Effectiveness of Manual Therapy and Neuromuscular Training in the Management of Knee Osteoarthritis

Sponsor

University of Tabuk (Other)

Overall Status

Recruiting

CT.gov ID

NCT05659849

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the short-term effectiveness of manual therapy with neuromuscular training and conventional physical therapy with neuromuscular training in patients with knee osteoarthritis.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: Manual therapy techniques Device: Transcutaneous Electrical Nerve Stimulation (TENS)	N/A

Detailed Description

Knee osteoarthritis (OA) is a major public health problem, characterized by progressive degeneration and loss of articular cartilage, resulting in pain, limitation of movement, imbalance, functional disability, and diminished patient quality of life. Regular participation in physical activity has been recognized for several years as being beneficial in the management of knee OA. The role and effectiveness of manual therapy techniques and conventional physical therapy are evident from the existing literature, but no comparison was found for the combination of neuromuscular training (NMT) in patients with knee OA. Thus, the aim of this study is to compare the short-term effectiveness of manual therapy (MT) versus conventional physical therapy (CPT) with NMT in the management of knee OA after six weeks of treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Manual Therapy VS Conventional Physical Therapy With Neuromuscular Training in the Management of Knee Osteoarthritis

Actual Study Start Date :

Jun 16, 2022

Actual Primary Completion Date :

Dec 12, 2022

Anticipated Study Completion Date :

Jan 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Manual therapy with Neuromuscular training Manual physical therapy is intended to improve musculoskeletal function and pain by addressing impaired kinematics of the joint. Passive Joint Mobilization (PJM) was applied to knee distraction and dorsal glides, ventral glides, and patellar glides in all directions, which were applied at a rate of two to three oscillations per second for 1-2 min. Each direction was repeated three to six times. The neuromuscular training program consists of three parts: warming up, a circuit program, and cooling down. The program was performed twice a week for 6 weeks, with each session lasting for 60 minutes.	Other: Manual therapy techniques Passive joint mobilization techniques are applied to the affected knee joint. For the first week (three sessions), the joint mobilization exercises included grade I or II rhythmic oscillations. During the following weeks, grade III or IV oscillation techniques were applied, depending on the level of tolerance and pain of each patient. In knee distraction, the patients are in a prone position with 50° knee flexion, and the physical therapist applies the techniques. The dorsal and ventral glides was performed with the patient in a supine position.
Experimental: Conventional physical therapy with Neuromuscular training Physical therapists use a variety of transcutaneous electrical nerve stimulation (TENS) applications to reduce or alleviate pain for individuals with Knee OA. TENS (symmetrical biphasic waveform, frequency 32-50 Hz, pulse width 80 microseconds) for the same amount of time and the same number of days. The TENS electrodes were applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care was taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. The neuromuscular training program consists of three parts: warming up, a circuit program, and cooling down. The program was performed twice a week for 6 weeks, with each session lasting for 60 minutes.	Device: Transcutaneous Electrical Nerve Stimulation (TENS) Transcutaneous electrical nerve stimulation (TENS) therapy treats pain using low-voltage electric currents. A small device administers the electrical current to or near nerves. TENS treatment inhibits or changes pain perception.

Arm

Intervention/Treatment

Experimental: Manual therapy with Neuromuscular training

Manual physical therapy is intended to improve musculoskeletal function and pain by addressing impaired kinematics of the joint. Passive Joint Mobilization (PJM) was applied to knee distraction and dorsal glides, ventral glides, and patellar glides in all directions, which were applied at a rate of two to three oscillations per second for 1-2 min. Each direction was repeated three to six times. The neuromuscular training program consists of three parts: warming up, a circuit program, and cooling down. The program was performed twice a week for 6 weeks, with each session lasting for 60 minutes.

Other: Manual therapy techniques

Passive joint mobilization techniques are applied to the affected knee joint. For the first week (three sessions), the joint mobilization exercises included grade I or II rhythmic oscillations. During the following weeks, grade III or IV oscillation techniques were applied, depending on the level of tolerance and pain of each patient. In knee distraction, the patients are in a prone position with 50° knee flexion, and the physical therapist applies the techniques. The dorsal and ventral glides was performed with the patient in a supine position.

Experimental: Conventional physical therapy with Neuromuscular training

Physical therapists use a variety of transcutaneous electrical nerve stimulation (TENS) applications to reduce or alleviate pain for individuals with Knee OA. TENS (symmetrical biphasic waveform, frequency 32-50 Hz, pulse width 80 microseconds) for the same amount of time and the same number of days. The TENS electrodes were applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care was taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. The neuromuscular training program consists of three parts: warming up, a circuit program, and cooling down. The program was performed twice a week for 6 weeks, with each session lasting for 60 minutes.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Transcutaneous electrical nerve stimulation (TENS) therapy treats pain using low-voltage electric currents. A small device administers the electrical current to or near nerves. TENS treatment inhibits or changes pain perception.

Outcome Measures

Primary Outcome Measures

Numeric Pain Rating Scale [6 weeks]
The average pain intensity over the last week at the time of testing was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible.
Goniometric measurement for ROM [6 weeks]
To check the range of motion (ROM) of the knee joint, the joint will be extended as far as it can go while the person is lying on their back three times. The angle at the maximum flexion position was measured with a goniometer, and the average angle was recorded.
Western Ontario and Mc Master Osteoarthritis Index (WOMAC) [6 weeks]
It is a questionnaire for the evaluation of treatment results in patients with lower extremity osteoarthritis, and it divides difficulties in daily living into scales. WOMAC scores are recorded on a five-point Likert scale of 0-4, where 0 = no pain or limitation, 1 = mild pain or limitation, 2 = moderate pain or limitation, 3 = severe pain or limitation, and 4 = extreme pain or limitation. Maximum scores for pain, stiffness and physical functions were 20, 8, and 68, respectively, with total scores of 96 indicating greater disease severities.
Short-Form Health Survey (SF-36) [6 weeks]
This instrument consists of 36 items, grouped into eight domains: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, and mental health. A measurement scale with values ranging from 0 (the worst health status) to 100 (the best health status) was used to give each subject and each of the eight dimensions a score.
Single-leg stance time test [6 weeks]
This test has been used to assess static standing balance in individuals with knee OA. The single-leg stance test was measured by recording the time in seconds (30s maximum) while participants are asked to balance on one leg while keeping their hands on their hips. The test starts when the free foot lifts off the ground and is stopped if: (1) the swing limb touches the ground; (2) the stance foot moves on the floor; (3) the swing foot touches the tested limb; or (4) the hands move away from the hips.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Complaining of knee pain that has lasted longer than 3 months.
Pain level that is medium (pain score greater than or equal to 4).
No knee injuries.
Treatment not received in another physical therapy clinic in the past three months.
Painful range of motion in the knee.

Exclusion Criteria:

History of knee surgery
A systemic arthritic condition
Any other muscular, joint, or neurological condition affecting lower limb function.
Received physical therapy or an intra-articular injection in the knee within the past 3 months.