Clinical trial NCT04769531: Hip Joint Mobilizations and Strength Training in Patients With Knee OA Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee Osteo-arthritis
Musculoskeletal
lower extremity manual therapy
clinical trial Manual therapy
Resistance training
posture
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 66
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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

Eligibility 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 lower extremity
* Amputation of lower extremity
* Recent trauma to lower extremity
* A cortisone injection to the hip/ knee within 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

Primary outcomes:
measure: Visual analog scale
timeFrame: up to 6 weeks
measure: Four step square test
timeFrame: up to 6 weeks
measure: Koos
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Bushra Mehwish, MSAPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences
name: Shahzad Ali Syed, MSPT
role: STUDY_DIRECTOR
affiliation: Dow University of Health Sciences
name: Aftab Ahmed Mirza Baig, MSAPT
role: PRINCIPAL_INVESTIGATOR
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