Protocol summary
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Study aim
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The purpose of this study is to evaluate the effect of the effect of gluteus medius and quadratus lumborum muscle dry needling combined with therapeutic exercises on pain intensity, Pain threshold, function and balance in female athletes with patellofemoral pain syndrome.
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Design
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Two arm parallel group randomised trial with single-blind
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Settings and conduct
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In this clinical trial, individuals are included in the study if they are eligible and randomly assigned to one of the two intervention and control groups (each group of 20) using the Randomizer software
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Participants/Inclusion and exclusion criteria
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Women athletic patients with patellofemoral pain syndrome complaining gradual anterior knee pain during last 3 months and age between 18 to 45 years old are included. The patients with any previous knee trauma or other pathologies such as meniscus and ligament injuries are excluded.
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Intervention groups
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Minimal sample size for this study was determined as 20 patients in each group. Patients will randomly assigned either to control or intervention groups. Both groups will receive conventional physical therapy exercises for patellofemoral pain syndrome during 4 weeks (8 sessions), while the intervention group will receive gluteus medius and quadratus lumborum muscle dry needling.
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Main outcome variables
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Pain intensity
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120411009440N20
Registration date:
2018-08-02, 1397/05/11
Registration timing:
prospective
Last update:
2018-09-04, 1397/06/13
Update count:
1
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Registration date
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2018-08-02, 1397/05/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-08-05, 1397/05/14
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Expected recruitment end date
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2018-11-22, 1397/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the combined gluteus medius and quadratus lumborum dry needling & exercise with exercise alone on knee joint pain and function in female athletes with patellofemoral pain syndrome
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Public title
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The effect of gluteus medius and quadratus lumborum dry needling in patients with patellofemoral pain syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women aged 18 to 45 years old with unilateral or bilateral patellofemoral pain syndrome; anterior or retropatellar knee pain during at least 2 following activities: prolonged sitting, ascending or descending stair,squatting, kneeling, jumping and running; pain on palpation of medial and lateral patellar facets and positive patellar grind test; an insidious onset of symptoms not related to trauma for the last 3 months; Kujula scores less than 85 out of 100; numeric rate scale scores ranging 3 to 10 during last week. having trigger point in the gluteus medius muscle in the affected side and quadratos lumbar muscle in the non-affected side
Exclusion criteria:
Other knee joint pathologies such as meniscus and ligament injuries, osteoarthritis and tendon impairments; patellar subluxations or dislocations; Sinding-Larsen disease;Osgood–Schlatter disease; pelica syndrome;ankle and knee injury; hip joint pathologies such as ligament injuries, osteoarthritis and tendon impairments; subluxations or dislocations and hip injury; referral pain from other joints including lumbar spine, hip and sacroiliac joints and spinal fractures; LBP without source of myofascial; any pain during sitting such as Coccydynia; previous knee surgery; Structural and biomechanical problems such as: Varus and Valgus knee; overweight 32< BMI
Prohibition the use of dry needles such as:metabolic diseases such as diabetes, rheumatic diseases and neuromuscular diseases; pregnancy; Respiratory and peripheral vascular disease, cancer and any malignancy; Immune deficiency; Menstruation; needle phobia; Hemorrhagic diseases and the use of anticoagulant drugs; liver and kidney disease
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization tool:Statistical software
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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single blind, the assessor are not aware of the group
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-07-04, 1397/04/13
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Ethics committee reference number
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IR.SUMS.REC.1397.326
Health conditions studied
1
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Description of health condition studied
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Patellofemoral disorders
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain threshold
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Timepoint
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first and 8th sessions and 2 weeks after the intervention
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Method of measurement
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algometry
2
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Description
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Pain intensity
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Timepoint
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first and 8th sessions and 2 weeks after the intervention
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Method of measurement
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Numeric Rate Scale (NRS)
3
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Description
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Functional steping
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Timepoint
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first and 8th sessions and 2 weeks after the intervention
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Method of measurement
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Step down test
4
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Description
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function
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Timepoint
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first and 8th sessions and 2 weeks after the intervention
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Method of measurement
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kujula questionnaire
5
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Description
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balance
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Timepoint
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first and 8th sessions and 2 weeks after the intervention
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Method of measurement
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Y-Balance Test
Intervention groups
1
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Description
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Intervention group:The same as control group plus gluteus medius and quadratus lumborum dry needling for 4 sessions , are given over a period of four weeks one session per weeks.The needle technique is fast in and out into the muscle tight band in three times
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Category
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Rehabilitation
2
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Description
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Control group: Exercise progresively, first week: Stretching exercises for quadriceps, hamstring (2set 15 repetition, 10 second hold); quadriceps setting in 10 degree terminal knee extension(3set 10 repetition),second week:sideling straight leg raises and hip abductors and external rotator strengthening exercise (Clamshells)(3 set, 15 repetition).third week: plank, side plank (3set 20 repetition). Fourth week: minisquat، minilung، single leg stance step down (Stairs with height 18 cm) (3set 25 repetition)
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available