Osteoarthritis, KneeNCT04769531
Hip Joint Mobilizations and Strength Training in Patients With Knee OA Osteoarthritis
A study testing Hip Joint Mobilizations, Hip joint Muscle strength training and knee strengthening and flexibility exercises in people with Osteoarthritis, Knee, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Knee osteoarthritis has been ranked 11th highest contributor to non-fatal burdens in the world. Many research studies have discussed the relationship of hip muscle with knee joint stating that impaired hip strength can be a reason for knee pain. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Hip Joint Mobilizations, Hip joint Muscle strength training and knee strengthening and flexibility exercises
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2019to 30 Dec 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral or bilateral knee OA.
- Subjects of 50 years or above
- palpable bony enlargement
- Crepitus on knee motion
- morning stiffness for less than 30 minutes
- Kellgren and Lawrence scale: Grade 1-3
Who cannot join
- Patients with spinal surgery
- lower extremity arthroplasty
- Severe joint contractures and bony deformities of lower extremity
- Amputation of lower extremity
- Recent trauma to lower extremity
- A cortisone injection to the hip/ knee within previous 30 days
Show all 10Show fewer
- Patient having mechanical back pain .i.e. lumbosacral radiculopathy and sciatica
- Patient with lower extremity bony deformities either acquired or congenital
- Patient with advanced hip OA.
- Systemic arthritis or rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hip Joint Mobilizations and Strength Training on Pain, Physical Function and Dynamic Balance in Patients With Knee Osteoarthritis: A Randomized Control Trial
Knee osteoarthritis has been ranked 11th highest contributor to non-fatal burdens in the world. Many research studies have discussed the relationship of hip muscle with knee joint stating that impaired hip strength can be a reason for knee pain. Furthermore, mobilization has been shown to be helpful in reducing pain, increasing range of motion and physical function in Osteoarthritis. Despite the evidence, there are very few studies that actually conducted clinical trials to test the effectiveness of mobilizations and strengthening of hip muscles in knee Osteoarthritis. Therefore our aim is to evaluate the effectiveness of hip joint mobilizations and strength training in knee osteoarthritis.
OBJECTIVE: To determine the effects of hip joint mobilizations and strengthening exercises, on pain, physical function and dynamic balance in patients with knee osteoarthritis (OA) using Visual analog scale, Knee injury and Osteoarthritis Outcome Score and four square step test.
METHODOLOGY: A randomized control trial will be conducted on 66 subjects with knee osteoarthritis and age 50 years will be enrolled in this study after screening by referring consultants. This study will be carried out at Physiotherapy OPD of DUHS, Civil hospital Karachi and Rabia Moon Memorial Institute of Neurosciences Trust. Subjects will be assessed at baseline and after 18 sessions using Visual analog scale, Knee injury and Osteoarthritis Outcome Score and square step test for pain, physical functioning and dynamic balance respectively. The subjects will be allocated into three groups through simple random sampling. Group A (joint mobilization group) will receive hip mobilization techniques, hip strengthening exercises along with the best available knee exercises while group B (hip muscles strengthening group) will receive hip-strengthening exercises with the best available knee exercises. Group C (knee strengthening group) will be receiving the best available knee treatment including exercises only. Patients will receive a total of 18 sessions, 5 treatment sessions per week for four successive weeks. The data will be entered and analyzed using SPPS version 21. Repeated mean one way ANOVA will be applied to measure VAS and KOOS scores within the group, for pairwise comparison between groups, Tukey's test will be applied. Chi-square will be applied for FSST scoring. A P-Value less than 0.5 will be considered significant.
Read the detailed description
STUDY DESIGN:
A randomized control trial
STUDY SETTING:
The study will be carried out at an outpatient department of the Institute of Physical Medicine and Rehabilitation, Civil hospital and Rabia Moon Memorial Institute of Neurosciences Trust, Karachi
STUDY DURATION:
The duration of the study is 6 months after the approval of the synopsis. Each subject will receive a total of 18 sessions, 5 treatment sessions per week over the period of 4 weeks. Each treatment session accounts for 30-45 minutes.
STUDY POPULATION:
Subjects with knee osteoarthritis who fulfilled the following study inclusion and exclusion criteria:
INCLUSION CRITERIA
- Patients with unilateral or bilateral knee OA.
