Knee OsteoarthritisNCT06025929
Effect of Different Mobilization Techniques With Common Use of Interferential Therapy in Patients With Knee OA
A study testing Maitland's mobilization technique, Mulligan's mobilization techniques and Interferential Therapy (IFT) in people with Knee Osteoarthritis, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
This study aimed to determine the effects of different manual mobilization techniques on pain, muscle strength, and functional limitations in individuals with knee osteoarthritis (Knee OA). A double-blinded pretest-posttest experimental study. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Maitland's mobilization technique, Mulligan's mobilization techniques and Interferential Therapy (IFT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Apr 2017to 30 Oct 2017
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sub-acute or chronic osteoarthritis of knee.
- Age between 45-65 years.
- Gender Male and female.
- Subjects willing to participate in the study
Who cannot join
- Presence of R.A, polyarthritis or systemic inflammatory arthropathies.
- History of total knee arthroplasty or major knee trauma injury.
- Fracture of lower limb within the past 6 months.
- Hip or ankle instability, excessive weakness, surgery or major trauma injury.
- Intra-articular steroid injection in knee joint within 3 months.
- Cognitive problems.
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- Patient with severe cardiac or pulmonary disorders.
- Peripheral vascular disease.
- Tumour/malignancies/infections.
- Metallic implants in the lower limbs.
- Any severe deformity around the knee joint.
- Kellgren and Lawrence (KL) system47: up to grade 0-III.
- History of neurological and psychological disorders.
- High risk health status- e.g.- uncontrolled hypertension, diabetes, heart disease, angina type pain, nocturnal dyspnoea, shortness of breathing, tachycardia etc.
- Contraindications of IFT and mobilization.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University
Riyadh, 11433
About this study
Official title: Effectiveness of Maitland Mobilization Versus Mulligan Mobilization Techniques With Common Use of Interferential Therapy in Patients With Knee Joint Osteoarthritis
This study aimed to determine the effects of different manual mobilization techniques on pain, muscle strength, and functional limitations in individuals with knee osteoarthritis (Knee OA). A double-blinded pretest-posttest experimental study. This research employed a two-arm parallel group randomized comparative design. A total of thirty participants diagnosed with knee osteoarthritis were randomly assigned and equally divided into groups 1 and 2, each containing 15 participants. Both Group 1 and Group 2 underwent Maitland and Mulligan mobilization techniques, alongside a common Interferential therapy (IFT) regimen, over the course of three sessions per week for a duration of four weeks. The assessment of pain and functional disability outcomes was conducted through the application of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at the baseline and four weeks following the intervention. To determine the effects of the intervention within and between the groups, the outcome scores were subjected to analysis using both dependent and independent t-tests.
Read the detailed description
Knee osteoarthritis (OA) is a prevalent disorder with significant global health implications, its prevalence varying across populations due to intricate factors. Recent investigations highlight an age-related increase in knee OA prevalence, particularly impacting those aged 60 and above, with projections indicating heightened impact due to aging demographics. Recent pathogenesis studies illuminate the intricate molecular and cellular processes underlying knee osteoarthritis (OA), encompassing cartilage degradation, subchondral bone changes, and inflammation.Recent advancements have expanded knee osteoarthritis (OA) management, including medical, surgical, and physiotherapy interventions. Pharmacological treatments such as analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and disease-modifying osteoarthritis drugs (DMOADs) remain fundamental for pain alleviation and inflammation reduction. Intra-articular therapies like corticosteroid injections and hyaluronic acid supplements offer localized relief and potential disease-modifying effects.Surgical interventions like total knee arthroplasty (TKA) provide pain relief and improved function for end-stage OA. Minimally invasive techniques like partial knee replacements and patient-specific implants aim to preserve joint function and enhance outcomes. Physiotherapy and rehabilitation are crucial, in improving stability, muscle strength, and mobility. Studies highlight tailored exercises, neuromuscular training, and proprioceptive exercises in managing OA symptoms. The integration of these approaches underscores comprehensive knee OA management, addressing pain, function, and quality of life. The outcomes of this study could offer evidence-based recommendations for clinicians, aiding them in selecting the most appropriate manual therapy approach to alleviate pain, enhance joint mobility, and improve functional capacity in knee OA patients. Ultimately, this research seeks to contribute to the optimization of knee OA management strategies, improving the well-being of those affected.
