Clinical trial NCT06329128: Evaluation of the Effectiveness of Manual Therapy in Patients With Knee Osteoarthritis
Official title: Evaluation of the Effectiveness of Manual Therapy in Patients With Knee Osteoarthritis: Randomized Controlled Single-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Manual therapy
Exercise
Osteoarthritis
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were divided in two groups. One groups will get electrotherapy, exercise(home programme) and manuel therapy intervention. One group will be the control group. Control group will get electrotherapy and exercise (home programme).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The pain
timeFrame: through of the study, average 5 weeks and 3 months later
measure: Functional status
timeFrame: through of the study, average 5 weeks and 3 months later
measure: The quality of Life
timeFrame: through of the study, average 5 weeks and 3 months later
measure: Lower extremity functional strength and balance test
timeFrame: through of the study, average 5 weeks and 3 months later
measure: Functional mobility
timeFrame: through of the study, average 5 weeks and 3 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
state: Şahinbey
Study officials:
References:
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