- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07723014
Effects of Stecco Fascial Manipulation Versus Muscle Energy Technique on Pain Pressure Threshold, Range of Motion and Disability Among Patients With Sacroiliac Joint Dysfunction
2026. július 20. frissítette: Lahore University of Biological and Applied Sciences
This study holds significant importance as it directly addresses the need for effective physiotherapy interventions in patients with sacroiliac joint dysfunction, a condition that contributes substantially to lower back pain and disability.
By comparing the effects of Fascial Manipulation and Muscle Energy Technique on pain pressure threshold, disability, and range of motion, the study provides evidence-based guidance for clinicians in selecting the most appropriate treatment.
The findings can help physiotherapists develop more targeted rehabilitation plans, improve patient outcomes, and reduce treatment time.
Additionally, this research adds to the limited literature available on stecco fascial manipulation and muscle energy technique approaches for SI joint dysfunction and may encourage further studies to refine and expand conservative management strategies.
Ultimately, the study benefits both healthcare professionals and patients by promoting more efficient, safe, and effective physiotherapy care.
A tanulmány áttekintése
Állapot
Toborzás
Körülmények
Beavatkozás / kezelés
Részletes leírás
Pain and stiffness experienced from the Sacroiliac joint is referred to as sacroiliac joint (SIJ) dysfunction.
SIJ dysfunction typically results from abnormal motion and malalignment of the joint .Patients usually complain of deep-seated pain, which extends down the posterior thigh and up to the knee.
Pain can frequently mimic and be misdiagnosed as radicular pain.
SIJ dysfunction is not only a source of pain but also a significant contributor to functional disability, negatively affecting an individual's ability to perform activities of daily living.SIJD is curable with medical and physical therapy interventions.
The standard physical therapy (PT) interventions include manual joint mobilization, manipulation, bracing, massage, patient education, aerobic conditioning, muscle energy technique, and electrotherapeutic modalities such as heat, ultrasound, TENS, and lumbar exercises.
Lumbar exercises included knee to the same shoulder stretch, quadriceps stretch, hamstring stretch, posterior pelvic tilt, conventional back-bridge, conventional back-bridge with elevated one leg, and sit-up.
Although the effectiveness of the muscle energy technique on sacroiliac joint dysfunction to reduce pain and improve functional mobility.
Two sessions per week for four weeks.
In Recent research has investigated the effectiveness of Fascial Manipulation (FM) Stecco method in individuals with SIJ dysfunction.
A total of 52 participants will be randomly allocated into two intervention groups and will undergo stecco fascial manipulation and muscle energy technique over a period of 4 weeks.Outcome measures will be assessed at baseline, 1st weeks, and 4th week including pain self efficacy questionear(PSEQ), Algometer(Pain pressure threshold), Disability(oswetry disbility index) and lumber range of motion( Goniometer).
Therefore the study aims to compare the effect of stecco fascial manipulation and muscle energy technique on pain pressure thresold, range of motion, and disability among patients with sacroiliac joint dysfunction, in order to provide evidence based guidence for clinical practice.
Tanulmány típusa
Beavatkozó
Beiratkozás (Becsült)
52
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi kapcsolat
- Név: Shahzaib Salik
- Telefonszám: +923241479454
- E-mail: shahzaibsalik322@gmail.com
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: Yamna Mazher
- Telefonszám: +923327965489
- E-mail: yamna.mazhar@ubas.edu.pk
Tanulmányi helyek
-
-
Punjab Province
-
Lahore, Punjab Province, Pakisztán, 54000
- Toborzás
- Lahore General Hospital
-
-
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
Egészséges önkénteseket fogad
Nem
Leírás
Inclusion Criteria:Age between 30-45.
- Both male and female.
- Participants with a medical diagnosis of SIJD (posterior innominate and anterior innominate), pain and tenderness at PSIS, Sacral Sulcus, Ilia.
- Pain in the paraspinal muscles, gluteal or groin region, and radiating to either leg.
