NCT04645238

Brief Summary

The aim of this study is to determine and compare the effects of static and PNF hamstring stretching exercises on joint pain, hamstring flexibility and functional status in patients with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2019

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

September 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
Last Updated

April 9, 2025

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

November 20, 2020

Last Update Submit

April 5, 2025

Conditions

Keywords

Knee OsteoarthritisHamstringStretching

Outcome Measures

Primary Outcomes (2)

  • Active Knee Extension Test for Hamstring Flexibility

    Higher values represent better outcomes.

    Baseline and post-intervention

  • Active Knee Extension Test for Hamstring Flexibility

    Higher values represent better outcomes.

    Post-intervention and follow-up

Secondary Outcomes (6)

  • Visual Analogue Scale for Pain

    Baseline and post-intervention

  • Visual Analogue Scale for Pain

    Post-intervention and follow-up

  • Western Ontario and McMaster Universities Osteoarthritis Index

    Baseline and post-intervention

  • Western Ontario and McMaster Universities Osteoarthritis Index

    Post-intervention and follow-up

  • The Timed Up & Go Test

    Baseline and post-intervention

  • +1 more secondary outcomes

Study Arms (2)

Static Hamstring Stretching

ACTIVE COMPARATOR

Static Hamstring Stretching

Other: Static Stretching

PNF Stretching

ACTIVE COMPARATOR

PNF Hamstring Stretching (Hold-Relax)

Other: PNF Stretching

Interventions

Static hamstring stretching exercise lasting 30 seconds and 10 repetitions under the supervision of the physiotherapist

Static Hamstring Stretching

PNF hold-relax stretching technique that consists of 10 seconds isometric contraction, 30 seconds hamstring stretching and 10 repetitions under the supervision of the physiotherapist

PNF Stretching

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with knee osteoarthritis severity II, III, or IV according to the Kellgren-Lawrence Classification,
  • Individuals with positive active knee extension test,
  • Individuals with a body mass index of 30 or less,
  • Individuals with a pain severity of at least 3/10 according to the visual pain scale.

You may not qualify if:

  • Individuals with health problems that prevent them from doing the evaluations and exercises to be used in the study,
  • Individuals who exercise regularly for the last six months,
  • Individuals with a diagnosis of neurological disease affecting the lower extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fizyotem Medical Center

Trabzon, Turkey (Türkiye)

Location

Related Publications (12)

  • Reid DA, McNair PJ. Effects of an acute hamstring stretch in people with and without osteoarthritis of the knee. Physiotherapy. 2010 Mar;96(1):14-21. doi: 10.1016/j.physio.2009.06.010. Epub 2009 Sep 4.

    PMID: 20113758BACKGROUND
  • Hortobagyi T, Westerkamp L, Beam S, Moody J, Garry J, Holbert D, DeVita P. Altered hamstring-quadriceps muscle balance in patients with knee osteoarthritis. Clin Biomech (Bristol). 2005 Jan;20(1):97-104. doi: 10.1016/j.clinbiomech.2004.08.004.

    PMID: 15567543BACKGROUND
  • Krishnasamy P, Hall M, Robbins SR. The role of skeletal muscle in the pathophysiology and management of knee osteoarthritis. Rheumatology (Oxford). 2018 May 1;57(suppl_4):iv22-iv33. doi: 10.1093/rheumatology/kex515.

    PMID: 29351644BACKGROUND
  • Rutherford DJ, Hubley-Kozey CL, Stanish WD. Changes in knee joint muscle activation patterns during walking associated with increased structural severity in knee osteoarthritis. J Electromyogr Kinesiol. 2013 Jun;23(3):704-11. doi: 10.1016/j.jelekin.2013.01.003. Epub 2013 Jan 26.

    PMID: 23357547BACKGROUND
  • Lempke L, Wilkinson R, Murray C, Stanek J. The Effectiveness of PNF Versus Static Stretching on Increasing Hip-Flexion Range of Motion. J Sport Rehabil. 2018 May 1;27(3):289-294. doi: 10.1123/jsr.2016-0098. Epub 2018 May 22.

    PMID: 28182516BACKGROUND
  • Lim KI, Nam HC, Jung KS. Effects on hamstring muscle extensibility, muscle activity, and balance of different stretching techniques. J Phys Ther Sci. 2014 Feb;26(2):209-13. doi: 10.1589/jpts.26.209. Epub 2014 Feb 28.

    PMID: 24648633BACKGROUND
  • Hill KJ, Robinson KP, Cuchna JW, Hoch MC. Immediate Effects of Proprioceptive Neuromuscular Facilitation Stretching Programs Compared With Passive Stretching Programs for Hamstring Flexibility: A Critically Appraised Topic. J Sport Rehabil. 2017 Nov;26(6):567-572. doi: 10.1123/jsr.2016-0003. Epub 2016 Aug 24.

    PMID: 27632820BACKGROUND
  • Maddigan ME, Peach AA, Behm DG. A comparison of assisted and unassisted proprioceptive neuromuscular facilitation techniques and static stretching. J Strength Cond Res. 2012 May;26(5):1238-44. doi: 10.1519/JSC.0b013e3182510611.

    PMID: 22395273BACKGROUND
  • Fasen JM, O'Connor AM, Schwartz SL, Watson JO, Plastaras CT, Garvan CW, Bulcao C, Johnson SC, Akuthota V. A randomized controlled trial of hamstring stretching: comparison of four techniques. J Strength Cond Res. 2009 Mar;23(2):660-7. doi: 10.1519/JSC.0b013e318198fbd1.

    PMID: 19204565BACKGROUND
  • Yildirim MS, Ozyurek S, Tosun O, Uzer S, Gelecek N. Comparison of effects of static, proprioceptive neuromuscular facilitation and Mulligan stretching on hip flexion range of motion: a randomized controlled trial. Biol Sport. 2016 Mar;33(1):89-94. doi: 10.5604/20831862.1194126. Epub 2016 Feb 8.

    PMID: 26929476BACKGROUND
  • Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018.

    PMID: 29731662BACKGROUND
  • Song Q, Shen P, Mao M, Sun W, Zhang C, Li L. Proprioceptive neuromuscular facilitation improves pain and descending mechanics among elderly with knee osteoarthritis. Scand J Med Sci Sports. 2020 Sep;30(9):1655-1663. doi: 10.1111/sms.13709. Epub 2020 Jun 1.

    PMID: 32407583BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Nihal Gelecek, Professor

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 27, 2020

Study Start

September 1, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

April 9, 2025

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations