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

NCT07251959 | Enrolling By Invitation

• 1 other identifier: CE042403
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Back Pain; Neck Pain; Low Back Pain

Keywords

Chronic nonspecific spinal pain; Exercise therapy; Sham-therapy; Massage

Outcome Measures

Primary Outcomes (6)

• Work productivity and pain-related activity impairment (WPAI: Pain)

  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

  At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment

• Pain intensity (Numeric Rating Scale)

  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.

  At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment

• Patient Global Impression of Change (PGIC)

  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.'

  At 8 weeks (end of treatment), 3 months, and 6 months post-treatment

• Neck Disability Index (NDI)

  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

  At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment

• Oswestry Disability Index (ODI)

  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

  At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment

• Adverse events

  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.

  During the 8 weeks of interventions.

Secondary Outcomes (4)

• Anxiety (GAD-7)

  At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment

• Severity of depressive symptoms (PHQ-9)

  At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment

• Muscle Properties of Upper Trapezius (Myoton)

  At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment

• Muscle Properties of Lumbar zone (Myoton)

  At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment

Other Outcomes (1)

• Adequate participant blinding

  At 8 weeks (end of treatment), 3 months, and 6 months post-treatment

Study Arms (2)

Exercise therapy plus manual therapy

EXPERIMENTAL

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.

Behavioral: Exercise therapy; Procedure: Manual Therapy

Exercise therapy plus sham manual therapy

SHAM COMPARATOR

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.

Behavioral: Exercise therapy; Procedure: Sham Manual Therapy

Interventions

Exercise therapy BEHAVIORAL

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.

Exercise therapy plus manual therapy; Exercise therapy plus sham manual therapy

Manual Therapy PROCEDURE

Manual therapy maneuvers twice per week for 8 weeks

Exercise therapy plus manual therapy

Sham Manual Therapy PROCEDURE

Simulated manual therapy maneuvers twice per week for 8 weeks

Exercise therapy plus sham manual therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Back Pain; Neck Pain; Low Back Pain

Interventions

Exercise Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Complementary Therapies

Study Officials

• Martha C León-Garzón, PhD

  Catholic University of Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded. Both groups will receive the same exercise sessions, delivered in small groups of up to 8 individuals that include participants from both study arms. In addition, both groups will receive a manual intervention, consisting of either manual therapy or sham manual therapy. The success of blinding will be evaluated after the intervention period by asking participants whether they believe they received the experimental intervention and how confident they are in their response (0-10 numerical rating scale). Because most outcomes are self-reported, effective participant blinding will also ensure blinding of outcome assessment. For muscle tone assessment, independent assessors not involved in the study will perform the measurements. Data analysts will be blinded to group allocation. Only the therapists delivering the manual therapy interventions will be aware of group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

ES (1)