Piriformis SyndromeKTNCT01752179
Kinesio Taping Technique and Trigger Point
A study testing kinesio Tape : Width 5cm ,Length 35cm Y shape in people with Piriformis Syndrome, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
Trial summary
Kinesio taping is a novel method which recently has emerged as a viable option to treat of various musculoskeletal and neuromuscular deficits. The application of tape to injured soft tissues and joints provides support and protection for these structures. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- kinesio Tape : Width 5cm ,Length 35cm Y shape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- May 2011to Feb 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having trigger point and tenderness in piriformis muscle.
- Having at least three positive physical examination tests from FAIR, Freiberg Lasegue and Beaty test.
Who cannot join
- spinal surgery
- spinal or pelvic fracture
- disc herniation,
- facet arthropathy
- sacroiliitis
- osteoarthritis or fracture of the lower extremities
- systemic disease, such as arthritis or tuberculosis
Trial locations and contacts
1 site in 1 country.
Iran1 site
Akhavan Spine Physical Therapy Center, University of Social Welfare and Rehabilitation Sciences
Tehran, 1113813111
About this study
Official title: The Effect of Kinesio Taping Technique on Trigger Point of Piriformis Muscle
Kinesio taping is a novel method which recently has emerged as a viable option to treat of various musculoskeletal and neuromuscular deficits. The application of tape to injured soft tissues and joints provides support and protection for these structures. Many different techniques are used for injury prevention, treatment, rehabilitation, proprioception and sport. Elastic adhesive tape may be used to unload Myofacial Trigger Points (MTrPs), A trigger point can be located in fascia, ligaments, muscles, and tendons; however, MTrPs are also found in skeletal muscles and/or their fascia. An MTrP is a hyperirritable spot, associated with a taut band of a skeletal muscle that is painful on compression or stretch, and that can give rise to a typical referred pain pattern as well as autonomic phenomena. The use of tape along muscle to unload affected soft tissue seems to be effective in the treatment of trigger points by inhibiting overactive muscle, changing the orientation of fascia and a proprioceptive effect. The purpose of study was to determine the efficacy of Kinesio taping application on trigger point of piriformis muscle.
Read the detailed description
Piriformis syndrome is a peripheral neuritis of the sciatic nerve caused by an abnormal condition of the piriformis muscle. Some investigators consider it as a form of Myofacial pain syndrome which defined as the presence of exquisite tenderness at a nodule in a palpable taut band of muscle. Trigger points are able to produce referred pain, either spontaneously or on digital compression. Although myofascial trigger points are a widely recognized phenomenon in clinical practice, there remains much to be elucidated with regards to their pathophysiology. Conservative pharmacotherapy with nonsteroidal anti-inflammatory drugs (NSAID), muscle relaxants, and physical therapy modalities such as heat therapy, cold therapy, ultrasound, electrical current and stretching were traditionally used in the treatment of trigger points.
The utilization of Kinesio taping regarding to the proposed mechanisms including 1) restoring correct muscle function by supporting weakened muscles, (2) reducing congestion by improving the flow of blood and lymphatic fluid, (3) decreasing pain by stimulating neurological system, and (4) correcting misaligned joints by retrieving muscle spasm (5) enhancing proprioception through increased stimulation to cutaneous mechanoreceptors can be helpful in restoring muscle function in patients with Myofacial trigger points . However, there are not many controlled studies that have analyzed the effects of the Kinesio taping in their treatment. Therefore, the purpose of study was to determine the efficacy of KT application as an easy and appropriate method on trigger point of piriformis muscle.
- Conditions
- Piriformis Syndrome
- Being tested
- kinesio Tape : Width 5cm ,Length 35cm Y shape
- Keywords
- Kinesio taping, Piriformis syndrome, Trigger point
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio Tape : Width 5cm ,Length 35cm Y shapeProcedure or surgery
In the experimental group, Kinesio taping application of piriformis according to Kenzo Kase in 2003 is modified by using unloading technique (Macdolanld, 2004). Size and Shape of Tape is Width 5cm ,Length 35cm Y shape.
