exercise program

Other

Home exercise program will consist of joint range of motion, stretching, strengthening and proprioceptive exercises for lower extremity.

Primary outcomes

  1. Visual analog scale

    Time frame: six weeks

    change in knee pain intensity from baseline at 6 weeks,"0" point means that there is no pain, "10" point indicates severity of pain

  2. Single leg stability

    Time frame: six weeks

    change in overall stability index of athlete single leg stability test in Biodex Balance System (BBS) from baseline at 6 weeks. Stability level of platform will be set as static. The results can be compared with normative values in the BBS. Lower scores indicate better stability and higher scores mean poor balance.

  3. 6 minute walk test

    Time frame: six weeks

    change in walking distance from baseline at 6 weeks

  4. 5 times sit to stand test

    Time frame: six weeks

    change in time needed to complete the test from baseline at 6 weeks

  5. Stair climb test

    Time frame: six weeks

    change in time needed to complete the test form baseline at 6 weeks

  6. Hand-held dynamometer

    Time frame: six weeks

    changes quadriceps muscle strength from baseline at 6 weeks

Secondary outcomes

  1. Western Ontario and McMaster Universities osteoarthritis index (WOMAC)

    Time frame: six weeks

    change in scores from baseline at 6 weeks. Index consists of 24 items. In index maximum score is 96 points and minimum score is 0 point. Higher scores indicate worse symptoms, physical limitation.

  2. Fall risk

    Time frame: six weeks

    change in overall stability index of fall risk test in Biodex Balance System from baseline at 6 weeks. Lower scores indicate better balance and high scores mean high risk for fall.

  3. joint range of motion

    Time frame: six weeks

    change in knee joint range of motion from baseline at 6 weeks

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Collaborators

  • Medipol University

Registry information

Official study title

The Effects of Body Awareness Therapy on Pain, Balance and Functional Capacity in Patients With Knee Osteoarthritis

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2019
Registry last updated
Jul 1, 2020

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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