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Mindfulness Plus Supervised Rehabilitation vs Supervised Rehabilitation Alone for Chronic Neck Pain in Office Workers

2. Mai 2026 aktualisiert von: Anis Jellad, University of Monastir

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

Studienübersicht

Status

Noch keine Rekrutierung

Studientyp

Interventionell

Einschreibung (Geschätzt)

48

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
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.
Andere Namen:
  • Kognitive Verhaltenstherapie
  • Verhaltenstherapie

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.

Andere Namen:
  • Rehabilitation
Aktiver 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.

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.

Andere Namen:
  • Rehabilitation

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Neck pain using the VAS
Zeitfenster: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Neck Disability Index (NDI)
Zeitfenster: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Fear of movement using the Tampa Scale for Kinesiophobia
Zeitfenster: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Pain catastrophizing
Zeitfenster: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Perceived stress
Zeitfenster: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADs)
Zeitfenster: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
Zeitfenster: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention
Health-related quality of life using the SF-12
Zeitfenster: at participant enrollment (baseline) and ending immediately after the 8-week intervention
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.
at participant enrollment (baseline) and ending immediately after the 8-week intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Mai 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

2. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Mai 2026

Zuerst gepostet (Tatsächlich)

8. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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