Effects of Body Awareness Therapy in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165187
• Other study ID #: Kubra1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 20, 2020

Study information

• Verified date: June 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 20, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Eyup

Sponsors (2)

Lead Sponsor	Collaborator
Bezmialem Vakif University	Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	6 minute walk test	change in walking distance from baseline at 6 weeks	six weeks
Primary	5 times sit to stand test	change in time needed to complete the test from baseline at 6 weeks	six weeks
Primary	Stair climb test	change in time needed to complete the test form baseline at 6 weeks	six weeks
Primary	Hand-held dynamometer	changes quadriceps muscle strength from baseline at 6 weeks	six weeks
Secondary	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
Secondary	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
Secondary	joint range of motion	change in knee joint range of motion from baseline at 6 weeks	six weeks