Effects of Body Awareness Therapy in Knee Osteoarthritis

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Body Awareness Therapy; Other: Home exercise program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eyup
    • Istanbul, Eyup, Turkey
      • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAT+Home exercise program; The patients in this group will participate in BAT for 3 days a week for 6 weeks in addition to home exercise program.	Other: Body Awareness Therapy; 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.; Other: Home exercise program; Home exercise program will consist of joint range of motion, stretching, strengthening and proprioceptive exercises for lower extremity.
Active Comparator: Home exercise program; The patients in the control group will perform home exercise program, two times a day, 7 days a week for 6 weeks.	Other: Home exercise program; Home exercise program will consist of joint range of motion, stretching, strengthening and proprioceptive exercises for lower extremity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale	change in knee pain intensity from baseline at 6 weeks,"0" point means that there is no pain, "10" point indicates severity of pain	six weeks
Single leg stability	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.	six weeks
6 minute walk test	change in walking distance from baseline at 6 weeks	six weeks
5 times sit to stand test	change in time needed to complete the test from baseline at 6 weeks	six weeks
Stair climb test	change in time needed to complete the test form baseline at 6 weeks	six weeks
Hand-held dynamometer	changes quadriceps muscle strength from baseline at 6 weeks	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities osteoarthritis index (WOMAC)	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.	six weeks
Fall risk	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.	six weeks
joint range of motion	change in knee joint range of motion from baseline at 6 weeks	six weeks

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Collaborators: Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 20, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: knee osteoarthritis; pain; body awareness therapy; functional capacity
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Kubra1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No