<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04503304</url>
  </required_header>
  <id_info>
    <org_study_id>Hip Abductors strength in KOA</org_study_id>
    <nct_id>NCT04503304</nct_id>
  </id_info>
  <brief_title>Effect of Hip Abductors Versus Knee Extensor Strengthening in Knee Osteoarthritis</brief_title>
  <official_title>Effect of Hip Abductors Versus Knee Extensor Strengthening on Pain,Function and Quadriceps Isometric Strength in Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will try to answer the following question:&#xD;
&#xD;
      Would strengthening of hip abductors be equal to, or more effective than, knee extensors&#xD;
      strengthening in improving pain, function and knee extensors isometric strength in patients&#xD;
      with knee Osteoarthritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 70 patients with knee Osteoarthritis will be recruited All patients who will&#xD;
      participate in the study will be referred by orthopedists. Patients with knee osteoarthritis&#xD;
      will be included with age ranges from 50-70. They will be randomized into 2 groups; hip&#xD;
      abductors strengthening (HAS) group a will receive hip abductors strengthening exercises, and&#xD;
      knee extensors strengthening (KES) group will receive quadriceps strengthening exercise.&#xD;
&#xD;
      All patients who will meet the study criteria will get a complete knowledge of the objectives&#xD;
      and procedures of the study.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        1. Patients with knee Osteoarthritis grade II- III Kellgren- Lawrence scores&#xD;
&#xD;
        2. Their age is 50-70[Wang et al.,2019].&#xD;
&#xD;
        3. Body mass index (BMI) 25-30.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. Patients who had surgical intervention in the knee and/or hip.&#xD;
&#xD;
        2. Fracture in the lower limbs.&#xD;
&#xD;
        3. Malignancy&#xD;
&#xD;
        4. Any associated ligamentous injuries in knee or ankle.&#xD;
&#xD;
        5. Spinal Cord Injury.&#xD;
&#xD;
        6. Hormonal imbalance or on hormonal therapy&#xD;
&#xD;
        7. Knee injection within the last 6 months prior to the study. Outcome parameters including&#xD;
           Quadriceps Muscle Strength, the arabic version of Western Ontario and McMaster&#xD;
           Universities Arthritis Index questionnaire total score and 3 subscales and Timed Up and&#xD;
           Go test score&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>2 groups; hip abductors strengthening (HAS) group a will receive hip abductors strengthening exercises, and knee extensors strengthening (KES) group will receive quadriceps strengthening exercise.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quadriceps Muscle Strength assessment</measure>
    <time_frame>6 weeks</time_frame>
    <description>Quadriceps Muscle Strength assessment using Hand held Dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lower limb functional disability</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measuring lower limb functional disability using The Arabic version of reduced WOMAC (ArWOMAC) index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee function</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measuring function using The Timed Up &amp; Go Test (TUG):</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>HAS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hip abductors strengthening group&#xD;
Hip abduction -standing[Ferber et al.,2015].&#xD;
Sidelying hip abduction(clamshell)[Schache et al.,2016].&#xD;
lateral leg raise: in brief, the patients lie down on bed on the unaffected side, with the resistance band positioned around the distal thigh of the affected limb.;later, they raise the above lower limbs upwards for about 30 degrees, stay for 5- 10 s and slowly lay down[Xie et al.,2018].&#xD;
pelvic lift training, specifically, patients stand single-leg off the side at a 10-cm step. Later, they begin with the other limb that is lower than the step level, and contract the stance-limb hip abductor to raise the free leg to the step level while keeping the stance knee extended[Xie et al.,2018].&#xD;
Stretching Hamstrings [Fukuda et al.,2012]. Number of sets = 3, Repetitions =10 repetitions for each set</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KES group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>knee extensors strengthening group&#xD;
Isometric quadriceps setting&#xD;
Knee extensions from sitting with knee bend to 90&#xD;
Terminal knee extension from sitting.&#xD;
Stretching Hamstrings Number of sets = 3, Repetitions =10 repetitions for each set</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercises</intervention_name>
    <description>already included in arm/group descriptions.</description>
    <arm_group_label>HAS group</arm_group_label>
    <arm_group_label>KES group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with knee OA grade II- III Kellgren- Lawrence scores&#xD;
&#xD;
          2. Their age is 50-70[Wang et al.,2019].&#xD;
&#xD;
          3. Body mass index (BMI) 25-30.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who had surgical intervention in the knee and/or hip.&#xD;
&#xD;
          2. Fracture in the lower limbs.&#xD;
&#xD;
          3. Malignancy&#xD;
&#xD;
          4. Any associated ligamentous injuries in knee or ankle.&#xD;
&#xD;
          5. Spinal Cord Injury.&#xD;
&#xD;
          6. Hormonal imbalance or on hormonal therapy&#xD;
&#xD;
          7. Knee injection within the last 6 months prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of physical therapy</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.</citation>
    <PMID>26223312</PMID>
  </reference>
  <reference>
    <citation>Alghadir A, Anwer S, Iqbal ZA, Alsanawi HA. Cross-cultural adaptation, reliability and validity of the Arabic version of the reduced Western Ontario and McMaster Universities Osteoarthritis index in patients with knee osteoarthritis. Disabil Rehabil. 2016;38(7):689-94. doi: 10.3109/09638288.2015.1055380. Epub 2015 Jun 11.</citation>
    <PMID>26066566</PMID>
  </reference>
  <reference>
    <citation>Alnahdi AH, Zeni JA, Snyder-Mackler L. Hip abductor strength reliability and association with physical function after unilateral total knee arthroplasty: a cross-sectional study. Phys Ther. 2014 Aug;94(8):1154-62. doi: 10.2522/ptj.20130335. Epub 2014 Mar 20.</citation>
    <PMID>24652473</PMID>
  </reference>
  <reference>
    <citation>Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Gray R, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hand. Arthritis Rheum. 1990 Nov;33(11):1601-10. doi: 10.1002/art.1780331101.</citation>
    <PMID>2242058</PMID>
  </reference>
  <reference>
    <citation>Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505-14. doi: 10.1002/art.1780340502.</citation>
    <PMID>2025304</PMID>
  </reference>
  <reference>
    <citation>Al-Zahrani KS, Bakheit AM. A study of the gait characteristics of patients with chronic osteoarthritis of the knee. Disabil Rehabil. 2002 Mar 20;24(5):275-80. doi: 10.1080/09638280110087098.</citation>
    <PMID>12004973</PMID>
  </reference>
  <reference>
    <citation>Amin S, Baker K, Niu J, Clancy M, Goggins J, Guermazi A, Grigoryan M, Hunter DJ, Felson DT. Quadriceps strength and the risk of cartilage loss and symptom progression in knee osteoarthritis. Arthritis Rheum. 2009 Jan;60(1):189-98. doi: 10.1002/art.24182.</citation>
    <PMID>19116936</PMID>
  </reference>
  <reference>
    <citation>Arden N, Nevitt MC. Osteoarthritis: epidemiology. Best Pract Res Clin Rheumatol. 2006 Feb;20(1):3-25. doi: 10.1016/j.berh.2005.09.007.</citation>
    <PMID>16483904</PMID>
  </reference>
  <reference>
    <citation>Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.</citation>
    <PMID>3068365</PMID>
  </reference>
  <reference>
    <citation>Bennell KL, Hunt MA, Wrigley TV, Hunter DJ, McManus FJ, Hodges PW, Li L, Hinman RS. Hip strengthening reduces symptoms but not knee load in people with medial knee osteoarthritis and varus malalignment: a randomised controlled trial. Osteoarthritis Cartilage. 2010 May;18(5):621-8. doi: 10.1016/j.joca.2010.01.010. Epub 2010 Feb 6.</citation>
    <PMID>20175973</PMID>
  </reference>
  <reference>
    <citation>Boling MC, Bolgla LA, Mattacola CG, Uhl TL, Hosey RG. Outcomes of a weight-bearing rehabilitation program for patients diagnosed with patellofemoral pain syndrome. Arch Phys Med Rehabil. 2006 Nov;87(11):1428-35. doi: 10.1016/j.apmr.2006.07.264.</citation>
    <PMID>17084115</PMID>
  </reference>
  <reference>
    <citation>Cools AM, Vanderstukken F, Vereecken F, Duprez M, Heyman K, Goethals N, Johansson F. Eccentric and isometric shoulder rotator cuff strength testing using a hand-held dynamometer: reference values for overhead athletes. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3838-3847. doi: 10.1007/s00167-015-3755-9. Epub 2015 Aug 21.</citation>
    <PMID>26294055</PMID>
  </reference>
  <reference>
    <citation>Costa RA, Oliveira LM, Watanabe SH, Jones A, Natour J. Isokinetic assessment of the hip muscles in patients with osteoarthritis of the knee. Clinics (Sao Paulo). 2010;65(12):1253-9. doi: 10.1590/s1807-59322010001200006.</citation>
    <PMID>21340212</PMID>
  </reference>
  <reference>
    <citation>Culvenor AG, Wirth W, Roth M, Hunter DJ, Eckstein F. Predictive Capacity of Thigh Muscle Strength in Symptomatic and/or Radiographic Knee Osteoarthritis Progression: Data from the Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium. Am J Phys Med Rehabil. 2016 Dec;95(12):931-938. doi: 10.1097/PHM.0000000000000534.</citation>
    <PMID>27175558</PMID>
  </reference>
