Protocol summary

Study aim
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.
Design
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
Settings and conduct
At Muhammad Institute of Medical and Allied Sciences Multan after getting approval from institutional ethical committee
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Control group: Curcumin-aloe vera gel + ultrasound + eccentric exercises. Intervention group: Placebo aloe vera gel + ultrasound + eccentric exercises.
Main outcome variables
Pain, Knee ROM, Muscle strength ,Tendon thickness , Quality of life ,CRP, ESR and Tendon function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N16
Registration date: 2025-01-22, 1403/11/03
Registration timing: registered_while_recruiting

Last update: 2025-01-22, 1403/11/03
Update count: 0
Registration date
2025-01-22, 1403/11/03
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-01, 1403/10/12
Expected recruitment end date
2025-04-03, 1404/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation And Evaluation of Curcumin Gel Along With Ultrasound and Eccentric Exercises On Patellar Tendinopathy Management
Public title
Curcumin Gel Along With Ultrasound and Eccentric Exercises On Patellar Tendinopathy Management
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
Bosan Road
City
Multan
Postal code
66000
Approval date
2024-11-29, 1403/09/09
Ethics committee reference number
MIMAS/24/08/IAK

Health conditions studied

1

Description of health condition studied
Patellar Tendinopathy
ICD-10 code
M76.50
ICD-10 code description
Patellar tendinitis, unspecified knee

Primary outcomes

1

Description
Pain
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
Numerical Pain rating scale and Western Ontario and McMaster Universities Osteoarthritis Index

2

Description
Knee range of motion (ROM)
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
Goniometer

3

Description
Tendon thickness
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
ultrasound

4

Description
Tendon function
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
Victorian Institute of Sport Assessment-Achilles (VISA-A)

Secondary outcomes

1

Description
Muscle Strength
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
Hand dynamometer

2

Description
Erythrocyte sedimentation rate (ESR)
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
Lab test

3

Description
Quality of life
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
SF-36 scale

4

Description
C-Reactive proteins
Timepoint
Before interventions and 8 weeks after intervention
Method of measurement
Lab test

Intervention groups

1

Description
Intervention group: Group A: Curcumin-aloe vera gel + ultrasound + eccentric exercises; Ultrasound Application: - Administer therapeutic ultrasound using a frequency of 3 MHz in pulsed mode (intensity of 1–1.5 W/cm²) for 5–10 minutes on the patellar tendon area. Apply curcumin-aloe vera gel before ultrasound therapy to enhance penetration. Treatment frequency: 3 times per week. Focus on slow eccentric loading exercises for the quadriceps, such as decline squats. - Exercise progression: Gradually increase weight/resistance over 8 weeks. - Sessions: 3–4 times per week, supervised by a physiotherapist.
Category
Treatment - Drugs

2

Description
Control group: Group B: Placebo-aloe vera gel + ultrasound + eccentric exercises (Ultrasound Application: - Administer therapeutic ultrasound using a frequency of 3 MHz in pulsed mode (intensity of 1–1.5 W/cm²) for 5–10 minutes on the patellar tendon area. Apply placebo-aloe vera gel before ultrasound therapy to enhance penetration. Treatment frequency: 3 times per week. Focus on slow eccentric loading exercises for the quadriceps, such as decline squats. - Exercise progression: Gradually increase weight/resistance over 8 weeks. - Sessions: 3–4 times per week, supervised by a physiotherapist.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Muhammad physical therapy clinic and rehabilitation center, Multan
Full name of responsible person
Komal Ammar Bukhari
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 312 6827130
Email
komalbukhari608@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan
Full name of responsible person
Qurat-Ul-Ain
Street address
Multan
City
MULTAN
Postal code
66000
Phone
+92 312 6827130
Email
qain0635@gmail.com
Grant name
Student fund
Grant code / Reference number
MIMAS/25/08/Aroosa
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences, Multan
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Maliha Khalid Khan
Position
Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Multan
City
MULTAN
Province
Punjab
Postal code
66000
Phone
+92 312 6827130
Email
malihatareen1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture
Full name of responsible person
Imran Ahmad Khan
Position
Coordinator Department of Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Old shuja Abad road Multan
City
-----Select-----
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan
Full name of responsible person
Aroosa Jabeen
Position
Punjab
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Multan
City
MULTAN
Province
Punjab
Postal code
66000
Phone
+92 326 8581608
Email
aroosajabeen908@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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