Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-31 @ 7:52 AM
Study NCT ID:
NCT07293195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Effects of Heat vs Contrast Therapy With Otago Exercises on Patellofemoral Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-06', 'studyFirstSubmitDate': '2025-12-06', 'studyFirstSubmitQcDate': '2025-12-06', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Swelling', 'timeFrame': '4 Weeks', 'description': 'Swelling, also known as edema, is the enlargement of body tissues due to fluid accumulation. It can occur in various parts of the body, such as the hands, feet, ankles, or even internally within organs. Swelling is often a symptom of an underlying condition, including injuries, infections, or medical conditions like heart or kidney problems. Measured by an in elastic tape (Girth measurement)'}, {'measure': 'Pain Intensity', 'timeFrame': '4 Weeks', 'description': 'The International Association for the Study of Pain (IASP) 1979 has described Pain as a feeling of discomfort and emotion resulting from actual or potential harm to body tissues. It is a core subjective occurrence, shaped over time by childhood incidents of harm or emotional trauma. From a physiological perspective, pain is triggered by stimuli that pose a risk of tissue injury. Hence, pain is perceived as a conscious and individualized experience with tissue damage potential harm to bodily structures. Assessed by using the NPRS scale.'}, {'measure': 'Range Of Motion', 'timeFrame': '4 Weeks', 'description': 'Assessing joint range of motion (ROM) is frequently employed in physiotherapy especially in outpatient orthopedic departments and primary care facilities. Core objectives of physical therapists is to help patients recover their joint flexibility, build strength, and return to normal physical functioning. Assessing range of motion is fundamental for detecting limitations in movement and serves as an essential tool for evaluating progress over time. Measured by Universal goniometer.'}], 'secondaryOutcomes': [{'measure': 'Functional limtations', 'timeFrame': '4 Weeks', 'description': 'Functional limitation is defined as a loss of functional capability in performing routine mental or physical tasks needed for independent living, without any influence from environmental factors. The Oxford Knee Score (OKS) given by Dawson et al. in 1998 assesses knee pain severity and functional capacity using a scoring system from 0 (most severe impairment) to 48 (full function and no pain).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patellofemoral pain syndrome(PFPS), Heat therapy(HT), Contrast therapy(CT),Otago exercise program(OEP)'], 'conditions': ['Patellofemoral Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the adjunctive effects of heat therapy and contrast therapy when combined with the Otago exercise program in individuals with patellofemoral pain syndrome aged 18 to 40 years. The study aims to assess whether these interventions can help reduce pain and swelling, improve knee range of motion, and decrease functional limitations associated with patellofemoral pain syndrome. Researchers will compare two groups one receiving heat therapy with the Otago exercise program and the other receiving contrast therapy with the Otago exercise program to see which approach provides greater improvement in outcomes. Participants will undergo regular supervised sessions that include the assigned thermal therapy and a structured set of Otago exercises targeting lower limb strength, balance, and mobility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants having age group between 18 and 40 years with anterior, retropatellar, or peripatellar pain with at least severity of 3/10 on the numerical pain rating scale.\n\nParticipants who have reported anterior knee pain for at least three months during at least two of the following activities: seating for prolonged periods of time; ascending and descending stairs; squatting; running and jumping, or have had experienced crepitus (popping, or crackling) while walking or running, pain on palpation, insidious pain lasting at least two months.\n\nPositive patellar compression and Grind tests.\n\nClinical evidence of lateral patellar tracking, given its established role in patellofemoral joint dysfunction.\n\nPain produced by at least two of the following four tests: (i) isometric muscle contraction with a mild bent knee, (ii) patellofemoral joint line palpation, (iii) compression of patella against the femur and (iv) active resisted knee extension were enrolled in the study.\n\nExclusion Criteria:\n\nPain lasting less than three months, previous knee operations, meniscal lesions, patellar instability (subluxation/dislocation), clinical evidence of tendinopathy or ligamentous injury, fractures or dislocations involving the pelvis, spinal surgical history, osteoporosis, pregnancy, neurological diseases or radiological findings of chondromalacia beyond grade 2 on MRI, ultrasound, or X-ray.