Effects of Dynamic Soft Tissue Mobilization in Reducing Hamstring Tightness in Knee Osteoarthritis

January 27, 2022 updated by: Syed Shahzad Ali, Dow University of Health Sciences

Dynamic Soft Tissue Mobilization vs Proprioceptive Neuromuscular Facilitation in Reducing Hamstring Muscle Tightness in Patients With Knee Osteoarthritis: a Randomized Control Trial

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.

Study Overview

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

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sindh
      • Karachi, Sindh, Pakistan, 75400
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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:
  • soft tissue mobilization
  • DSTM
  • dynamic soft tissue technique
application of cold pack on knee joint for 10 minutes
Other Names:
  • Cold pack
  • Icing

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:
  • Isometrics
  • knee strengthening exercises
  • Isometric quads
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.
application of cold pack on knee joint for 10 minutes
Other Names:
  • Cold pack
  • Icing

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:
  • Isometrics
  • knee strengthening exercises
  • Isometric quads
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:
  • PNF stretchings
  • PNF exercises
  • PNF stretching exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale in centimetre
Time Frame: upto 4 weeks
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
Active Knee Extension Angle Test in degree
Time Frame: upto 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Knee Injury and Osteoarthritis Outcome Score
Time Frame: upto 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 10, 2022

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 00003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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