Back PainNCT07251959
Workplace Exercise Therapy With or Without Manual Therapy in Chronic Spinal Pain
A study testing Exercise therapy and Manual Therapy in people with Back Pain and Neck Pain, run by Catholic University of Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain, Neck Pain, Low Back Pain
- What is being tested?
- Exercise therapy and Manual Therapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 29 Sep 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Back Pain, Neck Pain, Low Back Pain
- Being tested
- Exercise therapy, Manual Therapy, Sham Manual Therapy
- Keywords
- Chronic nonspecific spinal pain, Exercise therapy, Sham-therapy, Massage
- Medical subject headings
- Back Pain, Neck Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapyBehavioural
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 TherapyProcedure or surgery
Manual therapy maneuvers twice per week for 8 weeks
Sham Manual TherapyProcedure or surgery
Simulated manual therapy maneuvers twice per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise therapy; Procedure: Sham Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.'
Measured: 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
Measured: 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
Measured: 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.
Measured: During the 8 weeks of interventions.
Secondary outcomes (4)
Anxiety (GAD-7)
The GAD-7 questionnaire assesses the severity of generalized anxiety symptoms over the past two weeks, with higher scores indicating greater anxiety levels
Measured: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
Severity of depressive symptoms (PHQ-9)
The PHQ-9 questionnaire assesses the severity of depressive symptoms over the past two weeks, with higher scores indicating greater depression levels
Measured: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
Muscle Properties of Upper Trapezius (Myoton)
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.
Measured: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
Muscle Properties of Lumbar zone (Myoton)
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.
Measured: At baseline, 8 weeks (end of treatment), 3 months, and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start29 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Cecilia León Garzón, Catholic University of Murcia
- Investigators
- Martha C León-Garzón, PhD, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251959
- Sponsor's protocol ID
- CE042403
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07251959
- Acronym / sponsor ID
- CE042403
- Conditions
- Back Pain, Neck Pain, Low Back Pain
- Keywords
- Chronic nonspecific spinal pain, Exercise therapy, Sham-therapy, Massage
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Catholic University of MurciaUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy plus manual therapy | Experimental | Behavioral: Exercise therapy, Procedure: Manual TherapyParticipants 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. |
| Exercise therapy plus sham manual therapy | Sham comparator | Behavioral: Exercise therapy, Procedure: Sham Manual TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise therapyExercises 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. | Behavioural | Exercise therapy plus manual therapy, Exercise therapy plus sham manual therapy |
| Manual TherapyManual therapy maneuvers twice per week for 8 weeks | Procedure or surgery | Exercise therapy plus manual therapy |
| Sham Manual TherapySimulated manual therapy maneuvers twice per week for 8 weeks | Procedure or surgery | Exercise therapy plus sham manual therapy |
Primary outcome
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
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.
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.'
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
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
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martha C León-Garzón, PhD principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy and Manual Therapy in people with Back Pain and Neck Pain, run by Catholic University of Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.