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

Primary Purpose

Knee Osteoarthritis, Muscle Tightness, Range of Motion

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dynamic soft tissue mobilization
Proprioceptive neuromuscular facilitation stretching
Cryotherapy
Isometric knee strengthening excercises
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dow University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dynamic soft tissue mobilization

Proprioceptive neuromuscular facilitation stretching

Arm Description

Dynamic soft tissue mobilization (DSTM) is a soft tissue mobilization technique use to treat tight spasm using progressive muscle activation.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 8, 2021
Last Updated
January 27, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04925895
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Muscle Tightness, Range of Motion, Dynamic Stretching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Other than the principal investigator, another physiotherapist will work as outcomes assessor who will blind to the intervention type given to the patient who will be assessed.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic soft tissue mobilization
Arm Type
Experimental
Arm Description
Dynamic soft tissue mobilization (DSTM) is a soft tissue mobilization technique use to treat tight spasm using progressive muscle activation.
Arm Title
Proprioceptive neuromuscular facilitation stretching
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dynamic soft tissue mobilization
Other Intervention Name(s)
DSTM, dynamic soft tissue technique, soft tissue mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Proprioceptive neuromuscular facilitation stretching
Other Intervention Name(s)
PNF stretchings, PNF exercises, PNF stretching exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Other Intervention Name(s)
Cold pack, Icing
Intervention Description
application of cold pack on knee joint for 10 minutes
Intervention Type
Other
Intervention Name(s)
Isometric knee strengthening excercises
Other Intervention Name(s)
Isometrics, knee strengthening exercises, Isometric quads
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale in centimetre
Description
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).
Time Frame
upto 4 weeks
Title
Active Knee Extension Angle Test in degree
Description
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.
Time Frame
upto 4 weeks
Secondary Outcome Measure Information:
Title
The Knee Injury and Osteoarthritis Outcome Score
Description
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.
Time Frame
upto 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khadija Nafees, MSAPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shahzad Ali Syed, MSPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, MSAPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75400
Country
Pakistan

12. IPD Sharing Statement

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

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