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

2. maj 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andre navne:
  • Kognitiv adfærdsterapi
  • Adfærdsterapi

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.

Andre navne:
  • genoptræning
Aktiv 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.

Andre navne:
  • genoptræning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neck pain using the VAS
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neck Disability Index (NDI)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

2. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. maj 2026

Sidst verificeret

1. maj 2026

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