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Different Proprioceptive Neuromuscular Facilitation (PNF) Technique in Patients With Knee Osteoarthritis

Primary Purpose

Muscle Weakness, Balance Disorders, Knee Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hotpack
Ultrasound
Combine Exercise
Repeated Contraction Exercise
Standart Exercise Therapy
Sponsored by
Karamanoğlu Mehmetbey University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between the ages of 45-65
  • The diagnosis of stage 1-2 osteoarthritis by the orthopedist
  • Volunteerig for research
  • No hearing, vision and speech impediment

Exclusion Criteria:

  • Patients with intra-articular contracture,
  • No Meniscus and no ligament problems
  • Presence of any neurological or cardiopulmonary disease that may affect the results of the study

Sites / Locations

  • Hacettepe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Repeated Contraction Exercise Group

Combine Exercise Group

Standart Exercise Therapy

Arm Description

Repeated Contractions Exercise Group, Hotpack apply for knee 20 minute, Ultrasound is a termal ajan which use for 10 minute and Repeated Stretch (Repeated Contractions) exercise. Repeated Contractions exercise is type of Proprioceptive Neuromusculer Facilititation Exercise. 3 session for 6 weeks.

Combination of Isotonics Exercise Group, Hotpack apply for knee 20 minute, Ultrasound is a termal ajan which use for 10 minute Combination of Isotonics Exercise. Combination of Isotonics Exercise is type of PNF. Combined concentric, eccentric, and stabilizing contractions of one group of muscles (agonists) without relaxation. 3 Session for 6 weeks.

Classic Physiotherapy: Hotpack, Ultrasound, Standart exercise program to improve Quadriceps, Hamstring and hip muscle strength. 3 session for 6 weeks.

Outcomes

Primary Outcome Measures

Quadriceps Femoris Muscle Strength
Quadriceps Femoris muscle strength is evaluated Biodex System. Patients performs knee extension strongly and system analyzed. System gives us Peak Torque which indicates the muscle's maximum strength capability. 1 repetition maximum (RM) isotonic strength test.

Secondary Outcome Measures

Knee Proprioception (30-45 and 60 degree)
Proprioception is evaluated with Biodex System (30-45 and 60 degree)
KOOS score
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document: KOOS Scoring). A total score has not been validated and is not recommended.
Step test
Climb and step in 10 steps. Brief time is better.
Womac Score
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
6 Minute walking test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. "The object of this test is to walk as far as possible for 6 minutes. More walk in a short time is better performance.
Balance
Balance is evaluated Biodex Balance System (BBS). This device, clinicians can assess neuromuscular control by quantifying the ability to maintain dynamic bilateral and unilateral postural stability on a static or unstable surface. In the measurement with the BBS, the personal values of the patient are determined and compared to reference values. Balance deficits are determined on this basis. BBS permits three measurements to be obtained including overall stability index (OSI), anterior-posterior stability index (APSI) and medial-lateral stability index (MLSI). Balance and risk of fall were assessed using two trials over a period of 30 seconds with 10 seconds rest in between. If total score close zero, accepted better.
Knee Pain Severity
Pain is evaluated with visual analog scale. The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. ''0'' means no pain, ''10'' means much pain, ''5'' means moderate pain.
Algometer
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold.The handheld algometer had a 1-cm2 round rubber application surface.The investigator placed the digital pressure algometer on a site to be inspected and pressed against the tester in a vertical direction while increasing the force at a constant rate of 1 kg/cm2. The investigator instructed the subjects to express pain either by saying "ouch" or raising their hands when only slight pain was felt.

Full Information

First Posted
December 11, 2017
Last Updated
February 22, 2022
Sponsor
Karamanoğlu Mehmetbey University
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1. Study Identification

Unique Protocol Identification Number
NCT03615521
Brief Title
Different Proprioceptive Neuromuscular Facilitation (PNF) Technique in Patients With Knee Osteoarthritis
Official Title
Diz Osteoartritinde Farklı Proprioseptif Nöromüsküler Fasilitasyon Tekniklerinin, Ağrı, Propriosepsiyon, Postural Kontrol, Kas Kuvveti, Eklem Hareket Açıklığı ve Diz Fonksiyonları Üzerine Olan Etkileri
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karamanoğlu Mehmetbey University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the effects of 6-week physiotherapy and rehabilitation programs involving different 'Proprioceptive Neuromuscular Facilitation' (PNF) techniques in patients with knee osteoarthritis on pain, proprioception, postural control, muscle strength, range of motion and knee functions
Detailed Description
The results obtained from this study will contribute to the selection of PNF technique which is most suitable for physiotherapies working on knee osteoarthritis in clinics as well as demonstrating the efficacy of PNF which has been studied in the literature very few times. As a result of this study, the evidence value of the PNF technique will be determined in the physiotherapy and rehabilitation program of patients with knee osteoarthritis, and the efficacy of this technique, which is theoretically adopted, will be demonstrated scientifically. It will also determine the most ideal of the two PNF techniques to be applied in patients with knee osteoarthritis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Balance Disorders, Knee Pain, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Repeated Contraction Exercise Group
Arm Type
Experimental
Arm Description
Repeated Contractions Exercise Group, Hotpack apply for knee 20 minute, Ultrasound is a termal ajan which use for 10 minute and Repeated Stretch (Repeated Contractions) exercise. Repeated Contractions exercise is type of Proprioceptive Neuromusculer Facilititation Exercise. 3 session for 6 weeks.
Arm Title
Combine Exercise Group
Arm Type
Experimental
Arm Description
Combination of Isotonics Exercise Group, Hotpack apply for knee 20 minute, Ultrasound is a termal ajan which use for 10 minute Combination of Isotonics Exercise. Combination of Isotonics Exercise is type of PNF. Combined concentric, eccentric, and stabilizing contractions of one group of muscles (agonists) without relaxation. 3 Session for 6 weeks.
Arm Title
Standart Exercise Therapy
Arm Type
Experimental
Arm Description
Classic Physiotherapy: Hotpack, Ultrasound, Standart exercise program to improve Quadriceps, Hamstring and hip muscle strength. 3 session for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Hotpack
Intervention Description
Hotpack applied 20 minutes for knee 3 session for 6 weeks
Intervention Type
Other
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound applied 10 minutes for knee 3 session for 6 weeks
Intervention Type
Other
Intervention Name(s)
Combine Exercise
Intervention Description
Proprioceptive Neuromusculer Facilitation Technique İnclude eccentric and concentric contractions 3 session for 6 week
Intervention Type
Other
Intervention Name(s)
Repeated Contraction Exercise
Intervention Description
Proprioceptive Neuromusculer Facilitation Technique include concentric contractions 3 session for 6 week
Intervention Type
Other
Intervention Name(s)
Standart Exercise Therapy
Intervention Description
Quadriceps, hamstring and hip muscle strength exercise. Hamstring stretch exercise. 3 session for 6 week
Primary Outcome Measure Information:
Title
Quadriceps Femoris Muscle Strength
Description
Quadriceps Femoris muscle strength is evaluated Biodex System. Patients performs knee extension strongly and system analyzed. System gives us Peak Torque which indicates the muscle's maximum strength capability. 1 repetition maximum (RM) isotonic strength test.
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Knee Proprioception (30-45 and 60 degree)
Description
Proprioception is evaluated with Biodex System (30-45 and 60 degree)
Time Frame
6 week
Title
KOOS score
Description
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document: KOOS Scoring). A total score has not been validated and is not recommended.
Time Frame
6 week
Title
Step test
Description
Climb and step in 10 steps. Brief time is better.
Time Frame
6 week
Title
Womac Score
Description
It is a self-administered questionnaire consisting of 24 items divided into 3 subscales Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
6 week
Title
6 Minute walking test
Description
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. "The object of this test is to walk as far as possible for 6 minutes. More walk in a short time is better performance.
Time Frame
6 week
Title
Balance
Description
Balance is evaluated Biodex Balance System (BBS). This device, clinicians can assess neuromuscular control by quantifying the ability to maintain dynamic bilateral and unilateral postural stability on a static or unstable surface. In the measurement with the BBS, the personal values of the patient are determined and compared to reference values. Balance deficits are determined on this basis. BBS permits three measurements to be obtained including overall stability index (OSI), anterior-posterior stability index (APSI) and medial-lateral stability index (MLSI). Balance and risk of fall were assessed using two trials over a period of 30 seconds with 10 seconds rest in between. If total score close zero, accepted better.
Time Frame
6 week
Title
Knee Pain Severity
Description
Pain is evaluated with visual analog scale. The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. ''0'' means no pain, ''10'' means much pain, ''5'' means moderate pain.
Time Frame
6 week
Title
Algometer
Description
Algometers are devices that can be used to identify the pressure and/or force eliciting a pressure-pain threshold.The handheld algometer had a 1-cm2 round rubber application surface.The investigator placed the digital pressure algometer on a site to be inspected and pressed against the tester in a vertical direction while increasing the force at a constant rate of 1 kg/cm2. The investigator instructed the subjects to express pain either by saying "ouch" or raising their hands when only slight pain was felt.
Time Frame
6 week
Other Pre-specified Outcome Measures:
Title
Time up and go test
Description
Patient stand up, walk to the line on the floor and turn around and walk back to the chair and sit down. Start timing on the word "GO" and stop timing when the subject is seated again correctly in the chair with their back resting on the back of the chair. Normal healthy elderly usually complete the task in ten seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more.
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between the ages of 45-65 The diagnosis of stage 1-2 osteoarthritis by the orthopedist Volunteerig for research No hearing, vision and speech impediment Exclusion Criteria: Patients with intra-articular contracture, No Meniscus and no ligament problems Presence of any neurological or cardiopulmonary disease that may affect the results of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filiz Can, Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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Different Proprioceptive Neuromuscular Facilitation (PNF) Technique in Patients With Knee Osteoarthritis

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