- Subjects of 50 years or above
- palpable bony enlargement
- Crepitus on knee motion
- morning stiffness for less than 30 minutes
- Kellgren and Lawrence scale: Grade 1-3
EXCLUSION CRITERIA
- Patients with spinal surgery
- lower extremity arthroplasty
- Severe joint contractures and bony deformities of the lower extremity
- Amputation of lower extremity
- Recent trauma to lower extremity
- A cortisone injection to the hip/ knee within the previous 30 days
- Patient having mechanical back pain .i.e. lumbosacral radiculopathy and sciatica
- Patient with lower extremity bony deformities either acquired or congenital
- Patient with advanced hip OA.
- Systemic arthritis or rheumatoid arthritis
SAMPLE SIZE:
Total 66 patients will be carried out, 22 in each group that include 2 patients as a drop out per group. Using PASS version 11 software, two independent sample t-test and 95% confidence interval 80% power of the test, mean ± S.D of VAS in group A is 4.67 ± 1.59 and group B is 3.6 ± 1.06. The calculated sample size is 27 per group. But due to the unavailability of patients, we will take 22 patients per group within 6 months.
SAMPLING TECHNIQUE:
Non- probability purposive sampling technique. Treatment will be allocated normally using a random number sheet generated by a statistician.
DATA COLLECTION PROCEDURE:
Data collection will begin right after the approval. Subjects fulfilling the inclusion criteria will be selected. Informed consent would be obtained after explaining the study objectives and procedure. Each enrolled patient will be randomly allocated using a computer-generated random number list in group A or group B or group C. All patients will be blinded to the type of intervention. The outcome measures would be used to collect data from all participants. The Visual analog scale for pain intensity, Knee injury and osteoarthritis outcome score for physical functions along with four-step square test for dynamic balance would be used and recorded. Outcome results would be obtained at the baseline before starting the treatment after 3 weeks as a follow-up and after 6 weeks after the completion of the study. The study will be carried out for 6 weeks. 18 sessions of 30-45 minutes will be given. Every attempt within ethical constraints will be made to obtain and record outcome data. If symptoms precipitate, subjects will be advised to use a hot pack or cold pack and prescribe an analgesic to control pain and discomfort.
STUDY VARIABLES
i DEPENDENT:
VAS, KOOS, FFST
ii. INDEPENDENT:
Age, gender, strengthening, mobilization
STATISTICAL ANALYSES:
For pair-wise comparison between groups, repeated mean one-way ANOVA will be applied and if there is any difference we will apply Tukey's test. For within-group, chi-square and repeated one-way ANOVA will be applied for FSST and VAS, KOOS respectively.
Baseline, midline and final readings will be taken for each group
- Conditions
- Osteoarthritis, Knee
- Being tested
- Hip Joint Mobilizations, Hip joint Muscle strength training, knee strengthening and flexibility exercises
- Keywords
- Knee Osteo-arthritis, Musculoskeletal, lower extremity manual therapy, clinical trial Manual therapy, Resistance training, posture
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Joint MobilizationsOther
- Anterior-posterior glide ii. Posterior-anterior glide iii. Caudal glide iv. Posterior-anterior glide with Abduction, flexion, and lateral rotation
Hip joint Muscle strength trainingOther
- Hip abduction in side-lying ii. Hip extension in the prone position iii. Sideways walk iv. Hip abduction in stand up position v. Hip hitching
knee strengthening and flexibility exercisesOther
- STRENGTHENING EXERCISES: Knee extension static quads set, terminal knee extension while standing up, sitting leg press, partial squat, step-ups. ii. STRETCHING EXERCISES:: stretching of the calf, hamstring, and quadriceps-femoris. iii. RANGE OF MOTION EXERCISES: Knee in mid-flexion to full-extension, Knee in mid-flexion to full-flexion:
| Study group | Role | What they receive |
|---|---|---|
| Hip Joint Mobilizations | Experimental | Hip joint mobilizations Hip strength training Knee exercises Receives: Other: Hip Joint Mobilizations; Other: Hip joint Muscle strength training; Other: knee strengthening and flexibility exercises |
| Hip & Knee Muscles strength training | Experimental | Hip strength training Knee exercises Receives: Other: Hip joint Muscle strength training; Other: knee strengthening and flexibility exercises |
| Knee Muscles strength training | Active comparator | Knee exercises Receives: Other: knee strengthening and flexibility exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Visual analog scale (VAS) is a tool evaluating subjective attitudes that cannot be directly measurable, it has a good Test-retest reliability. This scoring range from 0 to 10 cm, Where 0 stands for no pain and 10 indicates worse possible pain.
Measured: up to 6 weeks
Four step square test
Four square step tests is a tool for assessing the dynamic balance and mobility while standing. It also assess the fall risk.
Measured: up to 6 weeks
Koos
The Knee Injury and Osteoarthritis Outcome Score is a PROM having five sub scales used for knee osteoarthritis (OA), it monitors the course of disease and final outcomes following interventions. Each subscale is scored from 0 (extreme problems) to 100 (no problems). It has high test-retest reliability.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start15 Jan 2019
- Primary completion30 Aug 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Model description
- It is a randomized control trial. Total 66 patients will be carry out, 22 in each of the three groups that include 2 patients as a drop out per group. There will be two interventional groups and one control group. Treatment will be allocated normally using random number sheet generated by statistician.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bushra Mehwish, MSAPT, Principal investigator, Dow University of Health SciencesShahzad Ali Syed, MSPT, Study director, Dow University of Health SciencesAftab Ahmed Mirza Baig, MSAPT, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769531
- Sponsor's protocol ID
- 00001
- Status last verified
- Jan 2022
- First submitted
- 21 Feb 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
PubMed 24024017Mora JC, Przkora R, Cruz-Almeida Y. Knee osteoarthritis: pathophysiology and current treatment modalities. J Pain Res. 2018 Oct 5;11:2189-2196. doi: 10.2147/JPR.S154002. eCollection 2018.
PubMed 30323653Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
PubMed 24553908Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.
PubMed 28808025Iqbal MN, Haidri FR, Motiani B, Mannan A. Frequency of factors associated with knee osteoarthritis. J Pak Med Assoc. 2011 Aug;61(8):786-9.
PubMed 22356003Ro DH, Lee J, Lee J, Park JY, Han HS, Lee MC. Effects of Knee Osteoarthritis on Hip and Ankle Gait Mechanics. Adv Orthop. 2019 Mar 24;2019:9757369. doi: 10.1155/2019/9757369. eCollection 2019.
PubMed 31019809A. Tanvi, R. Amrita, R. Deepak, P. Kopa. Comparison of effect of hip joint mobilization and hip joint muscle strengthening exercises with knee osteoarthritis. Scientific Research Journal of India. 2014;3
Currier LL, Froehlich PJ, Carow SD, McAndrew RK, Cliborne AV, Boyles RE, Mansfield LT, Wainner RS. Development of a clinical prediction rule to identify patients with knee pain and clinical evidence of knee osteoarthritis who demonstrate a favorable short-term response to hip mobilization. Phys Ther. 2007 Sep;87(9):1106-19. doi: 10.2522/ptj.20060066. Epub 2007 Jul 3.
PubMed 17609333Cliborne AV, Wainner RS, Rhon DI, Judd CD, Fee TT, Matekel RL, Whitman JM. Clinical hip tests and a functional squat test in patients with knee osteoarthritis: reliability, prevalence of positive test findings, and short-term response to hip mobilization. J Orthop Sports Phys Ther. 2004 Nov;34(11):676-85. doi: 10.2519/jospt.2004.34.11.676.
PubMed 15609488Ahmad A, Daud M. A COMPARATIVE STUDY BETWEEN JOINT MOBILIZATION AND CONVENTIONAL PHYSIOTHERAPY IN KNEE OSTEOARTHRITIS. Int J Physio [Internet]. 2016Apr.8 [cited 2021Feb.2];3(2):159-62. Available from: https://www.ijphy.org/index.php/journal/article/view/207
A. Tanvi, R. Amrita, R. Deepak, P. Kopa.Comparison of effect of hip joint mobilization and hip joint muscle strengthening exercises with knee osteoarthritis. Scientific Research J of Ind 2014;3(1)
Santos TR, Oliveira BA, Ocarino JM, Holt KG, Fonseca ST. Effectiveness of hip muscle strengthening in patellofemoral pain syndrome patients: a systematic review. Braz J Phys Ther. 2015 May-Jun;19(3):167-76. doi: 10.1590/bjpt-rbf.2014.0089. Epub 2015 May 29.
