Evaluation of the Effectiveness of Manual Therapy in Patients With Knee Osteoarthritis

NCT ID: NCT06329128

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-25
• Study Completion Date: 2024-09-30

Brief Summary

The aim of this study is to investigate the effects of three different applications (Manual therapy, electrotherapy and home program) on long-term pain, joint range of motion and, secondarily, the functional level of the knee.

Detailed Description

Osteoarthritis (OA); It is a chronic degenerative joint disorder characterized by joint pain, stiffness, decreased range of motion and muscle weakness. The main goal of healthcare professionals is to control the pain that increases with the gradually decreasing quality of life and to improve functions as a result. Conservative treatments include medical approaches as well as methods with demonstrated therapeutic effects such as exercise and physical activity. Exercise plays an important role in the management of chronic disabling disease. Looking at systematic reviews, there is high evidence that exercise reduces pain and improves physical function in patients with knee osteoarthritis. Manual therapy approaches have also been used recently to inhibit movement limitation and pain in the joint, and studies showing their benefits are increasing. The American College of Rheumatology has stated that it is beneficial to add manual therapy sessions to individual exercises in rehabilitation methods for patients. In terms of physiotherapy approaches in OA, electrotherapy modalities with low evidence are used. Among these modalities, the effects of TENS and Ultrasound are the most studied applications. Although the effects of TENS compared to placebo have been shown, there are also opposite results regarding TENS and ultrasound applications. There are many studies in the literature comparing types of manual therapy and investigating their combination with exercise. Some studies have demonstrated the effects of combining exercise treatments with a manual therapy program in improving pain and function. A recent study showed that patients who participated in an MT program had improved functional level compared to those who did not receive MT, but exercise therapy alone was superior in improving performance-based functional scores. A few studies comparing manual therapy with electrotherapy have been conducted recently. In this study, TENS and cold application were shown to be ineffective in improving pain, joint stiffness and physical functions compared to manual therapy in patients with OA. While manual therapy can reduce pain in OA thanks to its neurophysiological effects, it also aims to correct the changed arthrokinematics by restoring the optimal kinematics between joint accessory mobility and joint surfaces. Taylor et al. showed that the combination of exercise and extension mobilization applied in a single session can reduce end-range rotational stiffness. However, in the applications, comparisons are made between manual therapy and exercise combination or manual therapy and electrotherapy modalities. To our knowledge, there is no study in the literature comparing three different applications. Therefore, we hypothesized that manual therapy would be more effective than electrotherapy modalities and a home program in the long term in patients with knee OA. The aim of this study is to investigate the effects of three different applications (Manual therapy, electrotherapy and home program) on long-term pain, joint range of motion and, secondarily, the functional level of the knee.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Study Group

This group will get manuel therapy that combinated electroterapy and hm programme (exercise).

Group Type: EXPERIMENTAL

Experimental: Study Group

Intervention Type: OTHER

A 15-session (5 days a week / 3 weeks) physiotherapy and rehabilitation (electrotherapy and home program) program will be applied to both groups.

Electrotherapy application; It will consist of Hotpack (15 minutes), TENS (20 minutes), Ultrasound (10 minutes) applications. For the home program, a program consisting of isometric and isotonic exercises will be given to the muscles around the knee. The home program will be followed with an exercise diary.

In the manual therapy group, in addition to the above treatment, manual therapy will be given 3 days a week. The content of the manual therapy program is as follows;

• Patellofemoral joint superior-inferior mobilization
• Medial-lateral mobilization with active knee flexion
• Tibiofemoral joint ventral (anterior-posterior) mobilization
• Tibiofemoral traction mobilization

Control Group

This group will get traditional therapy (electrotherapy and exercise)

Group Type: ACTIVE_COMPARATOR

Active Comparator: Control Group

Intervention Type: OTHER

A 15-session (5 days a week / 3 weeks) physiotherapy and rehabilitation (electrotherapy and home program) program will be applied to both groups.

Electrotherapy application; It will consist of Hotpack (15 minutes), TENS (20 minutes), Ultrasound (10 minutes) applications. For the home program, a program consisting of isometric and isotonic exercises will be given to the muscles around the knee. The home program will be followed with an exercise diary.

Interventions

Experimental: Study Group

A 15-session (5 days a week / 3 weeks) physiotherapy and rehabilitation (electrotherapy and home program) program will be applied to both groups.

Electrotherapy application; It will consist of Hotpack (15 minutes), TENS (20 minutes), Ultrasound (10 minutes) applications. For the home program, a program consisting of isometric and isotonic exercises will be given to the muscles around the knee. The home program will be followed with an exercise diary.

In the manual therapy group, in addition to the above treatment, manual therapy will be given 3 days a week. The content of the manual therapy program is as follows;

• Patellofemoral joint superior-inferior mobilization
• Medial-lateral mobilization with active knee flexion
• Tibiofemoral joint ventral (anterior-posterior) mobilization
• Tibiofemoral traction mobilization

Intervention Type: OTHER

Active Comparator: Control Group

A 15-session (5 days a week / 3 weeks) physiotherapy and rehabilitation (electrotherapy and home program) program will be applied to both groups.

Electrotherapy application; It will consist of Hotpack (15 minutes), TENS (20 minutes), Ultrasound (10 minutes) applications. For the home program, a program consisting of isometric and isotonic exercises will be given to the muscles around the knee. The home program will be followed with an exercise diary.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of knee osteoarthritis according to the clinical and radiological diagnostic criteria of the American College of Rheumatology
• Patients with osteoarthritis stage II or III according to the Kellgren-Lawrence classification

Exclusion Criteria

• Having had knee surgery or lower extremity surgery
• Those who have received any physical therapy program in the last week
• Those with serious arrhythmia or a pacemaker
• Inflammatory arthritis or neuromuscular
• Having a history of malignancy
• Pregnant
• Those with open wounds and infections in the knee area
• Those with severe hypoesthesia or neurological disease
• Those with bleeding conditions and thrombophlebitis

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hasan Kalyoncu University

OTHER

Sponsor Role: lead

Responsible Party

Tuğba GÖNEN

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hasan Kalyoncu University

Gaziantep, Şahinbey, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Tuğba GÖNEN, Asst. Prof.

Role: CONTACT

tugba.badat@hku.edu.tr

05050905846

References

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Other Identifiers

2022/04

Identifier Type: -

Identifier Source: org_study_id