- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07624188
Effect of Sensory Motor Training for Neck Muscles on Hand Grip Strength in Post-menopausal Fibromyalgia Neck Pain.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Fibromyalgia is a chronic disease accompanied by widespread body pain, heightened tenderness in specific anatomical regions, fatigue, sleep disorders, and irritable bowel syndrome.
Prevalence of fibromyalgia is approximately 2-4% in the general population. It predominantly affects 80-90% of women and typically peaks between the ages of 50 and 60.
Post-menopausal fibromyalgia may be attributed to hormonal changes, particularly the decline in estrogen, which plays a role in pain modulation, mood regulation and sleep quality. This hormonal shift, combined with age-related changes in the central nervous system, altered cortisol levels, increased prevalence of psychological comorbidities such as anxiety and depression may contribute to the development or worsening of fibromyalgia symptoms in post-menopausal women.
Neck pain affects about 70-90% of fibromyalgia patients. It can lead to muscle tension, nerve compression, and altered neuromuscular control, particularly affecting the cervical spine and upper limb function. These changes may impair motor output and reduce hand grip strength.
Improving hand grip strength can contribute to better quality of life, functional independence, and may reduce reliance on medication.
Sensory motor training is an emerging rehabilitation approach designed to improve the interaction between sensory input and motor output. It enhances proprioception, coordination, and motor control, which are often impaired in patients with fibromyalgia due to central sensitization and neuromuscular dysfunction.
Sensory motor neck training using laser pointer technique enhances cervical proprioception and motor control in patients with neck pain by providing visual feedback to guide accurate head movements.
So, this study will be conducted to provide new evidences and information about the effect of sensory motor training on hand grip strength in post-menopausal fibromyalgia neck pain to manage this problem upon them and add new information to the field of physical therapy.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Esraa Massoud, Master
- Numer telefonu: 01555358802
- E-mail: fikryesraa148@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Afaf Botla, Professor
- Numer telefonu: 01283126608
- E-mail: drafafmohamed@cu.edu.eg
Lokalizacje studiów
-
-
-
Cairo, Egipt
- Esraa Fikry Massoud
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Fifty post-menopausal women clinically diagnosed with fibromyalgia neck pain for more than 3 months.
- Their age will be ranged from 50-60 years old.
- Their body mass index (BMI) will be less than 30 kg/m².
- Their hand grip strength is less than 20 kg for dominant hand as measured by hand-held dynamometer.
- Their neck pain score is ≥ 4 as measured by the visual analogue scale (VAS).
- The right hand is the dominant for all of them.
Exclusion Criteria:
- Participants will be excluded from the study if they have:
- Recent cervical trauma or surgery.
- Neurological disorders.
- Diabetes mellitus.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Neuro dynamic nerve gliding exercises
The participants will receive neuro dynamic nerve gliding exercises in the form of median, radial and ulnar nerve gliding exercises for 50 minutes/session.
|
The participants will receive neuro dynamic nerve gliding exercises in the form of median, radial and ulnar nerve gliding exercises for 50 minutes/session (for 15 repetitions, each repetition held for 1-2 minutes with 30 seconds rest intervals between each repetition)
|
|
Eksperymentalny: Sensory motor neck training and neuro dynamic nerve gliding exercises
The participants will receive sensory motor neck training using laser pointer technique for 15 minutes/session, 3 times/week for four weeks in addition to neuro dynamic nerve gliding exercises in the form of median, radial and ulnar nerve gliding exercises for 50 minutes/session.
|
The participants will receive neuro dynamic nerve gliding exercises in the form of median, radial and ulnar nerve gliding exercises for 50 minutes/session (for 15 repetitions, each repetition held for 1-2 minutes with 30 seconds rest intervals between each repetition)
The participants will perform sensory motor neck training by using laser pointer exercise for 15 minutes/session, 3times/ week for four weeks.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Assessment of hand grip strength
Ramy czasowe: 4 weeks
|
The hand-held dynamometer (Hoggan Health Industries, Salt Lake City, USA) is an enclosed hydraulic system recording the applied strength in kilograms. Hand grip strength will be measured for all participants in both groups before and after the end of the study. Each participant in both groups will be asked to place hand-held dynamometer in her hand, with her arm beside the trunk, the shoulder in a neutral position, the elbow flexed at 90° and to pull the metal bar with her fingers. This procedure will be conducted bilaterally. The mean of three trials for each side (with 3 min resting periods between repetitions to avoid fatigue) will be calculated |
4 weeks
|
|
Assessment of Disability of the Arm, Shoulder and Hand (DASH)
Ramy czasowe: 4 weeks
|
This 30-item tool evaluates symptoms along with physical function, specifically focusing on the level of disability, and offers five response options for each item. Each item offers five response options, spanning from 1, indicating "no difficulty or symptoms present," to 5, indicating "incapable of participating in an activity or experiencing very severe symptoms." Greater score on the DASH indicates increased levels of disability. The DASH score is used to assess upper limb disability, with higher scores indicating greater impairment. A score of 0 reflects no disability, 1-20 indicates mild disability, 21-40 is moderate, 41-60 is severe, and 61-100 represents very severe disability. |
4 weeks
|
|
Assessment of neck pressure pain threshold
Ramy czasowe: 4 weeks
|
The force dial FDK 20 algometer is a handheld device used to assess the pressure pain threshold (PPT), which is the minimum amount of pressure that induces a sensation of pain. It provides an objective measure of mechanical pain sensitivity in neck. Each participant will be asked to assume upright position with feet flat, arms relaxed, and neck in a neutral position. Pressure will be applied perpendicularly to the site of pain at a constant rate of 1 kg/cm² per second. Each participant will be instructed to indicate when the sensation changed from pressure to the first feeling of pain. Three readings will be taken at each site with 30-60 seconds rest between trials, and the average will be recorded as the final PPT value |
4 weeks
|
|
Assessment of pain intensity
Ramy czasowe: 4 weeks
|
The visual analogue scale will be used to assess pain intensity.
It is a subjective method to determine pain intensity.
The scale consists of a 10-centimeter horizontal line, with the left end marked as "no pain" (0) and the right end marked as "worst possible pain" (10).
|
4 weeks
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Azza Nashed, Professor, Cairo University
- Dyrektor Studium: Mohamed Kaddah, Professor, Cairo University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- P.T.REC/012/00643
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .