Hamstring ContracturesNCT04668092
Functional DN for Shortened HS Muscle
A study testing Functional dry needling in people with Hamstring Contractures, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to find whether functional dry needle is helpful to increase the length of shortened hamstring muscle or not Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Hamstring Contractures
- What is being tested?
- Functional dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2019to 6 Dec 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 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Having hamstring length less than 80 degree during 90-90 SLR on goniometer,
- also the subject that suffers from knee Osteoarthritis,
- Spondylosis,
- LBP,
- Lumber radiculopathy,
- Subjects with MTrPs and those with hyper lordosis were recruited in the study
Who cannot join
- subjects suffering from blood clotting disorders such as hemophilia,
- those with deformities such as leg length discrepancy,
- compromised immune system,
- vascular diseases,
- Diabetes,
- People with congenital or metabolic bone disease such as Spondyloepiphyseal Dysplasia and Pregnancy were excluded from the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Saidu group of teaching hospital said sharif swat
Swat, Kpk, 19130
About this study
Official title: Immediate Effects of Functional Dry Needling on the Length of Shortened Hamstring Muscle
The aim of this study is to find whether functional dry needle is helpful to increase the length of shortened hamstring muscle or not
Read the detailed description
Single pretest-post clinical trial to find immediate effects of functional dry needling to increase the length of the shortened hamstring. This study will be carried on single group which will include male subjects only. The data will be recorded before and immediately after the treatment. A monofilament stainless steel needle will be inserted on three points on hamstring muscle which will include semitendinosus, semimembranosus and bicep femoris. Treatment session will consist of 1 minute 20 seconds for each point on the hamstring and the manipulation will be performed by "Pistoning technique" in which the needle will be drawn out (not fully out of skin) after inserted and then again pushed in and data will be recorded after the treatment session on the basis of increase in length of hamstring which will be measure through 90-90 SLR (AKE) and on the lower extremity functional scale (LEFS)
- Conditions
- Hamstring Contractures
- Being tested
- Functional dry needling
- Keywords
- Dry needling, LEFS, 90-90 SLR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional dry needlingOther
functional dry needling applied to hamstring for 1 minute and post interventional data collected
| Study group | Role | What they receive |
|---|---|---|
| Functional dry needling | Experimental | Functional dry needling for shortened hamstring muscle Receives: Other: Functional dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-90 Straight Leg Raise (SLR)
90-90 Straight Leg Raise (SLR) test is used to measure hamstring length through goniometer. The patient lie supine and flex the hip and extend the knee. The test is positive if the patient cannot go withing last 20 degrees of knee extension.
Measured: 1 day
Secondary outcomes (1)
Lower extremity Functional scale (LEFS)
Lower extremity Functional Scale is a 20 content scale design to measure the disability level of the patient on the basis of function of the lower extremity. Score ranges from "0" to "80". The lower the score the greater is the disability.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Feb 2019
- Primary completion20 Nov 2020
- Study completion6 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring ContracturesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668092
- Sponsor's protocol ID
- REC/00767 Qaisar Ali Khan
- Status last verified
- Mar 2022
- First submitted
- 9 Dec 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Functional Dry Needling on the Length of Shortened Hamstring Muscle
- ClinicalTrials.gov ID
- NCT04668092
- Acronym / sponsor ID
- REC/00767 Qaisar Ali Khan
- Conditions
- Hamstring Contractures
- Keywords
- Dry needling, LEFS, 90-90 SLR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 6 Dec 2020 (actual)
- First posted
- 16 Dec 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 find whether functional dry needle is helpful to increase the length of shortened hamstring muscle or not
Detailed description
Single pretest-post clinical trial to find immediate effects of functional dry needling to increase the length of the shortened hamstring. This study will be carried on single group which will include male subjects only. The data will be recorded before and immediately after the treatment. A monofilament stainless steel needle will be inserted on three points on hamstring muscle which will include semitendinosus, semimembranosus and bicep femoris. Treatment session will consist of 1 minute 20 seconds for each point on the hamstring and the manipulation will be performed by "Pistoning technique" in which the needle will be drawn out (not fully out of skin) after inserted and then again pushed in and data will be recorded after the treatment session on the basis of increase in length of hamstring which will be measure through 90-90 SLR (AKE) and on the lower extremity functional scale (LEFS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional dry needling | Experimental | Other: Functional dry needlingFunctional dry needling for shortened hamstring muscle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Having hamstring length less than 80 degree during 90-90 SLR on goniometer,
- also the subject that suffers from knee Osteoarthritis,
- Spondylosis,
- LBP,
- Lumber radiculopathy,
Key exclusion criteria (6 listed)
- subjects suffering from blood clotting disorders such as hemophilia,
- those with deformities such as leg length discrepancy,
- compromised immune system,
- vascular diseases,
- Diabetes,
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 |
|---|---|---|
| Functional dry needlingfunctional dry needling applied to hamstring for 1 minute and post interventional data collected | Other | Functional dry needling |
Primary outcome
90-90 Straight Leg Raise (SLR)
Time frame: 1 day
90-90 Straight Leg Raise (SLR) test is used to measure hamstring length through goniometer. The patient lie supine and flex the hip and extend the knee. The test is positive if the patient cannot go withing last 20 degrees of knee extension.
1 secondary outcome
Lower extremity Functional scale (LEFS)
Time frame: 1 day
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 23 Mar 2022.
- Adkitte R, Rane SG, Yeole U, Nandi B, Gawali P. Effect of muscle energy technique on flexibility of hamstring muscle in Indian national football players. Saudi Journal of Sports Medicine. 2016;16(1):28.Link provided by the sponsor.
- Odunaiya N, Hamzat T, Ajayi O. The effects of static stretch duration on the flexibility of hamstring muscles. African journal of biomedical research. 2005;8(2):79-82.Link provided by the sponsor.
- Phrompaet S, Paungmali A, Pirunsan U, Sitilertpisan P. Effects of pilates training on lumbo-pelvic stability and flexibility. Asian Journal of sports medicine. 2011;2(1):16.Link provided by the sponsor.
- Wang SS, Whitney SL, Burdett RG, Janosky JE. Lower extremity muscular flexibility in long distance runners. Journal of Orthopaedic \& Sports Physical Therapy. 1993;17(2):102-7.Link provided by the sponsor.
- Akinpelu AO, Bakare U, Adegoke BA. Influence of age on hamstring tightness in apparently healthy Nigerians. Journal of Nigeria Society of Physiotherapy. 2009;15(2):35-41.Link provided by the sponsor.
- Cagnie B, Elliott J, O'Leary S, D'hooge R, Dickx N, Danneels L. Muscle functional MRI as an imaging tool to evaluate muscle activity. journal of orthopaedic \& sports physical therapy. 2011;41(11):896-903Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Muhammad Affan Iqbal, Phd* 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 Functional dry needling in people with Hamstring Contractures, 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 6 inclusion and 6 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 23 Mar 2022. 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?
90-90 Straight Leg Raise (SLR) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2022.