Protocol summary
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Study aim
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The primary study aim of this study is to investigate the efficacy of an integrative treatment
approach combining eccentric exercises with curcumin-enhanced ultrasound therapy for the
management of knee tendinopathy.
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Design
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Pragmatic, community based, parallel group, double blinded, randomised controlled trial. Total 90 patients will be enrolled. Patients who met our inclusion criteria randomised into two groups. Control group-A and treatment group-B
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Settings and conduct
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At Muhammad Institute of Medical and Allied Sciences Multan after getting approval from institutional ethical committee
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Participants between 18 to 60 years of age; patellar tendinopathy, confirmed by a qualified healthcare professional; chronic patellar tendinopathy symptoms for at least 3 months; moderate severity of symptoms; no active inflammatory conditions.
Exclusion criteria: Individuals with acute (less than 3 months) patellar tendinopathy or other acute knee injuries;
Participants with other significant knee conditions (e.g., patellofemoral pain syndrome, osteoarthritis, ligament injuries, or meniscal tears) that may confound the outcomes or interact with the treatments being tested; surgical interventions involving the patellar tendon or knee in the past 6 months; Individuals with uncontrolled systemic diseases, including rheumatoid arthritis, diabetes mellitus, or severe cardiovascular or neurological conditions that could affect tendon healing or physical activity.
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Intervention groups
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Control group: Curcumin-aloe vera gel + ultrasound + eccentric exercises.
Intervention group: Placebo aloe vera gel + ultrasound + eccentric exercises.
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Main outcome variables
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Pain, Knee ROM, Muscle strength ,Tendon thickness , Quality of life ,CRP, ESR and Tendon function
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:
IRCT20230202057310N16
Registration date:
2025-01-22, 1403/11/03
Registration timing:
registered_while_recruiting
Last update:
2026-09-10, 1405/06/19
Update count:
1
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Registration date
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2025-01-22, 1403/11/03
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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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2025-01-01, 1403/10/12
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Expected recruitment end date
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2025-04-03, 1404/01/14
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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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Formulation And Evaluation of Curcumin Gel Along With Ultrasound and Eccentric Exercises On Patellar Tendinopathy Management
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Public title
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Curcumin Gel Along With Ultrasound and Eccentric Exercises On Patellar Tendinopathy Management
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Participants between 18 to 60 years of age
Clinical diagnosis of patellar tendinopathy, confirmed by a qualified healthcare professional Individuals
Experiencing chronic patellar tendinopathy symptoms for at least 3 months
Moderate severity of symptoms
No active inflammatory conditions (e.g., rheumatoid arthritis) or uncontrolled systemic diseases that might affect tendon healing or the safety of treatments.
Exclusion criteria:
Individuals with acute (less than 3 months) patellar tendinopathy or other acute knee injuries.
Participants with other significant knee conditions (e.g., patellofemoral pain syndrome, osteoarthritis, ligament injuries, or meniscal tears) that may confound the outcomes or interact with the treatments being tested
Those who have undergone surgical interventions involving the patellar tendon or knee in the past 6 months.
Individuals with uncontrolled systemic diseases, including rheumatoid arthritis, diabetes mellitus, or severe cardiovascular or neurological conditions that could affect tendon healing or physical activity.
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization process will be conducted using computer-generated random numbers to assign participants to treatment groups in a predefined allocation sequence. A stratified or block randomization approach will be used to ensure balance between groups for key variables (e.g., age, gender, baseline disease severity). Medications will be prepared and packaged in identical numbered white boxes according to the allocation sequence. Each box will have a unique medication number corresponding to the assigned treatment, ensuring blinding. The allocation sequence and treatment codes will be securely stored and accessible only to the principal investigator, who is not involved in participant interactions or outcome assessments.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The statistical analyst and outcome assessor will be blinded to treatment allocation by using securely stored randomization codes, accessible only to an independent party. Data will be analyzed using anonymous identifiers, and group allocation will be revealed only after data collection and analysis are complete. This ensures minimization of bias.
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Placebo
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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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2024-11-29, 1403/09/09
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Ethics committee reference number
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MIMAS/24/08/IAK
Health conditions studied
1
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Description of health condition studied
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Patellar Tendinopathy
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ICD-10 code
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M76.50
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ICD-10 code description
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Patellar tendinitis, unspecified knee
Primary outcomes
1
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Description
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Knee range of motion (ROM)
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Timepoint
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Before interventions and 8 weeks after intervention
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Method of measurement
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Goniometer
2
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Description
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Tendon thickness
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Timepoint
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Before interventions and 8 weeks after intervention
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Method of measurement
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ultrasound
3
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Description
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Tendon function
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Timepoint
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Before interventions and 8 weeks after intervention
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Method of measurement
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Victorian Institute of Sport Assessment-Achilles (VISA-A)
Secondary outcomes
1
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Description
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Muscle Strength
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Timepoint
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Before interventions and 8 weeks after intervention
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Method of measurement
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Hand dynamometer
2
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Description
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Erythrocyte sedimentation rate (ESR)
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Timepoint
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Before interventions and 8 weeks after intervention
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Method of measurement
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Lab test
3
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Description
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Quality of life
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Timepoint
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Before interventions and 8 weeks after intervention
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Method of measurement
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SF-36 scale
4
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Description
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C-Reactive proteins
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Timepoint
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Before interventions and 8 weeks after intervention
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Method of measurement
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Lab test
Intervention groups
1
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Description
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Intervention group: Group A (Eccentric Exercise + Curcumin–Aloe Vera Gel): Curcumin–aloe vera gel (2 g) will be applied topically to the patellar tendon, followed by a supervised eccentric exercise. The program included wall sits, Spanish squats, box squats, and reverse lunges. All exercises will perform in three sets of 15 repetitions each, at a controlled tempo of 3 seconds eccentric and 1 second concentric. Sessions occurred 4 times per week for 8 weeks, with progressive loading applied biweekly according to pain-free tolerance (0–3/10 NPRS during exercise).
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Category
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Treatment - Other
2
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Description
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Control group: Participants will receive2 g of curcumin–aloe vera gel apply topically over the patellar tendon and delivered transdermally using therapeutic ultrasound. Ultrasound will be administered at a frequency of 1 MHz, intensity of 1.5 W/cm², in pulsed mode for 10 minutes using a circular application technique. Treatment will be administered 4 times per week for 8 weeks. No eccentric exercise or other therapeutic exercise will be included in this group to isolate the effect of ultrasound-mediated transdermal delivery of the gel. Adherence will be monitored through clinic attendance registers and self-reported gel application logs.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Student fund
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Grant code / Reference number
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MIMAS/25/08/Aroosa
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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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Muhammad Institute of Medical and Allied Sciences, Multan
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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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Private
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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