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

NCT05659849 | Completed DMC

• 1 other identifier: UT-217-68-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee; Osteoarthritis; Manual therapy; TENS; Neuromuscular training

Outcome Measures

Primary Outcomes (5)

• Numeric Pain Rating Scale

  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.

  6 weeks

• Goniometric measurement for ROM

  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.

  6 weeks

• Western Ontario and Mc Master Osteoarthritis Index (WOMAC)

  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.

  6 weeks

• Short-Form Health Survey (SF-36)

  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.

  6 weeks

• Single-leg stance time test

  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.

  6 weeks

Study Arms (2)

Manual therapy with Neuromuscular training

EXPERIMENTAL

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. Neuromuscular training (NEMEX-TJR training program): (2 times per week for 6 weeks) The neuromuscular training program consists of 3 parts: warming up, a circuit program, and cooling down. The program is performed twice a week for 6 weeks, with each session lasts for 60 minutes.

Other: Manual therapy techniques

Conventional physical therapy with Neuromuscular training

EXPERIMENTAL

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. Neuromuscular training (NEMEX-TJR training program): (2 times per week for 6 weeks) The neuromuscular training program consists of 3 parts: warming up, a circuit program, and cooling down. The program is performed twice a week for 6 weeks, with each session lasts for 60 minutes.

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Interventions

Manual therapy techniques OTHER

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.

Manual therapy with Neuromuscular training

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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.

Conventional physical therapy with Neuromuscular training

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tabuk: lead

Study Sites (1)

University of Tabuk

Tabuk, North West, 71491, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 21, 2022
• Study Start: June 16, 2022
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)