\n\nRecent participation in lower-limb rehabilitation or structured training within six weeks, or prior diagnoses of rheumatoid arthritis, gout, or other rheumatic knee disorders.\n\nUse of NSAIDs in the preceding four weeks, prior history of cancer, infection, psychiatric conditions, cognitive impairment, autoimmune pathology, or neurological dysfunction likely to interfere with walking ability.'}, 'identificationModule': {'nctId': 'NCT07293195', 'acronym': 'PFPS OEP CT HT', 'briefTitle': 'Adjunctive Effects of Heat vs Contrast Therapy With Otago Exercises on Patellofemoral Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Lahore University of Biological and Applied Sciences'}, 'officialTitle': 'Adjunctive Effects of Heat Versus Contrast Therapy With Otago Exercises on Pain, Swelling, Range of Motion and Functional Limitations in Patients With Patellofemoral Pain Syndrome', 'orgStudyIdInfo': {'id': 'LCPT/DPT/ERB/31'}, 'secondaryIdInfos': [{'id': 'U1111-1332-0257', 'type': 'REGISTRY', 'domain': 'WHO- Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group: Heat therapy with Otago exercises', 'description': '1. Heat Therapy:\n\n * Frequency: 3 sessions/week for 4 weeks\n * Intensity: Mild to moderate heat (40°C)\n * Time: 15 minutes/session\n * Type: Passive superficial heat via electrical hot pack\n2. Otago Exercise Program:\n\n * Frequency: 3 sessions/week supervised + daily home exercise for 4 weeks\n * Intensity: Progressively increasing strength and balance\n * Time: 30 minutes/session (includes warm-up and cool-down)\n * Type: Functional, strength, and balance exercises for lower limbs\n3. Routine Physical Therapy (Medial Patellar Mobilization):\n\n * Frequency: 3 sessions/week for 4 weeks\n * Intensity: Gentle grade I/II mobilization\n * Time: 3 sets of 10 repetitions\n * Type: Passive sustained medial glides of patella', 'interventionNames': ['Other: Heat therapy+Otago exercise program', 'Other: Contrast therapy+ Otago exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Experimental Group: Contrast therapy with Otago exercises', 'description': '1. Contrast Therapy:\n\n * Frequency: 3 sessions/week for 4 weeks\n * Intensity: Heat (38-40°C) and cold (12-14°C)\n * Time: 15 minutes/session (4 min heat + 1 min cold cycles)\n * Type: Alternating hot/cold packs\n2. Otago Exercise Program:\n\n * Frequency: 3 sessions/week supervised + daily home exercise for 4 weeks\n * Intensity: Progressively increasing strength and balance\n * Time: 30 minutes/session (includes warm-up and cool-down)\n * Type: Functional, strength, and balance exercises for lower limbs\n3. Routine Physical Therapy (Medial Patellar Mobilization):\n\n * Frequency: 3 sessions/week for 4 weeks\n * Intensity: Gentle grade I/II mobilization\n * Time: 3 sets of 10 repetitions\n * Type: Passive sustained medial glides of patella', 'interventionNames': ['Other: Heat therapy+Otago exercise program']}], 'interventions': [{'name': 'Heat therapy+Otago exercise program', 'type': 'OTHER', 'otherNames': ['Hot pack', 'Electrical Hot pack'], 'description': 'Heat therapy is a non-surgical technique being recognized for its application in knee pain management. HT enhances blood flow, alleviates pain, and aids tissue repair. It have been effective in knee osteoarthritis but have yet to be fully explored for the treatment of PFPS.', 'armGroupLabels': ['Active Experimental Group: Contrast therapy with Otago exercises', 'Experimental Group: Heat therapy with Otago exercises']}, {'name': 'Contrast therapy+ Otago exercise program', 'type': 'OTHER', 'description': 'Contrast therapy (CT), a commonly used thermal treatment, is gaining attention as a non-invasive option for managing knee pain. By alternating between heat and cold, CT helps stimulate circulation, reduce swelling, and ease joint stiffness. While it has shown benefits in other knee conditions, its potential role in treating patellofemoral pain syndrome (PFPS) is still not well established.', 'armGroupLabels': ['Experimental Group: Heat therapy with Otago exercises']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Umber Nawaz, PhD Scholar', 'role': 'CONTACT', 'email': 'dr.umber21@gmail.com', 'phone': '+923334888279'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '6 months', 'ipdSharing': 'YES', 'description': 'Will be shared after research publication', 'accessCriteria': 'Researcher, Layman,'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lahore University of Biological and Applied Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Umber Nawaz', 'investigatorAffiliation': 'Lahore University of Biological and Applied Sciences'}}}}