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

Catholic University of Murcia

Status: Invitation-only

Conditions: Back Pain; Neck Pain; Low Back Pain

Treatments: Procedure: Manual Therapy; Procedure: Sham Manual Therapy; Behavioral: Exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07251959

CE042403

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Exercise therapy plus manual therapy

Experimental group

Description:

Participants will receive 15-minute exercise therapy sessions twice per week at the workplace, including a 2-minute warm-up, 11-minute main phase, and 2-minute cool-down. The warm-up includes joint mobilization and low-load exercises. The main phase comprises six exercises in supersets, three sets of 10-12 reps with 30-second rests, divided into two blocks and targeting neck, back, and limbs, using body weight and elastic bands, with intensity rated 6-7/10 on the Borg Scale. The cool-down includes breathing and stretching exercises. Participants will also receive 15-minute manual therapy sessions twice per week, including the following myofascial techniques: nuchal ligament technique, transverse and longitudinal sliding of the paravertebral muscles on both sides of the back, and sustained pressure techniques applied to the trapezius and thoracolumbar fascia.

Treatment:

Behavioral: Exercise therapy

Procedure: Manual Therapy

Exercise therapy plus sham manual therapy

Sham Comparator group

Description:

Participants will receive the same exercise therapy protocol as the experimental group. In addition, they will receive 15-minute sham manual therapy sessions twice per week, delivered at the workplace. The sham intervention will mimic the duration, positioning, and therapist contact of the manual therapy procedures but will be applied without therapeutic intent or specific techniques to avoid producing physiological effects.

Treatment:

Procedure: Sham Manual Therapy

Behavioral: Exercise therapy