- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04925895
Effects of Dynamic Soft Tissue Mobilization in Reducing Hamstring Tightness in Knee Osteoarthritis
Dynamic Soft Tissue Mobilization vs Proprioceptive Neuromuscular Facilitation in Reducing Hamstring Muscle Tightness in Patients With Knee Osteoarthritis: a Randomized Control Trial
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sindh
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Karachi, Sindh, Pakistan, 75400
- Dow University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dynamic soft tissue mobilization
Dynamic soft tissue mobilization (DSTM) is a soft tissue mobilization technique use to treat tight spasm using progressive muscle activation.
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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.
Other Names:
application of cold pack on knee joint for 10 minutes
Other Names:
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.
Other Names:
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Active Comparator: Proprioceptive neuromuscular facilitation stretching
PNF stretching technique, a type of flexibility training that is effective in improving muscle flexibility and restore functional ranges using a wide array of techniques.
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application of cold pack on knee joint for 10 minutes
Other Names:
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.
Other Names:
The position of the patient will be supine lying with 90⁰ 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale in centimetre
Time Frame: upto 4 weeks
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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).
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upto 4 weeks
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Active Knee Extension Angle Test in degree
Time Frame: upto 4 weeks
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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.
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upto 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Knee Injury and Osteoarthritis Outcome Score
Time Frame: upto 4 weeks
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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.
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upto 4 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Aftab Ahmed Mirza Baig, MSAPT, Dow University of Health Sciences
- Principal Investigator: Khadija Nafees, MSAPT, Dow University of Health Sciences
- Study Chair: Shahzad Ali Syed, MSPT, Dow University of Health Sciences
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
- 00003
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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