An interventional study of Mindfulness and supervised exercise in Chronic Neck Pain, sponsored by University of Monastir. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by University of Monastir · Not applicable, Interventional, and Treatment
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
1,360 studies on the registry are indexed under Neck Pain; 299 are open to participants now.
This study's planned enrollment of 48 is close to the median of 50 across 1,116 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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
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
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
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
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.
Time frame: at participant enrollment (baseline) and ending immediately after the 8-week intervention
Neck Disability Index (NDI)
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.
Time frame: at participant enrollment (baseline) and ending immediately after the 8-week intervention
Fear of movement using the Tampa Scale for Kinesiophobia
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.
Time frame: at participant enrollment (baseline) and ending immediately after the 8-week intervention
Pain catastrophizing
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.
Time frame: at participant enrollment (baseline) and ending immediately after the 8-week intervention
Perceived stress
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.
Time frame: at participant enrollment (baseline) and ending immediately after the 8-week intervention
Anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADs)
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.
Time frame: at participant enrollment (baseline) and ending immediately after the 8-week intervention
Sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: at participant enrollment (baseline) and ending immediately after the 8-week intervention
Health-related quality of life using the SF-12
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.
Time frame: at participant enrollment (baseline) and ending immediately after the 8-week intervention
No study locations are listed for this record.
Plan to share: No
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