NCT06371547

Brief Summary

The primary aim of this study is to investigate the effects of different types and durations of gastrocnemius stretching on the viscoelastic properties of the gastrocnemius muscle, Achilles tendon, and plantar fascia.In addition, pain threshold of the gastrocnemius muscle and plantar fascia, as well as on hamstring tightness will be measured.

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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

April 17, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

April 14, 2024

Last Update Submit

April 14, 2024

Conditions

Keywords

pain thresholdelasticity

Outcome Measures

Primary Outcomes (2)

  • Measurement of the Viscoelastic Properties

    The effect of stretches on the viscoelastic properties of the stretched muscle and its associated anatomical regions will be evaluated non-invasively using the myotonometer. Measurements will be taken on the medial and lateral gastrocnemius, Achilles tendon, and plantar fascia. The measurement areas will be marked prior to measurement. Measurements of the gastrocnemius and Achilles tendon will be taken with individuals lying prone, knees extended, and ankles in a neutral position. Measurement of plantar fascia tone will be taken with individuals lying prone, hips in neutral, knees extended, ankles in neutral position with goniometer assistance, and supported. All measurements will be taken three times, and the averages will be recorded.

    Change from baseline viscoelastic properties at seventh and fourteen day

  • Ankle-foot Dorsiflexion Index

    The ankle-foot dorsiflexion index will be used to assess both the tightness of the gastrocnemius muscle and the effectiveness of stretches. The individual's dorsiflexion range of motion will be measured using the lunge test, with measurements taken in both knee extension and flexion positions, and the difference between these measurements will be recorded as the ankle-foot dorsiflexion index.

    Change from baseline ankle dorsiflexion range of motion at seventh and fourteen day

Secondary Outcomes (2)

  • Measurement of the Mechanosensitivity

    Change from baseline pain at seventh and fourteen day

  • Assessment of Hamstring Tightness

    Change from baseline hamstring tightness at seventh and fourteen day

Other Outcomes (5)

  • Dominant Leg Determination

    At the baseline

  • Navicular Drop Test

    At the baseline

  • Self-reported Effects of Stretching Exercises

    Change from baseline self-reported effects of stretching exercises at seventh and fourteen day

  • +2 more other outcomes

Study Arms (4)

Sustained stretching of the gastrocnemius muscle with a towel

EXPERIMENTAL

The participant will place a towel under the plantar surface of the foot and, using both hands, pull the towel towards themselves until they feel a stretch in the calf muscle. Subsequently, they will be asked to maintain this position for 3 minutes. The stretching exercise will be performed in 3 sets per day.

Other: Stretching Exercise

Intermittent stretching of the gastrocnemius muscle with a towel

EXPERIMENTAL

In intermittent stretching with a towel, the individual will place a towel under the plantar surface of the foot and, using both hands, pull the towel towards themselves until they feel a stretch in the calf muscle. Subsequently, they will be instructed to maintain this position for 20 seconds. The stretching exercise will be performed in 2 sets per day, with 5 repetitions in each set.

Other: Stretching Exercise

Sustained stretching against the wall

EXPERIMENTAL

In sustained stretching against the wall, individuals will be asked to place their hands on the wall at shoulder width apart. One leg will be positioned behind the other. Then, the front knee will be bent while keeping the back knee in extension and the heel in contact with the ground. Individuals will be instructed to bend their knees until they feel a stretch in the calf muscle. Subsequently, they will be asked to maintain this position for 3 minutes. The stretching exercise will be performed in 3 sets per day.

Other: Stretching Exercise

Intermittent stretching against the wall

EXPERIMENTAL

During intermittent stretching against the wall, individuals will be instructed to place their hands on the wall at shoulder width apart. One leg will be positioned behind the other. Then, the knee of the front leg will be bent while the knee of the back leg continues to stay in extension, and the heel remains in contact with the ground. Individuals will be asked to bend their knee until they feel a stretch in the calf muscle. Subsequently, they will be instructed to maintain this position for 20 seconds. The stretching exercise will be performed in 2 sets per day, with 5 repetitions in each set.

Other: Stretching Exercise

Interventions

Participants will perform different types and durations of gastrocnemius muscle stretching exercises according to their assigned groups for two weeks.

Intermittent stretching against the wallIntermittent stretching of the gastrocnemius muscle with a towelSustained stretching against the wallSustained stretching of the gastrocnemius muscle with a towel

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age of 18 to 25 years
  • Having a gastrocnemius muscle tightness in the dominant side

You may not qualify if:

  • History of lower extremity surgery or trauma
  • Diagnosis of fibromyalgia, neurological disease, achilles tendinopathy, metatarsalgia, acute ankle sprain, tarsal tunnel syndrome, or heel pad syndrome
  • Having received physiotherapy related to the lower extremities within the last six months
  • A body mass index (BMI) above 30 kg/m2
  • Having received a local steroid injection within the last six weeks
  • The presence of a local infection
  • The presence of rheumatic or other systemic inflammatory diseases
  • Diabetes or other metabolic diseases
  • Nerve compression syndrome
  • Currently using painkillers
  • Diagnosis of neurological heel pain
  • A positive navicular drop test result
  • Having engaged in strenuous exercise within the last 24 hours
  • Not being fully compliant with the exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis Eren University

Bitlis, Merkez, 13000, Turkey (Türkiye)

Location

Related Publications (15)

  • Cullen NP, Singh D. Plantar fasciitis: a review. Br J Hosp Med (Lond). 2006 Feb;67(2):72-6. doi: 10.12968/hmed.2006.67.2.20465. No abstract available.

    PMID: 16498906BACKGROUND
  • Schwartz EN, Su J. Plantar fasciitis: a concise review. Perm J. 2014 Winter;18(1):e105-7. doi: 10.7812/TPP/13-113.

    PMID: 24626080BACKGROUND
  • Porter D, Barrill E, Oneacre K, May BD. The effects of duration and frequency of Achilles tendon stretching on dorsiflexion and outcome in painful heel syndrome: a randomized, blinded, control study. Foot Ankle Int. 2002 Jul;23(7):619-24. doi: 10.1177/107110070202300706.

    PMID: 12146772BACKGROUND
  • Liu CL, Li YP, Wang XQ, Zhang ZJ. Quantifying the Stiffness of Achilles Tendon: Intra- and Inter-Operator Reliability and the Effect of Ankle Joint Motion. Med Sci Monit. 2018 Jul 14;24:4876-4881. doi: 10.12659/MSM.909531.

    PMID: 30006997BACKGROUND
  • Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.

    PMID: 22506152BACKGROUND
  • Weerasinghe TW, Goonetilleke RS, Reischl U. Pressure thresholds and stiffness on the plantar surface of the human foot. Ergonomics. 2017 Jul;60(7):985-996. doi: 10.1080/00140139.2016.1229042. Epub 2016 Sep 26.

    PMID: 27609429BACKGROUND
  • Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. Foot (Edinb). 2014 Jun;24(2):66-71. doi: 10.1016/j.foot.2014.03.005. Epub 2014 Mar 21.

    PMID: 24703512BACKGROUND
  • Bolivar YA, Munuera PV, Padillo JP. Relationship between tightness of the posterior muscles of the lower limb and plantar fasciitis. Foot Ankle Int. 2013 Jan;34(1):42-8. doi: 10.1177/1071100712459173.

    PMID: 23386760BACKGROUND
  • McPoil TG, Cornwall MW. The relationship between static lower extremity measurements and rearfoot motion during walking. J Orthop Sports Phys Ther. 1996 Nov;24(5):309-14. doi: 10.2519/jospt.1996.24.5.309.

    PMID: 8902683BACKGROUND
  • Naruseviciute D, Kubilius R. The effect of high-intensity versus low-level laser therapy in the management of plantar fasciitis: randomized participant blind controlled trial. Clin Rehabil. 2020 Aug;34(8):1072-1082. doi: 10.1177/0269215520929073. Epub 2020 Jun 8.

    PMID: 32513018BACKGROUND
  • Monteagudo M, de Albornoz PM, Gutierrez B, Tabuenca J, Alvarez I. Plantar fasciopathy: A current concepts review. EFORT Open Rev. 2018 Aug 29;3(8):485-493. doi: 10.1302/2058-5241.3.170080. eCollection 2018 Aug.

    PMID: 30237906BACKGROUND
  • Hirata K, Kanehisa H, Miyamoto N. Acute effect of static stretching on passive stiffness of the human gastrocnemius fascicle measured by ultrasound shear wave elastography. Eur J Appl Physiol. 2017 Mar;117(3):493-499. doi: 10.1007/s00421-017-3550-z. Epub 2017 Feb 4.

    PMID: 28161870BACKGROUND
  • Kanehisa H, Ikegawa S, Tsunoda N, Fukunaga T. Cross-sectional areas of fat and muscle in limbs during growth and middle age. Int J Sports Med. 1994 Oct;15(7):420-5. doi: 10.1055/s-2007-1021081.

    PMID: 8002122BACKGROUND
  • Masood T, Bojsen-Moller J, Kalliokoski KK, Kirjavainen A, Aarimaa V, Peter Magnusson S, Finni T. Differential contributions of ankle plantarflexors during submaximal isometric muscle action: a PET and EMG study. J Electromyogr Kinesiol. 2014 Jun;24(3):367-74. doi: 10.1016/j.jelekin.2014.03.002. Epub 2014 Mar 20.

    PMID: 24717406BACKGROUND
  • Kamonseki DH, Goncalves GA, Yi LC, Junior IL. Effect of stretching with and without muscle strengthening exercises for the foot and hip in patients with plantar fasciitis: A randomized controlled single-blind clinical trial. Man Ther. 2016 Jun;23:76-82. doi: 10.1016/j.math.2015.10.006. Epub 2015 Oct 30.

    PMID: 26654252BACKGROUND

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ömer Dursun, Asst. Prof.

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR
  • Erhan Dincer, M.Sc.

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR
  • Cihan Önen, Asst. Prof.

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR
  • Abdurrahman Tanhan, Ph.D.

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Dursun, Asst. Prof.

CONTACT

Erhan Dincer, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Interventions and assessment will be performed by separate researchers.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

April 14, 2024

First Posted

April 17, 2024

Study Start

May 15, 2024

Primary Completion

October 15, 2024

Study Completion

December 15, 2024

Last Updated

April 17, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations