- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07402291
Effects of Mulligan's Pain Release Phenomenon and Kaltenborn Mobilizations on Knee Osteoarthritis
Comparative Effects of Mulligan's Pain Release Phenomenon and Kaltenborn Mobilizations on Pain, Range of Motion And Disability in Patients With Knee Osteoarthritis.
Knee osteoarthritis is a degenerative condition that is prevalent in older population and is associated with pain, stiffness, decreased range of motion and impaired function. Physical therapy techniques, such as Mulligan's Pain Release Phenomenon and Kaltenborn Mobilization are used to alleviate patient's symptoms.
A Randomized Clinical Trial was conducted at SAP Rehab Center (Saira Memorial hospital) and Pak Health Care, Lahore. 44 participants age between 40-65 years with Knee Osteoarthritis were randomly assigned into 2 groups. Both groups underwent treatment three times a week for total of six weeks. Group A received treatment through Mulligan's Pain Release Phenomenon along with conventional exercises. Group B received treatment through Kaltenborn mobilization and conventional exercises. Convectional treatment started with hot pack for 10 minutes followed by ultrasound for 8 minute, the program indcluded a series of exercises (Hamstring stretch, Gastrocnemius Stretch, Soleus Stretch and Rectus femoris Stretch all for 3 set with 10 repetitions and 10 seconds hold. Quadricep setting exercises 1 set with 10 repetitions, Full arc extension and Straight leg raises 1 set and 10 repetitions. the exercises program ended with cycling for 2 minutes. Outcome measures were conducted through NPRS for pain, WOMAC for functional disability, Universal Goniometer for range of motion at baseline and after 6 weeks. Data was analyzed through SPSS software version 27.
The aim of the study is to compare the effects of Mulligan's Pain Release Phenomenon and Kaltenborn Mobilization on pain, disability and range of motion in patients with early Knee Osteoarthritis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- SAP Rehab Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age included between 40-65 years
- NPRS pain rating above 3
- Both Genders
- Diagnosed with Grade 1 and Grade 2 knee osteoarthritis
- Unilateral knee pain
- Pain for more than 3 months
- Decrease range of motion
Exclusion Criteria:
- Age more than 60 years
- Bilateral knee pain
- Patellofemoral pain syndrome
- Rheumatoid Arthritis
- Fracture or ligamentous injury of lower extremity
- Any trauma, burn, infection or tumor around the knee
- Total knee replacement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Mulligan's pain release phenomenon
22 participants were allocated into Experimental group A, Mulligans Pain release compression were performed for 5 repetitions with 20-30 seconds hold with 5 seconds rest.
Convectional treatment included hot pack for 10 mins and ultrasound for 8 mins.
Exercises includes stretches for Hamstring, Gastrocnemius, Soleus and Rectus femoris for 3 set with 10 repetitions and 10 seconds hold.
Quadricep setting exercise, Full arc extension and Straight leg raises was done for 1 set of 10 repetitions and cycling was performed for 2 minutes.
A total of 18 sessions were conducted for 6 weeks with 3 sessions scheduled every week.
Outcome measures were measured in week 1 before the treatment and after 6 weeks of treatment.
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Experimental Group A was given Mulligan's pain release phenomenon compression techniques along with conventional therapy for 3 sessions per week for 6 weeks in total.
After Hot pack for 10 mins and Ultrasound for 8 mins participants performed series of exercises included targeted muscles stretchings (Hamstrings, Quadriceps, Soleus and Rectus femoris) 10 repetitions x 3 sets and 10 seconds hold.
Quadricep setting exercise, Full arc extension and Straight leg raises for 10 repetitions x 1 set followed by cycling for 2 mins.
|
|
Experimental: Kaltenborn mobilization with traction
22 participants were allocated into Experimental group B, Kaltenborn grade III mobilization with traction were performed for 10 repetitions with 3 sets treatment included hot pack for 10 mins and ultrasound for 8 mins.
Exercises includes stretches for Hamstring, Gastrocnemius, Soleus and Rectus femoris for 3 set with 10 repetitions and 10 seconds hold.
Quadricep setting exercise, Full arc extension and Straight leg raises was done for 1 set of 10 repetitions and cycling was performed for 2 minutes.
A total of 18 sessions were conducted for 6 weeks with 3 sessions scheduled every week.
Outcome measures were measured in week 1 before the treatment and after 6 weeks of treatment.
|
Experimental Group b was given grade III Kaltenborn mobilization with traction along with conventional therapy for 3 sessions per week for 6 weeks in total.
After Hot pack for 10 mins and Ultrasound for 8 mins participants performed series of exercises included targeted muscles stretchings (Hamstrings, Quadriceps, Soleus and Rectus femoris) 10 repetitions x 3 sets and 10 seconds hold.
Quadricep setting exercise, Full arc extension and Straight leg raises for 10 repetitions x 1 set followed by cycling for 2 mins.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric Pain Rating Scale (NPRS)
Time Frame: 6 weeks
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The Numeric Pain Rating Scale is a uni dimensional measure of pain severity in adults, including those with chronic pain caused by rheumatic disorders.
It is a 11 point numeric scale ranging from "0" representing no pain and "10" worst pain possible.
In this questionnaire the respondent selects a whole number from 0-10 that best reflects their intensity of pain, 1-3 means mild pain, 4-6 indicates moderate and 7-10 means severe pain.
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6 weeks
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 6 weeks
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Western Ontario and McMaster Universities Osteoarthritis Index is widely used is evaluation of hip and knee osteoarthritis.
This questionnaire have 24 items with 3 sub scales, measure pain (5 items), stiffness (2 items) and and physical function (17 items).
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6 weeks
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ROM Knee (Flexion)
Time Frame: 6 weeks
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Change from Baseline ROM of Knee Flexion was taken with the help of Universal Goniometer
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6 weeks
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ROM Knee (Extension)
Time Frame: 6 weeks
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Change from Baseline ROM of Knee Extension was taken with the help of Universal Goniometer
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ameena Amjad, Ph.D, Riphah International University
Publications and helpful links
General Publications
- Lalnunpuii A, Sarkar B, Alam S, Equebal A, Biswas A. Efficacy of mulligan mobilisation as compared to Maitland mobilisation in females with knee osteoarthritis: a double blind randomized controlled trial. International Journal of Therapies and Rehabilitation Research. 2017;6(2):37.
- Abramoff B, Caldera FE. Osteoarthritis: Pathology, Diagnosis, and Treatment Options. Med Clin North Am. 2020 Mar;104(2):293-311. doi: 10.1016/j.mcna.2019.10.007. Epub 2019 Dec 18.
- Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.
- Bhagat M, Neelapala YVR, Gangavelli R. Immediate effects of Mulligan's techniques on pain and functional mobility in individuals with knee osteoarthritis: A randomized control trial. Physiother Res Int. 2020 Jan;25(1):e1812. doi: 10.1002/pri.1812. Epub 2019 Sep 10.
- Ozden F, Nadiye Karaman O, Tugay N, Yalin Kilinc C, Mihriban Kilinc R, Umut Tugay B. The relationship of radiographic findings with pain, function, and quality of life in patients with knee osteoarthritis. J Clin Orthop Trauma. 2020 Jul;11(Suppl 4):S512-S517. doi: 10.1016/j.jcot.2020.04.006. Epub 2020 Apr 9.
- Taj S, Anwar K, Arshad H, Khalid M, Ali MQ, Hussain E. Effectiveness of Maitland Mobilization versus Pain release phenomena for pain, range of motion and disability in early knee osteoarthritis. Pakistan Journal of Medical & Health Sciences. 2023;17(01):30-.
- Bacon K, LaValley MP, Jafarzadeh SR, Felson D. Does cartilage loss cause pain in osteoarthritis and if so, how much? Ann Rheum Dis. 2020 Aug;79(8):1105-1110. doi: 10.1136/annrheumdis-2020-217363. Epub 2020 May 7.
- Sherazi F, Waqar S, Khalid M, Saleem K, Kiani SK, Shahzad M. Effect of knee joint mobilization on hamstring muscle length in patient with knee osteoarthritis. The Rehabilitation Journal. 2022;6(04):468-73.
- Olsson S, Akbarian E, Lind A, Razavian AS, Gordon M. Automating classification of osteoarthritis according to Kellgren-Lawrence in the knee using deep learning in an unfiltered adult population. BMC Musculoskelet Disord. 2021 Oct 2;22(1):844. doi: 10.1186/s12891-021-04722-7.
- Callahan LF, Cleveland RJ, Allen KD, Golightly Y. Racial/Ethnic, Socioeconomic, and Geographic Disparities in the Epidemiology of Knee and Hip Osteoarthritis. Rheum Dis Clin North Am. 2021 Feb;47(1):1-20. doi: 10.1016/j.rdc.2020.09.001. Epub 2020 Oct 29.
- Berteau JP. Knee Pain from Osteoarthritis: Pathogenesis, Risk Factors, and Recent Evidence on Physical Therapy Interventions. J Clin Med. 2022 Jun 7;11(12):3252. doi: 10.3390/jcm11123252.
- Xie R, Yao H, Mao AS, Zhu Y, Qi D, Jia Y, Gao M, Chen Y, Wang L, Wang DA, Wang K, Liu S, Ren L, Mao C. Biomimetic cartilage-lubricating polymers regenerate cartilage in rats with early osteoarthritis. Nat Biomed Eng. 2021 Oct;5(10):1189-1201. doi: 10.1038/s41551-021-00785-y. Epub 2021 Oct 4.
- Sanchez-Lopez E, Coras R, Torres A, Lane NE, Guma M. Synovial inflammation in osteoarthritis progression. Nat Rev Rheumatol. 2022 May;18(5):258-275. doi: 10.1038/s41584-022-00749-9. Epub 2022 Feb 14.
- Hendrika W, Reswari A. The effect of physiotherapy on pain improvement in patients with early knee osteoarthritis at RSU UKI. International Journal of Medical and Health Research. 2021;7(6):52-9.
- Elboim-Gabyzon M, Nahhas F. Laser therapy versus pulsed electromagnetic field therapy as treatment modalities for early knee osteoarthritis: a randomized controlled trial. BMC Geriatr. 2023 Mar 16;23(1):144. doi: 10.1186/s12877-022-03568-5.
- Umar M, Anwar A, Khan N, Marryam M, Rashid H. Effectiveness Of Kaltenborn Mobilization Versus Muscle Energy Technique On Shoulder Range Of Motion In Adhesive Capsulitis. Journal of Rawalpindi Medical College. 2023;27(3).
- Anwar S, Javaid M, Malik S, Asghar MU, Perveen W, Chaudary M. Effects of mulligan pain release phenomenon technique in management of patellofemoral pain syndrome: RCT. Pakistan Journal of Medical & Health Sciences. 2022;16(03):72-.
- Mangus BC, Hoffman LA, Hoffman MA, Altenburger P. Basic principles of extremity joint mobilization using a Kaltenborn approach. Journal of Sport Rehabilitation. 2002;11(4):235-50.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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