- Conditions
- Knee Osteoarthritis
- Being tested
- Maitland's mobilization technique, Mulligan's mobilization techniques, Interferential Therapy (IFT)
- Keywords
- Maitland mobilization, Mulligan mobilization, Knee pain, Interferential therapy, WOMAC, Functional limitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maitland's mobilization techniqueOther
Maitland's mobilization technique was performed on the patients with its all components, such as 1. Distraction 2. Anteroposterior glides 3. Posteroanterior glides 4. Medial glides and 5. Lateral glides.
Mulligan's mobilization techniquesOther
Mulligan's mobilization technique was performed on the patients with its all components using a therapeutic belt, such as 1. Medial mobilization with movement (MWM) for Knee flexion 2. Medial mobilization with movement (MWM) for Knee extension 3. Lateral mobilization with movement (MWM) for Knee flexion 4. Lateral mobilization with movement (MWM) for Knee extension.
Interferential Therapy (IFT)Other
Interferential Therapy was performed on the patients with the following parameters: career frequency 4000Hz; waveform: rectangular; sweep time: 1 second rise and fall and 5 second stay; Treatment duration: 10 minutes; sweep frequency: 10 to 130 Hz. The current intensity was adjusted until the subject reported feeling a strong tingling sensation without causing muscle contraction. A aquatic gel was applied before straping the electopads over treatment area for smooth electrical conduction.
| Study group | Role | What they receive |
|---|---|---|
| Maitland Group | Experimental | Maitland Group received Maitland's mobilization techninque in addition to an intereferential therapy. Receives: Other: Maitland's mobilization technique; Other: Interferential Therapy (IFT) |
| Mulligan Group | Active comparator | Mulligan Group received Mulligan's mobilization techninque in addition to an intereferential therapy. Receives: Other: Mulligan's mobilization techniques; Other: Interferential Therapy (IFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional limitations
Functional limitations was assessed using the Western Ontario and McMaster Universities (WOMAC) index. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start10 Apr 2017
- Primary completion14 Sep 2017
- Study completion30 Oct 2017
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- Burdwan Institute of Medical and Life Sciences (BIMLS)
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- AMIR IQBAL, MPT, Study chair, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025929
- Sponsor's protocol ID
- BIMLS/67/2017
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Maitland Mobilization Versus Mulligan Mobilization Techniques With Common Use of Interferential Therapy in Patients With Knee Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT06025929
- Acronym / sponsor ID
- BIMLS/67/2017
- Conditions
- Knee Osteoarthritis
- Keywords
- Maitland mobilization, Mulligan mobilization, Knee pain, Interferential therapy, WOMAC, Functional limitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- Burdwan Institute of Medical and Life Sciences (BIMLS)
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 6 Sep 2023 (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.
This study aimed to determine the effects of different manual mobilization techniques on pain, muscle strength, and functional limitations in individuals with knee osteoarthritis (Knee OA). A double-blinded pretest-posttest experimental study. This research employed a two-arm parallel group randomized comparative design. A total of thirty participants diagnosed with knee osteoarthritis were randomly assigned and equally divided into groups 1 and 2, each containing 15 participants. Both Group 1 and Group 2 underwent Maitland and Mulligan mobilization techniques, alongside a common Interferential therapy (IFT) regimen, over the course of three sessions per week for a duration of four weeks. The assessment of pain and functional disability outcomes was conducted through the application of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at the baseline and four weeks following the intervention. To determine the effects of the intervention within and between the groups, the outcome scores were subjected to analysis using both dependent and independent t-tests.
Detailed description
Knee osteoarthritis (OA) is a prevalent disorder with significant global health implications, its prevalence varying across populations due to intricate factors. Recent investigations highlight an age-related increase in knee OA prevalence, particularly impacting those aged 60 and above, with projections indicating heightened impact due to aging demographics. Recent pathogenesis studies illuminate the intricate molecular and cellular processes underlying knee osteoarthritis (OA), encompassing cartilage degradation, subchondral bone changes, and inflammation.Recent advancements have expanded knee osteoarthritis (OA) management, including medical, surgical, and physiotherapy interventions. Pharmacological treatments such as analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and disease-modifying osteoarthritis drugs (DMOADs) remain fundamental for pain alleviation and inflammation reduction. Intra-articular therapies like corticosteroid injections and hyaluronic acid supplements offer localized relief and potential disease-modifying effects.Surgical interventions like total knee arthroplasty (TKA) provide pain relief and improved function for end-stage OA. Minimally invasive techniques like partial knee replacements and patient-specific implants aim to preserve joint function and enhance outcomes. Physiotherapy and rehabilitation are crucial, in improving stability, muscle strength, and mobility. Studies highlight tailored exercises, neuromuscular training, and proprioceptive exercises in managing OA symptoms. The integration of these approaches underscores comprehensive knee OA management, addressing pain, function, and quality of life. The outcomes of this study could offer evidence-based recommendations for clinicians, aiding them in selecting the most appropriate manual therapy approach to alleviate pain, enhance joint mobility, and improve functional capacity in knee OA patients. Ultimately, this research seeks to contribute to the optimization of knee OA management strategies, improving the well-being of those affected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maitland Group | Experimental | Other: Maitland's mobilization technique, Other: Interferential Therapy (IFT)Maitland Group received Maitland's mobilization techninque in addition to an intereferential therapy. |
| Mulligan Group | Active comparator | Other: Mulligan's mobilization techniques, Other: Interferential Therapy (IFT)Mulligan Group received Mulligan's mobilization techninque in addition to an intereferential therapy. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sub-acute or chronic osteoarthritis of knee.
- Age between 45-65 years.
- Gender Male and female.
- Subjects willing to participate in the study
Key exclusion criteria (15 listed)
- Presence of R.A, polyarthritis or systemic inflammatory arthropathies.
- History of total knee arthroplasty or major knee trauma injury.
- Fracture of lower limb within the past 6 months.
- Hip or ankle instability, excessive weakness, surgery or major trauma injury.
- Intra-articular steroid injection in knee joint within 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 |
|---|---|---|
| Maitland's mobilization techniqueMaitland's mobilization technique was performed on the patients with its all components, such as 1. Distraction 2. Anteroposterior glides 3. Posteroanterior glides 4. Medial glides and 5. Lateral glides. | Other | Maitland Group |
| Mulligan's mobilization techniquesMulligan's mobilization technique was performed on the patients with its all components using a therapeutic belt, such as 1. Medial mobilization with movement (MWM) for Knee flexion 2. Medial mobilization with movement (MWM) for Knee extension 3. Lateral mobilization with movement (MWM) for Knee flexion 4. Lateral mobilization with movement (MWM) for Knee extension. | Other | Mulligan Group |
| Interferential Therapy (IFT)Interferential Therapy was performed on the patients with the following parameters: career frequency 4000Hz; waveform: rectangular; sweep time: 1 second rise and fall and 5 second stay; Treatment duration: 10 minutes; sweep frequency: 10 to 130 Hz. The current intensity was adjusted until the subject reported feeling a strong tingling sensation without causing muscle contraction. A aquatic gel was applied before straping the electopads over treatment area for smooth electrical conduction. | Other | Maitland Group, Mulligan Group |
Primary outcome
Functional limitations
Time frame: 4 weeks
Functional limitations was assessed using the Western Ontario and McMaster Universities (WOMAC) index. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
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 8 Sep 2023.
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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.
AMIR IQBAL, MPT study chair
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maitland's mobilization technique, Mulligan's mobilization techniques and Interferential Therapy (IFT) in people with Knee Osteoarthritis, run by King Saud University 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 4 inclusion and 15 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 8 Sep 2023. 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?
Functional limitations (time frame: 4 weeks). 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 8 Sep 2023.