- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07646327
Sustained Natural Apophyseal Glides With and Without Facilitated Positional Release Technique in Cervicogenic Dizziness
Effects of Sustained Natural Apophyseal Glides With and Without Facilitated Positional Release Technique on Pain, Dizziness, Range of Motion, and Functional Status Among Patients With Cervicogenic Dizziness
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Samrood Akram, PhD*
- Telefonní číslo: 03324806143
- E-mail: samrood.akram@riphah.edu.pk
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 54920
- Government Teaching Hospital Shahdara
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Kontakt:
- Rahat Afzal, MS-OMPT
- Telefonní číslo: 0316 4333853
- E-mail: rahatafzal850@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age group between 18 and 35 years
- Both male and female participants
- Non-traumatic cervicogenic dizziness with positive cervical torsion test
Exclusion Criteria:
• History of cervical trauma or head/face injury
- Vestibular disorder, i.e., BPPV
- Vertebrobasilar Insufficiency
- Positive Dix-Hallpike Maneuver, Alar Ligament Stress Test, and Vertebral Artery Test
- History of cardiovascular disorders
- Pregnancy
- Diagnosed psychological disorders
- History of cervical spine surgery
- Vertebral Fractures
- Spine disorders such as cervical spondylosis and disc herniation
- Presence of tumor
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: SNAGs along with Functional positional Release Technique
SNAGs (Sustained Natural Apophyseal Glides) and Functional Release Techniques (FRT) are highly effective, non-invasive manual therapy methods used to treat cervicogenic dizziness.
They target the faulty biomechanics, joint restrictions, and muscle hypertonicity in the upper cervical spine (C1-C3) that disrupt cervical proprioception and trigger dizziness.
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SNAG : The therapist will place the palmar aspect of the thumb reinforced by the opposite thumb over the spinous process of C2. The other fingers will apply light pressure on both sides of the face to stabilize the head The therapist will apply anterior glide to C2. Instruct the patient to move his/her neck in the offending direction. FRT: The therapist will palpate the upper trapezius tender point. After palpation, the patient's neck will be brought into a neutral position. The therapist will apply a gentle axial facilitating force (compressive force) through the head towards the feet and will quickly turn the patient's head in side flexion towards the tender point in a position of maximum relaxation. The therapist will maintain this position for 3 to 5 seconds, and the patient's neck will be turned into a neutral position. |
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Aktivní komparátor: SNAGs
SNAGs (Sustained Natural Apophyseal Glides) are targeted manual therapy techniques that combine sustained joint glides with active patient movement.
Highly effective for cervicogenic dizziness, they reduce neck pain, improve cervical range of motion, and decrease dizziness by restoring proper upper cervical spine biomechanics and alleviating joint restrictions
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The patient will be seated.
The therapist will stand behind the patient.
The therapist will place the palmar aspect of the thumb reinforced by the opposite thumb over the spinous process of C2.
The other fingers will apply light pressure on both sides of the face to stabilize the head The therapist will apply anterior glide to C2. Instruct the patient to move his/her neck in the offending direction.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Numeric Pain Rating Scale (NPRS) for Pain
Časové okno: Upto 4 weeks
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It is the most frequently used pain outcome measure.
It consists of a horizontal 10 cm straight line with 2 marks that have "no pain" (score of 0) and a "worst imaginable pain" (score of 10) at either end of the line.
On this scale, respondents will be asked to rate their level of pain before and after the treatment.
The test-retest reliability of NPRS is (ICC = 0.72), and the construct validity is (AUC = 0.78-0.93).
The Minimal Clinically Important Difference (MCID) is 2.5 points, suggesting a reduction of at least 2.5 points on the NPRS is clinically significant
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Upto 4 weeks
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Dizziness Handicap Inventory Scale (DHI) for dizziness
Časové okno: Upto 4 weeks
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The DHI questionnaire consists of 25 items with physical, emotional, and functional subscales.
This scale evaluates the self-perceived handicap from dizziness.
Patients will be asked to answer the questions considering their condition before and after the treatment.
Each item on the questionnaire ranges from 0 to 4. Scores of 16-34 indicate mild, 36-52 indicate moderate, and 54 points or more represent severe handicap.
The test-retest reliability of DHI is high (r = 0.92 to 0.97) and high internal consistency (alpha = 0.72 to 0.89).
The MCID for DHI is reported as ≥ 10 points
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Upto 4 weeks
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Universal Goniometer for ROM
Časové okno: Upto 4 weeks
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It was used to measure the cervical range of motion.
It is a less expensive and easy-to-use instrument.
It has two arms, one of which is stationary and the other is a movable arm.
The center of the UG is the fulcrum.
The test-retest reliability of the goniometer is excellent (ICC ≥ 0.98), and the inter-rater reliability is (ICC ≥ 0.94).
The Minimal Detectable Change (MDC ≤ 5.23% (≈ 2-3°) is considered a true change in ROM
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Upto 4 weeks
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Neck Disability Index (NDI) for disability
Časové okno: Upto 4 weeks
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The NDI questionnaire consists of 10 items designed to measure neck-specific disability.
Out of 10 items, 7 correlated with daily living activities, 2 with pain, and 1 with concentration.
Each item on the questionnaire ranges from 0 to 5, with higher scores indicating greater disability.
The test-retest reliability of NDI is high (r = 0.89), and the Construct validity is (r ≥ 0.70).
The MCID for NDI is >5 Points, meaning a reduction of 5 or more points is considered clinically meaningful
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Upto 4 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Rahat Afzal, MS-OMPT, Governement Teaching Hospital Shahdara Lahore.
Publikace a užitečné odkazy
Obecné publikace
- Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.
- Wrisley DM, Sparto PJ, Whitney SL, Furman JM. Cervicogenic dizziness: a review of diagnosis and treatment. J Orthop Sports Phys Ther. 2000 Dec;30(12):755-66. doi: 10.2519/jospt.2000.30.12.755.
- Sung YH. Suboccipital Muscles, Forward Head Posture, and Cervicogenic Dizziness. Medicina (Kaunas). 2022 Dec 5;58(12):1791. doi: 10.3390/medicina58121791.
- Luscher M, Theilgaard S, Edholm B. Prevalence and characteristics of diagnostic groups amongst 1034 patients seen in ENT practices for dizziness. J Laryngol Otol. 2014 Feb;128(2):128-33. doi: 10.1017/S0022215114000188. Epub 2014 Feb 13.
- Vural M, Karan A, Albayrak Gezer I, Caliskan A, Atar S, Yildiz Aydin F, Coskun Benlidayi I, Goksen A, Koldas Dogan S, Karacan G, Erdem R, Eda Kurt E, Kesiktas FN, Aydin T, Sahin N, Aydin Z, Ordahan B, Turkoglu G, Resorlu H, Doner D, Yilmaz F, Bertan H, Dulgeroglu D, Karaahmet OZ, Sonel Tur B, Moustafa E, Borman P, Iskender O, Ay S, Kurtaran A, Sirzai H, Evcik D, Capan N, Erhan B, Alptekin HK, Ural HI. Prevalence, etiology, and biopsychosocial risk factors of cervicogenic dizziness in patients with neck pain: A multi-center, cross-sectional study. Turk J Phys Med Rehabil. 2021 Dec 1;67(4):399-408. doi: 10.5606/tftrd.2021.7983. eCollection 2021 Dec.
- Bayraklı BB, Kuzu Ö, ÇElİK C. A Rare Cause of Vertigo: Cervicogenic Dizziness. Fiziksel Tıp ve Rehabilitasyon Bilimleri Dergisi. 2025;28:90-2.
- Moen U, Knapstad MK, Wilhelmsen KT, Goplen FK, Nordahl SHG, Berge JE, Natvig B, Meldrum D, Magnussen LH. Musculoskeletal pain patterns and association between dizziness symptoms and pain in patients with long term dizziness - a cross-sectional study. BMC Musculoskelet Disord. 2023 Mar 8;24(1):173. doi: 10.1186/s12891-023-06279-z.
- Takahashi S. Importance of cervicogenic general dizziness. J Rural Med. 2018 May;13(1):48-56. doi: 10.2185/jrm.2958. Epub 2018 May 29.
- Sung Y-H. Classification of cervicogenic dizziness. Hearing, Balance and Communication. 2023;21(1):10-5.
- Moon KM, Kim J, Seong Y, Suh BC, Kang K, Choe HK, Kim K. Proprioception, the regulator of motor function. BMB Rep. 2021 Aug;54(8):393-402. doi: 10.5483/BMBRep.2021.54.8.052.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- REC/RCR&AHS/25/0122 Aqsa
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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