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

65
Monitor

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
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Dec 2025May 2026

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 24, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2026

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 6, 2025

Last Update Submit

December 6, 2025

Conditions

Keywords

Patellofemoral pain syndrome(PFPS), Heat therapy(HT), Contrast therapy(CT),Otago exercise program(OEP)

Outcome Measures

Primary Outcomes (3)

  • Swelling

    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)

    4 Weeks

  • Pain Intensity

    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.

    4 Weeks

  • Range Of Motion

    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.

    4 Weeks

Secondary Outcomes (1)

  • Functional limtations

    4 Weeks

Study Arms (2)

Experimental Group: Heat therapy with Otago exercises

EXPERIMENTAL

1. Heat Therapy: * Frequency: 3 sessions/week for 4 weeks * Intensity: Mild to moderate heat (40°C) * Time: 15 minutes/session * Type: Passive superficial heat via electrical hot pack 2. Otago Exercise Program: * Frequency: 3 sessions/week supervised + daily home exercise for 4 weeks * Intensity: Progressively increasing strength and balance * Time: 30 minutes/session (includes warm-up and cool-down) * Type: Functional, strength, and balance exercises for lower limbs 3. 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

1. Contrast Therapy: * Frequency: 3 sessions/week for 4 weeks * Intensity: Heat (38-40°C) and cold (12-14°C) * Time: 15 minutes/session (4 min heat + 1 min cold cycles) * Type: Alternating hot/cold packs 2. Otago Exercise Program: * Frequency: 3 sessions/week supervised + daily home exercise for 4 weeks * Intensity: Progressively increasing strength and balance * Time: 30 minutes/session (includes warm-up and cool-down) * Type: Functional, strength, and balance exercises for lower limbs 3. 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:

  • Participants 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.
  • Participants 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.
  • Positive patellar compression and Grind tests.
  • Clinical evidence of lateral patellar tracking, given its established role in patellofemoral joint dysfunction.
  • Pain 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.

You may not qualify if:

  • Pain 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.
  • Recent participation in lower-limb rehabilitation or structured training within six weeks, or prior diagnoses of rheumatoid arthritis, gout, or other rheumatic knee disorders.
  • Use 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Umber Nawaz, PhD Scholar

CONTACT

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 (Estimated)

May 24, 2026

Study Completion (Estimated)

May 24, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

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,