- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07692126
Core Stability vs Scapular Stabilization on Hand Grip Strength in Chronic Myofascial Neck Pain
Core Stability Exercises Versus Scapular Stabilization Exercises on Hand Grip Strength in Patients With Chronic Myofascial Neck Pain
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Adnan AA Gharib, PHD
- Telefonní číslo: +201065798861
- E-mail: dradnanpts@gmail.com
Studijní záloha kontaktů
- Jméno: Magda Ramadan Zahran, Assistant Professor
- Telefonní číslo: 01065798861
- E-mail: dradnanpts@gmail.com
Studijní místa
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Giza Governorate
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Giza, Giza Governorate, Egypt, 11432
- Nábor
- Cairo University
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Kontakt:
- Magda Ramadan Zahran, Assistant Professor
- Telefonní číslo: 01065798861
- E-mail: dradnanpts@gmail.com
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Kontakt:
- Adnan AA Gharib, PHD
- Telefonní číslo: 01065798861
- E-mail: dradnanpts@gmail.com
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Vrchní vyšetřovatel:
- Adnan AA Gharib, PHD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Patients diagnosed with chronic myofascial neck pain depending on referral, and physical examination.
- Sixty patients diagnosed with chronic myofascial neck pain for more than six months.
- Patients age range will 25-45 years
- Patients body mass index (BMI) will be 18.5-24.9 kg/m2
- Each patient suffering from all active MTrPs in the upper trapezius muscle with painful/ tender nodule.
- Patients have a constant neck pain with positive jump sign when palpating the upper trapezius muscle.
- Patients have referred pain, and symptoms of ipsilateral hand muscle weakness.
- No history of undergoing physiotherapy modalities or corticosteroid injection therapies in the past six months before the study
Exclusion Criteria:
- Presence of signs of severe pathology such as malignancies, mainly of the cervical region.
- Fracture of the cervical spine.
- Cervical radiculopathy or myelopathy.
- Diabetes mellitus.
- Trauma, cognitive anomalies, and surgery around neck, shoulders, or hand.
- Fibromyalgia or vascular syndromes such as vertebral basilar insufficiency.
- Pregnancy.
- Having undergone physical therapy within the past three months before the study.
- Having corticosteroid injection therapies in the past 3 months before the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Experimental Group A (Core Stability)
consists of 20 participants who receive core stability exercises, plus the traditional physical therapy program in the form of ischemic compression of upper trapezius muscle, strain-counter strain of upper trapezius muscle, and muscle energy technique of upper trapezius muscle, three sessions per week for 6 weeks.
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The core stability exercise protocol will be conducted to experimental group (A), only. The core stability exercise protocol will be conducted for 40-45 minutes (10 minutes worm-up 'stretch exercises', 25 minutes core stabilization exercises, and 5-10 minutes cool down exercises 'stretch exercises') 3 sections/ week for six weeks 1. Diaphragm Core '';360 degree expansion breathing, weighted breathing 2. Transverse abdominis 'Abdominal drawing in maneuver, supine vacuum, pelvic tilt'; 3. Multifidus 'quadruped altered leg/arm, bridge with leg extension'; 4. Pelvic Floor muscles/Kegel, bridging, and bridging dog, and squat Core stability exercise.
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Experimentální: Experimental Group B (Scapular Stabilization)
consists of 20 participants who receive scapular stabilization exercise, plus the traditional physical therapy program, three sessions per week for 6 weeks.
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The scapular stabilization exercise protocol will be conducted to experimental group (B), only. The core scapular stabilization exercise protocol will be conducted for 40-45 minutes (10 minutes worm-up 'stretch exercises', 25 minutes scapular stabilization exercises, and 5-10 minutes cool down exercises 'stretch exercises') 3 sections/ week for six weeks a. Open chain stabilization exercises 'scapular elevation/depression, upward/downward rotation', b. Static closed chain stabilization exercises 'Protected weight bearing through both hands leaning against wall', c. Dynamic closed chain stabilization exercises 'scapular retraction' |
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Aktivní komparátor: Control Group C (Traditional Physical Therapy Program)
consists of 20 participants who receive the traditional physical therapy program, three sessions per week for 6 weeks, only
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Hand Grip Strength
Časové okno: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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Hand-held Dynamometer (SAMMONS PRESTON, INC.
Bolingbrook, IL604404989) will be used to measure it.
The patient will sit on a standard height chair with no armrest with his/ her forearm in a neutral position, and shoulder in adducted and neutral rotation, with elbow flexed 90 degrees (°).
The patient will be requested to squeeze the ipsilateral hand on the hand grip dynamometer handle accordingly to the ordered verbs 'i.e., one, two, three, squeeze…harder, harder'.
Three measures will be conducted with one minute a break in between, then the average will be recorded in value score.
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1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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Pinch Grip Strength
Časové okno: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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The pinch gauge (FEI, White plains, NY 10602, USA) will be used to measure the pinch grip strength, it is a valid and reliable tool.
The patient will sit on a standard height chair with no armrest with his/ her shoulder, elbow, forearm, and wrist in a neutral position.
The patient will be requested to squeeze the thumb pad as firm as possible against the lateral aspect of index fingers' middle phalanx, while the examiner will hold the distal end of the pinch gauge.
Three measures will be conducted with one minute a break in between, then the average will be recorded in a score value.
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1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Chronic Myofascial Neck Pain Intensity assessment using Numerical Pain Rating Scale:
Časové okno: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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Numerical Pain Rating Scale will be used to assess chronic myofascial neck pain intensity, The patient will be in a relaxed position then will be given the appendix which contains numerical pain rating scale.
It involves a 0-10 scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable" The patient will be instructed to place a vertical mark on the line to indicate his/her pain.
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1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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Pressure Pain Threshold using electronic pressure algometer
Časové okno: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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The electronic pressure algometer 'force one gauge model FDI' (Wagner instruments, Greenwash, CT, USA) will be used to measure it, it is a valid and reliable tool.
Over trigger point recognized via jump sign clinically, a dial-style pressure algometry will be installed while a steady vertical pressure will be applied.
When the patient reported only mild pain, the patient will be asked to raise hand to indicate it.
Three measures will be conducted with one minute a break in between, then average will be recorded in value.
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1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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Whole Upper Extremity Functional Level using Arabic-Q-DASH scale
Časové okno: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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The whole upper extremity functional level will be evaluated using Arabic-Q-DASH it is a valid and reliable tool.
The Arabic-Q-DASH is like the original questionnaire.
Items have a rating scale ranged from 1 to 5. The patient will be instructed to place a score that the examiner will transform it into a value between 0 and 100.
The high score indicates better hand function outcomes with exception of pain, where high value indicates more intense pain score.
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1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Sohair Shehata Rezkallah, Professor, Cairo University; Faculty of Physical Therapy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
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 identifikační čísla studie
- P.T.REC/012/006550
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