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

NCT07576556 | Not Yet Recruiting DMC

• 1 other identifier: MINDEX-NECK-RCT-2026
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Neck Pain

Keywords

office workers; supervised exercise; neck pain; stress; mindfulness

Outcome Measures

Primary Outcomes (1)

• Neck pain using the VAS

  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

Secondary Outcomes (7)

• Neck Disability Index (NDI)

  at participant enrollment (baseline) and ending immediately after the 8-week intervention

• Fear of movement using the Tampa Scale for Kinesiophobia

  at participant enrollment (baseline) and ending immediately after the 8-week intervention

• Pain catastrophizing

  at participant enrollment (baseline) and ending immediately after the 8-week intervention

• 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)

  at participant enrollment (baseline) and ending immediately after the 8-week intervention

Study Arms (2)

Mindfulness arm

EXPERIMENTAL

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

Behavioral: Mindfulness; Other: supervised exercise

Control arm

ACTIVE COMPARATOR

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.

Other: supervised exercise

Interventions

Mindfulness BEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy, Behavior Therapy

Mindfulness arm

supervised exercise OTHER

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.

Also known as: rehabilitation

Control arm; Mindfulness arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Office workers aged 18 years or older
• diagnosed with chronic neck pain for more the three months

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

MeSH Terms

Conditions

Neck Pain

Interventions

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Rehabilitation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Amr Chaabeni, MD

CONTACT

+21626729316; amrch97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: two-arm parallel-group clinical trial

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share