- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04789265
Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain
Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain: a Randomized Controlled Trial
In this study, it was planned to investigate the effectiveness of instrument-assisted soft tissue mobilisation (IASTM) in patients with chronic neck pain. Forty eight individuals with chronic neck pain between the ages of 18-70 were included in the study. Individuals were randomly divided into two groups as Combined Therapy (CT) (n = 24) and Exercise Therapy (ET) (n = 24) groups. All exercises were applied to the participants for 4 weeks, 3 times a week, by an experienced physiotherapist for 5 years under supervision. ET which included stretching and strengthening exercises involving the neck, shoulder and around the scapula muscles applied according to the tolerance of the individuals and targeted to be most beneficial in daily life activities.
CT in addition to the ET applied 3 times a week for 4 weeks, the participants received a total of 8 sessions of IASTM on the days they came to the treatment twice a week, before the ET. As soon as the participants came to the session, IASTM was applied first. Following the IASTM application, ET was applied in the same protocol and under the same therapist supervise with the ET group.
Before and after treatment, deep neck flexor muscle endurance (DNFME), pain severity with Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI), functional status with Neck Disability Index (NDI), quality of life with Nottingham Health Profile (NHP) treatment and treatment satisfaction was evaluated.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Beykoz
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Istanbul, Beykoz, Truthahn, 5557694774
- Aysegul Bostan
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Istanbul, Beykoz, Truthahn
- Aysegul Bostan
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria, Exclusion Criteria:
Individuals aged 18-70 years with neck pain due to a nonspecific disorder for at least 3 months were included.
Individuals with history of cancer (within the last five years), pregnancy, serious skin disorders, previous neck surgery, disc prolapse, spondylolisthesis, vertebral fractures, spinal stenosis, arthritis, osteoporosis, recent neck trauma (within the last 48 hours), severe night pain, symptoms of infection, psychological disorder, and those who received therapy for neck pain in the last 6 months were not included.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Combined Therapy (Instrumented Soft Tissue Mobilization)
|
IASTM is a new, non-invasive, conservative therapeutic approach.
Instead of the therapist's hands and fingers in treatment, these devices are used to provide contact mobilization power.
AYDM intervention, such as friction, rubbing massage treatments, requires the therapist to apply a significant amount of pressure.
The main purpose of IASTM is to eliminate scar tissue and to restore the normal function of the tissue following soft tissue regeneration.
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Kein Eingriff: Control Group (Exercise Therapy)
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Neck Flexor Muscle Endurance
Zeitfenster: baseline to 4 weeks after
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Neck flexor endurance of the participants were evaluated with a stopwatch for holding their neck in lying position.
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baseline to 4 weeks after
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Nottingham Health Profile
Zeitfenster: baseline to 4 weeks after
|
NSP is a general health status questionnaire that measures the physical, emotional and social conditions of individuals.
The questionnaire consists of 38 items and 6 sub-sections: physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items).
consists of.
Each item is answered as "yes" or "no".
The score that can be obtained from each section varies between 0 and 100.
|
baseline to 4 weeks after
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Neck Disability İndex
Zeitfenster: baseline to 4 weeks after
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The index, which evaluates subjective symptoms and activities of daily living, consists of 10 parts (pain intensity, personal care, lifting, reading, headache, concentration, work life, driving, sleep and leisure activities).
There are 6 options ranging from 0 to 5 points for each section.
The total score ranges from 0 to 50 (0: no apology; 50: maximum disability), with a higher total score indicating an increased disability.
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baseline to 4 weeks after
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Visual Analog Scale
Zeitfenster: baseline to 4 weeks after
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This scale consists of a 10 cm linear line.
The starting point of the line is 0, no pain; the last point, 10, the most severe pain encountered in life; 5 means a moderate pain.
The subjects were asked to rate the severity of their pain numerically on the scale.
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baseline to 4 weeks after
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 10376522
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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