- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07593235
Comparative Effects of Suboccipital Muscle Inhibition vs Instrument Assisted Soft Tissue Mobilization in Forward Head Posture
Přehled studie
Postavení
Detailní popis
Participants in this study will be randomly divided into two groups: Group A, which will undergo conventional physical therapy (hot pack, stretching, and strengthening), combined with suboccipital muscle inhibition (SMI), and Group B, which will receive conventional physical therapy (hot pack, stretching, and strengthening), along with instrument-assisted soft tissue mobilization (IASTM). Both groups will receive a total of 18 treatment sessions over a duration of 6 weeks, scheduled on alternate days (three sessions per week).
Each session will begin with application of a hot pack to the posterior cervical area (upper cervical spine) for 10 minutes while the patient lies in a relaxed prone position.
Following thermotherapy, Group A will undergo sub occipital muscle inhibition. The subjects will be placed in the supine position, with their eyes closed; the evaluator will sit at the head of an adjustable table and placed both palms under the subjects' head, contacting the evaluator's index, middle, and ring fingertips of both hands with the metacarpophalangeal joints in 90◦ flexion between the spinous process of the second cervical vertebra and the occipital condyles. Thereafter, painless and constant pressure will be exerted upward and toward the evaluator the pressure will be maintained for 2 minutes until tissue relaxation of the suboccipital region has been achieved. During the SMI technique, the subjects will be asked to keep their eyes closed to avoid eye movements that might change the suboccipital muscle tone Group B will undergo IASTM. Firstly explain the procedure, Position the patient comfortably to expose the target area. Apply emollient (e.g., massage cream or lubricant) to reduce friction. The technique will be delivered in unidirectional for 3- 5 minutes per muscle group, with controlled pressure and specific strokes (e.g., sweeping, fanning, strumming) adjusted according to patient tolerance (3 sessions/week). A cold pack may be applied to the treated area afterward to manage any potential soreness, minor inflammation, or bruising.
Then a structured stretching protocol will be implemented to address tight musculature commonly associated with Forward Head Posture (FHP). The targeted muscles include the pectoralis major, levator scapulae, sternocleidomastoid, and upper trapezius.
• Pectoralis major: Stand in open type doorway or a wall corner. Raise each arm to the sideways bent to 900, palm forward Rest the palm on wall. By slowly stepping forward using one foot, feel for stretch in chest and shoulder. Hold the position and step back and then relax. (27)
• Levator Scapulae: It is begun by sitting upright in chair, while rotating head to opposite side of that of anchored arm, chin tuck is to be performed toward the chest. With one hand grasping the back of head, gently pull downward until stretch is felt and hold.
- Sternocleidomastoid Patients will sit or stand tall with relaxed shoulders, gently tilt the head toward the opposite side (e.g., right ear to right shoulder), then slightly turn the chin upward and to the left, hold the position before repeating on the opposite side.
- Upper trapezius It involves sitting with the ipsilateral hand behind the back to stabilize the scapula, while the therapist applies a combination of cervical flexion, rotation to the tight side, and side-bending away from the tight side.
After stretching, a series of strengthening exercises will be conducted for muscles commonly weak in individuals with FHP, including the deep neck flexors, rhomboids, and serratus anterior.
- Deep neck flexors (chin tucks) Patients will perform chin tucks while standing with their back against a wall and feet slightly in front, nodding the head to slide the base of the skull toward the wall. Each repetition will be held for 5 seconds, repeated 10 times.
- Rhomboids (prone lateral raises) It will be done when the patient lies flat on the stomach, holding weights with arms extended and palms facing inward. The arms are lifted to the sides until parallel to the floor while squeezing the shoulder blades together, then slowly lowered.
- Serratus anterior (wall slide push-ups) The patient will stand with forearms against a wall and slides the arms upward while pushing the shoulder blades forward, simulating a push-up against the wall.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Iqra Shafiq, DPT
- Telefonní číslo: 03115055398
- E-mail: iqrashafiq944@gmail.com
Studijní záloha kontaktů
- Jméno: Hafiz Ali Bin Asim, MS-SPT
- Telefonní číslo: 03135088144
- E-mail: pt.ali.asim@gmail.com
Studijní místa
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-
Punjab Province
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Islamabad, Punjab Province, Pákistán, 44000
- Nábor
- Foundation University College of Physical Therapy
-
Kontakt:
- Iqra Shafiq, DPT
- Telefonní číslo: 03115055398
- E-mail: iqrashafiq944@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Both genders
- Age: 18-40 years
- Increased upper thoracic spine kyphosis
- Craniovertebral angle CVA of < 52°
Exclusion Criteria:
- Cervical radiculopathy
- Neurological deficit
- Previous surgery of cervical or thoracic spine
- Spondylolisthesis
- Spinal stenosis
- Rheumatoid arthritis
- Vertebrobasilar artery insufficiency
- Congenital deformities like kyphosis, scoliosis.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Group A: suboccipital muscle inhibition
Group A will receive total 18 sessions in 6 weeks (3 sessions per week on alternate days).
Each session will begin with application of a hot pack to the posterior cervical area (upper cervical spine) for 10 minutes while the patient lies in a relaxed prone position.Following thermotherapy, Group A will undergo sub occipital muscle inhibition.
The subjects will be placed in the supine position, with their eyes closed; the evaluator will sit at the head of an adjustable table and placed both palms under the subjects' head, contacting the evaluator's index, middle, and ring fingertips of both hands with the metacarpophalangeal joints in 90◦ flexion between the spinous process of the second cervical vertebra and the occipital condyles.
Thereafter, painless and constant pressure will be exerted upward and toward the evaluator the pressure will be maintained for 2 minutes until tissue relaxation of the suboccipital region has been achieved.
|
Group A will receive total 18 sessions in 6 weeks (3 sessions per week on alternate days).
Each session will begin with application of a hot pack to the posterior cervical area (upper cervical spine) for 10 minutes while the patient lies in a relaxed prone position.Following thermotherapy, Group A will undergo sub occipital muscle inhibition.
The subjects will be placed in the supine position, with their eyes closed; the evaluator will sit at the head of an adjustable table and placed both palms under the subjects' head, contacting the evaluator's index, middle, and ring fingertips of both hands with the metacarpophalangeal joints in 90◦ flexion between the spinous process of the second cervical vertebra and the occipital condyles.
Thereafter, painless and constant pressure will be exerted upward and toward the evaluator the pressure will be maintained for 2 minutes until tissue relaxation of the suboccipital region has been achieved.
|
|
Experimentální: Group B: Instrument assisted soft tissue mobilization
Group B will receive total 18 sessions in 6 weeks (3 sessions per week on alternate days).
Each session will begin with application of a hot pack to the posterior cervical area (upper cervical spine) for 10 minutes while the patient lies in a relaxed prone position.
Following thermotherapy, Group B will undergo IASTM.
Firstly explain the procedure, Position the patient comfortably to expose the target area.
Apply emollient (e.g., massage cream or lubricant) to reduce friction.
The technique will be delivered in unidirectional for 3- 5 minutes per muscle group, with controlled pressure and specific strokes (e.g., sweeping, fanning, strumming) adjusted according to patient tolerance (3 sessions/week).Then a structured stretching protocol will be implemented to address tight musculature in Forward Head Posture (FHP).
The targeted muscles include the pectoralis major, levator scapulae, sternocleidomastoid, and upper trapezius.
|
Group B will receive total 18 sessions in 6 weeks (3 sessions per week on alternate days).
Each session will begin with application of a hot pack to the posterior cervical area (upper cervical spine) for 10 minutes while the patient lies in a relaxed prone position.
Following thermotherapy, Group B will undergo IASTM.
Firstly explain the procedure, Position the patient comfortably to expose the target area.
Apply emollient (e.g., massage cream or lubricant) to reduce friction.
The technique will be delivered in unidirectional for 3- 5 minutes per muscle group, with controlled pressure and specific strokes (e.g., sweeping, fanning, strumming) adjusted according to patient tolerance (3 sessions/week).Then a structured stretching protocol will be implemented to address tight musculature in Forward Head Posture (FHP).
The targeted muscles include the pectoralis major, levator scapulae, sternocleidomastoid, and upper trapezius.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pain Intensity
Časové okno: baseline and post-intervention (week 6)
|
It will be measured by numeric pain rating scale in which patients rate their pain from 0 (no pain) to 10 (worst pain imaginable).
|
baseline and post-intervention (week 6)
|
|
Neck Disability Index (NDI)
Časové okno: baseline and post-intervention (week 6)
|
The Neck Disability Index (NDI) is a ten-item questionnaire based on the Owestry Low Back Pain Index that assesses disability associated with neck pain and whiplash.
Participant will select from one of six potential responses for each item ranging from no disability (0) to total disability (5).
The ten items are summed to gain the total score thus ranging from 0 (no disability) to 50 (maximum disability).
|
baseline and post-intervention (week 6)
|
|
DEEP NECK FLEXORS ENDURANCE TEST
Časové okno: baseline and post-intervention (week 6)
|
The test is performed in the supine and crook lying position with the chin maximally tucked and maintained isometrically, the subject lifted the head and neck until the head will be approximately 2.5 cm off the plinth while maintaining the chin retracted to the chest.
During the test verbal commands such as "tuck your chin in" or "hold your head up" will be given whenever there is a loss of chin tuck.
The test will be stopped if the subject's head touched the investigator's hand for more than one second, if the skin folds began to separate due to a loss of chin tuck for the same amount of time, or if the subject wanted to stop because of fatigue or pain.
The test will also be stopped if the subject lost more than 5° for over two seconds and in the end time will be measured in seconds by the therapist.
|
baseline and post-intervention (week 6)
|
|
CRANIOVERTEBRAL ANGLE
Časové okno: baseline and post-intervention (week 6)
|
Goniometer is used to measure craniovertebral angle (CVA) and subsequently forward head posture (FHP).
The CVA will be assessed in a relaxed sitting position on a high back chair with both feet on the floor and a position with the hips and knees maintained at 90◦.
The subjects' hands should be relaxed on the thighs, with the eyes looking forward in a horizontal eye level.
The CVA can be defined as the angle made by a horizontal line passing through C7 vertebra the line connecting the tragus of the ear.
Greater measure of CVA is indicative of an ideal alignment whereas a smaller value indicates forward head posture.
For this study we will place the immovable arm of the goniometer at the C7 spinous process and the movable arm at the tragus of the ear making an angle between the two lines, normal of which is 52◦ and angle less than that is considered as abnormal.
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baseline and post-intervention (week 6)
|
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Cervical Range of Motion
Časové okno: baseline, and post-intervention (week 6)
|
Goniometer is used to measure cervical range of motion that is available across a joint.
|
baseline, and post-intervention (week 6)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Iqra Shafiq, DPT, Foundation University Islamabad
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
Další identifikační čísla studie
- FUI/FUCP/CTR/09.26/Iqra Shafiq
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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