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

March 18, 2024 updated by: Tuğba GÖNEN, Hasan Kalyoncu University

Evaluation of the Effectiveness of Manual Therapy in Patients With Knee Osteoarthritis: Randomized Controlled Single-blind Clinical Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Locations

  • Turkey
    • Şahinbey
      • Gaziantep, Şahinbey, Turkey, 27100
        • Hasan Kalyoncu 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
This group will get manuel therapy that combinated electroterapy and hm programme (exercise).
Other: 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
Active Comparator: Control Group
This group will get traditional therapy (electrotherapy and exercise)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pain
Time Frame: through of the study, average 5 weeks and 3 months later
Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
through of the study, average 5 weeks and 3 months later
Functional status
Time Frame: through of the study, average 5 weeks and 3 months later
Western Ontario ve McMaster Universities (WOMAC) index will used to determine the knee osteoarthritis functional status. The questionnaire, developed at Western Ontario and McMaster University in 1982, includes a total of 24 items consisting of the subparameters Pain (5), Stiffness (2), and Physical function (17). Scoring of the items is done according to the Likert scale. The degree of pain and strain is indicated by giving points from 0 to 4 on the Likert scale. The total score is calculated as a percentage by multiplying the score by 100 and dividing by 96, which is the maximum total score.
through of the study, average 5 weeks and 3 months later
The quality of Life
Time Frame: through of the study, average 5 weeks and 3 months later
Nothingham Health Profile will used to determine the quality of life. Hunt et al. NHP, which was developed in 1981 and used to evaluate the quality of life, consists of 2 subsections. Part 1 includes the subparameters of Pain, Emotional Reactions, Sleep, Social Isolation, Physical Activity and Energy, and Part 2 measures the frequency of health-related problems in work and home life, hobbies, social and sexual life. Part 1 is measured between 0-600 points, and Part 2 is measured between 0-7 points. As the score increases, the quality of life decreases
through of the study, average 5 weeks and 3 months later
Lower extremity functional strength and balance test
Time Frame: through of the study, average 5 weeks and 3 months later
Sit to stand test will used to determine Lower extremity strength and balance. The sit to stand test, which evaluates lower extremity muscle strength and endurance and is frequently used in osteoarthritis patients, is performed on a chair without armrests with a height of approximately 44 cm. The patient sits in the middle of the chair with his back straight. Feet touch the ground approximately shoulder-width apart, with one foot slightly in front of the other to help maintain balance. Arms are crossed on the shoulders and the patient is asked to stand up and sit like this for 30 seconds. Sitting and standing for less than 10 repetitions after 30 seconds indicates lower extremity weakness.
through of the study, average 5 weeks and 3 months later
Functional mobility
Time Frame: through of the study, average 5 weeks and 3 months later
Time up and go test will used to determine functional mobility. Time up and go test was developed by Podsiadlo et al. in 1991. It was developed by Mathias et al. as a modification of the Get-Up and Go Test. For performance measurement that evaluates fall risk and functional mobility, a 3-meter area is determined in front of the chair. The patient is asked to get up from the chair, walk a distance of 3 meters, and then come back and sit on the chair. Time is measured in seconds with a stopwatch. It is determined that there is a risk of falling when the test is completed in more than 12 seconds.
through of the study, average 5 weeks and 3 months later

Collaborators and Investigators

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

Sponsor

Hasan Kalyoncu 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 (Estimated)

March 25, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/04

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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