Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04925895
Other study ID # 00003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 22, 2021
Est. completion date January 10, 2022

Study information

Verified date January 2022
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date January 10, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Intervention

Other:
Dynamic soft tissue mobilization
Dynamic soft tissue mobilization will be given in the following sequence, In supine position with 90° flexion of knee and hip joint deep longitudinal strokes will be applied from distal to proximal direction along with the tightened area of hamstring while passively stretching the hamstring. Total 5 longitudinal strokes will be applied followed by shaking for 20 seconds. Then progressed to the next dynamic technique in the above-mentioned sequence but the patient will be asked to do leg extension actively to achieve reciprocal inhibition of the hamstring muscle. In The next step, the subject will apply a force to the therapist's hand to engage the hamstring eccentrically as the muscle will be lengthened to its end range. In that position, the therapist will apply 5 deep longitudinal strokes from the distal towards the proximal direction on tight hamstring muscles.
Proprioceptive neuromuscular facilitation stretching
The position of the patient will be supine lying with 90° flexion of hip. Therapist will passively extend the knee joint where patient will feel a mild stretch. Then therapist will ask the patient to do knee flexion in counter resistance applied by the therapist by using about 50% of his maximum strength and isometric contraction of hamstring muscles will be achieved. Patient will maintain that isometric contraction for 8 seconds then relax on therapist command. Just after relaxation therapist will further stretch the hamstring muscle to the point of mild to moderate painless stretch and patient will hold it for 30 seconds. Three repetitions will be applied in each session.
Cryotherapy
application of cold pack on knee joint for 10 minutes
Isometric knee strengthening excercises
i. Isometric hip adductors exercises in crook lying: Two sets of 10 repetitions with a 10-seconds hold will be carried out. ii. Isometric quadriceps strengthening exercises in supine lying: A towel roll underneath the knee joint will be used to perform this exercise. Two sets of 10 repetitions with a 10-seconds hold will be performed.

Locations

Country Name City State
Pakistan Dow University of Health Sciences Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue scale in centimetre A bidirectional scale for subjective measurement for pain comprises of a 10 cm line labeling parallel on both sides, starts with least "no pain" (0 cm) and end on most "worst pain" (10 cm). upto 4 weeks
Primary Active Knee Extension Angle Test in degree It will used to assessing the hamstring muscle length by using goniometry with 90° of hip flexion. higher the degree higher will be the knee extension. upto 4 weeks
Secondary The Knee Injury and Osteoarthritis Outcome Score It is a patient related outcome measure, having 5 sub-scales, designed to check disease development and outcomes followed by surgical, pharmaceutical, physical therapy or other interventions.100 indicates no problem and 0 indicates extreme problem. upto 4 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04651673 - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed NCT05677399 - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise. N/A
Active, not recruiting NCT04043819 - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis Phase 1
Recruiting NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee Phase 3
Completed NCT05014542 - Needling Techniques for Knee Osteoarthritis N/A
Recruiting NCT05892133 - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty N/A
Recruiting NCT05528965 - Parallel Versus Perpendicular Technique for Genicular Radiofrequency N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting NCT02003976 - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone N/A
Active, not recruiting NCT04017533 - Stability of Uncemented Medially Stabilized TKA N/A
Completed NCT04779164 - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis N/A
Recruiting NCT04006314 - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis N/A
Recruiting NCT05423587 - Genicular Artery Embolisation for Knee Osteoarthritis II N/A
Enrolling by invitation NCT04145401 - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting NCT03781843 - Effects of Genicular Nerve Block in Knee Osteoarthritis N/A
Recruiting NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05324163 - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis Phase 3
Completed NCT05529914 - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis N/A
Recruiting NCT05693493 - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA? N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A