- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07695064
Comparing the Effects of Manual Cross Friction Massage Versus Instrument-Assisted Soft Tissue Mobilization on Pain, Range of Motion, And Functional Disability in Patients With Chronic Lateral Epicondylitis: A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
KPK
-
Peshawar, KPK, Pakistan, 25000
- Ibadat International University, Islamabad
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Both male and female aged between 18 to 60 years with a clinical diagnosis of lateral elbow pain lasting for≥ 6 months duration VAS score ≥ 4 during resisted wrist extension or grip activity ≥1 of the following tests being positive . Mill's test pain on passive wrist flexion and elbow extension Cozen's test pain on resisted wrist extension, elbow extended, wrist in flexion and medial deviation .
Painful palpation at the origin of the ECRB or lateral epicondyle
Exclusion Criteria:
- Participants will be excluded as:
History of recent fracture,dislocation,or surgery near the elbow joint in the last 3 month Neurological or systemic inflammatory conditions (e.g., rheumatoid arthritis) Current use of corticosteroid injections in the elbow region within the past 6 weeks Previous physiotherapy interventions for the same complaint in the last 3 months.
Skin disorders or open wounds near the treatment area.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Manual Cross Friction Massage (CFM)
Arm Description: Patient seated , elbow flexed ~90 degree , forearm pronated , extensor tendon exposed and released.
Thumb / index finger applies firm transverse pressure .
|
Patient seated , elbow flexed ~90 degree , forearm pronated , extensor tendon exposed and released.
Thumb / index finger applies firm transverse pressure .
Short , deep ,rhythmic strokes perpendicular to ECRB tendon fibers (5 to 10 min ).Total duration 35 - 40 mins.
3 sessions per week for 6 weeks.
|
|
Aktiv komparator: Group B: Instrument-Assisted Soft Tissue Mobilization (IASTM)
Seated,Elbow flexed ~ 90 degree , forearm pronated, extensor tendon exposed and relaxed.
Stainless steel IASTMCurve bar S shape , dual grip tool was used with moderate ,tolerable pressure .
|
Seated,Elbow flexed ~ 90 degree , forearm pronated, extensor tendon exposed and relaxed.
Stainless steel IASTMCurve bar S shape , dual grip tool was used with moderate ,tolerable pressure .
Longitudinal sweeping (1-2 min ) , Cross fiber stokes (1-2 min), Fanning over tender point ( 1- 2min).
Flushing stokes (1min).40
-45 mins total time .
3 sessions per week for 6 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analog Scale.
Tidsramme: Assessments were performed at baseline (week 0) and post intervention (week 6).
|
A Visual Analogue Scale (VAS) was used to measure pain intensity during rest.
The level of pain was recorded on a 10 cm line where 0 was classified as "no pain" and 10 was classified as "worst possible pain".
Subjects were asked to indicate their pain level by placing a mark along this horizontal line
|
Assessments were performed at baseline (week 0) and post intervention (week 6).
|
|
Goniometer
Tidsramme: Assessments was performed at baseline (week 0) and post intervention (week 6).
|
ROM measured was used a standard universal goniometer, which is considered a valid, reliable, and widely accepted clinical tool for assessing joint angles in musculoskeletal conditions.
Measurements were taken for wrist flexion, wrist extension, and elbow movements, following standardized positioning and landmark alignment to ensure consistency and accuracy.
|
Assessments was performed at baseline (week 0) and post intervention (week 6).
|
|
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire
Tidsramme: Assessments was performed at baseline (week 0) and post intervention (week 6).
|
Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire is an instrument that has been developed specifically for use with this disorder [16].
It takes the form of a 15-item questionnaire, with five items addressing pain and 10 concerned with functional deficit.
For each item, the respondent uses a 0- 10 numerical scale to rate the average pain or difficulty they have experienced over the previous week while carrying out various activities that are commonly painful in tennis elbow.
The marking system ensures that pain and function are weighted equally in the total score.
Higher scores represent greater se- verity and the maximum score is 100
|
Assessments was performed at baseline (week 0) and post intervention (week 6).
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IIUI/RERC/ADT/2026/01/206
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Chronic Lateral Epicondylitis
-
Universidad Católica de ÁvilaAfsluttetHumeral Epicondylitis, LateralSpanien
-
Hospital for Special Surgery, New YorkAfsluttetLateral epikondylitis | Lateral epikondylitis, uspecificeret albue | Lateral epikondylitis, venstre albue | Lateral epikondylitis, højre albue | Lateral Epicondylitis (Tennisalbue) Bilateral | Medial epikondylitis | Medial epikondylitis, højre albue | Medial epikondylitis, venstre albueForenede Stater
-
Istanbul Training and Research HospitalAfsluttetLateral epikondylitis | Sammenligning af autologt blodkortikosteroid og deres kombinerede injektion til behandling af lateral epicondylitisKalkun
-
European University of LefkeAfsluttetLateral Epicondylitis (Tennisalbue) Bilateral | Smerter i armen, uspecificeret | Tenosynovitis albue
-
Jules Bordet InstituteMacopharma; Belgian Hematological SocietyRekrutteringRefractory Chronic Graft Versus Host Disease (cGVHD)Belgien
-
Mayo ClinicThe Patient Company, LLCAfsluttetLateral patientoverførselForenede Stater
-
Riphah International UniversityIkke rekrutterer endnu
-
University of BaghdadAfsluttetLateral sinus løftIrak
-
University Ramon LlullRekrutteringAmyotrofisk Lateral SkleroseSpanien
-
Arthrex, Inc.Aktiv, ikke rekrutterendeLateral ankel ustabilitetForenede Stater