Clinical trial NCT04925895: Effects of Dynamic Soft Tissue Mobilization in Reducing Hamstring Tightness in Knee Osteoarthritis
Official title: Dynamic Soft Tissue Mobilization vs Proprioceptive Neuromuscular Facilitation in Reducing Hamstring Muscle Tightness in Patients With Knee Osteoarthritis: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Muscle Tightness
Range of Motion
Dynamic Stretching
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single blinded randomized control trial in which total 48 patients will be enrolled and randomly allocated into 2 interventional groups equally. The randomization will be carried out through an open source software "research randomizer" by statistician.
Primary purpose: TREATMENT

Brief summary: The objective of this randomized control trial is to evaluate the effectiveness of dynamic soft tissue mobilization in comparison with the proprioceptive neuromuscular facilitation (hold-relax) technique in reducing hamstring muscle tightness, pain and improving physical functions in patients with knee osteoarthritis by using Visual Analog Scale-10 cm, Active Knee Extension Angle Test in degree and Knee Injury and Osteoarthritis Outcome Score. This study will be carried out at Sindh Institute of Physical Medicine and Rehabilitation and Dow Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences, Karachi on the basis of non-probability purposive sample technique with screening for study criteria through a consultant physician (blinded) . After taking informed consent all participants will be randomly allocated into 2 groups i.e. 24 in interventional group 'A' and 24 in interventional group 'B' through second researcher who is not involved in screening, baseline assessment and providing intervention.The interventional group 'A' will received dynamic soft tissue mobilization on hamstring muscle along with cryotherapy on knee joint and isometric strengthening exercises for knee osteoarthritis while the interventional group 'B' will received proprioceptive neuromuscular facilitation (hold relax) technique on hamstring muscle along with cryotherapy on knee joint and isometric strengthening exercises for knee osteoarthritis. Twelve sessions will be given each of 30 minutes.Outcomes will be assessed at baseline and at last session.

Detailed description: All the participants will referred by the physiatrist as diagnosed with knee osteoarthritis. All the data will be collected within ethical constraints. Only principal investigator will access to the data as it will be in her custody. Patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management will be strictly performed within codes of ethics.

The sample size of 48 patients (24 in one group) is calculated by using open epi software version 3, Paired Means Power Analysis with 99% Confidence Interval and 95% power of test, mean ± S.D of VAS 5.27 ± 0.8 in group A and 3.81±1.4 in group B on the basis of previous findings. The missing data will be considered during analysis and results interpretation for any inconsistency in results.Data were stored and analyzed using IBM-SPSS version 23.0, Mean with standard deviation will be calculated for all quantitative variables. Counts with percentages will be presented for quantitative variables. parametric or non parametric tests will be used to compare outcome variables within and between groups after sessions completion. P-values less than 0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Subjects with 40 years of age and above
* Patients with hamstring tightness
* ACR clinical + radiological classification criteria for knee osteoarthritis

Exclusion Criteria:

* Patients with positive sciatic nerve test (SLR)
* Patients with neurological disorder impacting on lower extremity
* Musculoskeletal knee deformity e.g. varus
* Patients with lower limb internal fixation
* History of previous lower limb arthroplasty or another knee surgery
* Patients with history of infectious disease or malignancy effecting the lower extremity .
* Using assistive device(stick/cane)
* History of spinal surgery
* Patient having low backache or sciatica

Primary outcomes:
measure: Visual analogue scale in centimetre
timeFrame: upto 4 weeks
measure: Active Knee Extension Angle Test in degree
timeFrame: upto 4 weeks
Secondary outcomes:
measure: The Knee Injury and Osteoarthritis Outcome Score
timeFrame: upto 4 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Khadija Nafees, MSAPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences
name: Shahzad Ali Syed, MSPT
role: STUDY_CHAIR
affiliation: Dow University of Health Sciences
name: Aftab Ahmed Mirza Baig, MSAPT
role: PRINCIPAL_INVESTIGATOR
References: