Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:00 AM
Study NCT ID:
NCT07396233
Status:
RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Diagonal Proprioceptive Neuromuscular Facilitation Patterns on Pain and Functional Outcomes in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Data analyst will also be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-07', 'studyFirstSubmitDate': '2026-02-01', 'studyFirstSubmitQcDate': '2026-02-01', 'lastUpdatePostDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity will be assessed with Visual Analogue Scale', 'timeFrame': 'Baseline and after 6 weeks of intervention', 'description': "The Visual Analogue Scale is a unidimensional measure of pain intensity, used to record patients' pain progression, or assess pain severity in different conditions. It is 0 to 10 cm scale. Patients rate their pain on the scale. Higher the score in centimeter, severe will be the pain experienced."}, {'measure': 'Change in range of motion will be assessed with Universal Goniometer', 'timeFrame': 'Baseline and after 6 weeks of intervention.', 'description': 'The universal goniometer is an instrument for the precise measurement of range of movement angles in degree, especially one used to measure the angles before and after range of motion. Increase in the degree of angle suggests increase in range of movement.'}], 'secondaryOutcomes': [{'measure': 'Change in functional disability will be assessed with Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Baseline and after 6 weeks of intervention.', 'description': "The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems regarding functional disability. It consists of total 100 scores. Increase in scores suggests better function and decrease in scores suggests increased functional disability."}, {'measure': 'Change in hamstring flexibility will be assessed with Active Knee Extension test.', 'timeFrame': 'Baseline and after 6 weeks of intervention.', 'description': 'The Active Knee Extension (AKE) test will be used to assess hamstring muscle length using a goniometer with the hip flexion position at 90°. A greater knee extension angle indicates greater hamstring muscle length.'}, {'measure': 'Change in dynamic balance will be assessed with Four Step Square Test (FSST)', 'timeFrame': 'Baseline and after 6 weeks of intervention.', 'description': 'The Four Square Step Test will be used to assess dynamic balance. It is measured in seconds. A higher completion times indicate poorer dynamic balance and a greater risk of falls.'}, {'measure': 'Change in fatigue level will be assessed with Multidimensional Fatigue Inventory questionnaire.', 'timeFrame': 'Baseline and after 6 weeks of intervention.', 'description': 'The multidimensional fatigue inventory is a 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Higher total scores correspond with more acute levels of fatigue.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee Osteoarthritis', 'Functional Disability', 'Knee Pain', 'Conventional Training', 'Osteoarthritis', 'Arthritis', 'Musculoskeletal Disease', 'Joint Disease'], 'conditions': ['Knee Osteoarthristis', 'Osteearthritis', 'Knee Pain Arthritis']}, 'referencesModule': {'references': [{'pmid': '37268961', 'type': 'BACKGROUND', 'citation': 'Nafees K, Baig AAM, Ali SS, Ishaque F. Dynamic soft tissue mobilization versus proprioceptive neuromuscular facilitation in reducing hamstring muscle tightness in patients with knee osteoarthritis: a randomized control trial. BMC Musculoskelet Disord. 2023 Jun 2;24(1):447. doi: 10.1186/s12891-023-06571-y.'}, {'pmid': '36780435', 'type': 'BACKGROUND', 'citation': 'Gao B, Li L, Shen P, Zhou Z, Xu P, Sun W, Zhang C, Song Q. Effects of proprioceptive neuromuscular facilitation stretching in relieving pain and balancing knee loading during stepping over obstacles among older adults with knee osteoarthritis: A randomized controlled trial. PLoS One. 2023 Feb 13;18(2):e0280941. doi: 10.1371/journal.pone.0280941. eCollection 2023.'}, {'pmid': '37745043', 'type': 'BACKGROUND', 'citation': 'Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.'}, {'pmid': '32407583', 'type': 'BACKGROUND', 'citation': 'Song Q, Shen P, Mao M, Sun W, Zhang C, Li L. Proprioceptive neuromuscular facilitation improves pain and descending mechanics among elderly with knee osteoarthritis. Scand J Med Sci Sports. 2020 Sep;30(9):1655-1663. doi: 10.1111/sms.13709. Epub 2020 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial will be conducted at the Department of Physiotherapy, Dr. Ziauddin Hospital and Al-Rayaz Hospital, Karachi, Pakistan. A total of 150 patients diagnosed with knee osteoarthritis, aged between 40-60 years, will be recruited through a non-probability purposive sampling technique. Written informed consent will be obtained from all eligible participants prior to enrollment. The participants will be randomly allocated by the help of computer generated randomization sheet, into two groups i.e. experimental and the control group, with 75 participants in each group. Group A (experimental group) will receive diagonal proprioceptive neuromuscular facilitation (PNF) pattern exercises, while Group B (control group) will receive conventional strength training exercises. Heat therapy will be administered to both groups. All participants will be assessed using a standardized assessment form. Outcome measures will include pain intensity, knee range of motion, functional disability, hamstring flexibility, dynamic balance, and fatigue level. A single blinded assessor will assess all participants at baseline and at post intervention. Treatment sessions will be given thrice a week on alternate days for 6 weeks.', 'detailedDescription': 'The Statistical Package for the Social Sciences (SPSS) version 23 will be used for data analysis. Mean and standard deviation will be calculated for quantitative variables such as age. Qualitative variables will be presented as frequencies and percentages. Outcome measures (decrease pain intensity, improve functional disability, increase knee range of motion, improve hamstring flexibility, dynamic balance, and fatigue level) recorded at baseline and after 18th session of intervention will be compared and analyzed. Repeated measures ANOVA will be applied for statistical analysis. A p-value of less than 0.05 will be considered as the level of statistical significance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both male and females with an age range between 40-60 years.\n* Patients diagnosed with unilateral or bilateral Knee OA.\n* Grade-II or grade-III on kellgren and Lawrence classification.\n* Patients having pain intensity more than 3.4 cm on VAS as minimum cut off value.\n* Duration of knee OA more than 3 months (chronic).\n\nExclusion Criteria:\n\n* Patients with any neurological disorder.\n* History of lower limb arthroplasty or any other knee surgery.\n* Septic knee arthritis.\n* Inflammatory rheumatic disease such as rheumatoid arthritis and gout.\n* Cancer or any other malignancy such as bone tumor.\n* Knee deformities such as contracture, genu valgum and genu varum.\n* History of ligamentous injury and meniscal tear.'}, 'identificationModule': {'nctId': 'NCT07396233', 'briefTitle': 'Effects of Diagonal Proprioceptive Neuromuscular Facilitation Patterns on Pain and Functional Outcomes in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Karachi'}, 'officialTitle': 'Effects of Diagonal Proprioceptive Neuromuscular Facilitation Patterns on Pain and Functional Outcomes in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'IBC KU-549/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagonal Proprioceptive Neuromuscular Facilitation (PNF) Pattern Exercises + Heat Therapy.', 'description': 'This arm will receive PNF pattern exercises using Diagonal 1 and Diagonal 2 Lower Limb Patterns of PNF and the heat therapy', 'interventionNames': ['Other: Diagonal Proprioceptive Neuromuscular Facilitation (PNF) Pattern Exercises', 'Other: Heat Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Strength Training Exercises + Heat Therapy', 'description': 'This arm will receive evidence based treatment of Quadripceps and Hip Abductor Strengthening exercises and the heat therapy.', 'interventionNames': ['Other: Conventional Strength Training Exercises', 'Other: Heat Therapy']}], 'interventions': [{'name': 'Diagonal Proprioceptive Neuromuscular Facilitation (PNF) Pattern Exercises', 'type': 'OTHER', 'description': 'Diagonal PNF pattern exercises include Diagonal 1 and Diagonal 2 lower limb pattern movements performed against resistance to improve strength, flexibility, and functional performance.', 'armGroupLabels': ['Diagonal Proprioceptive Neuromuscular Facilitation (PNF) Pattern Exercises + Heat Therapy.']}, {'name': 'Conventional Strength Training Exercises', 'type': 'OTHER', 'description': 'The conventional strength training exercises include quadriceps and hip abductor strengthening performed using resisted active movements to improve muscle strength and functional ability.', 'armGroupLabels': ['Conventional Strength Training Exercises + Heat Therapy']}, {'name': 'Heat Therapy', 'type': 'OTHER', 'description': 'Heat therapy will be given for 10 minutes by the help of electric heating pad.', 'armGroupLabels': ['Conventional Strength Training Exercises + Heat Therapy', 'Diagonal Proprioceptive Neuromuscular Facilitation (PNF) Pattern Exercises + Heat Therapy.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74600', 'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Rabia Hassan, MSAPT', 'role': 'CONTACT', 'email': 'rabiahassan096@gmail.com', 'phone': '03345448859'}], 'facility': 'Al-Rayaz Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74600', 'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Rabia Hassan, MSAPT', 'role': 'CONTACT', 'email': 'rabiahassan096@gmail.com', 'phone': '03345448859'}], 'facility': 'Dr. Ziauddin Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Rabia Hassan, MSAPT', 'role': 'CONTACT', 'email': 'rabiahassan096@gmail.com', 'phone': '+923345448859'}, {'name': 'Basit Ansari, PhD', 'role': 'CONTACT', 'email': 'basitansari@hotmail.com', 'phone': '+923222279221'}], 'overallOfficials': [{'name': 'Rabia Hassan, MSAPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University'}, {'name': 'Basit Ansari, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Karachi'}, {'name': 'Aftab Ahmed Mirza Baig, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IQRA University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in physical medicine rehabilitation and knee osteoarthritis management.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Karachi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rabia Hassan', 'investigatorAffiliation': 'University of Karachi'}}}}