Neck PainNCT05845346
Efficacy of Two Physiotherapy Intervention Methods Applied in Subjects in the Social-healthcare Setting With Nonspecific Neck Pain.
A study testing Electrotherapy-Transcutaneous Electrical Stimulation (TENS), Massage therapy and Stretching exercises 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 compare the effectiveness of two physiotherapy treatments, one based on the application of massage most current analgesic TENS compared to a second massage treatment based on more specific stretching techniques in subject in th social-health care setting with non-specific neck… 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?
- Electrotherapy-Transcutaneous Electrical Stimulation (TENS), Massage therapy and Stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 30 Jun 2023
- 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
- Age range between 18-60 years.
- Cervical pain of non-specific origin or Cervicalgia type I and II according to the Quebec - Task Force on Spinal Disorders.
- Be willing to participate in the study and sign the informed consent form.
- Have at least one year of seniority in the company exercising the current professional activity within the team of socio-health personnel.
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: Efficacy of Two Physiotherapy Intervention Methods Applied in Subjects in the Social-healthcare Setting With Nonspecific Neck Pain
The overall objective of this study is to compare the effectiveness of two physiotherapy treatments, one based on the application of massage most current analgesic TENS compared to a second massage treatment based on more specific stretching techniques in subject in th social-health care setting with non-specific neck pain.
Read the detailed description
The subjects included in the sample will be evaluated according to the above-mentioned parameters by researchers trained and assigned for this purpose.
The data collection of the different variables will be carried out before and after the completion of the programs designed for the study. The programs designed for the experimental groups have a duration of 10 sessions, twice a week.
- Conditions
- Neck Pain
- Being tested
- Electrotherapy-Transcutaneous Electrical Stimulation (TENS), Massage therapy, Stretching exercises, Ischaemic Compression Technique
- Keywords
- inespecif pain, physicaltherapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrotherapy-Transcutaneous Electrical Stimulation (TENS)Other
Ten electrotherapy sessions lasting 30 minutes were carried out. Analgesic currents of the TENS type, placed in the cervical region.
Massage therapyOther
Ten massage therapy sessions lasting 20 minutes each were carried out. Techniques such as superficial rubbing, deep rubbing, kneading and gliding pressure were performed on the cervical region.
Stretching exercisesOther
Ten stretching exercise sessions.The stretching exercise modality performed consisted of passive static stretching with a sequence of 30s-10s-30s-10s.
Ischaemic Compression TechniqueOther
Ten Ischaemic Compression Technique sessions. The execution of the technique is described as follows: after locating a painful point (trigger point), pressure is applied until pain is generated, then a position is sought where the pain disappears, the position of maximum comfort, which is maintained for 90 seconds (sec), after which time the patient is returned to the starting position in a passive manner.
| Study group | Role | What they receive |
|---|---|---|
| Group TENS | Experimental | Experimental group 1 will undergo a physiotherapy treatment based on TENS-type analgesic currents and application of massage therapy for neck pain. Receives: Other: Electrotherapy-Transcutaneous Electrical Stimulation (TENS); Other: Massage therapy; Other: Ischaemic Compression Technique |
| Group STRECHING | Experimental | Experimental group 2 will undergo a physiotherapy treatment based on stretching and the application of massage therapy therapy for neck pain. Receives: Other: Massage therapy; Other: Stretching exercises; Other: Ischaemic Compression Technique |
| 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 on whose extremes have two adjectives, absence of pain and pain unbearable.
Measured: 5 weeks
Changes in Range of Motion
Measurement of joint amplitude with goniometry. The 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
Changes in Disability
Neck Disability Index 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 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
General Health
The 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Feb 2023
- Primary completion31 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- 100 participants (estimated)
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
- Luis Espejo Antunez, Study director, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845346
- Sponsor's protocol ID
- 38/2014
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Covarrubias-Gomez A, Guevara-Lopez U, Lara-Solares A, Tamayo-Valenzuela AC, Salinas-Cruz J, Torres-Gonzalez R. [Clinical pattern of patients cared for at pain clinic by first time]. Rev Med Inst Mex Seguro Soc. 2008 Sep-Oct;46(5):467-72. Spanish.
PubMed 19241653Torres Cueco R. La columna cervical: síndromes clínicos y su tratamiento manipulativo. Ed panamericana. 2008; 233-234.
Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
PubMed 10872758Amer- Cuenca J.J. Programación y aplicación de la estimulación nerviosa eléctrica transcutanea (TENS): guía de práctica clínica basada en la evidencia. Fisioterapia 2010; 32(6):271-278.
Fuentes JP, Armijo Olivo S, Magee DJ, Gross DP. Effectiveness of interferential current therapy in the management of musculoskeletal pain: a systematic review and meta-analysis. Phys Ther. 2010 Sep;90(9):1219-38. doi: 10.2522/ptj.20090335. Epub 2010 Jul 22.
PubMed 20651012Jonhoson MI, Tabasam G. A double blind placebo controlled investigation into the analgesic effects of inferential currents (IFC) and transcutaneous electrical nerve stimulation (TENS) on cold-induced pain in healthy subjects. Physiother Theory Pract 1999; 15: 217-33
Calle Fuentes P, Muñoz- Cruzado y Barba M, Catalán Matamoros D, Fuentes Hervías M.T. Los efectos de los estiramientos musculares: ¿que sabemos realmente? Rev Iberoam Fisioter Kinesol 2006; 9(1):36-44.
Meseguer-Henarejos, B, Medina-I-Mirapeix, F, Canovas-Gascón J.J, Esteban-Argente, I, Torres-Vaquero A.I, Alcántara F. Prevalencia, consecuencias y factores de riesgo de la cervicalgia. Fisioterapia. 2000; 22 (monográfico 2): 13-32
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Physiotherapy Intervention Methods Applied in Subjects in the Social-healthcare Setting With Nonspecific Neck Pain
- ClinicalTrials.gov ID
- NCT05845346
- Acronym / sponsor ID
- 38/2014
- Conditions
- Neck Pain
- Keywords
- inespecif pain, physicaltherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 May 2023 (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 compare the effectiveness of two physiotherapy treatments, one based on the application of massage most current analgesic TENS compared to a second massage treatment based on more specific stretching techniques in subject in th social-health care setting with non-specific neck pain.
Detailed description
The subjects included in the sample will be evaluated according to the above-mentioned parameters by researchers trained and assigned for this purpose.
The data collection of the different variables will be carried out before and after the completion of the programs designed for the study. The programs designed for the experimental groups 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Group TENS | Experimental | Other: Electrotherapy-Transcutaneous Electrical Stimulation (TENS), Other: Massage therapy, Other: Ischaemic Compression TechniqueExperimental group 1 will undergo a physiotherapy treatment based on TENS-type analgesic currents and application of massage therapy for neck pain. |
| Group STRECHING | Experimental | Other: Massage therapy, Other: Stretching exercises, Other: Ischaemic Compression TechniqueExperimental group 2 will undergo a physiotherapy treatment based on stretching and the application of massage therapy therapy for 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 (4 listed)
- Age range between 18-60 years.
- Cervical pain of non-specific origin or Cervicalgia type I and II according to the Quebec - Task Force on Spinal Disorders.
- Be willing to participate in the study and sign the informed consent form.
- Have at least one year of seniority in the company exercising the current professional activity within the team of socio-health personnel.
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 |
|---|---|---|
| Electrotherapy-Transcutaneous Electrical Stimulation (TENS)Ten electrotherapy sessions lasting 30 minutes were carried out. Analgesic currents of the TENS type, placed in the cervical region. | Other | Group TENS |
| Massage therapyTen massage therapy sessions lasting 20 minutes each were carried out. Techniques such as superficial rubbing, deep rubbing, kneading and gliding pressure were performed on the cervical region. | Other | Group STRECHING, Group TENS |
| Stretching exercisesTen stretching exercise sessions.The stretching exercise modality performed consisted of passive static stretching with a sequence of 30s-10s-30s-10s. | Other | Group STRECHING |
| Ischaemic Compression TechniqueTen Ischaemic Compression Technique sessions. The execution of the technique is described as follows: after locating a painful point (trigger point), pressure is applied until pain is generated, then a position is sought where the pain disappears, the position of maximum comfort, which is maintained for 90 seconds (sec), after which time the patient is returned to the starting position in a passive manner. | Other | Group STRECHING, Group TENS |
Primary outcome
Changes in Pain
Time frame: 5 weeks
A visual analog scale (VAS). The scale is represented by a 10 centimeter line on whose extremes have two adjectives, absence of pain and pain unbearable.
Changes in Range of Motion
Time frame: 5 weeks
Measurement of joint amplitude with goniometry. The 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
Changes in Disability
Time frame: 5 weeks
Neck Disability Index 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 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.
General Health
Time frame: 5 weeks
The SF-12 contains 12 questions distributed in each of the 8 dimensions. The higher the score, the better the state of health.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 19241653Covarrubias-Gomez A, Guevara-Lopez U, Lara-Solares A, Tamayo-Valenzuela AC, Salinas-Cruz J, Torres-Gonzalez R. [Clinical pattern of patients cared for at pain clinic by first time]. Rev Med Inst Mex Seguro Soc. 2008 Sep-Oct;46(5):467-72. Spanish.
- BackgroundTorres Cueco R. La columna cervical: síndromes clínicos y su tratamiento manipulativo. Ed panamericana. 2008; 233-234.
- Background: PubMed 10872758Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
- BackgroundAmer- Cuenca J.J. Programación y aplicación de la estimulación nerviosa eléctrica transcutanea (TENS): guía de práctica clínica basada en la evidencia. Fisioterapia 2010; 32(6):271-278.
- Background: PubMed 20651012Fuentes JP, Armijo Olivo S, Magee DJ, Gross DP. Effectiveness of interferential current therapy in the management of musculoskeletal pain: a systematic review and meta-analysis. Phys Ther. 2010 Sep;90(9):1219-38. doi: 10.2522/ptj.20090335. Epub 2010 Jul 22.
- BackgroundJonhoson MI, Tabasam G. A double blind placebo controlled investigation into the analgesic effects of inferential currents (IFC) and transcutaneous electrical nerve stimulation (TENS) on cold-induced pain in healthy subjects. Physiother Theory Pract 1999; 15: 217-33
- BackgroundCalle Fuentes P, Muñoz- Cruzado y Barba M, Catalán Matamoros D, Fuentes Hervías M.T. Los efectos de los estiramientos musculares: ¿que sabemos realmente? Rev Iberoam Fisioter Kinesol 2006; 9(1):36-44.
- BackgroundMeseguer-Henarejos, B, Medina-I-Mirapeix, F, Canovas-Gascón J.J, Esteban-Argente, I, Torres-Vaquero A.I, Alcántara F. Prevalencia, consecuencias y factores de riesgo de la cervicalgia. Fisioterapia. 2000; 22 (monográfico 2): 13-32
- 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.
Luis Espejo Antunez study director
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 Electrotherapy-Transcutaneous Electrical Stimulation (TENS), Massage therapy and Stretching exercises 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 4 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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?
Results are not available in the source record.
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 5 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 NCT05845346, which also lists 8 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 6 May 2023.