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

Sponsor
Dow University of Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04925895
Collaborator
(none)
48
1
2
8.6
5.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dynamic soft tissue mobilization
  • Other: Proprioceptive neuromuscular facilitation stretching
  • Other: Cryotherapy
  • Other: Isometric knee strengthening excercises
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Single (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.
Primary Purpose:
Treatment
Official Title:
Dynamic Soft Tissue Mobilization vs Proprioceptive Neuromuscular Facilitation in Reducing Hamstring Muscle Tightness in Patients With Knee Osteoarthritis: a Randomized Control Trial
Actual Study Start Date :
Apr 22, 2021
Actual Primary Completion Date :
Jan 1, 2022
Actual Study Completion Date :
Jan 10, 2022

Arms and Interventions

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.

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

    Other: Proprioceptive neuromuscular facilitation stretching
    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
  • Other: Cryotherapy
    application of cold pack on knee joint for 10 minutes
    Other Names:
  • Cold pack
  • Icing
  • Other: 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.
    Other Names:
  • Isometrics
  • knee strengthening exercises
  • Isometric quads
  • Outcome Measures

    Primary Outcome Measures

    1. Visual analogue scale in centimetre [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).

    2. Active Knee Extension Angle Test in degree [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.

    Secondary Outcome Measures

    1. The Knee Injury and Osteoarthritis Outcome Score [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dow University of Health Sciences Karachi Sindh Pakistan 75400

    Sponsors and Collaborators

    • Dow University of Health Sciences

    Investigators

    • Principal Investigator: Khadija Nafees, MSAPT, Dow University of Health Sciences
    • Study Chair: Shahzad Ali Syed, MSPT, Dow University of Health Sciences
    • Principal Investigator: Aftab Ahmed Mirza Baig, MSAPT, Dow University of Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Syed Shahzad Ali, Principal Investigator, Dow University of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04925895
    Other Study ID Numbers:
    • 00003
    First Posted:
    Jun 14, 2021
    Last Update Posted:
    Feb 10, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 10, 2022