- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04645238
Comparison of the Effects of Static and PNF Hamstring Stretching Exercises in Patients With Knee Osteoarthritis
February 2, 2021 updated by: İlke KARA, PT, Dokuz Eylul University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A total of 36 patients between the ages of 40 and 75 who were diagnosed with Kellgren-Lawrence Stage II and III knee OA by the physician were included in the study.
Participants were divided into two groups as static stretching group (n = 18) or PNF stretching group (n = 18).
Patients' demographic and clinical information was recorded.
Pain intensity was evaluated with visual pain scale, hamstring flexibility with Active Knee Extension Test, functional status with Western Ontario and McMasters University Osteoarthritis Index and Timed Get Up and Go Test.
In addition to the standard physiotherapy program, the subjects praticed stretching exercises for 15 sessions according to the groups that they've been separated.
Evaluations were repeated in the end of the treatment (4th week) and in the 3rd month after the treatment.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Trabzon, Turkey
- Fizyotem Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Static Hamstring Stretching
|
Static hamstring stretching exercise lasting 30 seconds and 10 repetitions under the supervision of the physiotherapist
|
Active Comparator: PNF Stretching
PNF Hamstring Stretching (Hold-Relax)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Active Knee Extension Test for Hamstring Flexibility
Time Frame: Baseline and post-intervention, up to 4 weeks
|
Higher values represent better outcomes.
|
Baseline and post-intervention, up to 4 weeks
|
Active Knee Extension Test for Hamstring Flexibility
Time Frame: Post-intervention and follow-up, up to 3 months
|
Higher values represent better outcomes.
|
Post-intervention and follow-up, up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale for Pain
Time Frame: Baseline and post-intervention, up to 4 weeks
|
The scale varies from 0 to 10. Higher values represent worse outcomes.
|
Baseline and post-intervention, up to 4 weeks
|
Visual Analogue Scale for Pain
Time Frame: Post-intervention and follow-up, up to 3 months
|
The scale varies from 0 to 10. Higher values represent worse outcomes.
|
Post-intervention and follow-up, up to 3 months
|
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: Baseline and post-intervention, up to 4 weeks
|
The scale varies from 0 to 96.
Higher values represent worse outcomes.
|
Baseline and post-intervention, up to 4 weeks
|
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: Post-intervention and follow-up, up to 3 months
|
The scale varies from 0 to 96.
Higher values represent worse outcomes.
|
Post-intervention and follow-up, up to 3 months
|
The Timed Up & Go Test
Time Frame: Baseline and post-intervention, up to 4 weeks
|
Higher values represent worse outcomes.
|
Baseline and post-intervention, up to 4 weeks
|
The Timed Up & Go Test
Time Frame: Post-intervention and follow-up, up to 3 months
|
Higher values represent worse outcomes.
|
Post-intervention and follow-up, up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nihal GELECEK, Professor, Dokuz Eylul University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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, Avon). 2005 Jan;20(1):97-104. doi: 10.1016/j.clinbiomech.2004.08.004.
- 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. Erratum In: Rheumatology (Oxford). 2018 May 1;57(suppl_4):iv124.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
November 20, 2020
First Submitted That Met QC Criteria
November 20, 2020
First Posted (Actual)
November 27, 2020
Study Record Updates
Last Update Posted (Actual)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 2, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEU-FTR-IK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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