Knee OsteoarthritisNCT04818307
Mulligan Mobilization With Movement Versus Macquarie Injury Management Group in Function and Pain of Knee Osteoarthritis
A study testing Macquarie Injury Management group and Mulligan Mobilization with Movement in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
Knee pain is one of the most usual pain that commonly affects people especially in the late age. It can be caused by osteoarthritis, poor posture or sitting position, bad bending or improper lifting. It is usually not caused by a serious illness. It is the most common cause of disability. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Macquarie Injury Management group and Mulligan Mobilization with Movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2020to 30 Dec 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ACR criteria for knee will be over age 50
- less than 30 minutes of morning stiffness,
- Crepitus on active motion,
- Tenderness
- Enlargement
- No palpable warmth of synovium.
- Osteoarthritis grade 1 and 2 by Kelly-green and Lawrence method.
Who cannot join
- Any surgical procedure done in past 6 months and metal implants in lower extremity.
- Any infection and neoplastic disorder.
- Post traumatic knee stiffness.
- Secondary knee O A peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Effects of Mulligan Mobilization With Movement Versus Macquarie Injury Management Group on Function and Pain of Knee Osteoarthritis
Knee pain is one of the most usual pain that commonly affects people especially in the late age. It can be caused by osteoarthritis, poor posture or sitting position, bad bending or improper lifting. It is usually not caused by a serious illness. It is the most common cause of disability. To compare the long term effects of Mulligan Mobilization with Movement versus Macquarie Injury Management Group on pain and function of knee osteoarthritis.
Read the detailed description
It was a randomized clinical trial conducted in Revival Physiotherapy Center, Lahore. A convenient sample of 26 diagnosed patients with osteoarthritis was included in the study. Subjects were randomly distributed in to two groups with use of flip coin method Group of randomization. Group 1 patients got MIMG with routine physical therapy and Group 2 got MWM with routine physical therapy. Visual analogue Scale (VAS),Non modified WOMAC were used to assess all patients before and after 4 weeks of intervention. Statistical analysis was computed by SPSS 20.0.
- Conditions
- Knee Osteoarthritis
- Being tested
- Macquarie Injury Management group, Mulligan Mobilization with Movement
- Keywords
- Knee Pain, Movement with Mobilization
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macquarie Injury Management groupOther
Group A was treated by MIMG (soft tissue mobilization) with base line treatment (Hot pack for 10 mint, Quadriceps Isometrics, Stretching). For the application of technique subject lies supine with extended knee, therapist places both hands on the knee and gently apply soft tissue release. This procedure was applied for 2 to 3 minutes.
Mulligan Mobilization with MovementOther
Group B was treated by Mulligan Mobilization with movement with base line treatment (Hot Pack for 10 mints, Quadriceps Isometrics, Stretching). For the application of technique subject lies supine with 30 degree knee flexion, therapist places right hand below the knee and left hand above the knee. Apply the lateral glide on the joint. This procedure was applied for 3 times.
| Study group | Role | What they receive |
|---|---|---|
| Macquarie Injury Management group | Experimental | Not described Receives: Other: Macquarie Injury Management group |
| Mulligan Mobilization with Movement | Active comparator | Not described Receives: Other: Mulligan Mobilization with Movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue scale
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: 6 months
WOMAC
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. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Apr 2020
- Primary completion30 Nov 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Shabbir, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818307
- Sponsor's protocol ID
- REC/Lhr/1064
- Status last verified
- Aug 2021
- First submitted
- 25 Mar 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kandada S, Heggannavar A. Effect of Mulligan's MWM versus Macquarie Injury Management Group (MIMG) protocol on pain and function in osteoarthritis of knee: a randomised clinical trial. IJTRR. 2015;4(4):125-31.
Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.
PubMed 23559821Felson DT. The epidemiology of knee osteoarthritis: results from the Framingham Osteoarthritis Study. Semin Arthritis Rheum. 1990 Dec;20(3 Suppl 1):42-50. doi: 10.1016/0049-0172(90)90046-i.
PubMed 2287948Felson DT, Gale DR, Elon Gale M, Niu J, Hunter DJ, Goggins J, Lavalley MP. Osteophytes and progression of knee osteoarthritis. Rheumatology (Oxford). 2005 Jan;44(1):100-4. doi: 10.1093/rheumatology/keh411. Epub 2004 Sep 20.
PubMed 15381791Cooper C, McAlindon T, Coggon D, Egger P, Dieppe P. Occupational activity and osteoarthritis of the knee. Ann Rheum Dis. 1994 Feb;53(2):90-3. doi: 10.1136/ard.53.2.90.
PubMed 8129467Alshami AM. Knee osteoarthritis related pain: a narrative review of diagnosis and treatment. Int J Health Sci (Qassim). 2014 Jan;8(1):85-104. doi: 10.12816/0006075.
PubMed 24899883
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Mulligan Mobilization With Movement Versus Macquarie Injury Management Group on Function and Pain of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04818307
- Acronym / sponsor ID
- REC/Lhr/1064
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Pain, Movement with Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 26 Mar 2021 (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 pain is one of the most usual pain that commonly affects people especially in the late age. It can be caused by osteoarthritis, poor posture or sitting position, bad bending or improper lifting. It is usually not caused by a serious illness. It is the most common cause of disability. To compare the long term effects of Mulligan Mobilization with Movement versus Macquarie Injury Management Group on pain and function of knee osteoarthritis.
Detailed description
It was a randomized clinical trial conducted in Revival Physiotherapy Center, Lahore. A convenient sample of 26 diagnosed patients with osteoarthritis was included in the study. Subjects were randomly distributed in to two groups with use of flip coin method Group of randomization. Group 1 patients got MIMG with routine physical therapy and Group 2 got MWM with routine physical therapy. Visual analogue Scale (VAS),Non modified WOMAC were used to assess all patients before and after 4 weeks of intervention. Statistical analysis was computed by SPSS 20.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macquarie Injury Management group | Experimental | Other: Macquarie Injury Management group |
| Mulligan Mobilization with Movement | Active comparator | Other: Mulligan Mobilization with Movement |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ACR criteria for knee will be over age 50
- less than 30 minutes of morning stiffness,
- Crepitus on active motion,
- Tenderness
- Enlargement
Key exclusion criteria (4 listed)
- Any surgical procedure done in past 6 months and metal implants in lower extremity.
- Any infection and neoplastic disorder.
- Post traumatic knee stiffness.
- Secondary knee O A peripheral vascular disease
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 |
|---|---|---|
| Macquarie Injury Management groupGroup A was treated by MIMG (soft tissue mobilization) with base line treatment (Hot pack for 10 mint, Quadriceps Isometrics, Stretching). For the application of technique subject lies supine with extended knee, therapist places both hands on the knee and gently apply soft tissue release. This procedure was applied for 2 to 3 minutes. | Other | Macquarie Injury Management group |
| Mulligan Mobilization with MovementGroup B was treated by Mulligan Mobilization with movement with base line treatment (Hot Pack for 10 mints, Quadriceps Isometrics, Stretching). For the application of technique subject lies supine with 30 degree knee flexion, therapist places right hand below the knee and left hand above the knee. Apply the lateral glide on the joint. This procedure was applied for 3 times. | Other | Mulligan Mobilization with Movement |
Primary outcome
Visual Analogue scale
Time frame: 6 months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
WOMAC
Time frame: 6 months
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. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores.
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 2 Sep 2021.
- BackgroundKandada S, Heggannavar A. Effect of Mulligan's MWM versus Macquarie Injury Management Group (MIMG) protocol on pain and function in osteoarthritis of knee: a randomised clinical trial. IJTRR. 2015;4(4):125-31.
- Background: PubMed 23559821Bhatia D, Bejarano T, Novo M. Current interventions in the management of knee osteoarthritis. J Pharm Bioallied Sci. 2013 Jan;5(1):30-8. doi: 10.4103/0975-7406.106561.
- Background: PubMed 2287948Felson DT. The epidemiology of knee osteoarthritis: results from the Framingham Osteoarthritis Study. Semin Arthritis Rheum. 1990 Dec;20(3 Suppl 1):42-50. doi: 10.1016/0049-0172(90)90046-i.
- Background: PubMed 15381791Felson DT, Gale DR, Elon Gale M, Niu J, Hunter DJ, Goggins J, Lavalley MP. Osteophytes and progression of knee osteoarthritis. Rheumatology (Oxford). 2005 Jan;44(1):100-4. doi: 10.1093/rheumatology/keh411. Epub 2004 Sep 20.
- Background: PubMed 8129467Cooper C, McAlindon T, Coggon D, Egger P, Dieppe P. Occupational activity and osteoarthritis of the knee. Ann Rheum Dis. 1994 Feb;53(2):90-3. doi: 10.1136/ard.53.2.90.
- Background: PubMed 24899883Alshami AM. Knee osteoarthritis related pain: a narrative review of diagnosis and treatment. Int J Health Sci (Qassim). 2014 Jan;8(1):85-104. doi: 10.12816/0006075.
- 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.
Maryam Shabbir principal investigator
Riphah International 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 Macquarie Injury Management group and Mulligan Mobilization with Movement in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
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 7 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 2 Sep 2021. 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 Pakistan. 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?
Visual Analogue scale (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04818307, which also lists 6 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 2 Sep 2021.