Knee OsteoarthritisNCT06751095
Effects Of Maitland's Mobilization At Mid Versus End Range In Knee Osteoarthritis Patients
A study testing Maitland's Mobilization in End range and Maitland's mobilization in Mid range in people with Knee Osteoarthritis, run by Riphah International University.
Trial summary
Knee Osteoarthritis (OA) is the most common form of arthritis affecting mostly elderly people contributing to major cause of disability worldwide.In knee osteoarthritis Maitland's manual therapy technique could be the most effective technique among all in decreasing pain sensitivity and increasing range of motion in… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Maitland's Mobilization in End range and Maitland's mobilization in Mid range
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with age between 40 to 60 years.
- Participants of both genders will be included.
- Patient with unilateral/bilateral symptomatic tibiofemoral knee OA.
- Patient suffering from stiffness less than 30 minutes
- Patients with radiologically diagnosed case of grade 2 knee OA according to the Kellgren and Lawrence scale
- Patients with reported peak knee pain of >3 on visual analogue scale (VAS)
Who cannot join
- Participants with acute inflammation of knee
- Participants with severe degenerative lumbar spine disease e.g spondylolisthesis
- Participants with systemic inflammatory arthritic or neurological conditions
- Participants with intraarticular injection in the prior 3 months
- Participants with unstable heart condition
- Participants with received physical therapy of knee in last 3 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects Of Maitland's Mobilization At Mid Versus End Range On Pain, Range Of Motion And Functional Disability In Patients With Knee Osteoarthritis.
Knee Osteoarthritis (OA) is the most common form of arthritis affecting mostly elderly people contributing to major cause of disability worldwide.In knee osteoarthritis Maitland's manual therapy technique could be the most effective technique among all in decreasing pain sensitivity and increasing range of motion in knee OA.The aim of this study to compare effects of Maitland's mobilization at mid range versus end range on pain. range of motion and functional disability in patients with knee OA, providing useful insights for healthcare professionals to optimize treatment strategies and enhance outcomes in this context.
Read the detailed description
Knee Osteoarthritis (OA) is the most common form of arthritis affecting mostly elderly people contributing to major cause of disability worldwide.In knee osteoarthritis Maitland's manual therapy technique could be the most effective technique among all in decreasing pain sensitivity and increasing range of motion in knee OA.The aim of this study to compare effects of Maitland's mobilization at mid range versus end range on pain. range of motion and functional disability in patients with knee OA, providing useful insights for healthcare professionals to optimize treatment strategies and enhance outcomes in this context.
This Randomized Clinical Trial will be conducted at DHQ Gujrat through consecutive sampling technique on 44 patients which will be allocated using simple random sampling through sealed opaque enveloped into (Group A and Group B).Maitland's mobilization at end range(Group A) incorporates the end range Maitland's mobilization,strengthening exercises, knee isometrics, transcutaneous electrical stimulation(TENS) and heating pad .
Maitland's mobilization in Mid range (Group B) will be treated with Mid range Maitland's mobilization, TENS,strengthening exercises,knee isometrics and heating pad.Outcomes, encompassing pain levels, range of motion(ROM), and functional disability will be evaluated through Visual analogue scale (VAS),Goniometer and WOMAC scale.The treatment plan spans 4 weeks, comprising 3 sessions per week. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Data will be collected at baseline and after 4 weeks of follow up.
- Conditions
- Knee Osteoarthritis
- Being tested
- Maitland's Mobilization in End range, Maitland's mobilization in Mid range
- Keywords
- joint range of motion, knee osteoarthritis
- 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 in End rangeOther
End-range mobilization will be performed individually in flexion and extension end range of the tibiofemoral joint .(0-135 degree)
Maitland's mobilization in Mid rangeOther
Mid range Maitland's mobilization will be performed in (approx. 50-70° knee flexion) of the tibiofemoral joint
| Study group | Role | What they receive |
|---|---|---|
| Maitland's Mobilization in End Range | Experimental | End-range mobilization will be performed individually in flexion and extension end range of the tibiofemoral joint(0-135 degree). Receives: Other: Maitland's Mobilization in End range |
| Maitland's Mobilization in Mid Range | Experimental | Mid range Maitland's mobilization will be performed in (approx. 50-70° knee flexion) of the tibiofemoral joint. Receives: Other: Maitland's mobilization in Mid range |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numerical Pain Rating Scale (NPRS) is a commonly used self-report measure to assess the intensity of pain experienced by individuals. Participants rate their pain on a numerical scale, typically ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 4 Weeks
Secondary outcomes (2)
WOMAC Osteoarthritis INDEX
The western Ontario and McMaster Universities Arthritis Index(WOMAC) is widely uses in the evaluation of Hip and Knee Osteoarthritis. It is a self administrated questionnaire consisting of 24 item divided into 3 sub-scales: Pain(5items) ,stiffness(2 items) and physical function (17 items)
Measured: 4 weeks
Universal Goniometer
It will measure range of motion of Knee
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 posted27 Dec 2024
- Study start10 Jan 2025 (estimated)
- Primary completion25 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zainab Amjad Dr., DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751095
- Sponsor's protocol ID
- REC/RCR&AHS/24/0114
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suzuki Y, Iijima H, Tashiro Y, Kajiwara Y, Zeidan H, Shimoura K, Nishida Y, Bito T, Nakai K, Tatsumi M, Yoshimi S, Tsuboyama T, Aoyama T. Home exercise therapy to improve muscle strength and joint flexibility effectively treats pre-radiographic knee OA in community-dwelling elderly: a randomized controlled trial. Clin Rheumatol. 2019 Jan;38(1):133-141. doi: 10.1007/s10067-018-4263-3. Epub 2018 Aug 30.
PubMed 30167975Steultjens MP, Dekker J, van Baar ME, Oostendorp RA, Bijlsma JW. Range of joint motion and disability in patients with osteoarthritis of the knee or hip. Rheumatology (Oxford). 2000 Sep;39(9):955-61. doi: 10.1093/rheumatology/39.9.955.
PubMed 10986299Pozsgai M, Udvaracz K, Peter IA, Than P, Nusser N. Effect of single end-range and not end-range Maitland mobilization on pressure pain threshold and functional measures in knee osteoarthritis: randomised, controlled clinical trial. Eur J Phys Rehabil Med. 2022 Oct;58(5):774-783. doi: 10.23736/S1973-9087.22.07506-2. Epub 2022 Sep 12.
PubMed 36094367
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Maitland's Mobilization At Mid Versus End Range On Pain, Range Of Motion And Functional Disability In Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06751095
- Acronym / sponsor ID
- REC/RCR&AHS/24/0114
- Conditions
- Knee Osteoarthritis
- Keywords
- joint range of motion, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- 25 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
Knee Osteoarthritis (OA) is the most common form of arthritis affecting mostly elderly people contributing to major cause of disability worldwide.In knee osteoarthritis Maitland's manual therapy technique could be the most effective technique among all in decreasing pain sensitivity and increasing range of motion in knee OA.The aim of this study to compare effects of Maitland's mobilization at mid range versus end range on pain. range of motion and functional disability in patients with knee OA, providing useful insights for healthcare professionals to optimize treatment strategies and enhance outcomes in this context.
Detailed description
Knee Osteoarthritis (OA) is the most common form of arthritis affecting mostly elderly people contributing to major cause of disability worldwide.In knee osteoarthritis Maitland's manual therapy technique could be the most effective technique among all in decreasing pain sensitivity and increasing range of motion in knee OA.The aim of this study to compare effects of Maitland's mobilization at mid range versus end range on pain. range of motion and functional disability in patients with knee OA, providing useful insights for healthcare professionals to optimize treatment strategies and enhance outcomes in this context.
This Randomized Clinical Trial will be conducted at DHQ Gujrat through consecutive sampling technique on 44 patients which will be allocated using simple random sampling through sealed opaque enveloped into (Group A and Group B).Maitland's mobilization at end range(Group A) incorporates the end range Maitland's mobilization,strengthening exercises, knee isometrics, transcutaneous electrical stimulation(TENS) and heating pad .
Maitland's mobilization in Mid range (Group B) will be treated with Mid range Maitland's mobilization, TENS,strengthening exercises,knee isometrics and heating pad.Outcomes, encompassing pain levels, range of motion(ROM), and functional disability will be evaluated through Visual analogue scale (VAS),Goniometer and WOMAC scale.The treatment plan spans 4 weeks, comprising 3 sessions per week. Data will be analyzed during SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Data will be collected at baseline and after 4 weeks of follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maitland's Mobilization in End Range | Experimental | Other: Maitland's Mobilization in End rangeEnd-range mobilization will be performed individually in flexion and extension end range of the tibiofemoral joint(0-135 degree). |
| Maitland's Mobilization in Mid Range | Experimental | Other: Maitland's mobilization in Mid rangeMid range Maitland's mobilization will be performed in (approx. 50-70° knee flexion) of the tibiofemoral joint. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants with age between 40 to 60 years.
- Participants of both genders will be included.
- Patient with unilateral/bilateral symptomatic tibiofemoral knee OA.
- Patient suffering from stiffness less than 30 minutes
- Patients with radiologically diagnosed case of grade 2 knee OA according to the Kellgren and Lawrence scale
Key exclusion criteria (6 listed)
- Participants with acute inflammation of knee
- Participants with severe degenerative lumbar spine disease e.g spondylolisthesis
- Participants with systemic inflammatory arthritic or neurological conditions
- Participants with intraarticular injection in the prior 3 months
- Participants with unstable heart condition
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 in End rangeEnd-range mobilization will be performed individually in flexion and extension end range of the tibiofemoral joint .(0-135 degree) | Other | Maitland's Mobilization in End Range |
| Maitland's mobilization in Mid rangeMid range Maitland's mobilization will be performed in (approx. 50-70° knee flexion) of the tibiofemoral joint | Other | Maitland's Mobilization in Mid Range |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 Weeks
The Numerical Pain Rating Scale (NPRS) is a commonly used self-report measure to assess the intensity of pain experienced by individuals. Participants rate their pain on a numerical scale, typically ranging from 0 (no pain) to 10 (worst possible pain).
2 secondary outcomes
WOMAC Osteoarthritis INDEX
Time frame: 4 weeks
Universal Goniometer
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 30167975Suzuki Y, Iijima H, Tashiro Y, Kajiwara Y, Zeidan H, Shimoura K, Nishida Y, Bito T, Nakai K, Tatsumi M, Yoshimi S, Tsuboyama T, Aoyama T. Home exercise therapy to improve muscle strength and joint flexibility effectively treats pre-radiographic knee OA in community-dwelling elderly: a randomized controlled trial. Clin Rheumatol. 2019 Jan;38(1):133-141. doi: 10.1007/s10067-018-4263-3. Epub 2018 Aug 30.
- Background: PubMed 10986299Steultjens MP, Dekker J, van Baar ME, Oostendorp RA, Bijlsma JW. Range of joint motion and disability in patients with osteoarthritis of the knee or hip. Rheumatology (Oxford). 2000 Sep;39(9):955-61. doi: 10.1093/rheumatology/39.9.955.
- Background: PubMed 36094367Pozsgai M, Udvaracz K, Peter IA, Than P, Nusser N. Effect of single end-range and not end-range Maitland mobilization on pressure pain threshold and functional measures in knee osteoarthritis: randomised, controlled clinical trial. Eur J Phys Rehabil Med. 2022 Oct;58(5):774-783. doi: 10.23736/S1973-9087.22.07506-2. Epub 2022 Sep 12.
- 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.
Zainab Amjad Dr., DPT principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing Maitland's Mobilization in End range and Maitland's mobilization in Mid range in people with Knee Osteoarthritis, run by Riphah International University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saba Rafique Dr., DPT,MS-OMPT (03034045433, saba.rafique@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06751095, which also lists 3 linked publications.
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 27 Dec 2024.