Chronic Neck Pain
Conditions
Keywords
office workers, supervised exercise, neck pain, stress, mindfulness
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
Interventions
BEHAVIORALMindfulness
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.
OTHERsupervised exercise
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.
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
two-arm parallel-group clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck pain using the VAS | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality using the Pittsburgh Sleep Quality Index (PSQI) | 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. |
| Health-related quality of life using the SF-12 | 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. |
| Neck Disability Index (NDI) | 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. |
| Fear of movement using the Tampa Scale for Kinesiophobia | 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. |
| Pain catastrophizing | 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. |
| Anxiety and depression symptoms using the Hospital Anxiety and Depression Scale (HADs) | 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. |
| Perceived stress | 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. |
Contacts
CONTACTAmr Chaabeni, MD
Outcome results
None listed