- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07251959
Workplace Exercise Therapy With or Without Manual Therapy in Chronic Spinal Pain
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Murcia, Spain, 30107
- Catholic University of Murcia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise therapy plus manual therapy
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.
|
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
|
|
Sham Comparator: Exercise therapy plus sham manual therapy
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.
|
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.
Simulated manual therapy maneuvers twice per week for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
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.
|
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
|
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)
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
|
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
|
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
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.
|
During the 8 weeks of interventions.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety (GAD-7)
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
|
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
|
The PHQ-9 questionnaire assesses the severity of depressive symptoms over the past two weeks, with higher scores indicating greater depression levels
|
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
|
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.
|
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
|
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.
|
At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adequate participant blinding
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).
|
At 8 weeks (end of treatment), 3 months, and 6 months post-treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martha C León-Garzón, PhD, Catholic University of Murcia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Back Pain
- Low Back Pain
- Neck Pain
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Patient Care
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise Therapy
- Musculoskeletal Manipulations
Other Study ID Numbers
- CE042403
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Back Pain
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Stryker InstrumentsNot yet recruitingBack Pain Lower Back | Verteborgenic Low Back PainUnited States
-
Adia Med of Winter Park LLCRecruitingLower Back Pain | Chronic Lower Back Pain | Chronic Mechanical Lower Back PainUnited States
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
Columbia UniversityUpright Technologies Ltd.CompletedLower Back Pain | Back Pain | Postural Low Back PainUnited States
-
Balgrist University HospitalUniversity of Zurich, Epidemiology, Biostatistics and Prevention InstituteCompletedBack Pain | Back Pain With Radiation | Back Pain, LowSwitzerland
-
Vanderbilt University Medical CenterWithdrawnBack Pain, Low | Back Pain Without RadiationUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on Exercise therapy
-
University Hospital, GhentCompletedInsertional Achilles TendinopathyBelgium
-
Norwegian University of Science and TechnologyCompletedPatellofemoral Pain Syndrome
-
Istanbul Physical Medicine Rehabilitation Training...Completedthe Effect of Virtual Reality on Stroke Rehabilitation
-
Proaxis TherapyVirginia Commonwealth University; Arcadia University; National Athletic Trainers...CompletedShoulder Impingement SyndromeUnited States
-
Taipei Medical UniversityNot yet recruiting
-
Royal College of Surgeons, IrelandUnknownHip OsteoarthritisIreland
-
University Hospital, GhentCompletedAchilles TendinopathyBelgium
-
Gazi UniversityCompletedTemporomandibular DisorderTurkey
-
George Washington UniversityCompletedPrematurityUnited States
-
Medipol UniversityCompletedHemiplegia | Gait, Hemiplegic | Motor Function | Balance; DistortedTurkey