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IRCT20221228056970N1 IRCT 2023-01-21 Tehran University of Medical Sciences Comparison Study of Low- energy versus Middle- energy Extracorporeal ShockwaveTreatment on Pain Level and Functional Activity in Patients with Sub acute Pes Anserine Bursitis Pes Anserine Bursitis Comparison Study of Low- energy versus Middle- energy Extracorporeal Shockwave Therapy on Pain Level and Functional Activity in Patients with Sub acute Pes Anserine Bursitis. a Single- Blind Randomized Clinical Trial 2022-12-14 anticipated 28 Complete https://irct.ir/trial/67737 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple randomization technique, so that each participant has the opportunity to choose the intervention group randomly by pick up a small piece of paper that help to identify type of interventions, Blinding description: The researcher considered blinding method so that the patients will not have any idea that they are in the conventional low- energy extracorporeal shockwave therapy group or middle- energy extracorporeal shockwave therapy group since the extracorporeal shockwave therapy producer device is similar in both ESWT groups. Besides, the statistical analysis is accomplished by a researcher wii not have any idea about the type of intervention for each group. N/A Sub-acute pes anserine bursitis. Intervention 1: Control group : Low energy extracorporeal shock wave therapy has been used previously and showed some improvements. Therefore, patients in this group will be considered as the control group. The patient in this group will receive low- energy extracorporeal shock wave therapy once per week for three weeks with characteristics of focus, 1,000 shocks/session, energy flux density EFD per shock 0.08 mJ/mm2. The device that will be used for this purpose is enPulsPro - Zimmer MedizinSysteme (Made in Germany). In addition, patients in this group will get standard care including quadriceps strengthening program consisting of isometric quadriceps exercise plus a short period (7 minutes) of mild heating (infra-red). The patients were instructed to sit down with a towel placed beneath their knees and press their knees against the towel while stretching their knees. Then, the patients were asked to maintain this position for 10 s and return to the starting position slowly for 70 contractions. The patients in this group will get 500 initial shocks as warm up with similar characteristics and then will be under the ESWT application. Each patient will be evaluated before and after 2 weeks and then 3 weeks of physical therapy interventions. Intervention 2: Intervention group: The patient in this group will receive middle- energy extracorporeal shock wave therapy once per week for three weeks with characteristics of focus, 2,000 shocks/session, energy flux density EFD per shock 0.16 mJ/mm2. The device that will be used for this purpose is enPulsPro - Zimmer MedizinSysteme (Made in Germany). In addition, patients in this group will get standard care including quadriceps strengthening program consisting of isometric quadriceps exercise plus a short period (7 minutes) of mild heating (infra-red). The patients were instructed to sit down with a towel placed beneath their knees and press their knees against the towel while stretching their knees. Then, the patients were asked to maintain this position for 10 s and return to the starting position slowly for 70 contractions. The patients in this group will get 500 initial shocks as warm up with similar characteristics and then will be under the ESWT application. Each patient will be evaluated before and after 2 weeks and then 3 weeks of physical therapy interventions. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because sharing IPD is useless according to the our study, We should consider all the sample size.
public Raghad Talib Taha Khazraji
No. 8., Baghdad- AlBayyaa
Baghdad- AlBayyaa Iraq 10017 +964 770 785 6144 raghad_talib2008@yahoo.com Tehran University of Medical Sciences scientific Dr. Siamak Bashardoust Tajali
School of Rehabilitation,No:336, Next to Safialishah Street, Piche Shemiran, Enghelab Avenue
Tehran Iran (Islamic Republic of) 1148965111 +98 912 107 9244 s_bashardoust@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 30- 55 years. Both genders - males and females. Educational level literate patients (at least Diploma). Patients with subacute pes anserine bursitis (differential diagnosed by the rheumatologist specialist). Knee pain ≥3 up to 7 on Numeric Pain Rating Scale (NPRS) at first session of assessment. The patients must be able to ambulate at least 30 meters on flat surface without a walking device and also able to perform simple physical exercises with minimal support. 30 years 55 years Both Absent for two or more continuous sessions. Have an enormous increase on pain level. Have a severe decrease function in knee through the sessions Have concomitant disease affecting their knee such as rheumatoid arthritis, recent injury, and surgery of knee. Have had intra- articular corticosteroid injection during last 6 months, history of cancer, dementia, neurologic deficits, heart pacemaker, pregnancy, uncontrolled cardiovascular disorders. Rehabilitation Rehabilitation Control group : Low energy extracorporeal shock wave therapy has been used previously and showed some improvements. Therefore, patients in this group will be considered as the control group. The patient in this group will receive low- energy extracorporeal shock wave therapy once per week for three weeks with characteristics of focus, 1,000 shocks/session, energy flux density EFD per shock 0.08 mJ/mm2. The device that will be used for this purpose is enPulsPro - Zimmer MedizinSysteme (Made in Germany). In addition, patients in this group will get standard care including quadriceps strengthening program consisting of isometric quadriceps exercise plus a short period (7 minutes) of mild heating (infra-red). The patients were instructed to sit down with a towel placed beneath their knees and press their knees against the towel while stretching their knees. Then, the patients were asked to maintain this position for 10 s and return to the starting position slowly for 70 contractions. The patients in this group will get 500 initial shocks as warm up with similar characteristics and then will be under the ESWT application. Each patient will be evaluated before and after 2 weeks and then 3 weeks of physical therapy interventions. Intervention group: The patient in this group will receive middle- energy extracorporeal shock wave therapy once per week for three weeks with characteristics of focus, 2,000 shocks/session, energy flux density EFD per shock 0.16 mJ/mm2. The device that will be used for this purpose is enPulsPro - Zimmer MedizinSysteme (Made in Germany). In addition, patients in this group will get standard care including quadriceps strengthening program consisting of isometric quadriceps exercise plus a short period (7 minutes) of mild heating (infra-red). The patients were instructed to sit down with a towel placed beneath their knees and press their knees against the towel while stretching their knees. Then, the patients were asked to maintain this position for 10 s and return to the starting position slowly for 70 contractions. The patients in this group will get 500 initial shocks as warm up with similar characteristics and then will be under the ESWT application. Each patient will be evaluated before and after 2 weeks and then 3 weeks of physical therapy interventions. 1. Numeric Pain Rating Scale (NRS) 2. McGill pain questionnaire (MPQ) 3. Western Ontario and McMaster Universities (WOMAC) 4. Timed Up and Go Test. Timepoint: Before intervention, after 2 weeks and after 3 weeks. Method of measurement: 1. The Numeric Pain Rating Scale is a unidimensional measure of pain intensity, is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 –10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line. Similar to the pain VAS, the NRS is anchored by terms describing pain severity extremes. An 11- point numeric scale, 0 representing one pain extreme (no pain) and 10 representing the other pain extreme (pain as bad as you can imagine and worst pain imaginable). 2. Short-Form McGill Pain Questionnaire A multidimensional pain questionnaire. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as (0: none, 1 : mild, 2 : moderate or 3 : severe) . Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The SF-MPQ also includes the Present Pain Intensity (PPI) index of the standard MPQ and a visual analogue scale (VAS). 3. Functional activity by Western Ontario and McMaster Universities (WOMAC) Osteoarthritis index. The WOMAC is a widely used, reliable, valid, and responsive measure of outcome in people with OA of the knee .It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright, Stiffness (2 items): after first walking and later in the day, Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores are totaled for each subscale (maximum totals, 20 [pain], 8 [stiffness], and 68 [physical function]) and normalized to a 100-point scale. A global score can be given by summing the three subscale scores .Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. The area of assessment includes activities of daily living, functional mobility, gait, general health and quality of life. Participants will be given a standard paper form of WOMAC index questionnaire to fill it before and after the intervention. Arabic version of WOMAC will be used; because it will be easier for Arab patients to read and understand it without need for a translator, and to avoid translation bias. All patients who had difficulty in self- administration of WOMAC assessment questionnaires because they could not read and write were helped by their caregiver or by a person blinded to the purpose of the tools. Timed Up and Go Test. Timepoint: Before intervention, after 2 weeks and after 3 weeks. Method of measurement: Functional Mobility by Timed Up and Go Test .TUG test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults. The test requires the subject to rise from a chair, walk 3.0 m at a comfortable pace to a mark placed on the floor, turn around at the 3.0 m mark, walk back to the starting point, and return to sitting in the chair. Individuals who take longer than 30 seconds to complete the test need physical assistance with transfers and generally cannot manage steps while Individuals who can complete the test in less than 20 seconds will likely be independently mobile and most can manage steps and walk outside the home. Tehran University of Medical Sciences Approved 2022-12-11 Research Ethics Committees of School of Nursing and Midwifery and Rehabilitation, Tehran University Buliding No. 1, The North Door of University, Poursina Street, Ghods St, Enghelab Avenue. Tehran Tehran Iran (Islamic Republic of)