Hamstring TightnessNCT05393960
Effects of Lumbosacral Mobility Program on Tight Hamstrings
A study testing Lumbosacral manual therapy mobilization, lumber mobility exercises and home based self strechings program. and home based self strechings program only. in people with Hamstring Tightness, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be randomized controlled trial to determine the effects of lumbosacral mobility program on muscle length in sedentary young adults with tight hamstrings. Only the eligible subjects who fulfill the inclusion criteria will be included in the study. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hamstring Tightness
- What is being tested?
- Lumbosacral manual therapy mobilization, lumber mobility exercises and home based self strechings program. and home based self strechings program only.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2022to 30 Jan 2023
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-30 years
- Sedentary life style
- BMI < 23 non-obese
- Hamstring shortness ≥ 20° using the active knee extension test (aket)
- No history of orthopedic/neurologic disorders in the lower extremity
- No history of back pain in last 2 weeks
- No contraindication for using manual therapy
- No joint limitation in the lower extremities
Who cannot join
- Any systemic soft tissue and bony disease
- Fracture
- Neuropathy
- Congenital deformities of spine
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
FMH Institute of allied health sciences
Lahore, Punjab Province
About this study
Official title: Effects of Lumbosacral Mobility Program on Muscle Length in Sedentary Young Adults With Tight Hamstrings
The study will be randomized controlled trial to determine the effects of lumbosacral mobility program on muscle length in sedentary young adults with tight hamstrings. Only the eligible subjects who fulfill the inclusion criteria will be included in the study. A sample of 78 subjects will be taken and randomly allocated into two groups with 39 each. Group A will be given three treatments. Manual therapy, mobility exercise therapy and home based self stretching program. Manual therapy mobilization posterior-anterior glides at lumber facets joints, transverse glides at spinous process \& Posterior-anterior glides at SI joint. Glides will be performed 3 times with 5 repetitions. Mobility exercise therapy (Single knee to chest, double knee to chest, Lumbar rotation, Lumbar extension, Pelvic tilting). A total of 30 min sessions three times a week on alternate days for 1 week \& home-based self-stretches program twice a day for three times a week on alternate days for 1 week. Group B will be given home-based self-stretching program twice a day for three times a week on alternate days for 1 week .The baseline values of all the dependent variable will be recorded on day one and at the end of the 1-week treatment session, using goniometry, active and passive knee extension test, passive straight leg raising and lower extremity functional scale will be used
Read the detailed description
The hamstring muscle group consists of four muscles (semitendinosus, semimembranosus, biceps femoris long head, biceps femoris short head). It's a two-joint muscle working simultaneously to act as a hip extensor and knee flexor. It also functions to maintain the stability of the knee joint. The hamstring plays important role in daily activities like running \& walking. A lot of factors affecting hamstring function, one of them is flexibility, it is defined as the extent to which muscle length contributes to maximal joint range of motion. It is a well-known muscle of has a shortening tendency. There are many methods for treating hamstrings flexibility/tightness/shortening. Routinely, physiotherapists are using stretching \& strengthening exercises, instruments assisted in soft tissue mobilization. The current study focuses on two treatments manual therapy \& lumber mobility exercises
- Conditions
- Hamstring Tightness
- Being tested
- Lumbosacral manual therapy mobilization, lumber mobility exercises and home based self strechings program., home based self strechings program only.
