Catholic University of Murcia
Murcia, 30107, Spain
NCT Number: NCT07251959
Implementing workplace strategies to manage symptoms in office workers with chronic nonspecific spinal pain (CNSP) may improve both health- and work-related outcomes, as adherence to these interventions is more feasible in this context. Exercise therapy is considered the first-line treatment for CNSP; however, the added value of combining exercise therapy with manual therapy remains inconclusive. This study aims to examine the effects of short sessions of exercise therapy plus manual therapy, compared with exercise therapy plus sham manual therapy, delivered in the workplace, on health- and work-related outcomes in office workers with CNSP.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Murcia, 30107, Spain
Objectives: To evaluate the effects of short sessions of exercise therapy plus manual therapy compared with exercise therapy plus sham manual therapy at work on self-perceived productivity, disability, global impression of change, pain intensity, depression, anxiety, and muscle tone.
Methods: A randomized controlled trial will be conducted. The study protocol was approved by the Research Ethics Committee of Catholic University of Murcia (UCAM) (CE042403). Eligible participants will be office workers from the UCAM University with nonspecific spinal pain. Participants will be randomized into two groups. The experimental group will receive exercise therapy plus manual therapy, while the control group will receive exercise therapy plus sham manual therapy. Both groups will complete two 15-minute sessions of exercise therapy per week for 8 weeks. In addition, the experimental group will receive two 15-minute sessions of manual therapy per week, while the control group will receive sham manual therapy during the same period.
Outcomes: The primary outcomes will be self-perceived productivity, disability, patient global impression of change, and pain intensity. Secondary outcomes will include depression, anxiety, and muscle tone. Assessments will be conducted at baseline, post-intervention, and at 3- and 6-month follow-ups. Any possible adverse events will be registered during the 8-weeks of interventions.
Sample Size Estimation: Sample size was calculated using G*Power 3.1. To detect differences between groups over time, a small effect size (f = 0.17) was assumed, with 80% power and a 5% alpha level, indicating a minimum of 50 participants. Allowing for a 20% dropout rate, the target sample size was set at 60 participants (30 per group).
Statistical Analysis: A repeated-measures ANOVA (time × group) will be used. Mauchly's test will assess sphericity; if violated, the Greenhouse-Geisser correction will be applied. Post-hoc pairwise comparisons will be adjusted using Bonferroni correction. Effect sizes will be reported as partial eta-squared, and Cohen's d will be used for post-hoc comparisons. A chi-square test will assess the effectiveness of blinding by evaluating participants' perceptions of the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exercises will target the neck, upper and lower back, and upper and lower limbs, and will include military press, lateral raises, front raises, trapezius raises, rear deltoid exercise, low- and high-row exercises, good mornings with extended arms, deadlifts, squats, lunges, biceps curls, chest press, and calf raises. The protocol will be performed twice a week for 8 weeks.
Manual therapy maneuvers twice per week for 8 weeks
Simulated manual therapy maneuvers twice per week for 8 weeks
Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
WPAI: Pain is a self-reported instrument which assess impact of pain on work productivity and daily activities, including absenteeism, work-impairment, presenteeism, and activity-impairment
Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
The Numeric Rating Scale (NRS) measures pain intensity on a scale from 0 (no pain) to 10 (worst possible pain), allowing self-reported assessment of pain intensity over the past week.
Time frame: At 8 weeks (end of treatment), 3 months, and 6 months post-treatment
The Patient Global Impression of Change (PGIC) assesses a patient's overall perception of improvement or change in their condition since the start of treatment, using a standardized 7-point scale from 'very much improved' to 'very much worse.'
Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
Neck Disability Index (NDI) measures self-reported neck pain-related disability, including impact on daily activities, work, and function; higher scores indicate greater disability. Administered only to participants reporting neck pain
Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
The Oswestry Disability Index (ODI) measures self-reported disability related to low back pain, evaluating the impact on daily activities, work, and functional limitations, with higher scores indicating greater disability. Administered only to participants reporting low back pain
Time frame: During the 8 weeks of interventions.
Adverse events will be defined as any undesirable or harmful outcomes occurring during or after the intervention. At each exercise or manual therapy session, participants will be asked whether they have experienced any exacerbation of symptoms, including but not limited to pain, unusual fatigue, edema, tendinopathy, excessive delayed-onset muscle soreness (≥7/10), bursitis, or any other symptoms that limit or interfere with daily activities.
Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
The GAD-7 questionnaire assesses the severity of generalized anxiety symptoms over the past two weeks, with higher scores indicating greater anxiety levels
Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
The PHQ-9 questionnaire assesses the severity of depressive symptoms over the past two weeks, with higher scores indicating greater depression levels
Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
Myoton device measures mechanical properties of skeletal muscle. Upper trapezius tone will be measured at the midpoint between the C7 spinous process and the posterior acromion border on both sides. The three firing mode will be used.
Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
Myoton device measures mechanical properties of lumbar muscles. Tone will be measured 2.5 cm lateral to the L4-L5 space using the three-firing mode on both sides.
Time frame: At 8 weeks (end of treatment), 3 months, and 6 months post-treatment
The success of participant blinding will be evaluated by asking participants whether they believe they received the experimental intervention and how confident they are in their response (0-10 numerical rating scale).
Catholic University of Murcia
Other
Impact of Short Sessions of Exercise Therapy Plus Manual Therapy at Work on Health- and Work-related Outcomes in Office Workers With Chronic Nonspecific Spinal Pain
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