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Osteo Arthritis KneeNCT04944056

Effects of Compression Mobilization in OA Patients

A study testing conventional physiotherapy and compression mobilization in people with Osteo Arthritis Knee, run by Mir Arif Hussain at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study Design was randomized control trial in which data was collected From Riphah Rehabilitation And Research Center and Pakistan Railway Hospital-IIMCT. Convenient sampling technique was used for data collection. 39 patients having knee osteoarthritis were recruited in this study. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
conventional physiotherapy and compression mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 sitePakistan
Study dates
21 Jun 2021to 11 Jul 2021
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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age Limit 30 to 60
  • Unilateral OA Knee
  • Moderate OA

Who cannot join

  • No Associated Bone Disease
  • Lumber Radiculopathy
  • Osteoporosis
  • Any MSK Deformity

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah Rehabilitation And Research Center and Pakistan Railway Hospital-IIMCT

    Islamabad, Capital, 44000

Other trials in Pakistan

About this study

Official title: Effect of Compression Mobilization (Kaltenborn Technique) in Knee Osteoarthritis Patients

The study Design was randomized control trial in which data was collected From Riphah Rehabilitation And Research Center and Pakistan Railway Hospital-IIMCT. Convenient sampling technique was used for data collection. 39 patients having knee osteoarthritis were recruited in this study. After taking consent from patients, patients were divided randomly into two groups through lottery method. The Experimental Group received compression mobilization with Conventional Physiotherapy (n = 19) and the Control group received Conventional Physiotherapy (n = 20). Research data was collected through structural questionnaire. the main variables were ROM, MMT, Muscle length and mBBS.

Read the detailed description

Osteoarthritis (OA) is a disease which since long times is considered to be a "wear and tear" malfunctioning disease leading to a loss of cartilage. Osteoarthritis is considered as a "degenerative joint disease Osteoarthritis is a term used for disease in which destruction of cartilage is involved (articular), with a bone thickening (subchondral) and formation of new bone. . Joint swelling is also considered as one significant clinical feature of osteoarthritis attributes to inflammation. Osteoarthritis is one of the most common type in arthritis as well as the major cause of chronic musculoskeletal pain. In addition it is attributed to mobility disability in the elder or high aged population all over the world. If we have a glimpse of Asia, prevalence rate of knee osteoarthritis is believed to be higher in the elder population most probably in women. Susan et all conducted a mega level study related to symptomatic OA, where it has been observed that there is an increasing shift in the incidental rates of OA with the age. So, it was concluded that incidence related to knee OA in women limiting the age between 70-89, approached per year is 1% in women and they had the higher rates as compared to males, especially once they are over 50 years of age. Levelling-off or declining shift tends to occur for both groups approximately at the age of 80. Research says that in China, this prevailing rate of mentioned osteoarthritis disease is 7.50%, with a ratio of 10.9 \& 13.6% in males and females respectively. Bangladesh and India reports 5.80 \& 10.20% respectively. Now considering mainland of Pakistan, 28% urban whereas 25% rural population suffer this particular disease.

Women are likely to suffer more with the OA as compared to men and they also tend to undergo the disease of OA with more severity. The marked increase of OA in females at menopause stages has directed towards investigational hypothesis that hormonal imbalance factor may perform a significant role for the developing of OA. However, results appearing on estrogen effects, either it's endogenous or exogenous, on OA as revealed from various observational researches have been contradictory. In a randomize clinical trials(the Heart and Estrogen/Progestin Replacement Study) considering the group of elder postmenopausal females suffering from heart disease, none significant variation was observed in persistence of knee pain or any associated disability while comparing those undergoing estrogen plus progestin therapy or those taking placebo.

The prevalence of OA disease and joints patterns that are effected by OA possibly vary amongst the ethnic and racial groups. The frequency of Hand and Hip OA was found remarkably less in Chinese, concluded in the Beijing Osteoarthritis Study, in resemblance to whites researched under Framingham Study. it's important to mention that Chinese females observed under the Beijing Osteoarthritis Study had considerably high prevalence of both symptomatic knee OA and radiographic knee OA as compared to white females at Framingham Study. Results while having consideration of Johnston County Osteoarthritis Project have showed the prevalence of hip OA in African American females(23%) was similar to that in white ladies (22%), with a conclusion that prevalence was a bit higher in African American men (21%) than that in white.

Result of various studies showed that dietary factor is a subject of considerable interest related to OA affected individuals. Vitamin D is considered as most advantageous nutritional factor for OA patients. Insufficiency of this specified vitamin will lead to bones thinness, brittleness or any mishaps.

Corpulence (Obesity leading to overweight) have since long been predicted as the most potent risk factor to OA, especially knee OA. A more consistence and reliable evidence found is that the alarming effects occurs due to obesity are the risks of bi-lateral radiography and symptomatic hip OA. So, it is considered that application of increased loads on joints is probably a major cause, but not necessarily, a mechanism by which the obesity results into hip or knee OA. Whereas, an application of overloading the knee and hip joints could possibly directed towards synovial joint breakdown and failure of ligamentous as well as other structural support.

A lot many studies provides evidence that knee injury is surely one of the strongest factor for risking OA. Severe conditions of injury to joints structures, particularly mentioning the meniscal tear that requiring meniscectomy, or trans-articular fracture or anterior cruciate ligament injury; may these all results into increased risk involvement of OA development and also musculoskeletal symptomatology.

Repeated use of particular joints for work is marked with the increasing risk of OA. The risk factor involved in the development of knee OA was at least two times more for men whose consistency in jobs require both kneeling and carrying or squatness in a mid-life would definitely have more risk of developing OA by the nature of their commitments as compared to women whose job commitments do not offer these physical activities in common. Therefore, its a must mention that knee OA risks which are associated with squatness or kneeling are much higher amongst those who are overweighed or who are indulgent in lifting.

Being tested
conventional physiotherapy, compression mobilization
Keywords
NPRS, mBBS, MMT, O.A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional physiotherapyOther

    • Ultrasound therapy 3-4 minutes.
    • Tibiofemoral AP and PA glides 1 set x10reps x 3 sets.
    • Patellar glides 1 set x 5 reps x 3 sets.
    • Quads isometrics 1 set x 10 reps.
    • Hams self stretching 1 sets x 10 reps.

    Home plan:

    • Quads isometrics 1 set x 10 reps.
    • Hams self stretching 1 sets x 10 reps.
    • Active range of motion.
  • compression mobilizationOther

    • Ultrasound therapy 3-4 minutes.
    • Tibiofemoral AP and PA glides 1 set x10reps x 3 sets.
    • Patellar glides 1 set x 5 reps x 3 sets.
    • Quads isometrics 1 set x 10 reps.
    • Hams self stretching 1 sets x 10 reps.
    • Compression mobilization 1 set x 10 reps x 3sets.

    Home plan:

    • Quads isometrics 1 set x 10 reps.
    • Hams self stretching 1 sets x 10 reps.
    • Active range of motion.
Study groups in NCT04944056
Study groupRoleWhat they receive
Control GroupActive comparatorIt includes ultrasound therapy, glides, exercises and home plan.
Receives: Other: conventional physiotherapy
Experimental GroupExperimentalIt includes ultrasound therapy, glides, exercises, compression mobilization and home plan.
Receives: Other: compression mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vernier Calliper For Joint Gap Measurement.

    Vernier caliper, instrument for making very accurate linear measurements introduced in 1631 by Pierre Vernier of France. It can be used for joint space via x-ray radiograph of a joint.

    Measured: 2 weeks

  2. Numeric Pain Rating Scale

    Numeric pain rating scale is a scale used to quantify pain intensity. It is divided into eleven equal parts; for example 0 - 10. O means that there is no pain at all, 1 - 3 divisional range falls in the mild category pain , 4 - 6 indicates the symptoms of moderate pain while 7 - 10 reading symptoms the severity of pain.

    Measured: 2 weeks

  3. Goniometry for knee ROM

    The Range of motion was assessed by Goniometer. The placement of goniometer for flexion as follows the Axis of goniometer was placed at lateral epicondyle of femur laterally , stationary arm was along femur and the moving arm was along the fibula and the patient position was supine then ask the patient to flex knee until hip flexion came up to 90 degrees while monitors the measurements through goniometer .

