Workplace Exercise Therapy With or Without Manual Therapy in Chronic Spinal Pain

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral Exercise therapy
  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.
• Procedure Manual Therapy
  Manual therapy maneuvers twice per week for 8 weeks
• Procedure Sham Manual Therapy
  Simulated manual therapy maneuvers twice per week for 8 weeks

Primary outcome measures

• Work productivity and pain-related activity impairment (WPAI: Pain) [Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment]
• Pain intensity (Numeric Rating Scale) [Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment]
• Patient Global Impression of Change (PGIC) [Time frame: At 8 weeks (end of treatment), 3 months, and 6 months post-treatment]
• Neck Disability Index (NDI) [Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment]
• Oswestry Disability Index (ODI) [Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment]
• Adverse events [Time frame: During the 8 weeks of interventions.]

Secondary outcome measures (4)

• Anxiety (GAD-7) [Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment]
• Severity of depressive symptoms (PHQ-9) [Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment]
• Muscle Properties of Upper Trapezius (Myoton) [Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment]
• Muscle Properties of Lumbar zone (Myoton) [Time frame: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment]

Eligibility criteria

Inclusion criteria

• Administrative professionals engaged in sedentary desk-based work utilizing visual display terminals (VDTs) for data processing and information management from the UCAM University
• Chronic nonspecific spinal pain defined as pain (≥4/10 on a numeric rating scale) persisting for at least the past 3 months and/or present on ≥50% of days during the previous 6 months
• The anatomical region of pain is defined from the occipital area to the gluteal folds

Exclusion criteria

• Participants with diagnosed conditions causing back pain, such as ankylosing spondylitis, infections, or other specific causes, including vertebral fractures
• Participants currently receiving any rehabilitative or pharmacological treatment for back pain during the 3 weeks prior to study enrollment
• Participants diagnosed with medical conditions that would prevent them from safely performing therapeutic exercise without medical supervision
• Participants who answer "Yes" to one or more questions on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+), indicating potential contraindications to physical activity, unless cleared by a healthcare provider

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Catholic University of Murcia — Murcia

Identifiers

NCT: NCT07251959 · CE042403

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