Neck PainNCT06346249
Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain.
A study testing Electrical Stimulation Therapy, Manual Therapy and Exercise Therapeutic in people with Neck Pain, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Electrical Stimulation Therapy, Manual Therapy and Exercise Therapeutic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 4 Mar 2024to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Cervicalgia with neurological involvement or caused by pathologies such as: inflammatory disease, neurological disease, rheumatic disease, severe osteoporosis, fracture, dislocation, vertebro-basilar insufficiency, neoplasia or infection.
- Spine surgery.
- Present metallic implants at the spinal column level.
- Have received physiotherapy or alternative treatment in the last 6 months before starting the study.
- To present any type of inconvenience to the application of electrotherapy (score ≥45 points in EAPP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain: a Five Week Intervention With a One Month Follow-up Study.
The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain.
Read the detailed description
The subjects included in the sample will be evaluated according to the aforementioned parameters by researchers trained and assigned for this purpose.
The data collection of the different variables will be performed before and after the completion of the program designed for the study. The physiotherapy intervention for the experimental group will have a duration of 10 sessions, twice a week.
- Conditions
- Neck Pain
- Being tested
- Electrical Stimulation Therapy, Manual Therapy, Exercise Therapeutic
- Keywords
- non specific pain, physiotherapy, manual therapy, electrical stimulation therapy, therapeutic exercise
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Stimulation TherapyOther
Ten Electrical Stimulation Therapy sessions lasting 30 minutes were carried out. Analgesic currents of the TENS type, placed in the cervical region.
Manual TherapyOther
Manual Therapy consistin of soft tissue mobilization and release techniques over the neck and craniocervical regions. Ten sessions.
Exercise TherapeuticOther
The exercise therapeutic program consisting of neck movement control and stretching exercise. Ten sessions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrical stimulation therapy in healthcare workers with non-specific neck pain. Receives: Other: Electrical Stimulation Therapy; Other: Manual Therapy; Other: Exercise Therapeutic |
| Control Group | No intervention | The control group will not undergo any physiotherapy treatment therapy for neck pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain
A visual analog scale (VAS). The scale is represented by a 10-centimeter line at the ends of which there are two adjectives whose ends there are two adjectives, absence of pain (0) and unbearable pain (10). The higher the score, the greater the pain.
Measured: 5 weeks
Changes Pressure Pain
Pressure Pain with Algometry. To assess the mechanosensitivity of the trigger points , the pain threshold was measured at the pressure.
Unit of measure Kg/cm2.
Measured: 5 weeks
Changes in Disability
Neck Disability Index ( NDI) through which will give us the degree of disability neck pain.The NDI consists of 10 sections, 4 of them are related to subjective symptoms (pain intensity, headache, head, ability to concentrate and quality of sleep) and the other 6 are related to basic activities of daily living (ABVD) (personal care, ability to lift weights, reading, work, driving, leisure activities and free time). Each of the sections presents 6 possible answers, scoring these from 0 to 5 according to the progression of functional disability.
Measured: 5 weeks
Secondary outcomes (2)
Changes in Range of Motion
Measurement of joint amplitude with goniometry. The Range of Motion (ROM) exploration was performed with the subjects in sitting in order to stabilize the pelvis and the thoracic-lumbar spine. From this position, the degrees of maximum position reached by the subjects in each of the 6 movements of space.
Unit of measurement in degrees of articulation.
Measured: 5 weeks
General Health.
The Physical and Mental Health summary scales-12 (SF-12) contains 12 questions distributed in each of the 8 dimensions. The higher the score, the better the state of health.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start4 Mar 2024
- Primary completion30 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neck 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Ángeles Cardero Durán, Universidad de Extremadura
- Investigators
- María de los Ángeles Cardero Durán, Doctor, Principal investigator, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346249
- Sponsor's protocol ID
- 49/2024
- Status last verified
- Feb 2024
- First submitted
- 12 Mar 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guzman J, Hurwitz EL, Carroll LJ, Haldeman S, Cote P, Carragee EJ, Peloso PM, van der Velde G, Holm LW, Hogg-Johnson S, Nordin M, Cassidy JD; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. A new conceptual model of neck pain: linking onset, course, and care: the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S14-23. doi: 10.1097/BRS.0b013e3181643efb.
PubMed 18204387de Campos TF, Maher CG, Steffens D, Fuller JT, Hancock MJ. Exercise programs may be effective in preventing a new episode of neck pain: a systematic review and meta-analysis. J Physiother. 2018 Jul;64(3):159-165. doi: 10.1016/j.jphys.2018.05.003. Epub 2018 Jun 19.
PubMed 29908853Nyman T, Grooten WJ, Wiktorin C, Liwing J, Norrman L. Sickness absence and concurrent low back and neck-shoulder pain: results from the MUSIC-Norrtalje study. Eur Spine J. 2007 May;16(5):631-8. doi: 10.1007/s00586-006-0152-6. Epub 2006 Jun 2.
PubMed 16741741Heintz MM, Hegedus EJ. Multimodal management of mechanical neck pain using a treatment based classification system. J Man Manip Ther. 2008;16(4):217-24. doi: 10.1179/106698108790818260.
PubMed 19771194Carroll LJ, Hogg-Johnson S, Cote P, van der Velde G, Holm LW, Carragee EJ, Hurwitz EL, Peloso PM, Cassidy JD, Guzman J, Nordin M, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Course and prognostic factors for neck pain in workers: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S93-100. doi: 10.1097/BRS.0b013e31816445d4.
PubMed 18204406Driessen MT, Proper KI, van Tulder MW, Anema JR, Bongers PM, van der Beek AJ. The effectiveness of physical and organisational ergonomic interventions on low back pain and neck pain: a systematic review. Occup Environ Med. 2010 Apr;67(4):277-85. doi: 10.1136/oem.2009.047548.
PubMed 20360197Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
PubMed 28826164Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30.
PubMed 25269764Cardero Duran MLA, Espejo Antunez L, Fernandez Morales C, Albornoz Cabello M, Rodriguez Mansilla J. Workplace-Based Physiotherapy of Elderly Care Workers With Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. J Occup Environ Med. 2026 Feb 1;68(2):e172-e181. doi: 10.1097/JOM.0000000000003566. Epub 2025 Oct 3.
PubMed 41042388
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain: a Five Week Intervention With a One Month Follow-up Study.
- ClinicalTrials.gov ID
- NCT06346249
- Acronym / sponsor ID
- 49/2024
- Conditions
- Neck Pain
- Keywords
- non specific pain, physiotherapy, manual therapy, electrical stimulation therapy, therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 4 Apr 2024 (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.
The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain.
Detailed description
The subjects included in the sample will be evaluated according to the aforementioned parameters by researchers trained and assigned for this purpose.
The data collection of the different variables will be performed before and after the completion of the program designed for the study. The physiotherapy intervention for the experimental group will have a duration of 10 sessions, twice a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Electrical Stimulation Therapy, Other: Manual Therapy, Other: Exercise TherapeuticThe overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrical stimulation therapy in healthcare workers with non-specific neck pain. |
| Control Group | No intervention | –The control group will not undergo any physiotherapy treatment therapy for neck pain. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Cervicalgia with neurological involvement or caused by pathologies such as: inflammatory disease, neurological disease, rheumatic disease, severe osteoporosis, fracture, dislocation, vertebro-basilar insufficiency, neoplasia or infection.
- Spine surgery.
- Present metallic implants at the spinal column level.
- Have received physiotherapy or alternative treatment in the last 6 months before starting the study.
- To present any type of inconvenience to the application of electrotherapy (score ≥45 points in EAPP).
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 |
|---|---|---|
| Electrical Stimulation TherapyTen Electrical Stimulation Therapy sessions lasting 30 minutes were carried out. Analgesic currents of the TENS type, placed in the cervical region. | Other | Experimental Group |
| Manual TherapyManual Therapy consistin of soft tissue mobilization and release techniques over the neck and craniocervical regions. Ten sessions. | Other | Experimental Group |
| Exercise TherapeuticThe exercise therapeutic program consisting of neck movement control and stretching exercise. Ten sessions. | Other | Experimental Group |
Primary outcome
Changes in Pain
Time frame: 5 weeks
A visual analog scale (VAS). The scale is represented by a 10-centimeter line at the ends of which there are two adjectives whose ends there are two adjectives, absence of pain (0) and unbearable pain (10). The higher the score, the greater the pain.
