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

NCT04830748 | Completed

• 1 other identifier: MT & TE & 1ry KOA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

1. 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. 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. 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. 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. 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. 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.

Conditions

Knee Osteoarthritis

Keywords

Traction; Distraction; Therapeutic exercises

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 4 weeks

Secondary Outcomes (4)

• Measurement of Functional Disability change after 4 weeks of intervention

  baseline, 4 weeks

• Measurement of Isometric quadriceps and hamstring Muscle Strength change after 4 weeks of intervention

  baseline, 4 weeks

• Measurement of Functional Performance change after 4 weeks of intervention using the 40 meter fast paced walk test

  baseline, 4 weeks

• Measurement of Functional Performance change after 4 weeks of intervention using the 12 step stair climb test

  baseline, 4 weeks

Study Arms (2)

Therapeutic exercises group

ACTIVE COMPARATOR

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

Other: Therapeutic exercises

Therapeutic exercises and mechanical traction group

EXPERIMENTAL

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

Other: Mechanical knee traction; Other: Therapeutic exercises

Interventions

Mechanical knee traction OTHER

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).

Therapeutic exercises and mechanical traction group

Therapeutic exercises OTHER

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.

Therapeutic exercises and mechanical traction group; Therapeutic exercises group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy Cairo university

Cairo, Giza Governorate, 12613, Egypt

Location

Related Publications (17)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Karima Abdelaty Hassan, lecturer

  Cairo University

  STUDY DIRECTOR

• Ibrahim Magdy Elnaggar, Prof

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at faculty of physical therapy

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: April 5, 2021
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 8, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)