Taping method include :
- stretches the piriformis muscle in side lying position ,the affected leg is upper most with hip in flexion, adduction and internal rotation.
- puts the base of tape over the contralateral of sacrum with no tension.
- attaches the superior tail on the buttock over the upper part of piriformis and ends at the greater trochanter of the femur.
- attaches the lower tail by lifting up the soft tissue and ends at the greater trochanter of the femur.
This is an origin to insertion application.
| Study group | Role | What they receive |
|---|---|---|
| kinesio tape | Experimental | kinesio Tape : Width 5cm ,Length 35cm Y shape Receives: Procedure: kinesio Tape : Width 5cm ,Length 35cm Y shape |
| Control group | No intervention | without using Kinesio tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain intensity immediately after kinesio taping application and Change from baseline in pain intensity at three day follow-up.
Change in pain intensity measured based on visual analogue scale at baseline, immediately after kinesio taping application and three day follow up . To measure the pain intensity in patients, a 100-mm visual analogue scale (VAS) is used. Score 0 corresponds to "no pain at all" and score 100 to "the worst imaginable pain"
Measured: Three days
Secondary outcomes (1)
Change from baseline in hip internal rotation immediately after kinesio taping application and Change from baseline in hip internal rotation at three day follow-up
Hip internal rotation is measured in the prone situation at baseline, immediately after kinesio taping application and three day follow up. Patients was asked to bent knee to 90, the axis of goniometer was placed at center of knee joint and the arms of the goniometer were aligned parallel to long axis of tibia then patient moved her leg outwardly as far as she could without allowing the pelvis movement, the stationary arm was hold in the start point while moving arm was aligned to long axis of tibia at the end range of internal rotation, this range was recorded as internal rotation of hip joint.
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Piriformis SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahimeh Hashemirad, University of Social Welfare and Rehabilitation Science
- Investigators
- Fahimeh Hashemirad, MSc, Principal investigator, Akhavan Spine Physical Therapy Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.Fahimeh Hashemirad, MSc, Study director, University of Social Welfare and Rehabilitation Sciences, Evin, Tehran, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752179
- Sponsor's protocol ID
- 90/801/T/1/5055
- Acronym
- KT
- Status last verified
- Feb 2013
- First submitted
- 17 Nov 2012
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kinesio Taping Technique on Trigger Point of Piriformis Muscle
- ClinicalTrials.gov ID
- NCT01752179
- Acronym / sponsor ID
- KT / 90/801/T/1/5055
- Conditions
- Piriformis Syndrome
- Keywords
- Kinesio taping, Piriformis syndrome, Trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Dec 2012 (estimated)
- 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.
Kinesio taping is a novel method which recently has emerged as a viable option to treat of various musculoskeletal and neuromuscular deficits. The application of tape to injured soft tissues and joints provides support and protection for these structures. Many different techniques are used for injury prevention, treatment, rehabilitation, proprioception and sport. Elastic adhesive tape may be used to unload Myofacial Trigger Points (MTrPs), A trigger point can be located in fascia, ligaments, muscles, and tendons; however, MTrPs are also found in skeletal muscles and/or their fascia. An MTrP is a hyperirritable spot, associated with a taut band of a skeletal muscle that is painful on compression or stretch, and that can give rise to a typical referred pain pattern as well as autonomic phenomena. The use of tape along muscle to unload affected soft tissue seems to be effective in the treatment of trigger points by inhibiting overactive muscle, changing the orientation of fascia and a proprioceptive effect. The purpose of study was to determine the efficacy of Kinesio taping application on trigger point of piriformis muscle.
Detailed description
Piriformis syndrome is a peripheral neuritis of the sciatic nerve caused by an abnormal condition of the piriformis muscle. Some investigators consider it as a form of Myofacial pain syndrome which defined as the presence of exquisite tenderness at a nodule in a palpable taut band of muscle. Trigger points are able to produce referred pain, either spontaneously or on digital compression. Although myofascial trigger points are a widely recognized phenomenon in clinical practice, there remains much to be elucidated with regards to their pathophysiology. Conservative pharmacotherapy with nonsteroidal anti-inflammatory drugs (NSAID), muscle relaxants, and physical therapy modalities such as heat therapy, cold therapy, ultrasound, electrical current and stretching were traditionally used in the treatment of trigger points.
The utilization of Kinesio taping regarding to the proposed mechanisms including 1) restoring correct muscle function by supporting weakened muscles, (2) reducing congestion by improving the flow of blood and lymphatic fluid, (3) decreasing pain by stimulating neurological system, and (4) correcting misaligned joints by retrieving muscle spasm (5) enhancing proprioception through increased stimulation to cutaneous mechanoreceptors can be helpful in restoring muscle function in patients with Myofacial trigger points . However, there are not many controlled studies that have analyzed the effects of the Kinesio taping in their treatment. Therefore, the purpose of study was to determine the efficacy of KT application as an easy and appropriate method on trigger point of piriformis muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kinesio tape | Experimental | Procedure: kinesio Tape : Width 5cm ,Length 35cm Y shapekinesio Tape : Width 5cm ,Length 35cm Y shape |
| Control group | No intervention | –without using Kinesio tape |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having trigger point and tenderness in piriformis muscle.
- Having at least three positive physical examination tests from FAIR, Freiberg Lasegue and Beaty test.
Key exclusion criteria (7 listed)
- spinal surgery
- spinal or pelvic fracture
- disc herniation,
- facet arthropathy
- sacroiliitis
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 |
|---|---|---|
| kinesio Tape : Width 5cm ,Length 35cm Y shapeIn the experimental group, Kinesio taping application of piriformis according to Kenzo Kase in 2003 is modified by using unloading technique (Macdolanld, 2004). Size and Shape of Tape is Width 5cm ,Length 35cm Y shape. Taping method include : 1. stretches the piriformis muscle in side lying position ,the affected leg is upper most with hip in flexion, adduction and internal rotation. 2. puts the base of tape over the contralateral of sacrum with no tension. 3. attaches the superior tail on the buttock over the upper part of piriformis and ends at the greater trochanter of the femur. 4. attaches the lower tail by lifting up the soft tissue and ends at the greater trochanter of the femur. This is an origin to insertion application. | Procedure or surgery | kinesio tape |
Primary outcome
Change from baseline in pain intensity immediately after kinesio taping application and Change from baseline in pain intensity at three day follow-up.
Time frame: Three days
Change in pain intensity measured based on visual analogue scale at baseline, immediately after kinesio taping application and three day follow up . To measure the pain intensity in patients, a 100-mm visual analogue scale (VAS) is used. Score 0 corresponds to "no pain at all" and score 100 to "the worst imaginable pain"
1 secondary outcome
Change from baseline in hip internal rotation immediately after kinesio taping application and Change from baseline in hip internal rotation at three day follow-up
Time frame: Three days
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 1 Mar 2013.
Related trials for Piriformis Syndrome
Not yet recruitingPhase 2
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Comparative Effects of Post-Isometric Relaxation and Reciprocal Inhibition Techniques inPiriformis Syndrome
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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.
Fahimeh Hashemirad, MSc principal investigator
Akhavan Spine Physical Therapy Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.
Fahimeh Hashemirad, MSc study director
University of Social Welfare and Rehabilitation Sciences, Evin, Tehran, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kinesio Tape : Width 5cm ,Length 35cm Y shape in people with Piriformis Syndrome, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
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 2 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: finished, as of the sponsor's last update on 1 Mar 2013. 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 Iran. 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?
Change from baseline in pain intensity immediately after kinesio taping application and Change from baseline in pain intensity at three day follow-up. (time frame: Three days). 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 1 Mar 2013.