PubMed 26039034Bennell KL, Hunt MA, Wrigley TV, Hunter DJ, McManus FJ, Hodges PW, Li L, Hinman RS. Hip strengthening reduces symptoms but not knee load in people with medial knee osteoarthritis and varus malalignment: a randomised controlled trial. Osteoarthritis Cartilage. 2010 May;18(5):621-8. doi: 10.1016/j.joca.2010.01.010. Epub 2010 Feb 6.
PubMed 20175973Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x.
PubMed 27295978Moore M, Barker K. The validity and reliability of the four square step test in different adult populations: a systematic review. Syst Rev. 2017 Sep 11;6(1):187. doi: 10.1186/s13643-017-0577-5.
PubMed 28893312
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hip Joint Mobilizations and Strength Training on Pain, Physical Function and Dynamic Balance in Patients With Knee Osteoarthritis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04769531
- Acronym / sponsor ID
- 00001
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee Osteo-arthritis, Musculoskeletal, lower extremity manual therapy, clinical trial Manual therapy, Resistance training, posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 24 Feb 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 osteoarthritis has been ranked 11th highest contributor to non-fatal burdens in the world. Many research studies have discussed the relationship of hip muscle with knee joint stating that impaired hip strength can be a reason for knee pain. Furthermore, mobilization has been shown to be helpful in reducing pain, increasing range of motion and physical function in Osteoarthritis. Despite the evidence, there are very few studies that actually conducted clinical trials to test the effectiveness of mobilizations and strengthening of hip muscles in knee Osteoarthritis. Therefore our aim is to evaluate the effectiveness of hip joint mobilizations and strength training in knee osteoarthritis.
OBJECTIVE: To determine the effects of hip joint mobilizations and strengthening exercises, on pain, physical function and dynamic balance in patients with knee osteoarthritis (OA) using Visual analog scale, Knee injury and Osteoarthritis Outcome Score and four square step test.
METHODOLOGY: A randomized control trial will be conducted on 66 subjects with knee osteoarthritis and age 50 years will be enrolled in this study after screening by referring consultants. This study will be carried out at Physiotherapy OPD of DUHS, Civil hospital Karachi and Rabia Moon Memorial Institute of Neurosciences Trust. Subjects will be assessed at baseline and after 18 sessions using Visual analog scale, Knee injury and Osteoarthritis Outcome Score and square step test for pain, physical functioning and dynamic balance respectively. The subjects will be allocated into three groups through simple random sampling. Group A (joint mobilization group) will receive hip mobilization techniques, hip strengthening exercises along with the best available knee exercises while group B (hip muscles strengthening group) will receive hip-strengthening exercises with the best available knee exercises. Group C (knee strengthening group) will be receiving the best available knee treatment including exercises only. Patients will receive a total of 18 sessions, 5 treatment sessions per week for four successive weeks. The data will be entered and analyzed using SPPS version 21. Repeated mean one way ANOVA will be applied to measure VAS and KOOS scores within the group, for pairwise comparison between groups, Tukey's test will be applied. Chi-square will be applied for FSST scoring. A P-Value less than 0.5 will be considered significant.
Detailed description
STUDY DESIGN:
A randomized control trial
STUDY SETTING:
The study will be carried out at an outpatient department of the Institute of Physical Medicine and Rehabilitation, Civil hospital and Rabia Moon Memorial Institute of Neurosciences Trust, Karachi
STUDY DURATION:
The duration of the study is 6 months after the approval of the synopsis. Each subject will receive a total of 18 sessions, 5 treatment sessions per week over the period of 4 weeks. Each treatment session accounts for 30-45 minutes.
STUDY POPULATION:
Subjects with knee osteoarthritis who fulfilled the following study inclusion and exclusion criteria:
INCLUSION CRITERIA
- Patients with unilateral or bilateral knee OA.
- Subjects of 50 years or above
- palpable bony enlargement
- Crepitus on knee motion
- morning stiffness for less than 30 minutes
- Kellgren and Lawrence scale: Grade 1-3
EXCLUSION CRITERIA
- Patients with spinal surgery
- lower extremity arthroplasty
- Severe joint contractures and bony deformities of the lower extremity
- Amputation of lower extremity
- Recent trauma to lower extremity
- A cortisone injection to the hip/ knee within the previous 30 days
- Patient having mechanical back pain .i.e. lumbosacral radiculopathy and sciatica
- Patient with lower extremity bony deformities either acquired or congenital
- Patient with advanced hip OA.