Changes Pressure Pain
Time frame: 5 weeks
Pressure Pain with Algometry. To assess the mechanosensitivity of the trigger points , the pain threshold was measured at the pressure. Unit of measure Kg/cm2.
Changes in Disability
Time frame: 5 weeks
Neck Disability Index ( NDI) through which will give us the degree of disability neck pain.The NDI consists of 10 sections, 4 of them are related to subjective symptoms (pain intensity, headache, head, ability to concentrate and quality of sleep) and the other 6 are related to basic activities of daily living (ABVD) (personal care, ability to lift weights, reading, work, driving, leisure activities and free time). Each of the sections presents 6 possible answers, scoring these from 0 to 5 according to the progression of functional disability.
2 secondary outcomes
Changes in Range of Motion
Time frame: 5 weeks
General Health.
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 18204387Guzman J, Hurwitz EL, Carroll LJ, Haldeman S, Cote P, Carragee EJ, Peloso PM, van der Velde G, Holm LW, Hogg-Johnson S, Nordin M, Cassidy JD; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. A new conceptual model of neck pain: linking onset, course, and care: the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S14-23. doi: 10.1097/BRS.0b013e3181643efb.
- Background: PubMed 29908853de Campos TF, Maher CG, Steffens D, Fuller JT, Hancock MJ. Exercise programs may be effective in preventing a new episode of neck pain: a systematic review and meta-analysis. J Physiother. 2018 Jul;64(3):159-165. doi: 10.1016/j.jphys.2018.05.003. Epub 2018 Jun 19.
- Background: PubMed 16741741Nyman T, Grooten WJ, Wiktorin C, Liwing J, Norrman L. Sickness absence and concurrent low back and neck-shoulder pain: results from the MUSIC-Norrtalje study. Eur Spine J. 2007 May;16(5):631-8. doi: 10.1007/s00586-006-0152-6. Epub 2006 Jun 2.
- Background: PubMed 19771194Heintz MM, Hegedus EJ. Multimodal management of mechanical neck pain using a treatment based classification system. J Man Manip Ther. 2008;16(4):217-24. doi: 10.1179/106698108790818260.
- Background: PubMed 18204406Carroll LJ, Hogg-Johnson S, Cote P, van der Velde G, Holm LW, Carragee EJ, Hurwitz EL, Peloso PM, Cassidy JD, Guzman J, Nordin M, Haldeman S; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Course and prognostic factors for neck pain in workers: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S93-100. doi: 10.1097/BRS.0b013e31816445d4.
- Background: PubMed 20360197Driessen MT, Proper KI, van Tulder MW, Anema JR, Bongers PM, van der Beek AJ. The effectiveness of physical and organisational ergonomic interventions on low back pain and neck pain: a systematic review. Occup Environ Med. 2010 Apr;67(4):277-85. doi: 10.1136/oem.2009.047548.
- Background: PubMed 28826164Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
- Background: PubMed 25269764Llamas-Ramos R, Pecos-Martin D, Gallego-Izquierdo T, Llamas-Ramos I, Plaza-Manzano G, Ortega-Santiago R, Cleland J, Fernandez-de-Las-Penas C. Comparison of the short-term outcomes between trigger point dry needling and trigger point manual therapy for the management of chronic mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Nov;44(11):852-61. doi: 10.2519/jospt.2014.5229. Epub 2014 Sep 30.
- Derived from this study: PubMed 41042388Cardero Duran MLA, Espejo Antunez L, Fernandez Morales C, Albornoz Cabello M, Rodriguez Mansilla J. Workplace-Based Physiotherapy of Elderly Care Workers With Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. J Occup Environ Med. 2026 Feb 1;68(2):e172-e181. doi: 10.1097/JOM.0000000000003566. Epub 2025 Oct 3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
María de los Ángeles Cardero Durán, Doctor principal investigator
Universidad de Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation Therapy, Manual Therapy and Exercise Therapeutic in people with Neck Pain, run by Universidad de Extremadura 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 0 inclusion and 5 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: finished, as of the sponsor's last update on 1 May 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Pain (time frame: 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06346249, which also lists 9 linked publications.
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 1 May 2025.