- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07576556
Mindfulness Plus Supervised Rehabilitation vs Supervised Rehabilitation Alone for Chronic Neck Pain in Office Workers
Effect of Mindfulness Combined With Supervised Rehabilitation Versus Supervised Rehabilitation Alone in Office Workers With Chronic Neck Pain: Protocol for a Randomized Controlled Trial
The goal of this clinical trial is to learn if adding mindfulness to supervised rehabilitation exercises improves outcomes in office workers with chronic neck pain. It will also evaluate the impact of this combined approach on psychosocial factors and quality of life. The main questions it aims to answer are:
Does mindfulness combined with supervised exercises reduce neck pain intensity more than supervised exercises alone? Does the combined intervention improve neck-related disability, psychosocial outcomes, and quality of life?
Researchers will compare a mindfulness-based intervention plus supervised rehabilitation exercises to supervised rehabilitation exercises alone to determine whether the combined approach provides additional benefit.
Participants will:
Be randomly assigned to receive either mindfulness plus supervised exercises or supervised exercises alone for 8 weeks Attend weekly 60-minute mindfulness sessions (experimental group only) and twice-weekly supervised exercise sessions Undergo assessments at the beginning and at the end of the intervention period
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Amr Chaabeni, MD
- Numer telefonu: +21626729316
- E-mail: amrch97@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Office workers aged 18 years or older
- diagnosed with chronic neck pain for more the three months
Exclusion Criteria:
- history of neck surgery
- history of cervical trauma
- history of neurological disorders affecting the neck or upper extremities
- currently receiving other treatments for neck pain, such as injections or surgical interventions
- Participants with significant psychiatric disorders that could interfere with study participation or adherence to the intervention
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Mindfulness arm
Participants in the intervention group will follow an 8-week supervised program combining mindfulness training and therapeutic exercise.
The intervention includes one weekly 60-minute mindfulness session and two supervised exercise sessions (each lasting 30 minutes), delivered by a trained professional according to a standardized protocol.
Mindfulness sessions will be conducted in small groups and incorporate structured practices including mindful breathing, body scanning, guided imagery, and relaxation techniques.
Mindful breathing focuses on sustained, non-judgmental attention to the breath to enhance present-moment awareness and modulate pain perception.
Body scanning involves systematic attention to body regions to increase awareness of sensations and tension.
Guided imagery and relaxation techniques (e.g., progressive muscle relaxation, meditation) aim to promote relaxation and reduce pain-related distress
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Mindfulness training incorporates structured practices such as mindful breathing, body scanning, guided imagery, and relaxation techniques.
Mindful breathing focuses on sustained, non-judgmental attention to the breath to enhance present-moment awareness and modulate pain perception.
Body scanning involves systematic attention to body regions to increase awareness of physical sensations and tension.
Guided imagery and relaxation techniques, including progressive muscle relaxation and meditation, aim to promote relaxation and reduce pain-related distress.
Inne nazwy:
The program will focus on standardized stretching, strengthening, and postural exercises commonly prescribed in routine musculoskeletal rehabilitation. Stretching exercises will target the cervical region and will include neck flexion, extension, and lateral flexion stretches, each performed in a seated upright position, held for 30 seconds, and repeated three times per direction. Strengthening exercises will emphasize cervical muscle activation and endurance and will include neck retraction exercises (chin pull-back) and isometric neck strengthening performed against manual resistance in flexion, extension, and lateral directions, with standardized hold times and repetitions. Postural exercises will focus on cervical and scapular alignment and will include chin tucks and shoulder blade squeezes, performed with controlled holds and repeated sets.
Inne nazwy:
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Aktywny komparator: Control arm
Participants in the control group will follow an 8-week supervised conventional exercise program consisting of two sessions per week, each lasting 30 minutes, delivered according to a standardized protocol.
The program includes stretching, strengthening, and postural exercises commonly used in musculoskeletal rehabilitation.
Stretching targets the cervical region (flexion, extension, lateral flexion), with each stretch held for 30 seconds and repeated three times.
Strengthening focuses on cervical muscle activation and endurance through neck retraction and isometric exercises against manual resistance in multiple directions.
Postural exercises emphasize cervical and scapular alignment, including chin tucks and scapular retraction performed with controlled holds.
All sessions are supervised, and participants continue their usual occupational activities.
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The program will focus on standardized stretching, strengthening, and postural exercises commonly prescribed in routine musculoskeletal rehabilitation. Stretching exercises will target the cervical region and will include neck flexion, extension, and lateral flexion stretches, each performed in a seated upright position, held for 30 seconds, and repeated three times per direction. Strengthening exercises will emphasize cervical muscle activation and endurance and will include neck retraction exercises (chin pull-back) and isometric neck strengthening performed against manual resistance in flexion, extension, and lateral directions, with standardized hold times and repetitions. Postural exercises will focus on cervical and scapular alignment and will include chin tucks and shoulder blade squeezes, performed with controlled holds and repeated sets.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Neck pain using the VAS
Ramy czasowe: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Neck pain intensity is the primary outcome, assessed using the Visual Analogue Scale (VAS).
Participants rate their pain on a 100-mm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (100), with higher scores indicating greater pain intensity.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Neck Disability Index (NDI)
Ramy czasowe: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The NDI consists of 10 items (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation), each scored from 0 to 5, yielding a total score between 0 and 50.
Higher scores indicate greater disability.
the NDI have a strong internal consistency, high test-retest reliability, and sensitivity to clinical change.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Fear of movement using the Tampa Scale for Kinesiophobia
Ramy czasowe: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The Tampa Scale for Kinesiophobia (TSK) will be employed to evaluate participants' fear of movement and re-injury.
The scale consists of 17 items, each rated from 1 to 4, with higher scores indicating greater kinesiophobia.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Pain catastrophizing
Ramy czasowe: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Catastrophic thinking will be assessed with the Pain Catastrophizing Scale (PCS).
This instrument evaluates the extent to which individuals engage in catastrophic thoughts related to their pain.
it consists of 13 items, each ranging from 0 (not at all) to 4 (all the time).
Higher scores indicate greater levels of catastrophizing.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Perceived stress
Ramy czasowe: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The Perceived Stress Scale (PSS) evaluates the perception of stress in individuals and is essential for understanding how mindfulness interventions may reduce stress levels among participants.
the PSS measures perceived stress over the past month.
it includes 10 items each rated from 0 (never) to 4 (very often).
Higher scores indicate greater perceived stress.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADs)
Ramy czasowe: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The HADS is a validated instrument widely used in both hospital and general populations to evaluate psychological distress, which is particularly relevant in the context of chronic pain.
It consists of 14 items divided into two subscales, anxiety and depression, with 7 items each from 0 to 3. higher subscale scores reflect more severe symptoms of anxiety or depression.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Ramy czasowe: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The PSQI is a validated self-report instrument that evaluates sleep quality and disturbances over the past month.
It comprises 19 items with a score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Health-related quality of life using the SF-12
Ramy czasowe: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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The SF-12 evaluates overall well-being by capturing both physical and mental health dimensions.
It provides two standardized summary scores: the Physical Component Score (PCS) and the Mental Component Score (MCS), each range from 0 to 100, with higher scores indicating better health status.
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at participant enrollment (baseline) and ending immediately after the 8-week intervention
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Współpracownicy i badacze
Sponsor
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
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Ból
- Objawy neurologiczne
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Ból szyi
- Lecznictwo
- Opieka nad pacjentem
- Usługi zdrowotne
- Zakłady opieki zdrowotnej i usługi
- Psychoterapia
- Dyscypliny i działania behawioralne
- Opieka postpenitencjarna
- Ciągłość opieki nad pacjentem
- Terapia behawioralna poznawcza
- Rehabilitacja
- Uważność
- Terapia behawioralna
Inne numery identyfikacyjne badania
- MINDEX-NECK-RCT-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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