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

December 7, 2022 updated by: moaaz ragab riyad amin, Cairo University

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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Cairo, Giza, Egypt, 12613
        • Faculty of Physical Therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Therapeutic exercises group
The first group will receive therapeutic exercises in the form of stretching and strengthening exercises of the knee.
Other: Therapeutic exercises

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.
Experimental: Therapeutic exercises and mechanical traction group
The experimental group will receive the same exercise program of the first group preceded by continuous mechanical traction of the knee.
Other: Therapeutic exercises

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.

Other: Mechanical knee traction
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Functional Disability change after 4 weeks of intervention
Time Frame: baseline, 4 weeks
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.
baseline, 4 weeks
Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention
Time Frame: baseline, 4 weeks

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).
baseline, 4 weeks
Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test
Time Frame: baseline, 4 weeks
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.
baseline, 4 weeks
Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test
Time Frame: baseline, 4 weeks
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.
baseline, 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Karima Abdelaty Hassan, lecturer, Cairo University
  • Study Director: Ibrahim Magdy Elnaggar, Prof, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT & TE & 1ry KOA

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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