- 3 Positive special tests for SIJD (Faber test, Thigh thrust test, Distraction test, compression test, and Gaenslen test).
- Pain lasting for less than 3 months.
Exclusion Criteria:
- Subjects with leg length discrepancy.
- Subjects with any pathology observed in the lower extremity.
- Subjects with pre-diagnosed tumors of the hip and spine.
- Pregnancy.
- Subjects with any history of recent trauma involving the lower limb.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Stecco fascial manipulation
26 patient were given the Stecco myofascial manipulation on the retro-lumbi which are located over the muscle bellies of the erector spinae at the T12- L1 level, retro-talus which are located in the myotendinous passage of the gastrocnemius, retro-thorax, which are located over the muscle bellies of the erector spinae, at the level of T4-T5, extra-thorax, which are located medially to the scapula, at the level of the scapular spine, over the rhomboid and serratus posterior superior muscle, extra-lumbi which are situated below the 12th rib, over the insertion of the oblique muscle.
Fascial manipulation was not performed directly over the painful area; instead, selected fascial points situated at least 20 cm away from the site of pain were treated to avoid local tissue irritation and to utilize the principle of fascial continuity
|
Stecco myofascial manipulation on the retro-lumbi which are located over the muscle bellies of the erector spinae at the T12- L1 level, retro-talus which are located in the myotendinous passage of the gastrocnemius, retro-thorax, which are located over the muscle bellies of the erector spinae, at the level of T4-T5, extra-thorax, which are located medially to the scapula, at the level of the scapular spine, over the rhomboid and serratus posterior superior muscle, extra-lumbi which are situated below the 12th rib, over the insertion of the oblique muscle.
Fascial manipulation was not performed directly over the painful area; instead, selected fascial points situated at least 20 cm away from the site of pain were treated to avoid local tissue irritation and to utilize the principle of fascial continuity.
Manual manipulation was performed using sustained deep pressure applied with the therapist's knuckles or elbow, combined with friction over the identified points.
|
|
Egyéb: Muscle Energy Technique
26 patients were given the muscle energy technique MET was applied in two forms: Anterior and posterior dysfunction of the SIJ.
The MET technique for correction of anterior dysfunction of the sacroiliac joint was performed by placing the individual in a lateral position on the opposite side to that of the dysfunction.
The blocked leg was taken by the examiner, while the unaffected leg remained extended on the stretcher.
The leg was placed in hip flexion until the first point of tension that prevented the posterior rotation of the ilium was found.
While this technique was being used, the patient was asked to push his leg into hip extension while the examiner held it and prevented movement.
Four contractions were performed, resisted by the therapist, and held for 7-10 s.
The individual was then asked to relax the leg, and the examiner continued to perform the hip flexion until a new point of tension was found
|
MET was applied in two forms: Anterior and posterior dysfunction of the SIJ.
The MET technique for correction of anterior dysfunction of the sacroiliac joint was performed by placing the individual in a lateral position on the opposite side to that of the dysfunction.
The blocked leg was taken by the examiner, while the unaffected leg remained extended on the stretcher.
The leg was placed in hip flexion until the first point of tension that prevented the posterior rotation of the ilium was found.hold it for 10 second and apply four repitation.In order to correct the SIJ dysfunction due to a posteriorly rotated ilium, the individual was placed in a prone position with his or her unaffected side leg in extension, while the affected side leg was in knee flexion.
The therapist held the leg in a 90◦ flexion and tried to help hip extension so as to get the ilium to rotate posteriorly in order to correct the dysfunction.
Hold it for 10 second and apply for four repitation.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Goniometer
Időkeret: [ baseline, 4 weeks( followup)]
|
Lumbar range of motion (ROM) was assessed using a universal goniometer, a simple, handheld clinical instrument specifically designed to measure joint angles and the extent of movement in degrees.
The goniometer consists of two arms and a central fulcrum, allowing accurate quantification of active lumbar movements, including flexion, extension, lateral flexion, and rotation.
