Knee OsteoarthritisNCT05659849
Effectiveness of Manual Therapy and Neuromuscular Training in the Management of Knee Osteoarthritis
A study testing Manual therapy techniques and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Knee Osteoarthritis, run by University of Tabuk at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Manual therapy techniques and Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 16 Jun 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Manual Therapy VS Conventional Physical Therapy With Neuromuscular Training in the Management of Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Manual therapy techniques, Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Knee, Osteoarthritis, Manual therapy, TENS, Neuromuscular training
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy techniquesOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start16 Jun 2022
- Primary completion30 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tabuk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahul Hameed Pakkir Mohamed, University of Tabuk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659849
- Sponsor's protocol ID
- UT-217-68-2022
- Status last verified
- Jul 2024
- First submitted
- 12 Dec 2022
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Therapy VS Conventional Physical Therapy With Neuromuscular Training in the Management of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05659849
- Acronym / sponsor ID
- UT-217-68-2022
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Manual therapy, TENS, Neuromuscular training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of TabukUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy with Neuromuscular training | Experimental | Other: Manual therapy techniquesManual 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. |
| Conventional physical therapy with Neuromuscular training | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual therapy techniquesPassive 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. | Other | Manual therapy with Neuromuscular training |
| 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. | Device | Conventional physical therapy with Neuromuscular training |
Primary outcome
Numeric Pain Rating Scale
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy techniques and Transcutaneous Electrical Nerve Stimulation (TENS) in people with Knee Osteoarthritis, run by University of Tabuk at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.