- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07576192
Effects of Deep Transverse Friction Massage and Instrument Assisted Soft Tissue Mobilization in Plantar Fasciitis.
4. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
52
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Imran Amjad
- Telefonnummer: 03324390125
- E-post: Imran.amjad@riphah.edu.pk
Studiesteder
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 6400
- Rekruttering
- Riphah medical center
-
Ta kontakt med:
- sobia ghafoor, MSPT-OM
- Telefonnummer: 03214979172
- E-post: Sobia.physio@gmail.com
-
Hovedetterforsker:
- Barera Fatima, MSPT(WH)
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: DEEP TRANSVERSE FRICTION MASSAGE
Deep friction massage (DFM), also known as cross friction massage, is a specific connective tissue massage
|
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
|
|
Eksperimentell: 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.
|
• 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Tidsramme: 6th week
|
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
|
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
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: sobia ghafoor, MSPT-OM, Riphah International University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2025
Primær fullføring (Antatt)
1. juni 2026
Studiet fullført (Antatt)
1. juli 2026
Datoer for studieregistrering
Først innsendt
4. mai 2026
Først innsendt som oppfylte QC-kriteriene
4. mai 2026
Først lagt ut (Faktiske)
8. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- REC/RCR & AHS/25/0501
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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