NCT07013617

Brief Summary

This randomized, Single-blind, parallel-group trial will compare the effects of three hamstring stretching interventions-general hamstring Muscle Energy Technique (MET), medial hamstring MET, and lateral hamstring MET-each combined with standardized TENS and progressive hip/knee strengthening, on hamstring flexibility (knee-extension ROM), anterior knee pain (Arabic Kujala score), pain intensity visual analogue scale (VAS), and lower-limb strength (hand-held dynamometer) in adults with patellofemoral pain syndrome (PFPS).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

June 14, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 2, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

patellofemoral pain syndromePFPShamstring flexibilityactive knee extension testmedial hamstringlateral hamstringspecific hamstring stretchMuscle Energy TechniqueTENSVisual Analogue ScaleHand Held Dynamometer (HHD)Kujala Score

Outcome Measures

Primary Outcomes (2)

  • hamstring flexibility (knee extension range of motion )

    measuring knee extension range of motion(hamstring flexibility) by active knee extension test using kinovea software

    4 weeks

  • Arabic Kujala Anterior knee pain score

    Arabic Kujala Anterior knee pain score is used to measure pain and functional activities in anterior knee pain patients consisting of 13 questions, the Patient will be asked to mark the most suitable answer for him. Each answer has points up to 5 or 10, and the total score is 100. The higher the score, the better for the patient.

    4 weeks

Secondary Outcomes (2)

  • pain intensity by visual analogue scale (VAS)

    4 weeks

  • lower limb strength using handheld dynamometer

    4 weeks

Study Arms (3)

Arm A (general hamstring stretch group)

ACTIVE COMPARATOR

* General hamstring Muscle energy technique (MET) * TENS 20 min * Hip/knee strengthening program

Device: Transcutaneous Electrical Nerve Stimulation DeviceOther: Strength exercises for lower limbOther: Hamstring Stretch Muscle Energy Technique(MET) (General )

Arm B (medial hamstring stretch)

ACTIVE COMPARATOR

* Medial hamstring MET * TENS 20 min * Hip/knee strengthening program

Device: Transcutaneous Electrical Nerve Stimulation DeviceOther: Strength exercises for lower limbOther: Medial Hamstring Muscle energy technique(MET) stretch

Arm C (lateral hamstring stretch)

ACTIVE COMPARATOR

* Lateral hamstring MET * TENS 20 min * Hip/knee strengthening program

Device: Transcutaneous Electrical Nerve Stimulation DeviceOther: Strength exercises for lower limbOther: Lateral hamstring Muscle Energy Technique(MET)Stretch

Interventions

Each participant will receive 20 minutes of TENS, Electrodes will be positioned around the patella with a 5 - 7 cm distance in between, The TENS settings include a continuous asymmetric biphasic square-pulse wave, a pulse width of 120 microseconds, and a pulse rate of 180 Hz.

Also known as: TENS
Arm A (general hamstring stretch group)Arm B (medial hamstring stretch)Arm C (lateral hamstring stretch)

Each participant will receive progressive strengthening program targeting the hip and knee, begin with 3 sets of 10 repetitions and progress to 3 sets of 20 repetitions.

Arm A (general hamstring stretch group)Arm B (medial hamstring stretch)Arm C (lateral hamstring stretch)

The participant will be supine and the leg will be taken into hip flexion until a tightness is felt then patient will be asked to push down with his lower leg and hold the contraction for 10 seconds then relax for 2 to 3 seconds then the therapist will take the patient's leg into further flexion for 30 seconds this will be repeated for 3 times each session .

Also known as: Non-Specific hamstring stretch MET
Arm A (general hamstring stretch group)

The Participant will be supine' then the therapist will take his leg in flexion, abduction and external rotation at the same time until he feels tightness then he will ask the patient to push his leg down and in or toward him and hold the contraction for 10 seconds then relax for 2 to 3 seconds then therapist will take the patient's leg in more abduction 'external rotation and flexion for 30 seconds, this will be repeated for 3 times each session

Also known as: specific medial hamstring MET stretch
Arm B (medial hamstring stretch)

The Participant will be supine' then the therapist will take his leg in flexion, adduction and internal rotation at the same time until he feels a tightness then he will ask the patient to push his leg down and out or away from him him and hold the contraction for 10 seconds then relax for 2 to 3 seconds then therapist will take the patient's leg in more adduction 'internal rotation and flexion for 30 seconds, this will be repeated for 3 times each session

Also known as: Specific lateral hamstring MET stretch
Arm C (lateral hamstring stretch)

Eligibility Criteria

Age18 Years - 37 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anterior or retropatellar knee pain lasting at least three months
  • Pain reproduced by at least two functional tasks: squatting, kneeling, prolonged sitting, stair climbing, hopping or running
  • Pain intensity of ≥3 on a Visual Analog Scale
  • positive active knee extension test (inability to achieve greater than 160° of knee extension with the hip at 90° of flexion)
  • Body mass index (BMI) \< 30 Kg/m² and \> 18Kg/m²

You may not qualify if:

  • Previous knee surgery
  • History of knee pathologies, such as meniscal injury' ligament injury, or knee osteoarthritis
  • Psychological, cardiovascular' or neurological disorders
  • Dizziness or fainting while doing exercises, pregnancy, or any contraindications to exercise
  • Physical therapy treatment in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Giza, Giza Governorate, 12613, Egypt

Location

Related Publications (8)

  • Zahra Rojhani-Shirazi, Mohamad Reza Salimifard, Fatemeh Barzintaj. Comparison of the effects of static stretching and muscle energy technique on Hamstring flexibility, pain, and function in athletes with patellofemoral pain. J Adv Pharm Edu Res 2021;11(S1):33-38.

    BACKGROUND
  • Lopes HS, Waiteman MC, Priore LB, Glaviano NR, Bazett-Jones DM, Briani RV, Azevedo FM. There is more to the knee joint than just the quadriceps: A systematic review with meta-analysis and evidence gap map of hamstring strength, flexibility, and morphology in individuals with gradual-onset knee disorders. J Sport Health Sci. 2024 Jul;13(4):521-536. doi: 10.1016/j.jshs.2023.08.004. Epub 2023 Sep 3.

    PMID: 37669706BACKGROUND
  • Wallis JA, Roddy L, Bottrell J, Parslow S, Taylor NF. A Systematic Review of Clinical Practice Guidelines for Physical Therapist Management of Patellofemoral Pain. Phys Ther. 2021 Mar 3;101(3):pzab021. doi: 10.1093/ptj/pzab021.

    PMID: 33533400BACKGROUND
  • Hamdan M, Haddad B, Isleem U, Hamad A, Hussein L, Shawareb Y, Hadidi F, Alryalat SA, Samarah O, Khanfar A, Alzoubi B. Validation of the Arabic version of the Kujala patellofemoral pain scoring system. J Orthop Sci. 2019 Mar;24(2):290-293. doi: 10.1016/j.jos.2018.09.008. Epub 2018 Oct 10.

    PMID: 30316659BACKGROUND
  • John Gibbons. (2022). Muscle energy techniques: a practical guide for physical therapists / JOHN GIBBONS (second edition). Lotus publishing / North Atlantic book

    BACKGROUND
  • Puig-Divi A, Escalona-Marfil C, Padulles-Riu JM, Busquets A, Padulles-Chando X, Marcos-Ruiz D. Validity and reliability of the Kinovea program in obtaining angles and distances using coordinates in 4 perspectives. PLoS One. 2019 Jun 5;14(6):e0216448. doi: 10.1371/journal.pone.0216448. eCollection 2019.

    PMID: 31166989BACKGROUND
  • Hott A, Brox JI, Pripp AH, Juel NG, Liavaag S. Patellofemoral pain: One year results of a randomized trial comparing hip exercise, knee exercise, or free activity. Scand J Med Sci Sports. 2020 Apr;30(4):741-753. doi: 10.1111/sms.13613. Epub 2020 Jan 5.

    PMID: 31846113BACKGROUND
  • Constantinou A, Mamais I, Papathanasiou G, Lamnisos D, Stasinopoulos D. Comparing hip and knee focused exercises versus hip and knee focused exercises with the use of blood flow restriction training in adults with patellofemoral pain. Eur J Phys Rehabil Med. 2022 Apr;58(2):225-235. doi: 10.23736/S1973-9087.22.06691-6. Epub 2022 Jan 5.

    PMID: 34985237BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Central Study Contacts

Amna Ibrahim Shemila, BSc

CONTACT

Ahmed Omar Abdelnaeem, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

June 14, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations