Knee OsteoarthritisNCT04645238
Comparison of the Effects of Static and PNF Hamstring Stretching Exercises in Patients With Knee Osteoarthritis
A study testing Static Stretching and PNF Stretching in people with Knee Osteoarthritis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Static Stretching and PNF Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 or PNF stretching group. 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 practiced stretching exercises according to the groups that they've been separated. Evaluations were repeated in the end of the treatment and in the follow-up.
- Conditions
- Knee Osteoarthritis
- Being tested
- Static Stretching, PNF Stretching
- Keywords
- Knee Osteoarthritis, Hamstring, Stretching
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static StretchingOther
Static hamstring stretching exercise lasting 30 seconds and 10 repetitions under the supervision of the physiotherapist
PNF StretchingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Static Hamstring Stretching | Active comparator | Static Hamstring Stretching Receives: Other: Static Stretching |
| PNF Stretching | Active comparator | PNF Hamstring Stretching (Hold-Relax) Receives: Other: PNF Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Knee Extension Test for Hamstring Flexibility
Higher values represent better outcomes.
Measured: Baseline and post-intervention
Active Knee Extension Test for Hamstring Flexibility
Higher values represent better outcomes.
Measured: Post-intervention and follow-up
Secondary outcomes (6)
Visual Analogue Scale for Pain
The scale varies from 0 to 10. Higher values represent worse outcomes.
Measured: Baseline and post-intervention
Visual Analogue Scale for Pain
The scale varies from 0 to 10. Higher values represent worse outcomes.
Measured: Post-intervention and follow-up
Western Ontario and McMaster Universities Osteoarthritis Index
The scale varies from 0 to 96. Higher values represent worse outcomes.
Measured: Baseline and post-intervention
Western Ontario and McMaster Universities Osteoarthritis Index
The scale varies from 0 to 96. Higher values represent worse outcomes.
Measured: Post-intervention and follow-up
The Timed Up & Go Test
Higher values represent worse outcomes.
Measured: Baseline and post-intervention
The Timed Up & Go Test
Higher values represent worse outcomes.
Measured: Post-intervention and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Sep 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilke KARA, Dokuz Eylul University
- Investigators
- Nihal Gelecek, Professor, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645238
- Sponsor's protocol ID
- DEU-FTR-IK-01
- Status last verified
- Feb 2021
- First submitted
- 20 Nov 2020
- Last updated
- 9 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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). 2005 Jan;20(1):97-104. doi: 10.1016/j.clinbiomech.2004.08.004.
PubMed 15567543Krishnasamy 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.
PubMed 29351644Rutherford 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.
PubMed 23357547Lempke 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.
PubMed 28182516Hill 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.
PubMed 27632820Maddigan 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.
PubMed 22395273Reid 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.
PubMed 20113758Lim 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.
PubMed 24648633Fasen 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.
PubMed 19204565Yildirim 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.
PubMed 26929476Alghadir 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.
PubMed 29731662Song 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.
PubMed 32407583
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Static and PNF Hamstring Stretching Exercises in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04645238
- Acronym / sponsor ID
- DEU-FTR-IK-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Hamstring, Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 or PNF stretching group. 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 practiced stretching exercises according to the groups that they've been separated. Evaluations were repeated in the end of the treatment and in the follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static Hamstring Stretching | Active comparator | Other: Static StretchingStatic Hamstring Stretching |
| PNF Stretching | Active comparator | Other: PNF StretchingPNF Hamstring Stretching (Hold-Relax) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static StretchingStatic hamstring stretching exercise lasting 30 seconds and 10 repetitions under the supervision of the physiotherapist | Other | Static Hamstring Stretching |
| PNF StretchingPNF hold-relax stretching technique that consists of 10 seconds isometric contraction, 30 seconds hamstring stretching and 10 repetitions under the supervision of the physiotherapist | Other | PNF Stretching |
Primary outcome
Active Knee Extension Test for Hamstring Flexibility
Time frame: Baseline and post-intervention
Higher values represent better outcomes.
Active Knee Extension Test for Hamstring Flexibility
Time frame: Post-intervention and follow-up
Higher values represent better outcomes.
6 secondary outcomes
Visual Analogue Scale for Pain
Time frame: Baseline and post-intervention
Visual Analogue Scale for Pain
Time frame: Post-intervention and follow-up
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Baseline and post-intervention
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Post-intervention and follow-up
The Timed Up & Go Test
Time frame: Baseline and post-intervention
The Timed Up & Go Test
Time frame: Post-intervention and follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 15567543Hortobagyi 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.
- Background: PubMed 29351644Krishnasamy 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.
- Background: PubMed 23357547Rutherford 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.
- Background: PubMed 28182516Lempke 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.
- Background: PubMed 27632820Hill 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.
- Background: PubMed 22395273Maddigan 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.
- Results publication: PubMed 20113758Reid 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.
- Results publication: PubMed 24648633Lim 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.
- Results publication: PubMed 19204565Fasen 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.
- Results publication: PubMed 26929476Yildirim 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.
- Results publication: PubMed 29731662Alghadir 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.
- Results publication: PubMed 32407583Song 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihal Gelecek, Professor study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Stretching and PNF Stretching in people with Knee Osteoarthritis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Knee Extension Test for Hamstring Flexibility (time frame: Baseline and post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04645238, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.