- Systemic arthritis or rheumatoid arthritis
SAMPLE SIZE:
Total 66 patients will be carried out, 22 in each group that include 2 patients as a drop out per group. Using PASS version 11 software, two independent sample t-test and 95% confidence interval 80% power of the test, mean ± S.D of VAS in group A is 4.67 ± 1.59 and group B is 3.6 ± 1.06. The calculated sample size is 27 per group. But due to the unavailability of patients, we will take 22 patients per group within 6 months.
SAMPLING TECHNIQUE:
Non- probability purposive sampling technique. Treatment will be allocated normally using a random number sheet generated by a statistician.
DATA COLLECTION PROCEDURE:
Data collection will begin right after the approval. Subjects fulfilling the inclusion criteria will be selected. Informed consent would be obtained after explaining the study objectives and procedure. Each enrolled patient will be randomly allocated using a computer-generated random number list in group A or group B or group C. All patients will be blinded to the type of intervention. The outcome measures would be used to collect data from all participants. The Visual analog scale for pain intensity, Knee injury and osteoarthritis outcome score for physical functions along with four-step square test for dynamic balance would be used and recorded. Outcome results would be obtained at the baseline before starting the treatment after 3 weeks as a follow-up and after 6 weeks after the completion of the study. The study will be carried out for 6 weeks. 18 sessions of 30-45 minutes will be given. Every attempt within ethical constraints will be made to obtain and record outcome data. If symptoms precipitate, subjects will be advised to use a hot pack or cold pack and prescribe an analgesic to control pain and discomfort.
STUDY VARIABLES
i DEPENDENT:
VAS, KOOS, FFST
ii. INDEPENDENT:
Age, gender, strengthening, mobilization
STATISTICAL ANALYSES:
For pair-wise comparison between groups, repeated mean one-way ANOVA will be applied and if there is any difference we will apply Tukey's test. For within-group, chi-square and repeated one-way ANOVA will be applied for FSST and VAS, KOOS respectively.
Baseline, midline and final readings will be taken for each group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- It is a randomized control trial. Total 66 patients will be carry out, 22 in each of the three groups that include 2 patients as a drop out per group. There will be two interventional groups and one control group. Treatment will be allocated normally using random number sheet generated by statistician.
| Arm | Type | Receives |
|---|---|---|
| Hip Joint Mobilizations | Experimental | Other: Hip Joint Mobilizations, Other: Hip joint Muscle strength training, Other: knee strengthening and flexibility exercisesHip joint mobilizations Hip strength training Knee exercises |
| Hip & Knee Muscles strength training | Experimental | Other: Hip joint Muscle strength training, Other: knee strengthening and flexibility exercisesHip strength training Knee exercises |
| Knee Muscles strength training | Active comparator | Other: knee strengthening and flexibility exercisesKnee exercises |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with unilateral or bilateral knee OA.
- Subjects of 50 years or above
- palpable bony enlargement
- Crepitus on knee motion
- morning stiffness for less than 30 minutes
Key exclusion criteria (10 listed)
- Patients with spinal surgery
- lower extremity arthroplasty
- Severe joint contractures and bony deformities of lower extremity
- Amputation of lower extremity
- Recent trauma to lower extremity
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 |
|---|---|---|
| Hip Joint Mobilizationsi. Anterior-posterior glide ii. Posterior-anterior glide iii. Caudal glide iv. Posterior-anterior glide with Abduction, flexion, and lateral rotation | Other | Hip Joint Mobilizations |
| Hip joint Muscle strength trainingi. Hip abduction in side-lying ii. Hip extension in the prone position iii. Sideways walk iv. Hip abduction in stand up position v. Hip hitching | Other | Hip & Knee Muscles strength training, Hip Joint Mobilizations |
| knee strengthening and flexibility exercisesi. STRENGTHENING EXERCISES: Knee extension static quads set, terminal knee extension while standing up, sitting leg press, partial squat, step-ups. ii. STRETCHING EXERCISES:: stretching of the calf, hamstring, and quadriceps-femoris. iii. RANGE OF MOTION EXERCISES: Knee in mid-flexion to full-extension, Knee in mid-flexion to full-flexion: | Other | Hip & Knee Muscles strength training, Hip Joint Mobilizations, Knee Muscles strength training |
Primary outcome
Visual analog scale
Time frame: up to 6 weeks
Visual analog scale (VAS) is a tool evaluating subjective attitudes that cannot be directly measurable, it has a good Test-retest reliability. This scoring range from 0 to 10 cm, Where 0 stands for no pain and 10 indicates worse possible pain.
Four step square test
Time frame: up to 6 weeks
Four square step tests is a tool for assessing the dynamic balance and mobility while standing. It also assess the fall risk.
Koos
Time frame: up to 6 weeks
The Knee Injury and Osteoarthritis Outcome Score is a PROM having five sub scales used for knee osteoarthritis (OA), it monitors the course of disease and final outcomes following interventions. Each subscale is scored from 0 (extreme problems) to 100 (no problems). It has high test-retest reliability.
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 28 Jan 2022.
- Background: PubMed 24024017Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian J Intern Med. 2011 Spring;2(2):205-12.
- Background: PubMed 30323653Mora JC, Przkora R, Cruz-Almeida Y. Knee osteoarthritis: pathophysiology and current treatment modalities. J Pain Res. 2018 Oct 5;11:2189-2196. doi: 10.2147/JPR.S154002. eCollection 2018.
- Background: PubMed 24553908Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
- Background: PubMed 28808025Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.
- Background: PubMed 22356003Iqbal MN, Haidri FR, Motiani B, Mannan A. Frequency of factors associated with knee osteoarthritis. J Pak Med Assoc. 2011 Aug;61(8):786-9.
- Background: PubMed 31019809Ro DH, Lee J, Lee J, Park JY, Han HS, Lee MC. Effects of Knee Osteoarthritis on Hip and Ankle Gait Mechanics. Adv Orthop. 2019 Mar 24;2019:9757369. doi: 10.1155/2019/9757369. eCollection 2019.
- BackgroundA. Tanvi, R. Amrita, R. Deepak, P. Kopa. Comparison of effect of hip joint mobilization and hip joint muscle strengthening exercises with knee osteoarthritis. Scientific Research Journal of India. 2014;3
- Background: PubMed 17609333Currier LL, Froehlich PJ, Carow SD, McAndrew RK, Cliborne AV, Boyles RE, Mansfield LT, Wainner RS. Development of a clinical prediction rule to identify patients with knee pain and clinical evidence of knee osteoarthritis who demonstrate a favorable short-term response to hip mobilization. Phys Ther. 2007 Sep;87(9):1106-19. doi: 10.2522/ptj.20060066. Epub 2007 Jul 3.
- Background: PubMed 15609488Cliborne AV, Wainner RS, Rhon DI, Judd CD, Fee TT, Matekel RL, Whitman JM. Clinical hip tests and a functional squat test in patients with knee osteoarthritis: reliability, prevalence of positive test findings, and short-term response to hip mobilization. J Orthop Sports Phys Ther. 2004 Nov;34(11):676-85. doi: 10.2519/jospt.2004.34.11.676.
- BackgroundAhmad A, Daud M. A COMPARATIVE STUDY BETWEEN JOINT MOBILIZATION AND CONVENTIONAL PHYSIOTHERAPY IN KNEE OSTEOARTHRITIS. Int J Physio [Internet]. 2016Apr.8 [cited 2021Feb.2];3(2):159-62. Available from: https://www.ijphy.org/index.php/journal/article/view/207
- BackgroundA. Tanvi, R. Amrita, R. Deepak, P. Kopa.Comparison of effect of hip joint mobilization and hip joint muscle strengthening exercises with knee osteoarthritis. Scientific Research J of Ind 2014;3(1)
- Background: PubMed 26039034Santos TR, Oliveira BA, Ocarino JM, Holt KG, Fonseca ST. Effectiveness of hip muscle strengthening in patellofemoral pain syndrome patients: a systematic review. Braz J Phys Ther. 2015 May-Jun;19(3):167-76. doi: 10.1590/bjpt-rbf.2014.0089. Epub 2015 May 29.
- Individual participant dataSharing planned: No
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Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Bushra Mehwish, MSAPT principal investigator
Dow University of Health Sciences
Shahzad Ali Syed, MSPT study director
Dow University of Health Sciences
Aftab Ahmed Mirza Baig, MSAPT principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Joint Mobilizations, Hip joint Muscle strength training and knee strengthening and flexibility exercises in people with Osteoarthritis, Knee, run by Dow University of Health Sciences 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 6 inclusion and 10 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 28 Jan 2022. 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 analog scale (time frame: up to 6 weeks). The study lists 3 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 NCT04769531, which also lists 22 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 28 Jan 2022.