- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07576192
Effects of Deep Transverse Friction Massage and Instrument Assisted Soft Tissue Mobilization in Plantar Fasciitis.
4. maj 2026 opdateret af: Riphah International University
Comparative Effects of Deep Transverse Friction Massage and Instrument Assisted Soft Tissue Mobilization Techniques on Pain Intensity, Disability and Functional Capacity in Plantar Fasciitis.
The objective of study is to compare the pain intensity, disability and functional capacity by Deep Transverse Friction Massage and Instrument Assisted Soft Tissue Mobilization Techniques in patients with plantar fasciitis.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This randomized clinical trial will be conducted at Ghurki Trust and Teaching Hospital and Jinnah Hospital, Lahore.
The study will target pregnant females aged 18 to 40 years who are clinically diagnosed with plantar fasciitis using the Windlass test.
Exclusion criteria include a history of ankle or foot fracture or surgery within the past six months, as well as any neurological deficits.
A total of 52 participants will be recruited using the non-probability convenience sampling technique and randomly assigned into two equal groups.
Participants in both groups will receive the same baseline treatment.
Group A will receive Deep Transverse Friction Massage (DTFM), while Group B will receive Instrument Assisted Soft Tissue Mobilization Techniques (IASTMT).
The study aims to compare the effectiveness of these two manual therapy techniques on pain intensity, disability, and functional capacity.
The Numeric Pain Rating Scale (NPRS) will be used to assess pain levels.
Disability will be evaluated using the Foot Function Index (FFI), and the 6-Minute Walk Test (6MWT) will be employed to measure functional capacity.
Data collected from participants will be entered and statistically analyzed using SPSS version 21 to determine the comparative effectiveness of the two treatment approaches in managing plantar fasciitis during pregnancy.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
52
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: imran amjad
- Telefonnummer: 03324390125
- E-mail: imran.amjad@riphah.edu.pk
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan, 6400
- Rekruttering
- Riphah medical center
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Kontakt:
- sobia ghafoor, MSPT-OM
- Telefonnummer: 03214979172
- E-mail: Sobia.physio@gmail.com
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Ledende efterforsker:
- Barera Fatima, MSPT(WH)
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Pregnant females Second trimester 12th to 34th week
- Multiparous
- Plantar fasciitis diagnoses with Windlass test
- NPRS pain level 3 to 7
Exclusion Criteria:
- History of ankle and foot fractures
Surgery in previous 6 months
- Neurologic deficit High risk pregnancy
- Previous manual therapy interventions for the foot region
- Those who previously received systemic or local steroid injection within 3 months or locally injected with any other material
- Dermatological disease i.e; injury, trauma, foot ulcer over the foot
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: DEEP TRANSVERSE FRICTION MASSAGE
Deep friction massage (DFM), also known as cross friction massage, is a specific connective tissue massage
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12 sessions total (approx.1 and half month) and 2 sessions per week with mild to moderate manual pressure.
15 - 20 min per session will be given to patient for 6 weeks
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Eksperimentel: INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUES
ASTM techniques involve the use of specialized instruments to manipulate soft tissue structures.
These instruments are designed to provide an efficient detection of soft tissue dysfunction and accurate application of force during treatment.
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• 12 sessions total, (approximately 1 and half month) and 2 sessions per week.
Low to moderate pressure with tool will applied for 15 - 20 min per session for 6 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Numeric Pain Rating Scale (NPRS)
Tidsramme: 6th week
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The Numeric Pain Rating Scale (NPRS) was employed to evaluate pain intensity for all participants in both groups prior to and following the 8-week intervention program.
This is 11-point (0-10) self-reporting tool is presented as a 10-cm horizontal line where 0 indicates no pain, 1-3 signifies mild pain, 4-6 represents moderate pain, and 7-10 denotes severe pain.
The maximum value corresponds to the worst pain, while the minimum value indicates the absence of pain.
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6th week
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Foot Function Index (FFI)
Tidsramme: 6th week
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A Foot Function Index (FFI) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction.
The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales.
Both total and sub-scale scores are produced.
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6th week
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6 min walk test (6MWT)
Tidsramme: 6th week
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used to determine functional ability.
The individual walked swiftly for six minutes along a 100-foot hallway, recording the distance travelled in total.
If a person with plantar fasciitis has pain or discomfort in the foot during the test, it can suggest the presence of the condition.
During the 6-minute walk test, look for indicators of plantar fasciitis as follows.
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6th week
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: sobia ghafoor, MSPT-OM, Riphah International University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Sahr ME, Grünebaum A, Positano RC, Nwawka OK, Chervenak FA, Positano RG. Common foot and ankle disorders in pregnancy: the role of diagnostic ultrasound. Journal of perinatal medicine. 2024;52(7):674-87
- Foraldy J, Jehosua S, Momole A, Tumewah R, Runtuwene T, Wariki WMV. Plantar Fascia Thickness Difference Between Pregnant and Nulliparous in Indonesia. Journal of Medical Ultrasound. 2024;32(4):323-8.
- Khairy E, Esmail A, Amin FS, Qudahh MA, Zahran MR. Integrated Neuromuscular Inhibition Technique versus Instrument Assisted Soft Tissue Mobilization in Patients with Chronic Plantar Fasciitis. Egyptian Journal of Hospital Medicine. 2024;96(1):2570-7.
- Pisirici P, Cil ET, Coskunsu DK, Saylı U, Subasi F. Extracorporeal shockwave therapy versus graston instrument-assisted soft-tissue mobilization in chronic plantar heel pain: a randomized controlled trial. Journal of the American Podiatric Medical Association. 2022;112(6).
- Gala M, Kulkarni P, Kumar A. Comparison of immediate effect of plantar fascia release by roller massager and transverse friction massage on hamstring flexibility in desk job workers. Int J Physiother Res. 2021;9:3954-9.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2025
Primær færdiggørelse (Anslået)
1. juni 2026
Studieafslutning (Anslået)
1. juli 2026
Datoer for studieregistrering
Først indsendt
4. maj 2026
Først indsendt, der opfyldte QC-kriterier
4. maj 2026
Først opslået (Faktiske)
8. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- REC/RCR & AHS/25/0501
Plan for individuelle deltagerdata (IPD)
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