NCT07293195

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

December 6, 2025

Last Update Submit

August 25, 2026

Conditions

Keywords

Patellofemoral pain syndromeHeat TherapyContrast TherapyOtago Exercise Program

Outcome Measures

Primary Outcomes (3)

  • Swelling

    Measured by a inelastic tape (Girth measurement)

    4 Weeks

  • Pain Intensity

    Assessed by using the NPRS scale. 0-4 scored as No pain to mild pain 5-7 scored as Moderate pain 8-10 scored as Severe pain

    4 Weeks

  • Range Of Motion

    Measured by a universal goniometer.

    4 Weeks

Secondary Outcomes (1)

  • Functional limtations

    4 Weeks

Study Arms (2)

Experimental Group: Heat therapy with Otago exercises

EXPERIMENTAL

Heat Therapy: * Frequency: 3 sessions/week for 4 weeks * Intensity: Moderate heat * Time: 15 minutes/session * Type: Passive superficial heat via electrical hot pack Otago Exercise Program: * Frequency: 3 sessions/week supervised + daily home exercise for 4 weeks * Intensity: 3 sets of 10 repetitions with weekly progression from Level 1 to Level 3 over 4 weeks * Time: 30 minutes/session * Type: Strengthening and balance exercises for lower limbs Routine Physical Therapy (Medial Patellar Mobilization): * Frequency: 3 sessions/week for 4 weeks * Intensity: Gentle grade I/II mobilization * Time: 3 sets of 10 repetitions * Type: Passive sustained medial glides of patella

Other: Heat therapy+Otago exercise programOther: Contrast therapy+ Otago exercise program

Active Experimental Group: Contrast therapy with Otago exercises

ACTIVE COMPARATOR

Contrast Therapy: * Frequency: 3 sessions/week for 4 weeks * Intensity: Alternating heat and cold * Time: 15 minutes/session (4 min heat + 1 min cold cycles) * Type: Alternating heat and cold using standard electrical hot pack and cold gel pack Otago Exercise Program: * Frequency: 3 sessions/week supervised + daily home exercise for 4 weeks * Intensity: 3 sets of 10 repetitions with weekly progression from Level 1 to Level 3 over 4 weeks * Time: 30 minutes/session * Type: Strengthening and balance exercises for lower limbs Routine Physical Therapy (Medial Patellar Mobilization): * Frequency: 3 sessions/week for 4 weeks * Intensity: Gentle grade I/II mobilization * Time: 3 sets of 10 repetitions * Type: Passive sustained medial glides of patella

Other: Heat therapy+Otago exercise program

Interventions

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.

Experimental Group: Heat therapy with Otago exercises

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.

Also known as: Hot pack, Electrical Hot pack
Active Experimental Group: Contrast therapy with Otago exercisesExperimental Group: Heat therapy with Otago exercises

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-40 years experiencing pain in the front of the knee, including the peripatellar or retropatellar areas.
  • Patient having pain severity a minimum value of 4-7 on the numeric pain rating scale.
  • Participants presenting with anterior knee pain persisting for three months or longer.
  • Pre- diagnosed patients with positive patellar compression and Grind tests.
  • Patients with lateral patellar tracking.

You may not qualify if:

  • Pain having a duration of less than three months or patients with previous knee surgeries.
  • Recent engagement in structured lower-limb exercise or rehabilitation interventions.
  • Patients with pregnancy, malignancy or any neurological dysfunctions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki Trust Teaching Hospital

Lahore, Punjab Province, 57000, Pakistan

Location

MeSH Terms

Conditions

Patellofemoral Pain SyndromeHyperthermia

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 6, 2025

First Posted

December 19, 2025

Study Start

December 10, 2025

Primary Completion

May 10, 2026

Study Completion

May 12, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Will be shared after research publication

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
6 months
Access Criteria
Researcher, Layman,

Locations