- Keywords
- manual therapy, lumbar mobility, mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbosacral manual therapy mobilization, lumber mobility exercises and home based self strechings program.Other
Manual therapy, mobility exercise therapy and a home-based self-stretching program. Manual mobilization postero-anterior glides at lumber facets joints, Transverse glides at spinous process \& Posterior-anterior glides at SI joint. Glides will be performed 3 times with 5 repetitions. Mobility exercise therapy.
home based self strechings program only.Other
Home based self-stretching program includes 3 repetitions of 15 seconds duration stretch (with 20 seconds rest between each repetition). Repeat stretching exercises twice a day for 3 alternate days for 1 week. Piriformis stretch: in supine crook lying, placing the lateral side of the foot over the contralateral knee and pulling towards the chest with the hands. Quadriceps stretch: stand on your left leg, one knee touching the other, hold a chair or the wall to keep you steady if needed, grab your right foot, using your right hand, and pull it towards your butt. Hamstring stretch: To stretch the right leg, sit on the ground with the left leg bent at the knee with the foot facing inward. This is called the butterfly position. Extend the right leg, keeping it slightly bent at the knee. Bend forward at the waist, making sure to keep the back straight.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization | Experimental | Lumbosacral manual therapy mobilization Receives: Other: Lumbosacral manual therapy mobilization, lumber mobility exercises and home based self strechings program. |
| Stretching program | Other | home based self strechings program Receives: Other: home based self strechings program only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active knee extension test
A reliable tool for hamstring length measurement. Subject is in supine lying position on examination table while other leg is in extension position stabilized with two strap. One across midthigh and other across pelvis ( to prevent compensatory movements ) subject were asked to extens the knee until stretch sensation felt ayt posterior aspect of thigh. Note the range with goniometer
Measured: 1 Week
Passive knee extension test
A reliable tool for hamstring length measurement. Subject is in supine lying position on examination table while other leg is in extension position stabilized with two strap. One across midthigh and other across pelvis ( to prevent compensatory movements ) now passively extend subject's knee until stretch sensation felt at posterior aspect of thigh. Note the range with goniometer.
Measured: 1 Week
Goniometry
It is an affordable \& available tool for measurement of joint range of motion in degrees. (18) Passive Straight Leg Raise (SLR) test Subject is asked to maintain a position of supine lying on examination bed. Then passive SLR is performed by lifting subject heel. ( knee remains in extension ) pelvis should remain stabilize. look for the point at which discomfort starts. Note the range.
Measured: 1 Week
LEFS
It is well known validated tool used to assess the functioning of lower extremity. It's a 20 question test which further subgroups into 4. Questions based on physical activity of lower extremity
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 May 2022
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hamstring TightnessStudies 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil-ur Rehman, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393960
- Sponsor's protocol ID
- REC/RCR & AHS/ 22/0138 Kanwal
- Status last verified
- Mar 2023
- First submitted
- 23 May 2022
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stepien K, Smigielski R, Mouton C, Ciszek B, Engelhardt M, Seil R. Anatomy of proximal attachment, course, and innervation of hamstring muscles: a pictorial essay. Knee Surg Sports Traumatol Arthrosc. 2019 Mar;27(3):673-684. doi: 10.1007/s00167-018-5265-z. Epub 2018 Oct 29.
PubMed 30374579Kellis E. Intra- and Inter-Muscular Variations in Hamstring Architecture and Mechanics and Their Implications for Injury: A Narrative Review. Sports Med. 2018 Oct;48(10):2271-2283. doi: 10.1007/s40279-018-0975-4.
PubMed 30117053Chang JS, Kayani B, Plastow R, Singh S, Magan A, Haddad FS. Management of hamstring injuries: current concepts review. Bone Joint J. 2020 Oct;102-B(10):1281-1288. doi: 10.1302/0301-620X.102B10.BJJ-2020-1210.R1.
PubMed 32993323Guruhan S, Kafa N, Ecemis ZB, Guzel NA. Muscle Activation Differences During Eccentric Hamstring Exercises. Sports Health. 2021 Mar;13(2):181-186. doi: 10.1177/1941738120938649. Epub 2020 Aug 28.
PubMed 32857686Medeiros DM, Cini A, Sbruzzi G, Lima CS. Influence of static stretching on hamstring flexibility in healthy young adults: Systematic review and meta-analysis. Physiother Theory Pract. 2016 Aug;32(6):438-445. doi: 10.1080/09593985.2016.1204401. Epub 2016 Jul 26.
PubMed 27458757Shamsi M, Mirzaei M, Shahsavari S, Safari A, Saeb M. Modeling the effect of static stretching and strengthening exercise in lengthened position on balance in low back pain subject with shortened hamstring: a randomized controlled clinical trial. BMC Musculoskelet Disord. 2020 Dec 4;21(1):809. doi: 10.1186/s12891-020-03823-z.
PubMed 33276764Osailan A, Jamaan A, Talha K, Alhndi M. Instrument assisted soft tissue mobilization (IASTM) versus stretching: A comparison in effectiveness on hip active range of motion, muscle torque and power in people with hamstring tightness. J Bodyw Mov Ther. 2021 Jul;27:200-206. doi: 10.1016/j.jbmt.2021.03.001. Epub 2021 Mar 11.
PubMed 34391234Gunn LJ, Stewart JC, Morgan B, Metts ST, Magnuson JM, Iglowski NJ, Fritz SL, Arnot C. Instrument-assisted soft tissue mobilization and proprioceptive neuromuscular facilitation techniques improve hamstring flexibility better than static stretching alone: a randomized clinical trial. J Man Manip Ther. 2019 Feb;27(1):15-23. doi: 10.1080/10669817.2018.1475693. Epub 2018 Aug 1.
PubMed 30692839Moon JH, Jung JH, Won YS, Cho HY. Immediate effects of Graston Technique on hamstring muscle extensibility and pain intensity in patients with nonspecific low back pain. J Phys Ther Sci. 2017 Feb;29(2):224-227. doi: 10.1589/jpts.29.224. Epub 2017 Feb 24.
PubMed 28265144Sadler SG, Spink MJ, Ho A, De Jonge XJ, Chuter VH. Restriction in lateral bending range of motion, lumbar lordosis, and hamstring flexibility predicts the development of low back pain: a systematic review of prospective cohort studies. BMC Musculoskelet Disord. 2017 May 5;18(1):179. doi: 10.1186/s12891-017-1534-0.
PubMed 28476110
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lumbosacral Mobility Program on Muscle Length in Sedentary Young Adults With Tight Hamstrings
- ClinicalTrials.gov ID
- NCT05393960
- Acronym / sponsor ID
- REC/RCR & AHS/ 22/0138 Kanwal
- Conditions
- Hamstring Tightness
- Keywords
- manual therapy, lumbar mobility, mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 26 May 2022 (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 study will be randomized controlled trial to determine the effects of lumbosacral mobility program on muscle length in sedentary young adults with tight hamstrings. Only the eligible subjects who fulfill the inclusion criteria will be included in the study. A sample of 78 subjects will be taken and randomly allocated into two groups with 39 each. Group A will be given three treatments. Manual therapy, mobility exercise therapy and home based self stretching program. Manual therapy mobilization posterior-anterior glides at lumber facets joints, transverse glides at spinous process \& Posterior-anterior glides at SI joint. Glides will be performed 3 times with 5 repetitions. Mobility exercise therapy (Single knee to chest, double knee to chest, Lumbar rotation, Lumbar extension, Pelvic tilting). A total of 30 min sessions three times a week on alternate days for 1 week \& home-based self-stretches program twice a day for three times a week on alternate days for 1 week. Group B will be given home-based self-stretching program twice a day for three times a week on alternate days for 1 week .The baseline values of all the dependent variable will be recorded on day one and at the end of the 1-week treatment session, using goniometry, active and passive knee extension test, passive straight leg raising and lower extremity functional scale will be used
Detailed description
The hamstring muscle group consists of four muscles (semitendinosus, semimembranosus, biceps femoris long head, biceps femoris short head). It's a two-joint muscle working simultaneously to act as a hip extensor and knee flexor. It also functions to maintain the stability of the knee joint. The hamstring plays important role in daily activities like running \& walking. A lot of factors affecting hamstring function, one of them is flexibility, it is defined as the extent to which muscle length contributes to maximal joint range of motion. It is a well-known muscle of has a shortening tendency. There are many methods for treating hamstrings flexibility/tightness/shortening. Routinely, physiotherapists are using stretching \& strengthening exercises, instruments assisted in soft tissue mobilization. The current study focuses on two treatments manual therapy \& lumber mobility exercises
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization | Experimental | Other: Lumbosacral manual therapy mobilization, lumber mobility exercises and home based self strechings program.Lumbosacral manual therapy mobilization |
| Stretching program | Other | Other: home based self strechings program only.home based self strechings program |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 20-30 years
- Sedentary life style
- BMI < 23 non-obese
- Hamstring shortness ≥ 20° using the active knee extension test (aket)
- No history of orthopedic/neurologic disorders in the lower extremity
Key exclusion criteria (4 listed)
- Any systemic soft tissue and bony disease
- Fracture
- Neuropathy
- Congenital deformities of spine
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 |
|---|---|---|
| Lumbosacral manual therapy mobilization, lumber mobility exercises and home based self strechings program.Manual therapy, mobility exercise therapy and a home-based self-stretching program. Manual mobilization postero-anterior glides at lumber facets joints, Transverse glides at spinous process \& Posterior-anterior glides at SI joint. Glides will be performed 3 times with 5 repetitions. Mobility exercise therapy. | Other | Mobilization |
| home based self strechings program only.Home based self-stretching program includes 3 repetitions of 15 seconds duration stretch (with 20 seconds rest between each repetition). Repeat stretching exercises twice a day for 3 alternate days for 1 week. Piriformis stretch: in supine crook lying, placing the lateral side of the foot over the contralateral knee and pulling towards the chest with the hands. Quadriceps stretch: stand on your left leg, one knee touching the other, hold a chair or the wall to keep you steady if needed, grab your right foot, using your right hand, and pull it towards your butt. Hamstring stretch: To stretch the right leg, sit on the ground with the left leg bent at the knee with the foot facing inward. This is called the butterfly position. Extend the right leg, keeping it slightly bent at the knee. Bend forward at the waist, making sure to keep the back straight. | Other | Stretching program |
Primary outcome
Active knee extension test
Time frame: 1 Week
A reliable tool for hamstring length measurement. Subject is in supine lying position on examination table while other leg is in extension position stabilized with two strap. One across midthigh and other across pelvis ( to prevent compensatory movements ) subject were asked to extens the knee until stretch sensation felt ayt posterior aspect of thigh. Note the range with goniometer
Passive knee extension test
Time frame: 1 Week
A reliable tool for hamstring length measurement. Subject is in supine lying position on examination table while other leg is in extension position stabilized with two strap. One across midthigh and other across pelvis ( to prevent compensatory movements ) now passively extend subject's knee until stretch sensation felt at posterior aspect of thigh. Note the range with goniometer.
Goniometry
Time frame: 1 Week
It is an affordable \& available tool for measurement of joint range of motion in degrees. (18) Passive Straight Leg Raise (SLR) test Subject is asked to maintain a position of supine lying on examination bed. Then passive SLR is performed by lifting subject heel. ( knee remains in extension ) pelvis should remain stabilize. look for the point at which discomfort starts. Note the range.
LEFS
Time frame: 1 Week
It is well known validated tool used to assess the functioning of lower extremity. It's a 20 question test which further subgroups into 4. Questions based on physical activity of lower extremity
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 3 Apr 2023.
- Background: PubMed 30374579Stepien K, Smigielski R, Mouton C, Ciszek B, Engelhardt M, Seil R. Anatomy of proximal attachment, course, and innervation of hamstring muscles: a pictorial essay. Knee Surg Sports Traumatol Arthrosc. 2019 Mar;27(3):673-684. doi: 10.1007/s00167-018-5265-z. Epub 2018 Oct 29.
- Background: PubMed 30117053Kellis E. Intra- and Inter-Muscular Variations in Hamstring Architecture and Mechanics and Their Implications for Injury: A Narrative Review. Sports Med. 2018 Oct;48(10):2271-2283. doi: 10.1007/s40279-018-0975-4.
- Background: PubMed 32993323Chang JS, Kayani B, Plastow R, Singh S, Magan A, Haddad FS. Management of hamstring injuries: current concepts review. Bone Joint J. 2020 Oct;102-B(10):1281-1288. doi: 10.1302/0301-620X.102B10.BJJ-2020-1210.R1.
- Background: PubMed 32857686Guruhan S, Kafa N, Ecemis ZB, Guzel NA. Muscle Activation Differences During Eccentric Hamstring Exercises. Sports Health. 2021 Mar;13(2):181-186. doi: 10.1177/1941738120938649. Epub 2020 Aug 28.
- Background: PubMed 27458757Medeiros DM, Cini A, Sbruzzi G, Lima CS. Influence of static stretching on hamstring flexibility in healthy young adults: Systematic review and meta-analysis. Physiother Theory Pract. 2016 Aug;32(6):438-445. doi: 10.1080/09593985.2016.1204401. Epub 2016 Jul 26.
- Background: PubMed 33276764Shamsi M, Mirzaei M, Shahsavari S, Safari A, Saeb M. Modeling the effect of static stretching and strengthening exercise in lengthened position on balance in low back pain subject with shortened hamstring: a randomized controlled clinical trial. BMC Musculoskelet Disord. 2020 Dec 4;21(1):809. doi: 10.1186/s12891-020-03823-z.
- Background: PubMed 34391234Osailan A, Jamaan A, Talha K, Alhndi M. Instrument assisted soft tissue mobilization (IASTM) versus stretching: A comparison in effectiveness on hip active range of motion, muscle torque and power in people with hamstring tightness. J Bodyw Mov Ther. 2021 Jul;27:200-206. doi: 10.1016/j.jbmt.2021.03.001. Epub 2021 Mar 11.
- Background: PubMed 30692839Gunn LJ, Stewart JC, Morgan B, Metts ST, Magnuson JM, Iglowski NJ, Fritz SL, Arnot C. Instrument-assisted soft tissue mobilization and proprioceptive neuromuscular facilitation techniques improve hamstring flexibility better than static stretching alone: a randomized clinical trial. J Man Manip Ther. 2019 Feb;27(1):15-23. doi: 10.1080/10669817.2018.1475693. Epub 2018 Aug 1.
- Background: PubMed 28265144Moon JH, Jung JH, Won YS, Cho HY. Immediate effects of Graston Technique on hamstring muscle extensibility and pain intensity in patients with nonspecific low back pain. J Phys Ther Sci. 2017 Feb;29(2):224-227. doi: 10.1589/jpts.29.224. Epub 2017 Feb 24.
- Background: PubMed 28476110Sadler SG, Spink MJ, Ho A, De Jonge XJ, Chuter VH. Restriction in lateral bending range of motion, lumbar lordosis, and hamstring flexibility predicts the development of low back pain: a systematic review of prospective cohort studies. BMC Musculoskelet Disord. 2017 May 5;18(1):179. doi: 10.1186/s12891-017-1534-0.
- 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.
Syed Shakil-ur Rehman principal investigator
Riphah International 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 Lumbosacral manual therapy mobilization, lumber mobility exercises and home based self strechings program. and home based self strechings program only. in people with Hamstring Tightness, run by Riphah International University at 1 site in Pakistan.
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 8 inclusion and 4 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 3 Apr 2023. 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 Pakistan. 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 (time frame: 1 Week). The study lists 4 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 NCT05393960, which also lists 10 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 3 Apr 2023.