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Hamstring TightnessNCT03076840

The Immediate Effect of Kinesio Tape on Hamstring Muscle Length in Female Students of University of Dammam

A study testing Kinesio tape in people with Hamstring Tightness, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The hamstring muscle is an important muscle that affect the performance of almost all activities of daily living. Since this muscle is a large muscle that pass across two major joints (the hip and knee joint), it is more susceptible to become tight and to lose its extensibility. Read more about this study

Who is it for?
Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hamstring Tightness
What is being tested?
Kinesio tape
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteSaudi Arabia
Study dates
17 Feb 2016to Jul 2017
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 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female student with an age of 18-25 years
  • Body mass index between 18-30
  • Students with reduced hamstring length (hamstring tightness) as defined by the literature (popliteal angle less than 160 degree)

Who cannot join

  • Lower limb musculoskeletal pain
  • Abdominal, lower limb and spinal surgery
  • Pregnancy
  • Previous injury or trauma to hamstring muscle, hip, knee And ankle joint
  • Skin allergy, disease or hypersensitivity
  • Low back pain or any neurological impairment in the lower extremity
  • Body mass index above 30 or below 18

Trial locations and contacts

1 site in 1 country.

zainab SA Albeshri, bachlor contact

00966504830720

happysmile2004@hotmail.com

enas FA Alanany, Prof contact

0096655578650

eyoussef@uod.edu.sa

Saudi Arabia1 site, 1 recruiting
  • University of Dammam

    Dammam, Eastern Province, 009666

    enas FA Alanany, Prof, 00966555786350, eyoussef@uod.edu.sa

    Recruiting

Other trials in Saudi Arabia

About this study

The hamstring muscle is an important muscle that affect the performance of almost all activities of daily living. Since this muscle is a large muscle that pass across two major joints (the hip and knee joint), it is more susceptible to become tight and to lose its extensibility. On the other hand, there is no agreement on a standard protocol for the treatment of hamstring tightness. Kinesio tape is one of the options for treatment of hamstring muscle, it is a safe, passive and non-painful intervention, and if proven to be effective it will help individuals especially those with poor compliance and poor tolerance to painful stretching exercises. The aim of the present study is to investigate the acute effectiveness of Kinesio taping on hamstring muscles extensibility. 96 students with hamstring tightness will be recruited from the University of Dammam to participate in this prospective experimental study. All participants will be assigned randomly to either a Kinesio tape group, Sham tape group and control group. Outcome measures will be the hamstring length measurement by using active knee extension test and strength measurement for hamstring and quadriceps muscles by using a handheld dynamometer. Outcome measurement will be taken at baseline and 15 minutes after the intervention.

Read the detailed description

Design:

Prospective, pre-post experimental study with three groups (Kinesio tape group, sham tape group and control group)

Setting:

This study was conducted at the laboratory of University of Dammam one session (half an hour) for each participant.

Participants:

96 students with hamstring tightness were recruited from the University of Dammam as a sample of convenience to participate in this study. These students were enrolled in the study based on the following inclusion and exclusion criteria.

Inclusion Criteria:

  1. Female student with an age of 18-25 years
  2. Body mass index between 18-30)
  3. students with reduced hamstring length (hamstring tightness) as defined by the literature (popliteal angle less than 160 degree)

Exclusion criteria:

  1. lower limb musculoskeletal pain
  2. abdominal , lower limb and spinal surgery
  3. pregnancy
  4. previous injury or trauma to hamstring muscle, hip, knee And ankle joint
  5. Skin allergy, disease or hypersensitivity
  6. Low back pain or any neurological impairment in the lower extremity
  7. Body mass index above 30 or below 18

Procedure:

A poster announcement was published at University of Dammam, 96 female students were recruited from a convenience sampling of students. The possible participants were approached and the idea of the research (the duration of the participation, the length of treatment session, the goal of the research, any possible risks including skin irritation or allergy from the Kinesio tape) were explained to the student. The students were instructed about dealing with any skin irritation by removing the tape and applying ice in the area for 10-15 min, students were informed that there is no compensation for any skin reaction due the Kinesio tape, although this may be less likely to happen . The students were given the chance to ask questions. If the students agree to participate in the research, they were given the consent form to read and ask a question again for any details and then they were asked to sign the consent form.

After that, the subjects were scanned for the eligibility of fitting the inclusion and exclusion criteria by the primary researcher, This was done in a safe and secured room in the laboratories of physical therapy department where the evaluation and intervention procedures were taken place. If the students fit the eligibility, then the students were undergoing a tape allergy test by applying a small piece of Kinesio tape to the patient skin for 10 minute. If the students pass this test by having no allergy reaction, then they were enrolled in the study. Students age, height, weight and body mass index(BMI) were recorded, then the students were undergo a 5 minute walking as a warming up to pre-condition the muscles before the examination. Then, hamstring length measurement, strength measurement of hamstring and quadriceps muscle were done (All students data will be coded and stored with the primary researcher through a secured password to ensure the student data confidentiality).

The outcome measures:

  1. Hamstring length measurement: Hamstring muscle length was measured by using the active knee extension test (AKE)(Active knee extension is reliable and associated with minimal pelvic and lumber motion. Therefore, it considers a suitable and preferable test for evaluating the length of hamstring muscle. The knee extension angle (popliteal angle) was measured by using a conventional goniometer which is a reliable tool for measuring the range of motion The hamstring length measurement was performed with the student in a supine position with 90-degree hip flexion touching the horizontal bar apparatus.The non-tested lower limb was secured with a strap attached to the table. While the student maintains the contact between her thigh and the horizontal bar apparatus, she was asked to extend the leg as much as possible. The angle of the knee joint was measured by the researcher with a goniometer. The measurements were done three times, and the mean value were recorded
  2. Hamstring and quadriceps muscle strength measurement:

The hamstring and quadriceps muscle strength were measured by the primary researcher by using the handheld dynamometer. The hamstring strength measurement was done with the student in prone position, then the student was asked to flex the knee as hard as possible while the researcher try to prevent the movement with the handheld dynamometer just proximal to the medial malleolus. The quadriceps strength measurement was done with the same procedure but from sitting position and the student was asked to extend the knee

After finishing all of the baseline outcome measures (hamstring length measurement and the strength measurement), the student were given a number and were assigned randomly to either the Kinesio tape group or the sham tape group or the control group. Each group fellow their program. The outcome measurements were repeated after 15 min at the conclusion of the treatment period

Being tested
Kinesio tape
Keywords
hamstring tightness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinesio tapeOther

    Kinesio Taping is another option for the treatment of poor hamstring extensibility, It was developed by Kenzo Kase in 1970 and gained a wide popularity by the elite athletes during the various championships and Olympic Games

Study groups in NCT03076840
Study groupRoleWhat they receive
Kinesio tape groupActive comparatortreatment by: application of Kinesio tape in the hamstring muscle by using a 1 strip Y shape of (Kinesio Tex® Tape 5cm) insertion to origin technique to relieve the hamstring tightness while the muscle in stretched position for 15 second (hip flexion and knee extension and then application of the tape) with 25% stretch of the tape
Receives: Other: Kinesio tape
sham tape groupSham comparatortreatment by: application of Kinesio tape in the hamstring muscle by using a 1 strip I shape of (Kinesio Tex® Tape 5cm) with no stretch in the hamstring musculature and the tape applied perpendicular over the upper third of the hamstring muscle while the muscle in stretched position
Receives: Other: Kinesio tape
control groupNo interventionThe student in this group had no treatment in the same position of the previous groups (the hamstring muscle maintained in a stretching position for 15 second)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1- Hamstring length measurement

    Hamstring muscle length was measured by using the active knee extension test

    Measured: 5 min

Secondary outcomes (1)
  1. Hamstring and quadriceps muscle strength measurement

    The hamstring and quadriceps muscle strength were measured by the primary researcher by using the handheld dynamometer

    Measured: 5 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2017
  2. Study start17 Feb 2016
  3. Primary completionApr 2017 (estimated)
  4. Study completionJul 2017 (estimated)

Resources

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
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03076840
Sponsor's protocol ID
IRB-PGS-2015-03-220
Status last verified
Mar 2017
First submitted
7 Mar 2017
Last updated
21 Mar 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: only coded data

Publications

  • Albeshri ZS, Youssef EF. The Immediate Effect of Kinesio Tape on Hamstring Muscle Length and Strength in Female University Students: A Pre-post Experimental Study. Saudi J Med Med Sci. 2023 Jan-Mar;11(1):73-80. doi: 10.4103/sjmms.sjmms_585_22. Epub 2023 Jan 14.

    PubMed 36909004

Questions about this trial

What is this clinical trial studying?

A study testing Kinesio tape in people with Hamstring Tightness, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.

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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Mar 2017. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact zainab SA Albeshri, bachlor (00966504830720, happysmile2004@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1- Hamstring length measurement (time frame: 5 min). 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 NCT03076840, which also lists 1 linked publication.

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 21 Mar 2017.

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