Patellofemoral Pain SyndromeNCT02118246
The Effects of Dry Needling & Kinesio Tape on Anterior Knee Pain
A study testing Dry Needling and Kinesio Tape in people with Patellofemoral Pain Syndrome, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
Trial summary
Patellofemoral Pain Syndrome(PFPS) is one of the most common health-related complaints in today's societies. Myofascial pain syndrome(MPS) have been attributed as the main cause and primary source of musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 20 to 57 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Dry Needling and Kinesio Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Oct 2012to Sep 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 57 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of a palpable taut band in muscle.
- Presence of a hypersensitive tender spot in the taut band.
- Reproduction of the typical referred pain pattern of the trigger point in response to compression. To detect active trigger point, trigger point pressure tolerance was assessed using a mechanical pressure algometer. The investigator applied continuous pressure with the algometer with an approximate pressure of 2.5 kg/cm2.
- Spontaneous presence of the typical referred pain pattern and/or patient recognition of the referred pain as familiar.
- 5- Pain of at least 30 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 100 mm (worst imaginable pain).
Who cannot join
- had a history of fracture of knee joint, dislocation of patella
- previous knee or ankle surgery
- had a history of neurologic condition
- having physical therapy within the past month before the study
- pregnancy
- taking anticoagulants (e.g. warfarin)
- local infection
Trial locations and contacts
1 site in 1 country.
Iran1 site
University of Social Welfare and Rehabilitation Sciences
Tehran, Islamic Republic of, 1985713831
About this study
Official title: The Clinical Effects of Dry Needling & Kinesio Tape on Myofascial Trigger Point in the Vastus Lateralis Muscle in Subjects With PFPS
Patellofemoral Pain Syndrome(PFPS) is one of the most common health-related complaints in today's societies. Myofascial pain syndrome(MPS) have been attributed as the main cause and primary source of musculoskeletal pain. Trigger point of the vastus lateralis muscle may pull the patella superiorly and laterally, increasing compression of the patellofemoral joint during physical activities, result in PFPS and anterior knee pain. The purpose of this study was to investigate the effects of Dry Needling \& kinesio tape on trigger point of vastus lateralis muscle in PFPS subjects.
Read the detailed description
Pain intensity, pain pressure threshold and Disability of knee were collected at base line and at the end of treatment sessions.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Dry Needling, Kinesio Tape
- Keywords
- Knee pain,Dry Needling, kinesioTape,Trigger point
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingDevice
Also called Western Accupuncture
Dry needling was performed for one week, three times a week.
Kinesio TapeDevice
Also called Kenso Tape
Kinesio tape was performed for one week, three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | The taut band of trigger point in vastus lateralis muscle; localized between the thumb and index finger, was needled forward and backward repeatedly until there were no more local twitch response Receives: Device: Dry Needling |
| Kinesio Tape | Experimental | Y technique with 25% tension on the tails was applied. Direction of the technique was insertion to origin of the muscle and zone of the trigger point was placed at the center of Y strip. Receives: Device: Kinesio Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain intensity using Visual Analogue Scale (VAS) were collected at base line and at the end of treatment
Measured: one year
Secondary outcomes (1)
pain pressure threshold
A pressure threshold algometer was used to measure the pain pressure threshold of a Trigger point of the vastus lateralis muscle before treatment and the end of treatment(after one week).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Massoud Arab, University of Social Welfare and Rehabilitation Science
- Investigators
- Amir M Arab, PhD, Principal investigator, University of Social Welfare and Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118246
- Sponsor's protocol ID
- 930127
- Status last verified
- Apr 2014
- First submitted
- 16 Apr 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effects of Dry Needling & Kinesio Tape on Myofascial Trigger Point in the Vastus Lateralis Muscle in Subjects With PFPS
- ClinicalTrials.gov ID
- NCT02118246
- Acronym / sponsor ID
- 930127
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Knee pain,Dry Needling, kinesioTape,Trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Apr 2014 (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.
Patellofemoral Pain Syndrome(PFPS) is one of the most common health-related complaints in today's societies. Myofascial pain syndrome(MPS) have been attributed as the main cause and primary source of musculoskeletal pain. Trigger point of the vastus lateralis muscle may pull the patella superiorly and laterally, increasing compression of the patellofemoral joint during physical activities, result in PFPS and anterior knee pain. The purpose of this study was to investigate the effects of Dry Needling \& kinesio tape on trigger point of vastus lateralis muscle in PFPS subjects.
Detailed description
Pain intensity, pain pressure threshold and Disability of knee were collected at base line and at the end of treatment sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Device: Dry NeedlingThe taut band of trigger point in vastus lateralis muscle; localized between the thumb and index finger, was needled forward and backward repeatedly until there were no more local twitch response |
| Kinesio Tape | Experimental | Device: Kinesio TapeY technique with 25% tension on the tails was applied. Direction of the technique was insertion to origin of the muscle and zone of the trigger point was placed at the center of Y strip. |
Who may qualify
- Ages
- 20 to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Presence of a palpable taut band in muscle.
- Presence of a hypersensitive tender spot in the taut band.
- Reproduction of the typical referred pain pattern of the trigger point in response to compression. To detect active trigger point, trigger point pressure tolerance was assessed using a mechanical pressure algometer. The investigator applied continuous pressure with the algometer with an approximate pressure of 2.5 kg/cm2.
- Spontaneous presence of the typical referred pain pattern and/or patient recognition of the referred pain as familiar.
- 5- Pain of at least 30 mm on a visual analogue scale (VAS) from 0 mm (no pain) to 100 mm (worst imaginable pain).
Key exclusion criteria (7 listed)
- had a history of fracture of knee joint, dislocation of patella
- previous knee or ankle surgery
- had a history of neurologic condition
- having physical therapy within the past month before the study
- pregnancy
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 |
|---|---|---|
| Dry NeedlingAlso: Western AccupunctureDry needling was performed for one week, three times a week. | Device | Dry Needling |
| Kinesio TapeAlso: Kenso TapeKinesio tape was performed for one week, three times a week. | Device | Kinesio Tape |
Primary outcome
Pain
Time frame: one year
Pain intensity using Visual Analogue Scale (VAS) were collected at base line and at the end of treatment
1 secondary outcome
pain pressure threshold
Time frame: one year
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 21 Apr 2014.
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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.
Amir M Arab, PhD principal investigator
University of Social Welfare and Rehabilitation Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Kinesio Tape in people with Patellofemoral Pain 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 5 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 21 Apr 2014. 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?
Pain (time frame: one year). 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 21 Apr 2014.