Standardized patient positioning and anatomical landmark identification were used to enhance measurement accuracy.
Reduced lumbar ROM is commonly associated with pain and functional limitation in individuals with sacroiliac joint dysfunction.
|
[ baseline, 4 weeks( followup)]
|
|
Pain self-efficacy questionnaire (PSEQ)
Időkeret: baseline, 4 weeks (follow up)
|
Pain self-efficacy, defined as an individual's confidence in performing daily activities despite the presence of pain, was assessed using the Pain Self-Efficacy Questionnaire (PSEQ).
The PSEQ is a widely used, condition-independent, self-reported outcome measure designed to evaluate how confidently individuals can function while experiencing pain.
It consists of 10 items, each rated on a 7-point Likert scale (0-6), producing a total score ranging from 0 to 60, with higher scores indicating greater pain self-efficacy.
|
baseline, 4 weeks (follow up)
|
|
Algometer:
Időkeret: baseline, 4 weeks(followup)
|
Pressure pain threshold (PPT) was assessed using a handheld pressure algometer, an objective instrument designed to quantify mechanical pain sensitivity by applying controlled, gradually increasing pressure to soft tissues.
In this study, the algometer was applied over a standardized anatomical point in the sacroiliac joint region until the participant first perceived pain, at which point the corresponding value was recorded in kilograms or Newtons.
Higher PPT values indicate greater pain tolerance, whereas lower values reflect increased pain sensitivity.
|
baseline, 4 weeks(followup)
|
|
Oswestry disability index (ODI)
Időkeret: baseline, 4 weeks ( followup)]
|
Functional disability related to sacroiliac joint dysfunction was assessed using the Oswestry Disability Index (ODI), which is one of the most widely used and validated questionnaires for measuring disability associated with low back and pelvic pain.
The ODI is a condition-specific, self-reported outcome measure designed to assess the degree to which pain affects an individual's ability to perform activities of daily living, including personal care, lifting, walking, sitting, standing, sleeping, social life, and traveling.
It consists of 10 items, each scored on a 6-point scale (0-5), yielding a total score ranging from 0 to 50, which is commonly converted into a percentage score, with higher scores indicating greater functional disability.
|
baseline, 4 weeks ( followup)]
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
- Centner C, Wiegel P, Gollhofer A, Konig D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1.
- Sorensen B, Aagaard P, Hjortshoj MH, Hansen SK, Suetta C, Couppe C, Magnusson SP, Johannsen FE. Physiological and clinical effects of low-intensity blood-flow restricted resistance exercise compared to standard rehabilitation in adults with knee osteoarthritis-Protocol for a randomized controlled trial. PLoS One. 2023 Dec 14;18(12):e0295666. doi: 10.1371/journal.pone.0295666. eCollection 2023.
- Harper SA, Roberts LM, Layne AS, Jaeger BC, Gardner AK, Sibille KT, Wu SS, Vincent KR, Fillingim RB, Manini TM, Buford TW. Blood-Flow Restriction Resistance Exercise for Older Adults with Knee Osteoarthritis: A Pilot Randomized Clinical Trial. J Clin Med. 2019 Feb 21;8(2):265. doi: 10.3390/jcm8020265.
- Freitas EDS, Miller RM, Heishman AD, Aniceto RR, Silva JGC, Bemben MG. Perceptual responses to continuous versus intermittent blood flow restriction exercise: A randomized controlled trial. Physiol Behav. 2019 Dec 1;212:112717. doi: 10.1016/j.physbeh.2019.112717. Epub 2019 Oct 17.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2026. május 1.
Elsődleges befejezés (Becsült)
2026. július 30.
A tanulmány befejezése (Becsült)
2026. október 10.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. július 20.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 20.
Első közzététel (Tényleges)
2026. július 23.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. július 23.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 20.
Utolsó ellenőrzés
2026. július 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- UBAS/ERB/26/04/024
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Nem
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .