NCT04925895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

June 8, 2021

Last Update Submit

January 27, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • The Knee Injury and Osteoarthritis Outcome Score

    upto 4 weeks

Study Arms (2)

Dynamic soft tissue mobilization

EXPERIMENTAL

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

Other: Dynamic soft tissue mobilizationOther: CryotherapyOther: Isometric knee strengthening excercises

Proprioceptive neuromuscular facilitation stretching

ACTIVE COMPARATOR

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 stretchingOther: CryotherapyOther: Isometric knee strengthening excercises

Interventions

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.

Also known as: DSTM, dynamic soft tissue technique, soft tissue mobilization
Dynamic soft tissue mobilization

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.

Also known as: PNF stretchings, PNF exercises, PNF stretching exercise
Proprioceptive neuromuscular facilitation stretching

application of cold pack on knee joint for 10 minutes

Also known as: Cold pack, Icing
Dynamic soft tissue mobilizationProprioceptive neuromuscular facilitation stretching

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.

Also known as: Isometrics, knee strengthening exercises, Isometric quads
Dynamic soft tissue mobilizationProprioceptive neuromuscular facilitation stretching

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both genders
  • Subjects with 40 years of age and above
  • Patients with hamstring tightness
  • ACR clinical + radiological classification criteria for knee osteoarthritis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 75400, Pakistan

Location

Related Publications (1)

  • Nafees K, Baig AAM, Ali SS, Ishaque F. Dynamic soft tissue mobilization versus proprioceptive neuromuscular facilitation in reducing hamstring muscle tightness in patients with knee osteoarthritis: a randomized control trial. BMC Musculoskelet Disord. 2023 Jun 2;24(1):447. doi: 10.1186/s12891-023-06571-y.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Muscle Stretching ExercisesCryotherapyExercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Khadija Nafees, MSAPT

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Shahzad Ali Syed, MSPT

    Dow University of Health Sciences

    STUDY CHAIR
  • Aftab Ahmed Mirza Baig, MSAPT

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 14, 2021

Study Start

April 22, 2021

Primary Completion

January 1, 2022

Study Completion

January 10, 2022

Last Updated

February 10, 2022

Record last verified: 2022-01

Locations