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Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mechanical knee traction
Therapeutic exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Traction, Distraction, Therapeutic exercises

Eligibility Criteria

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

Inclusion Criteria:

  • Patients will have grade II of primary knee osteoarthritis.
  • Patients with bilateral primary knee osteoarthritis, the more painful knee will be selected as the affected knee in this study.
  • Age of patients will range from 45 years to 65 years old.
  • Duration of illness will range from 3- 12 months.

Exclusion Criteria:

  • Malignancy
  • presence of skin lesions or infections at the treatment sites

Sites / Locations

  • Faculty of physical therapy Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Therapeutic exercises group

Therapeutic exercises and mechanical traction group

Arm Description

The first group will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee.

The experimental group will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee.

Outcomes

Primary Outcome Measures

Measurement of knee pain severity change after 4 weeks of intervention
Knee pain severity will be measured on an 11-point numerical pain rating scale, where 0= no pain and 10= worst possible pain.

Secondary Outcome Measures

Measurement of Functional Disability change after 4 weeks of intervention
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered patient reported measure that is both valid and disease-specific.It has been translated and validated into Arabic language. It is a 24-item questionnaire, grouped into three subscales including pain; stiffness; and physical function. Total score ranges from 0 (best) to 96 (worst) points.
Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention
Isometric muscle strength (Nm/kg) will be recorded for quadriceps and hamstring muscle groups. Using a hand held dynamo-meter the torque generated by the muscle is measured in newton-metre (Nm) which is later normalised to body mass in kilograms (kg). muscle strength = Torque (Nm) / body mass (kg).
Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test
The 40 meter fast paced walk test is a performance-based test that measures short distance walking activity. Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests.
Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test
The 12 step stair climb test is a performance-based test that measures the time required to go up and down 12 stairs (step height, 17 cm; step depth, 30 cm). Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests.

Full Information

First Posted
March 19, 2021
Last Updated
December 7, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04830748
Brief Title
Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis
Official Title
Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to compare between therapeutic exercises and therapeutic exercises preceded by mechanical traction in treatment of patients with primary knee osteoarthritis attributed to the outcomes of pain, muscle strength, functional disability and functional performance. Hypotheses There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of knee pain severity in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on reduction of functional disability in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric quadriceps muscle strength in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on increasing isometric hamstring muscle strength in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing walking time in patients with primary knee osteoarthritis. There will be no significant difference between therapeutic exercises and therapeutic exercises preceded by mechanical traction on decreasing ascending and descending stairs time in patients with primary knee osteoarthritis.
Detailed Description
Knee osteoarthritis is the most common cause of musculoskeletal pain and disability, resulting in major disability and pain in affected individuals. It is a chronic degenerative disorder of multifactorial aetiology, including acute and/or chronic insults from normal wear and tear, age, obesity and joint injury. It nearly affects about one in each eight adults worldwide, its prevalence rates vary from 7.8 to 9.3% in Egyptian population. Current clinical guidelines recommend non pharmacological conservative strategies including physical therapy given their ease of application and relatively low cost with minimal adverse effects (e.g.: strengthening exercises, aerobic exercises, stretching exercises, hydrotherapy, manual therapy, massage therapy, thermotherapy, electrotherapy, ultrasound therapy, external support braces and taping). It was reported that therapeutic exercise is beneficial for patients with knee osteoarthritis in terms of outcomes of pain, function, performance and quality of life. In addition, it was reported that strengthening, flexibility and neuromotor skill exercises have a large efficacy over aerobic and mind body exercise. Unloading strategies should be proposed as a first line of therapy for the patient with knee osteoarthritis before any attempts are made at tissue regeneration, repair or replacement. Manual or mechanical knee joint distraction is a conservative technique that provides transient joint separation and unloading that aids in improving clinical symptoms of patients. Addition of mechanical knee distraction to therapeutic exercises helps in gaining the positive effects of both exercise and unloading techniques. Although this approach has not been used extensively or applied pragmatically, several studies were found showing promising results in terms of reducing pain at both rest and movement, improving knee flexion and extension range of motion, reducing disability, increasing functional abilities and improving the quality of life of patients. Forty male and female patients with the diagnosis of primary knee osteoarthritis will be recruited in this study. All patients will be assessed and treated in the outpatient clinic of the faculty of physical therapy, Cairo University. Patients will be randomly distributed into 2 equal experimental groups: the first experimental group will receive therapeutic exercises (stretching and strengthening exercise) while the second experimental group will receive mechanical traction of the knee followed by therapeutic exercises. All patients will be treated for 12 sessions, 3 times per week each other day for 4 weeks. Clinical assessments will include assessment of pain severity, functional disability, isometric muscle strength, and functional performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Traction, Distraction, Therapeutic exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups The first group will include 20 patients and will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee. The second group will include 20 patients and will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients will be blinded to study hypotheses and informed only about comparing different programs of treatment of knee osteoarthritis. After randomization, participants will only be provided with details of the program they will be undertaking.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic exercises group
Arm Type
Active Comparator
Arm Description
The first group will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee.
Arm Title
Therapeutic exercises and mechanical traction group
Arm Type
Experimental
Arm Description
The experimental group will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee.
Intervention Type
Other
Intervention Name(s)
Mechanical knee traction
Intervention Description
Continuous knee joint mechanical traction will be applied to the patients positioned in supine lying position with the affected knee flexed at 25-30 degrees by a wedge placed under the affected knee. The thigh will be secured with a strap for stabilization and the leg will be held by the specially designed greave with the weight of traction hanging throughout a pulley system. The amount of traction will be set to about 10% of body weight. The treatment will be applied for 20 minutes continuously, once a day, 3 times per week for 4 weeks. The traction force will be progressed gradually during the program ( e.g.: weekly increase force by 1% of body weight if the patient can tolerate the duration of 20 min with the preset force).
Intervention Type
Other
Intervention Name(s)
Therapeutic exercises
Intervention Description
Therapeutic exercises will be divided into stretching and strengthening exercises: Stretching will be done passively for the hamstring, rectus femoris and calf muscles. Each exercise will be done for 3 reps each with a hold period of 30-60 secs with a 30-60 rest period between reps. Strengthening exercises will be done for the quadriceps and hamstring muscles ( inner range knee extension- knee extension in sitting- straight leg raise in flexion- prone hamstring curl- standing hamstring curl- straight leg raise in extension). Exercise will be done for 3 sets each will consist of 10 reps with a rest period of 2-3 minutes between sets. The starting weight should be 50% of the patient's 1 RM. The end position will be held for 5 seconds. Progression will be achieved by increasing the exercise rep and intensity gradually throughout the program. E.g.: weekly increase force by 5% if patient can tolerate an increased repetition of 20 rep with the preset force.
Primary Outcome Measure Information:
Title
Measurement of knee pain severity change after 4 weeks of intervention
Description
Knee pain severity will be measured on an 11-point numerical pain rating scale, where 0= no pain and 10= worst possible pain.
Time Frame
baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Measurement of Functional Disability change after 4 weeks of intervention
Description
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered patient reported measure that is both valid and disease-specific.It has been translated and validated into Arabic language. It is a 24-item questionnaire, grouped into three subscales including pain; stiffness; and physical function. Total score ranges from 0 (best) to 96 (worst) points.
Time Frame
baseline, 4 weeks
Title
Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention
Description
Isometric muscle strength (Nm/kg) will be recorded for quadriceps and hamstring muscle groups. Using a hand held dynamo-meter the torque generated by the muscle is measured in newton-metre (Nm) which is later normalised to body mass in kilograms (kg). muscle strength = Torque (Nm) / body mass (kg).
Time Frame
baseline, 4 weeks
Title
Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test
Description
The 40 meter fast paced walk test is a performance-based test that measures short distance walking activity. Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests.
Time Frame
baseline, 4 weeks
Title
Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test
Description
The 12 step stair climb test is a performance-based test that measures the time required to go up and down 12 stairs (step height, 17 cm; step depth, 30 cm). Three trials will be done for each test with a 5 min. rest between trials and a 10 min. rest between tests.
Time Frame
baseline, 4 weeks

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: Patients will have grade II of primary knee osteoarthritis. Patients with bilateral primary knee osteoarthritis, the more painful knee will be selected as the affected knee in this study. Age of patients will range from 45 years to 65 years old. Duration of illness will range from 3- 12 months. Exclusion Criteria: Malignancy presence of skin lesions or infections at the treatment sites
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karima Abdelaty Hassan, lecturer
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ibrahim Magdy Elnaggar, Prof
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of physical therapy Cairo university
City
Cairo
State/Province
Giza
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis

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