  <reference>
    <citation>Eckstein F, Wirth W, Nevitt MC. Recent advances in osteoarthritis imaging--the osteoarthritis initiative. Nat Rev Rheumatol. 2012 Oct;8(10):622-30. doi: 10.1038/nrrheum.2012.113. Epub 2012 Jul 10.</citation>
    <PMID>22782003</PMID>
  </reference>
  <reference>
    <citation>Eckstein F, Hitzl W, Duryea J, Kent Kwoh C, Wirth W; OAI investigators. Baseline and longitudinal change in isometric muscle strength prior to radiographic progression in osteoarthritic and pre-osteoarthritic knees--data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2013 May;21(5):682-90. doi: 10.1016/j.joca.2013.02.658. Epub 2013 Mar 6.</citation>
    <PMID>23473978</PMID>
  </reference>
  <reference>
    <citation>Farr JN, Going SB, Lohman TG, Rankin L, Kasle S, Cornett M, Cussler E. Physical activity levels in patients with early knee osteoarthritis measured by accelerometry. Arthritis Rheum. 2008 Sep 15;59(9):1229-36. doi: 10.1002/art.24007.</citation>
    <PMID>18759320</PMID>
  </reference>
  <reference>
    <citation>Ferber R, Bolgla L, Earl-Boehm JE, Emery C, Hamstra-Wright K. Strengthening of the hip and core versus knee muscles for the treatment of patellofemoral pain: a multicenter randomized controlled trial. J Athl Train. 2015 Apr;50(4):366-77. doi: 10.4085/1062-6050-49.3.70. Epub 2014 Nov 3.</citation>
    <PMID>25365133</PMID>
  </reference>
  <reference>
    <citation>Fukuda TY, Rossetto FM, Magalhaes E, Bryk FF, Lucareli PR, de Almeida Aparecida Carvalho N. Short-term effects of hip abductors and lateral rotators strengthening in females with patellofemoral pain syndrome: a randomized controlled clinical trial. J Orthop Sports Phys Ther. 2010 Nov;40(11):736-42. doi: 10.2519/jospt.2010.3246.</citation>
    <PMID>21041965</PMID>
  </reference>
  <reference>
    <citation>Fukuda TY, Melo WP, Zaffalon BM, Rossetto FM, Magalhaes E, Bryk FF, Martin RL. Hip posterolateral musculature strengthening in sedentary women with patellofemoral pain syndrome: a randomized controlled clinical trial with 1-year follow-up. J Orthop Sports Phys Ther. 2012 Oct;42(10):823-30. doi: 10.2519/jospt.2012.4184. Epub 2012 Aug 2.</citation>
    <PMID>22951491</PMID>
  </reference>
  <reference>
    <citation>Glass NA, Torner JC, Frey Law LA, Wang K, Yang T, Nevitt MC, Felson DT, Lewis CE, Segal NA. The relationship between quadriceps muscle weakness and worsening of knee pain in the MOST cohort: a 5-year longitudinal study. Osteoarthritis Cartilage. 2013 Sep;21(9):1154-9. doi: 10.1016/j.joca.2013.05.016.</citation>
    <PMID>23973125</PMID>
  </reference>
  <reference>
    <citation>Hinman RS, Hunt MA, Creaby MW, Wrigley TV, McManus FJ, Bennell KL. Hip muscle weakness in individuals with medial knee osteoarthritis. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1190-3. doi: 10.1002/acr.20199.</citation>
    <PMID>20704005</PMID>
  </reference>
  <reference>
    <citation>Hott A, Liavaag S, Juel NG, Brox JI. Study protocol: a randomised controlled trial comparing the long term effects of isolated hip strengthening, quadriceps-based training and free physical activity for patellofemoral pain syndrome (anterior knee pain). BMC Musculoskelet Disord. 2015 Feb 25;16:40. doi: 10.1186/s12891-015-0493-6.</citation>
    <PMID>25879452</PMID>
  </reference>
  <reference>
    <citation>Hu B, Skou ST, Wise BL, Williams GN, Nevitt MC, Segal NA. Lower Quadriceps Rate of Force Development Is Associated With Worsening Physical Function in Adults With or at Risk for Knee Osteoarthritis: 36-Month Follow-Up Data From the Osteoarthritis Initiative. Arch Phys Med Rehabil. 2018 Jul;99(7):1352-1359. doi: 10.1016/j.apmr.2017.12.027. Epub 2018 Jan 31.</citation>
    <PMID>29408538</PMID>
  </reference>
  <reference>
    <citation>Hurd WJ, Morrey BF, Kaufman KR. The effects of anthropometric scaling parameters on normalized muscle strength in uninjured baseball pitchers. J Sport Rehabil. 2011 Aug;20(3):311-20. doi: 10.1123/jsr.20.3.311.</citation>
    <PMID>21828383</PMID>
  </reference>
  <reference>
    <citation>Ismail MM, Gamaleldein MH, Hassa KA. Closed kinetic chain exercises with or without additional hip strengthening exercises in management of patellofemoral pain syndrome: a randomized controlled trial. Eur J Phys Rehabil Med. 2013 Oct;49(5):687-98. Epub 2013 Jul 2.</citation>
    <PMID>23820880</PMID>
  </reference>
  <reference>
    <citation>KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.</citation>
    <PMID>13498604</PMID>
  </reference>
  <reference>
    <citation>Kemnitz J, Wirth W, Eckstein F, Ruhdorfer A, Culvenor AG. Longitudinal change in thigh muscle strength prior to and concurrent with symptomatic and radiographic knee osteoarthritis progression: data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2017 Oct;25(10):1633-1640. doi: 10.1016/j.joca.2017.07.003. Epub 2017 Jul 8.</citation>
    <PMID>28698106</PMID>
  </reference>
  <reference>
    <citation>Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.</citation>
    <PMID>22027216</PMID>
  </reference>
  <reference>
    <citation>Liao CD, Huang YC, Lin LF, Huang SW, Liou TH. Body mass index and functional mobility outcome following early rehabilitation after a total knee replacement: a retrospective study in Taiwan. Arthritis Care Res (Hoboken). 2015 May;67(6):799-808. doi: 10.1002/acr.22474.</citation>
    <PMID>25201765</PMID>
  </reference>
  <reference>
    <citation>Martin HJ, Yule V, Syddall HE, Dennison EM, Cooper C, Aihie Sayer A. Is hand-held dynamometry useful for the measurement of quadriceps strength in older people? A comparison with the gold standard Bodex dynamometry. Gerontology. 2006;52(3):154-9. doi: 10.1159/000091824.</citation>
    <PMID>16645295</PMID>
  </reference>
  <reference>
    <citation>McNair PJ, Colvin M, Reid D. Predicting maximal strength of quadriceps from submaximal performance in individuals with knee joint osteoarthritis. Arthritis Care Res (Hoboken). 2011 Feb;63(2):216-22. doi: 10.1002/acr.20368.</citation>
    <PMID>20890972</PMID>
  </reference>
  <reference>
    <citation>Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Williamson JD, Bennell KL, Guermazi A, Lyles M, Loeser RF. Strength Training for Arthritis Trial (START): design and rationale. BMC Musculoskelet Disord. 2013 Jul 15;14:208. doi: 10.1186/1471-2474-14-208.</citation>
    <PMID>23855596</PMID>
  </reference>
  <reference>
    <citation>Palmer K, Hebron C, Williams JM. A randomised trial into the effect of an isolated hip abductor strengthening programme and a functional motor control programme on knee kinematics and hip muscle strength. BMC Musculoskelet Disord. 2015 May 3;16:105. doi: 10.1186/s12891-015-0563-9.</citation>
    <PMID>25935843</PMID>
  </reference>
  <reference>
    <citation>Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.</citation>
    <PMID>22613940</PMID>
  </reference>
  <reference>
    <citation>Ringdahl E, Pandit S. Treatment of knee osteoarthritis. Am Fam Physician. 2011 Jun 1;83(11):1287-92.</citation>
    <PMID>21661710</PMID>
  </reference>
  <reference>
    <citation>Ruhdorfer A, Dannhauer T, Wirth W, Hitzl W, Kwoh CK, Guermazi A, Hunter DJ, Benichou O, Eckstein F; Osteoarthritis Initiative Investigators. Thigh muscle cross-sectional areas and strength in advanced versus early painful osteoarthritis: an exploratory between-knee, within-person comparison in osteoarthritis initiative participants. Arthritis Care Res (Hoboken). 2013 Jul;65(7):1034-42. doi: 10.1002/acr.21965.</citation>
    <PMID>23401316</PMID>
  </reference>
  <reference>
    <citation>Ruhdorfer A, Wirth W, Hitzl W, Nevitt M, Eckstein F; Osteoarthritis Initiative Investigators. Association of thigh muscle strength with knee symptoms and radiographic disease stage of osteoarthritis: data from the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1344-53. doi: 10.1002/acr.22317.</citation>
    <PMID>24578353</PMID>
  </reference>
  <reference>
    <citation>Ruhdorfer A, Wirth W, Eckstein F. Longitudinal Change in Thigh Muscle Strength Prior to and Concurrent With Minimum Clinically Important Worsening or Improvement in Knee Function: Data From the Osteoarthritis Initiative. Arthritis Rheumatol. 2016 Apr;68(4):826-36. doi: 10.1002/art.39484.</citation>
    <PMID>26556499</PMID>
  </reference>
  <reference>
    <citation>Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x.</citation>
    <PMID>27295978</PMID>
  </reference>
  <reference>
    <citation>Segal NA, Glass NA, Torner J, Yang M, Felson DT, Sharma L, Nevitt M, Lewis CE. Quadriceps weakness predicts risk for knee joint space narrowing in women in the MOST cohort. Osteoarthritis Cartilage. 2010 Jun;18(6):769-75. doi: 10.1016/j.joca.2010.02.002. Epub 2010 Feb 11.</citation>
    <PMID>20188686</PMID>
  </reference>
  <reference>
    <citation>Segal NA, Findlay C, Wang K, Torner JC, Nevitt MC. The longitudinal relationship between thigh muscle mass and the development of knee osteoarthritis. Osteoarthritis Cartilage. 2012 Dec;20(12):1534-40. doi: 10.1016/j.joca.2012.08.019. Epub 2012 Sep 3.</citation>
    <PMID>22954456</PMID>
  </reference>
  <reference>
    <citation>Sharma L, Dunlop DD, Cahue S, Song J, Hayes KW. Quadriceps strength and osteoarthritis progression in malaligned and lax knees. Ann Intern Med. 2003 Apr 15;138(8):613-9. doi: 10.7326/0003-4819-138-8-200304150-00006.</citation>
    <PMID>12693882</PMID>
  </reference>
  <reference>
    <citation>Skou ST, Simonsen O, Rasmussen S. Examination of muscle strength and pressure pain thresholds in knee osteoarthritis: test-retest reliability and agreement. J Geriatr Phys Ther. 2015 Jul-Sep;38(3):141-7. doi: 10.1519/JPT.0000000000000028.</citation>
    <PMID>25594517</PMID>
  </reference>
  <reference>
    <citation>Sled EA, Khoja L, Deluzio KJ, Olney SJ, Culham EG. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010 Jun;90(6):895-904. doi: 10.2522/ptj.20090294. Epub 2010 Apr 8.</citation>
    <PMID>20378679</PMID>
  </reference>
  <reference>
    <citation>Xie Y, Zhang C, Jiang W, Huang J, Xu L, Pang G, Tang H, Chen R, Yu J, Guo S, Xu F, Wang J. Quadriceps combined with hip abductor strengthening versus quadriceps strengthening in treating knee osteoarthritis: a study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2018 May 15;19(1):147. doi: 10.1186/s12891-018-2041-7.</citation>
    <PMID>29764409</PMID>
  </reference>
  <reference>
    <citation>Zeni JA Jr, Axe MJ, Snyder-Mackler L. Clinical predictors of elective total joint replacement in persons with end-stage knee osteoarthritis. BMC Musculoskelet Disord. 2010 May 6;11:86. doi: 10.1186/1471-2474-11-86.</citation>
    <PMID>20459622</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>May 1, 2021</last_update_submitted>
  <last_update_submitted_qc>May 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Aalaa Mohamed El-Amin Sweelam</investigator_full_name>
    <investigator_title>Teaching Assistant</investigator_title>
  </responsible_party>
  <keyword>Knee Osteoarthritis AND Hip Abductors AND Quadriceps</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>protocol copy, informed consent, statistical analysis</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04503304
org study id: Hip Abductors strength in KOA
nct id: NCT04503304
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will try to answer the following question:

      Would strengthening of hip abductors be equal to, or more effective than, knee extensors
      strengthening in improving pain, function and knee extensors isometric strength in patients
      with knee Osteoarthritis
A total of 70 patients with knee Osteoarthritis will be recruited All patients who will
      participate in the study will be referred by orthopedists. Patients with knee osteoarthritis
      will be included with age ranges from 50-70. They will be randomized into 2 groups; hip
      abductors strengthening (HAS) group a will receive hip abductors strengthening exercises, and
      knee extensors strengthening (KES) group will receive quadriceps strengthening exercise.

      All patients who will meet the study criteria will get a complete knowledge of the objectives
      and procedures of the study.

      Inclusion criteria:

        1. Patients with knee Osteoarthritis grade II- III Kellgren- Lawrence scores

        2. Their age is 50-70[Wang et al.,2019].

        3. Body mass index (BMI) 25-30.

      Exclusion criteria:

        1. Patients who had surgical intervention in the knee and/or hip.

        2. Fracture in the lower limbs.

        3. Malignancy

        4. Any associated ligamentous injuries in knee or ankle.

        5. Spinal Cord Injury.

        6. Hormonal imbalance or on hormonal therapy

        7. Knee injection within the last 6 months prior to the study. Outcome parameters including
           Quadriceps Muscle Strength, the arabic version of Western Ontario and McMaster
           Universities Arthritis Index questionnaire total score and 3 subscales and Timed Up and
           Go test score
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2 groups; hip abductors strengthening (HAS) group a will receive hip abductors strengthening exercises, and knee extensors strengthening (KES) group will receive quadriceps strengthening exercise.
primary purpose: Treatment
masking: None (Open Label)
measure: Quadriceps Muscle Strength assessment
time frame: 6 weeks
description: Quadriceps Muscle Strength assessment using Hand held Dynamometer
measure: lower limb functional disability
time frame: 6 weeks
description: Measuring lower limb functional disability using The Arabic version of reduced WOMAC (ArWOMAC) index
measure: Knee function
time frame: 6 weeks
description: Measuring function using The Timed Up & Go Test (TUG):
arm group label: HAS group
arm group type: Experimental
description: hip abductors strengthening group
Hip abduction -standing[Ferber et al.,2015].
Sidelying hip abduction(clamshell)[Schache et al.,2016].
lateral leg raise: in brief, the patients lie down on bed on the unaffected side, with the resistance band positioned around the distal thigh of the affected limb.;later, they raise the above lower limbs upwards for about 30 degrees, stay for 5- 10 s and slowly lay down[Xie et al.,2018].
pelvic lift training, specifically, patients stand single-leg off the side at a 10-cm step. Later, they begin with the other limb that is lower than the step level, and contract the stance-limb hip abductor to raise the free leg to the step level while keeping the stance knee extended[Xie et al.,2018].
Stretching Hamstrings [Fukuda et al.,2012]. Number of sets = 3, Repetitions =10 repetitions for each set
arm group label: KES group
arm group type: Active Comparator
description: knee extensors strengthening group
Isometric quadriceps setting
Knee extensions from sitting with knee bend to 90
Terminal knee extension from sitting.
Stretching Hamstrings Number of sets = 3, Repetitions =10 repetitions for each set
intervention type: Other
intervention name: Exercises
description: already included in arm/group descriptions.
arm group label: HAS group
arm group label: KES group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.
PMID: 26223312
citation: Alghadir A, Anwer S, Iqbal ZA, Alsanawi HA. Cross-cultural adaptation, reliability and validity of the Arabic version of the reduced Western Ontario and McMaster Universities Osteoarthritis index in patients with knee osteoarthritis. Disabil Rehabil. 2016;38(7):689-94. doi: 10.3109/09638288.2015.1055380. Epub 2015 Jun 11.
PMID: 26066566
citation: Alnahdi AH, Zeni JA, Snyder-Mackler L. Hip abductor strength reliability and association with physical function after unilateral total knee arthroplasty: a cross-sectional study. Phys Ther. 2014 Aug;94(8):1154-62. doi: 10.2522/ptj.20130335. Epub 2014 Mar 20.
PMID: 24652473
citation: Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Gray R, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hand. Arthritis Rheum. 1990 Nov;33(11):1601-10. doi: 10.1002/art.1780331101.
PMID: 2242058
citation: Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505-14. doi: 10.1002/art.1780340502.
PMID: 2025304
citation: Al-Zahrani KS, Bakheit AM. A study of the gait characteristics of patients with chronic osteoarthritis of the knee. Disabil Rehabil. 2002 Mar 20;24(5):275-80. doi: 10.1080/09638280110087098.
PMID: 12004973
citation: Amin S, Baker K, Niu J, Clancy M, Goggins J, Guermazi A, Grigoryan M, Hunter DJ, Felson DT. Quadriceps strength and the risk of cartilage loss and symptom progression in knee osteoarthritis. Arthritis Rheum. 2009 Jan;60(1):189-98. doi: 10.1002/art.24182.
PMID: 19116936
citation: Arden N, Nevitt MC. Osteoarthritis: epidemiology. Best Pract Res Clin Rheumatol. 2006 Feb;20(1):3-25. doi: 10.1016/j.berh.2005.09.007.
PMID: 16483904
citation: Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
PMID: 3068365
citation: Bennell KL, Hunt MA, Wrigley TV, Hunter DJ, McManus FJ, Hodges PW, Li L, Hinman RS. Hip strengthening reduces symptoms but not knee load in people with medial knee osteoarthritis and varus malalignment: a randomised controlled trial. Osteoarthritis Cartilage. 2010 May;18(5):621-8. doi: 10.1016/j.joca.2010.01.010. Epub 2010 Feb 6.
PMID: 20175973
citation: Boling MC, Bolgla LA, Mattacola CG, Uhl TL, Hosey RG. Outcomes of a weight-bearing rehabilitation program for patients diagnosed with patellofemoral pain syndrome. Arch Phys Med Rehabil. 2006 Nov;87(11):1428-35. doi: 10.1016/j.apmr.2006.07.264.
PMID: 17084115
citation: Cools AM, Vanderstukken F, Vereecken F, Duprez M, Heyman K, Goethals N, Johansson F. Eccentric and isometric shoulder rotator cuff strength testing using a hand-held dynamometer: reference values for overhead athletes. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3838-3847. doi: 10.1007/s00167-015-3755-9. Epub 2015 Aug 21.
PMID: 26294055
citation: Costa RA, Oliveira LM, Watanabe SH, Jones A, Natour J. Isokinetic assessment of the hip muscles in patients with osteoarthritis of the knee. Clinics (Sao Paulo). 2010;65(12):1253-9. doi: 10.1590/s1807-59322010001200006.
PMID: 21340212
citation: Culvenor AG, Wirth W, Roth M, Hunter DJ, Eckstein F. Predictive Capacity of Thigh Muscle Strength in Symptomatic and/or Radiographic Knee Osteoarthritis Progression: Data from the Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium. Am J Phys Med Rehabil. 2016 Dec;95(12):931-938. doi: 10.1097/PHM.0000000000000534.
PMID: 27175558
citation: Eckstein F, Wirth W, Nevitt MC. Recent advances in osteoarthritis imaging--the osteoarthritis initiative. Nat Rev Rheumatol. 2012 Oct;8(10):622-30. doi: 10.1038/nrrheum.2012.113. Epub 2012 Jul 10.
PMID: 22782003
citation: Eckstein F, Hitzl W, Duryea J, Kent Kwoh C, Wirth W; OAI investigators. Baseline and longitudinal change in isometric muscle strength prior to radiographic progression in osteoarthritic and pre-osteoarthritic knees--data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2013 May;21(5):682-90. doi: 10.1016/j.joca.2013.02.658. Epub 2013 Mar 6.
PMID: 23473978
citation: Farr JN, Going SB, Lohman TG, Rankin L, Kasle S, Cornett M, Cussler E. Physical activity levels in patients with early knee osteoarthritis measured by accelerometry. Arthritis Rheum. 2008 Sep 15;59(9):1229-36. doi: 10.1002/art.24007.
PMID: 18759320
citation: Ferber R, Bolgla L, Earl-Boehm JE, Emery C, Hamstra-Wright K. Strengthening of the hip and core versus knee muscles for the treatment of patellofemoral pain: a multicenter randomized controlled trial. J Athl Train. 2015 Apr;50(4):366-77. doi: 10.4085/1062-6050-49.3.70. Epub 2014 Nov 3.
PMID: 25365133
citation: Fukuda TY, Rossetto FM, Magalhaes E, Bryk FF, Lucareli PR, de Almeida Aparecida Carvalho N. Short-term effects of hip abductors and lateral rotators strengthening in females with patellofemoral pain syndrome: a randomized controlled clinical trial. J Orthop Sports Phys Ther. 2010 Nov;40(11):736-42. doi: 10.2519/jospt.2010.3246.
PMID: 21041965
citation: Fukuda TY, Melo WP, Zaffalon BM, Rossetto FM, Magalhaes E, Bryk FF, Martin RL. Hip posterolateral musculature strengthening in sedentary women with patellofemoral pain syndrome: a randomized controlled clinical trial with 1-year follow-up. J Orthop Sports Phys Ther. 2012 Oct;42(10):823-30. doi: 10.2519/jospt.2012.4184. Epub 2012 Aug 2.
PMID: 22951491
citation: Glass NA, Torner JC, Frey Law LA, Wang K, Yang T, Nevitt MC, Felson DT, Lewis CE, Segal NA. The relationship between quadriceps muscle weakness and worsening of knee pain in the MOST cohort: a 5-year longitudinal study. Osteoarthritis Cartilage. 2013 Sep;21(9):1154-9. doi: 10.1016/j.joca.2013.05.016.
PMID: 23973125
citation: Hinman RS, Hunt MA, Creaby MW, Wrigley TV, McManus FJ, Bennell KL. Hip muscle weakness in individuals with medial knee osteoarthritis. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1190-3. doi: 10.1002/acr.20199.
PMID: 20704005
citation: Hott A, Liavaag S, Juel NG, Brox JI. Study protocol: a randomised controlled trial comparing the long term effects of isolated hip strengthening, quadriceps-based training and free physical activity for patellofemoral pain syndrome (anterior knee pain). BMC Musculoskelet Disord. 2015 Feb 25;16:40. doi: 10.1186/s12891-015-0493-6.
PMID: 25879452
citation: Hu B, Skou ST, Wise BL, Williams GN, Nevitt MC, Segal NA. Lower Quadriceps Rate of Force Development Is Associated With Worsening Physical Function in Adults With or at Risk for Knee Osteoarthritis: 36-Month Follow-Up Data From the Osteoarthritis Initiative. Arch Phys Med Rehabil. 2018 Jul;99(7):1352-1359. doi: 10.1016/j.apmr.2017.12.027. Epub 2018 Jan 31.
PMID: 29408538
citation: Hurd WJ, Morrey BF, Kaufman KR. The effects of anthropometric scaling parameters on normalized muscle strength in uninjured baseball pitchers. J Sport Rehabil. 2011 Aug;20(3):311-20. doi: 10.1123/jsr.20.3.311.
PMID: 21828383
citation: Ismail MM, Gamaleldein MH, Hassa KA. Closed kinetic chain exercises with or without additional hip strengthening exercises in management of patellofemoral pain syndrome: a randomized controlled trial. Eur J Phys Rehabil Med. 2013 Oct;49(5):687-98. Epub 2013 Jul 2.
PMID: 23820880
citation: KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
PMID: 13498604
citation: Kemnitz J, Wirth W, Eckstein F, Ruhdorfer A, Culvenor AG. Longitudinal change in thigh muscle strength prior to and concurrent with symptomatic and radiographic knee osteoarthritis progression: data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2017 Oct;25(10):1633-1640. doi: 10.1016/j.joca.2017.07.003. Epub 2017 Jul 8.
PMID: 28698106
citation: Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.
PMID: 22027216
citation: Liao CD, Huang YC, Lin LF, Huang SW, Liou TH. Body mass index and functional mobility outcome following early rehabilitation after a total knee replacement: a retrospective study in Taiwan. Arthritis Care Res (Hoboken). 2015 May;67(6):799-808. doi: 10.1002/acr.22474.
PMID: 25201765
citation: Martin HJ, Yule V, Syddall HE, Dennison EM, Cooper C, Aihie Sayer A. Is hand-held dynamometry useful for the measurement of quadriceps strength in older people? A comparison with the gold standard Bodex dynamometry. Gerontology. 2006;52(3):154-9. doi: 10.1159/000091824.
PMID: 16645295
citation: McNair PJ, Colvin M, Reid D. Predicting maximal strength of quadriceps from submaximal performance in individuals with knee joint osteoarthritis. Arthritis Care Res (Hoboken). 2011 Feb;63(2):216-22. doi: 10.1002/acr.20368.
PMID: 20890972
citation: Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Williamson JD, Bennell KL, Guermazi A, Lyles M, Loeser RF. Strength Training for Arthritis Trial (START): design and rationale. BMC Musculoskelet Disord. 2013 Jul 15;14:208. doi: 10.1186/1471-2474-14-208.
PMID: 23855596
citation: Palmer K, Hebron C, Williams JM. A randomised trial into the effect of an isolated hip abductor strengthening programme and a functional motor control programme on knee kinematics and hip muscle strength. BMC Musculoskelet Disord. 2015 May 3;16:105. doi: 10.1186/s12891-015-0563-9.
PMID: 25935843
citation: Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.
PMID: 22613940
citation: Ringdahl E, Pandit S. Treatment of knee osteoarthritis. Am Fam Physician. 2011 Jun 1;83(11):1287-92.
PMID: 21661710
citation: Ruhdorfer A, Dannhauer T, Wirth W, Hitzl W, Kwoh CK, Guermazi A, Hunter DJ, Benichou O, Eckstein F; Osteoarthritis Initiative Investigators. Thigh muscle cross-sectional areas and strength in advanced versus early painful osteoarthritis: an exploratory between-knee, within-person comparison in osteoarthritis initiative participants. Arthritis Care Res (Hoboken). 2013 Jul;65(7):1034-42. doi: 10.1002/acr.21965.
PMID: 23401316
citation: Ruhdorfer A, Wirth W, Hitzl W, Nevitt M, Eckstein F; Osteoarthritis Initiative Investigators. Association of thigh muscle strength with knee symptoms and radiographic disease stage of osteoarthritis: data from the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1344-53. doi: 10.1002/acr.22317.
PMID: 24578353
citation: Ruhdorfer A, Wirth W, Eckstein F. Longitudinal Change in Thigh Muscle Strength Prior to and Concurrent With Minimum Clinically Important Worsening or Improvement in Knee Function: Data From the Osteoarthritis Initiative. Arthritis Rheumatol. 2016 Apr;68(4):826-36. doi: 10.1002/art.39484.
PMID: 26556499
citation: Schache MB, McClelland JA, Webster KE. Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial. BMC Musculoskelet Disord. 2016 Jun 13;17:259. doi: 10.1186/s12891-016-1104-x.
PMID: 27295978
citation: Segal NA, Glass NA, Torner J, Yang M, Felson DT, Sharma L, Nevitt M, Lewis CE. Quadriceps weakness predicts risk for knee joint space narrowing in women in the MOST cohort. Osteoarthritis Cartilage. 2010 Jun;18(6):769-75. doi: 10.1016/j.joca.2010.02.002. Epub 2010 Feb 11.
PMID: 20188686
citation: Segal NA, Findlay C, Wang K, Torner JC, Nevitt MC. The longitudinal relationship between thigh muscle mass and the development of knee osteoarthritis. Osteoarthritis Cartilage. 2012 Dec;20(12):1534-40. doi: 10.1016/j.joca.2012.08.019. Epub 2012 Sep 3.
PMID: 22954456
citation: Sharma L, Dunlop DD, Cahue S, Song J, Hayes KW. Quadriceps strength and osteoarthritis progression in malaligned and lax knees. Ann Intern Med. 2003 Apr 15;138(8):613-9. doi: 10.7326/0003-4819-138-8-200304150-00006.
PMID: 12693882
citation: Skou ST, Simonsen O, Rasmussen S. Examination of muscle strength and pressure pain thresholds in knee osteoarthritis: test-retest reliability and agreement. J Geriatr Phys Ther. 2015 Jul-Sep;38(3):141-7. doi: 10.1519/JPT.0000000000000028.
PMID: 25594517
citation: Sled EA, Khoja L, Deluzio KJ, Olney SJ, Culham EG. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010 Jun;90(6):895-904. doi: 10.2522/ptj.20090294. Epub 2010 Apr 8.
PMID: 20378679
citation: Xie Y, Zhang C, Jiang W, Huang J, Xu L, Pang G, Tang H, Chen R, Yu J, Guo S, Xu F, Wang J. Quadriceps combined with hip abductor strengthening versus quadriceps strengthening in treating knee osteoarthritis: a study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2018 May 15;19(1):147. doi: 10.1186/s12891-018-2041-7.
PMID: 29764409
citation: Zeni JA Jr, Axe MJ, Snyder-Mackler L. Clinical predictors of elective total joint replacement in persons with end-stage knee osteoarthritis. BMC Musculoskelet Disord. 2010 May 6;11:86. doi: 10.1186/1471-2474-11-86.
PMID: 20459622
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Aalaa Mohamed El-Amin Sweelam
investigator title: Teaching Assistant
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Yes
ipd description: protocol copy, informed consent, statistical analysis
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)