    Measured: 2 weeks

  4. Modified Berg Balance tool

    The Berg Balance Scale (BBS) is based on 14 items common to daily life activities used to evaluate functional balance .here berg balance scale is used to assess patients proprioception through different tasks.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start21 Jun 2021
  3. Primary completion11 Jul 2021
  4. Study completion11 Jul 2021

Resources

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
Model description
The experimental Group received compression mobilization with Conventional Physiotherapy and the control group received Conventional Physiotherapy
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944056
Sponsor's protocol ID
Shakeeba Shahzadi 00189
Status last verified
Sep 2021
First submitted
22 Jun 2021
Last updated
5 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013 Jan;21(1):16-21. doi: 10.1016/j.joca.2012.11.012. Epub 2012 Nov 27.

    PubMed 23194896
  • Blagojevic M, Jinks C, Jeffery A, Jordan KP. Risk factors for onset of osteoarthritis of the knee in older adults: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2010 Jan;18(1):24-33. doi: 10.1016/j.joca.2009.08.010. Epub 2009 Sep 2.

    PubMed 19751691
  • Brandt KD, Fife RS, Braunstein EM, Katz B. Radiographic grading of the severity of knee osteoarthritis: relation of the Kellgren and Lawrence grade to a grade based on joint space narrowing, and correlation with arthroscopic evidence of articular cartilage degeneration. Arthritis Rheum. 1991 Nov;34(11):1381-6. doi: 10.1002/art.1780341106.

    PubMed 1953815
  • van Saase JL, van Romunde LK, Cats A, Vandenbroucke JP, Valkenburg HA. Epidemiology of osteoarthritis: Zoetermeer survey. Comparison of radiological osteoarthritis in a Dutch population with that in 10 other populations. Ann Rheum Dis. 1989 Apr;48(4):271-80. doi: 10.1136/ard.48.4.271.

    PubMed 2712610
  • Rhon D. Re: Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage 2008;16:137-62. Osteoarthritis Cartilage. 2008 Dec;16(12):1585; author reply 1589. doi: 10.1016/j.joca.2008.04.019. Epub 2008 Jun 2. No abstract available.

    PubMed 18515155
  • Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.

    PubMed 24024017
  • Fransen M, Bridgett L, March L, Hoy D, Penserga E, Brooks P. The epidemiology of osteoarthritis in Asia. Int J Rheum Dis. 2011 May;14(2):113-21. doi: 10.1111/j.1756-185X.2011.01608.x.

    PubMed 21518309
  • Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: The Framingham Study. Am J Epidemiol. 2002 Dec 1;156(11):1021-7. doi: 10.1093/aje/kwf141.

    PubMed 12446258
  • Haq SA, Darmawan J, Islam MN, Uddin MZ, Das BB, Rahman F, Chowdhury MA, Alam MN, Mahmud TA, Chowdhury MR, Tahir M. Prevalence of rheumatic diseases and associated outcomes in rural and urban communities in Bangladesh: a COPCORD study. J Rheumatol. 2005 Feb;32(2):348-53.

    PubMed 15693098
  • Nelson AE, Braga L, Renner JB, Atashili J, Woodard J, Hochberg MC, Helmick CG, Jordan JM. Characterization of individual radiographic features of hip osteoarthritis in African American and White women and men: the Johnston County Osteoarthritis Project. Arthritis Care Res (Hoboken). 2010 Feb;62(2):190-7. doi: 10.1002/acr.20067.

    PubMed 20191517
  • Kon E, Mandelbaum B, Buda R, Filardo G, Delcogliano M, Timoncini A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular injection versus hyaluronic acid viscosupplementation as treatments for cartilage pathology: from early degeneration to osteoarthritis. Arthroscopy. 2011 Nov;27(11):1490-501. doi: 10.1016/j.arthro.2011.05.011. Epub 2011 Aug 10.

    PubMed 21831567
  • Takasaki H, Hall T, Jull G. Immediate and short-term effects of Mulligan's mobilization with movement on knee pain and disability associated with knee osteoarthritis--a prospective case series. Physiother Theory Pract. 2013 Feb;29(2):87-95. doi: 10.3109/09593985.2012.702854. Epub 2012 Jul 30.

    PubMed 22844980

Questions about this trial

What is this clinical trial studying?

A study testing conventional physiotherapy and compression mobilization in people with Osteo Arthritis Knee, run by Mir Arif Hussain 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 3 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 5 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?

Vernier Calliper For Joint Gap Measurement. (time frame: 2 weeks). The study lists 4 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 NCT04944056, which also lists 12 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 5 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.

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