NCT05169606

Brief Summary

Tissue flossing has been known to produce results such as pain relief and improved range of motion, this technique might yield positive results in knee OA patients as well. These effects can further be compared with existing treatment method for treatment of hamstring such as Active isolated stretch and Proprioceptive Neuromuscular facilitation. This study will be among the first to carry out the technique of flossing in knee OA patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 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

June 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

December 13, 2021

Last Update Submit

February 1, 2022

Conditions

Keywords

Tissue FlossingActive Isolated StretchProprioceptive Neuromuscular FacilitationKnee OsteoarthritisPainRange of motion

Outcome Measures

Primary Outcomes (2)

  • Straight Leg Raise for Flexibility

    The leg is raised straight raise test when performed when the subject is placed supine, the therapist grasps the ankle and lifts the leg straight up, while stabilises the same anterior superior iliac spine. If the leg cannot be raised beyond 80degrees the hamstrings is considered tight.

    for four weeks

  • Passive Knee Extension Test for Flexibility

    The patient is positioned in supine with the hip of the tested leg in 90 degrees of flexion.The contralateral leg stays flat on the examination table. The clinician extends the knee until reaching the maximal tolerable stretch of the hamstring muscle as indicated by the patient with the ipsilateral hip remaining in 90 of flexion. The knee angle is then measured with a goniometer.

    For four weeks

Secondary Outcomes (2)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    For four weeks

  • Numeric pain rating scale for pain

    for four weeks

Study Arms (3)

Tissue Flossing

EXPERIMENTAL

Tissue flossing is a technique that requires wrapping of a thick rubber band around a joint or muscle concomitantly performing ROM tasks for 1-3 minutes. The results include increase in range of motion and a decrease in pain of the effected muscles. The phenomenon behind getting results through this technique is hypothesized to be blood reperfusion to an occluded area via tissue flossing augments exercise performance mechanisms such as growth hormone, catecholamine responses, muscle force contractility and the efficiency of excitation-contraction coupling in the muscles. In addition, tissue flossing may influence fascia tightness via the fascial mechanoreceptors, therefore reducing muscle activity, resulting in a greater ROM. Nevertheless, the underlying mechanism for tissue flossing, these mechanisms remain speculative.

Other: Tissue FlossingOther: Active Isolated StretchOther: Proprioceptive Neuromuscular Facilitation

Active Isolated Stretch

EXPERIMENTAL

Active Isolated Stretch is a specific stretching program developed by Aaron Mattes over 30 years ago. Active isolated stretch is also found to be effective to increase flexibility and improve ROM.

Other: Tissue FlossingOther: Active Isolated StretchOther: Proprioceptive Neuromuscular Facilitation

Proprioceptive Neuromuscular Facilitation

EXPERIMENTAL

Proprioceptive neuromuscular facilitation (PNF) technique has already been found to have beneficial effects in improving hamstring flexibility and reducing pain in the knee joint of knee OA patients.

Other: Tissue FlossingOther: Active Isolated StretchOther: Proprioceptive Neuromuscular Facilitation

Interventions

Tissue flossing is a technique that requires wrapping of a thick rubber band around a joint or muscle concomitantly performing ROM tasks for 1-3 minutes. The results include increase in range of motion and a decrease in pain of the effected muscles. The phenomenon behind getting results through this technique is hypothesized to be blood reperfusion to an occluded area via tissue flossing augments exercise performance mechanisms such as growth hormone, catecholamine responses, muscle force contractility and the efficiency of excitation-contraction coupling in the muscles. In addition, tissue flossing may influence fascia tightness via the fascial mechanoreceptors, therefore reducing muscle activity, resulting in a greater ROM. Nevertheless, the underlying mechanism for tissue flossing, these mechanisms remain speculative.

Active Isolated StretchProprioceptive Neuromuscular FacilitationTissue Flossing

AIS is a specific stretching program developed by Aaron Mattes. This technique is based on these four basic principles: Isolate the muscle to be stretched. Repeat the stretch eight to 10 times. Hold each stretch for no more than two seconds. Exhale on the stretch; inhale on the release.

Active Isolated StretchProprioceptive Neuromuscular FacilitationTissue Flossing

Proprioceptive neuromuscular facilitation (PNF) technique has already been found to have beneficial effects in improving hamstring flexibility and reducing pain in the knee joint of knee OA patients

Active Isolated StretchProprioceptive Neuromuscular FacilitationTissue Flossing

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Grade 1 and Grade 2 osteoarthritis patients
  • Tight Hamstrings (pain in passive Straight Leg Raise \<70 degrees)
  • Willing to participate

You may not qualify if:

  • Patients who have latex allergy
  • Hypertension (i.e., resting systolic 130-159 mm Hg and diastolic 85-99 mm Hg)
  • Venous thrombotic disease
  • Heart diseases
  • Respiratory diseases apparent neurological, dermatitis, or neurological problems in their legs
  • Patients who do not give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alees Medical centre

Islamabad, Punjab Province, 44150, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2021

First Posted

December 27, 2021

Study Start

June 30, 2021

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

February 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations