Neck PainNCT04495465
Effects of Radial Shock Waves Therapy in the Treatment of Neck Pain
A study testing Radial Shock Wave Therapy and Manual Therapy in people with Neck Pain and Musculoskeletal Manipulations, run by University of Jaén at 1 site in Spain.
Trial summary
The aim of this study is to assess the effects of radial shock wave therapy in neck pain. For this objective, subjects recruited will be allocated in an experimental group or a placebo group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Musculoskeletal Manipulations, Extracorporeal Shockwave Therapy
- What is being tested?
- Radial Shock Wave Therapy and Manual Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 26 Feb 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed of neck pain.
Who cannot join
- Subjects who due to their own characteristics are not able to carry out the study tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Radial Shock Waves Therapy in the Treatment of Neck Pain: Randomized Clinical Trial
The aim of this study is to assess the effects of radial shock wave therapy in neck pain. For this objective, subjects recruited will be allocated in an experimental group or a placebo group. Both groups will receive one manual therapy and radial shock waves therapy (real for experimental group, a sham device for placebo group) session per week along one month. Neck pain, neck function, temporomandibular pain, temporomandibular function and quality of life measured will be performed before the intervention, after the last treatment and at one month follow-up.
Read the detailed description
Neck pain is defined as discomfort or more intense forms of pain that are localized to the cervical region. The multifactorial etiology of neck pain includes trauma, ergonomic factors such as inappropriate postures, repetitive movements, strong physical activity, individual factors such as age, BMI, genetic factors, behavioral factors, and psychosocial factors.
The prevalence of cervicalgia ranges from 16.7 to 75.1%, of which 50% will resolve within a short time and the other half will suffer pain for a longer time. There is a higher prevalence in widows and separated, people with few economic resources, jobs that involve physical effort, low educational level, anxiety and depression. Furthermore, there is a high relationship between cervical pain and temporomandibular disorders.
From this study, the investigators are going to carry out a non-invasive, analgesic, antiinflammatory treatment and without negative side effects for the patient through radial extracorporeal shock waves (rESWT), and manual therapy (TM). Among the effects produced by shock waves the investigators find that they improve circulation due to increased blood flow and oxygenation, at tissue level the permeability of the membrane increases and its metabolic process, therefore facilitating the activation of tissue regeneration processes experiencing dystrophic changes. Furthermore, shock waves cause anti-inflammatory effects and muscle relaxation.
The main objective of the study is to evaluate the capacity of the shock waves to improve the alterations due to neck pain. To meet the above objective, a single-blind randomized clinical trial study has been designed. The selected subjects will be of legal age diagnosed with neck pain and those subjects that due to their own characteristics are not able to carry out the study will be excluded. Subjects will receive a weekly physical therapy session for four weeks. Subjects will be randomly assigned to two groups: T1 intervention group consisting of subjects who will receive manual therapy treatment and shock waves and T2 placebo group in which the subjects will receive manual therapy and placebo shock waves.
- Being tested
- Radial Shock Wave Therapy, Manual Therapy, placebo shock waves
- Keywords
- Neck Pain, Musculoskeletal Manipulations, Extracorporeal Shockwave Therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Shock Wave TherapyOther
Also called Extracorporeal Shockwave Therapy
2000 shots of extracorporeal radial shock waves therapy on neck muscles at 4bars and 10 Hertzs
Manual TherapyOther
Also called Musculoskeletal Manipulations
25 minute massage to neck muscles
placebo shock wavesOther
3 minutes of placebo extracorporeal radial shock waves therapy on painful points of neck muscles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: manual therapy + shock waves | Experimental | Four sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of extracorporeal radial shock waves therapy on painful points of neck muscles at 2 bars and 10 Hetzs. Receives: Other: Radial Shock Wave Therapy; Other: Manual Therapy |
| Control group: manual therapy + placebo shock waves | Placebo comparator | Four sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of placebo extracorporeal radial shock waves therapy on painful points of neck muscles. Receives: Other: Manual Therapy; Other: placebo shock waves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain intensity
Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
Measured: baseline
Neck pain intensity
Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
Measured: at one month
Neck pain intensity
Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
Measured: at two months
Neck function
Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50.
Measured: baseline
Neck function
Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50
Measured: at one month
Neck function
Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50
Measured: at two months
Secondary outcomes (15)
temporomandibular pain intensity
Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
Measured: baseline
temporomandibular pain intensity
Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
Measured: at one month
temporomandibular pain intensity
Numeric Pain Rating Scale to assess the intensity of the temporomandibular pain intensity. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
Measured: at two months
Temporomandibular joint function
using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe).
Measured: baseline
Temporomandibular joint function
using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe).
Measured: at one month
Temporomandibular joint function
using Fonseca Anamnestic Index. Its structure consists of 10 questions with a three-point scale (0=no, 5= sometimes and 10= yes), with the overall score of the test ranging from 0 to 100. The FAI evaluates the presence or absence of symptoms caused by TMDs and their severity (mild, moderate and severe).
Measured: at two months
Health Related Quality of life
12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100.
Measured: baseline
Health Related Quality of life
12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100.
Measured: at one month
Health Related Quality of life
12-Item Short-Form Health Survey (SF-12): is a simple and quick questionnaire compared to its predecessor, the SF-36 that is self-administered and evaluates general quality of life from physical and emotional points of view. It consists of 12 questions that are presented with a variable number of answers. The final result of the test is obtained in a more exact way by means of a statistical processing instrument that provides the value of the physical and mental summary scores with values between 0 and 100.
Measured: at two months
Headache impact in quality of life.
The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers.
Measured: baseline
Headache impact in quality of life
The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers.
Measured: at one month
Headache impact in quality of life
The Headache Impact Test (HIT-6) is a self-administered headache questionnaire that consists of six questions with five possible answers. The possible outcomes are "never", "rarely", "sometimes", "very often" and "always". The numerical result is the sum of the answers.
Measured: at two months
Dizziness
Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25.
Measured: baseline
Dizziness
Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25.
Measured: at one month
Dizziness
Dizziness measured with Dizziness Handicap Inventory: is a self-implemented scale that identifies vertigo or lack of balance. The instrument consists of 25 questions that can be answered as yes, no or sometimes. This questionnaire identifies functional, physical and emotional problems related to balance disorders. Each dimension corresponds to different questions distributed randomly throughout the test. The functionality questions correspond to items 3, 5, 6, 7, 12, 14, 16, 19 and 24, the emotional questions correspond to items 2, 9, 10, 15, 18, 20, 21, 22 and 23, and the questions on the physical dimension correspond to items 1, 4, 8, 11, 13, 17 and 25.
Measured: at two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Jan 2021
- Primary completion19 Jan 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Two groups: experimental group and placebo group, receiving the intervention at the same time
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NOELIA ZAGALAZ ANULA, University of Jaén
- Investigators
- Rafael Lomas-Vega, PhD, Principal investigator, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495465
- Sponsor's protocol ID
- UJAShockWavesNeck2020
- Status last verified
- Mar 2021
- First submitted
- 27 Jul 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Radial Shock Waves Therapy in the Treatment of Neck Pain: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04495465
- Acronym / sponsor ID
- UJAShockWavesNeck2020
- Keywords
- Neck Pain, Musculoskeletal Manipulations, Extracorporeal Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 31 Jul 2020 (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 aim of this study is to assess the effects of radial shock wave therapy in neck pain. For this objective, subjects recruited will be allocated in an experimental group or a placebo group. Both groups will receive one manual therapy and radial shock waves therapy (real for experimental group, a sham device for placebo group) session per week along one month. Neck pain, neck function, temporomandibular pain, temporomandibular function and quality of life measured will be performed before the intervention, after the last treatment and at one month follow-up.
Detailed description
Neck pain is defined as discomfort or more intense forms of pain that are localized to the cervical region. The multifactorial etiology of neck pain includes trauma, ergonomic factors such as inappropriate postures, repetitive movements, strong physical activity, individual factors such as age, BMI, genetic factors, behavioral factors, and psychosocial factors.
The prevalence of cervicalgia ranges from 16.7 to 75.1%, of which 50% will resolve within a short time and the other half will suffer pain for a longer time. There is a higher prevalence in widows and separated, people with few economic resources, jobs that involve physical effort, low educational level, anxiety and depression. Furthermore, there is a high relationship between cervical pain and temporomandibular disorders.
From this study, the investigators are going to carry out a non-invasive, analgesic, antiinflammatory treatment and without negative side effects for the patient through radial extracorporeal shock waves (rESWT), and manual therapy (TM). Among the effects produced by shock waves the investigators find that they improve circulation due to increased blood flow and oxygenation, at tissue level the permeability of the membrane increases and its metabolic process, therefore facilitating the activation of tissue regeneration processes experiencing dystrophic changes. Furthermore, shock waves cause anti-inflammatory effects and muscle relaxation.
The main objective of the study is to evaluate the capacity of the shock waves to improve the alterations due to neck pain. To meet the above objective, a single-blind randomized clinical trial study has been designed. The selected subjects will be of legal age diagnosed with neck pain and those subjects that due to their own characteristics are not able to carry out the study will be excluded. Subjects will receive a weekly physical therapy session for four weeks. Subjects will be randomly assigned to two groups: T1 intervention group consisting of subjects who will receive manual therapy treatment and shock waves and T2 placebo group in which the subjects will receive manual therapy and placebo shock waves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: experimental group and placebo group, receiving the intervention at the same time
| Arm | Type | Receives |
|---|---|---|
| Experimental group: manual therapy + shock waves | Experimental | Other: Radial Shock Wave Therapy, Other: Manual TherapyFour sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of extracorporeal radial shock waves therapy on painful points of neck muscles at 2 bars and 10 Hetzs. |
| Control group: manual therapy + placebo shock waves | Placebo comparator | Other: Manual Therapy, Other: placebo shock wavesFour sessions (one per week along one month) of manual therapy (25 minutes of massage on neck muscles) and 3 minutes (2000 shocks aproximately) of placebo extracorporeal radial shock waves therapy on painful points of neck muscles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects diagnosed of neck pain.
Key exclusion criteria (1 listed)
- Subjects who due to their own characteristics are not able to carry out the study tests
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 |
|---|---|---|
| Radial Shock Wave TherapyAlso: Extracorporeal Shockwave Therapy2000 shots of extracorporeal radial shock waves therapy on neck muscles at 4bars and 10 Hertzs | Other | Experimental group: manual therapy + shock waves |
| Manual TherapyAlso: Musculoskeletal Manipulations25 minute massage to neck muscles | Other | Control group: manual therapy + placebo shock waves, Experimental group: manual therapy + shock waves |
| placebo shock waves3 minutes of placebo extracorporeal radial shock waves therapy on painful points of neck muscles. | Other | Control group: manual therapy + placebo shock waves |
Primary outcome
Neck pain intensity
Time frame: baseline
Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
Neck pain intensity
Time frame: at one month
Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
Neck pain intensity
Time frame: at two months
Numeric Pain Rating Scale to assess the intensity of the neck pain. The numeric Pain Rating Scale is a self-implemented pain intensity perception scale. In this test, all the possibilities are arranged at the same level, with 0 being the absence of pain and 10 being the maximum pain the patient is capable of imagining, organized in an increasing manner from left to right; the patient only has to mark with a cross the answer considered correct.
Neck function
Time frame: baseline
Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50.
Neck function
Time frame: at one month
Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50
Neck function
Time frame: at two months
Neck Disability Index. The Neck Disability Index is a questionnaire that assesses disability produced by neck pain. It consists of ten questions with six different answers that are ordered from least to most disability, with 0 corresponding to no disability and 5 corresponding to greatest disability. The result is the sum of the answers, ranging from 0 to 50. The categorization of the final result is as follows: "no disability" if the result is between 0 and 4, "moderate disability" between 15 and 24, and "complete disability" between 35 and 50
15 secondary outcomes
temporomandibular pain intensity
Time frame: baseline
temporomandibular pain intensity
Time frame: at one month
temporomandibular pain intensity
Time frame: at two months
Temporomandibular joint function
Time frame: baseline
Temporomandibular joint function
Time frame: at one month
Temporomandibular joint function
Time frame: at two months
Health Related Quality of life
Time frame: baseline
Health Related Quality of life
Time frame: at one month
Health Related Quality of life
Time frame: at two months
Headache impact in quality of life.
Time frame: baseline
Headache impact in quality of life
Time frame: at one month
Headache impact in quality of life
Time frame: at two months
Dizziness
Time frame: baseline
Dizziness
Time frame: at one month
Dizziness
Time frame: at two months
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 23 Mar 2021.
- 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.
Rafael Lomas-Vega, PhD principal investigator
University of Jaén
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Shock Wave Therapy and Manual Therapy in people with Neck Pain and Musculoskeletal Manipulations, run by University of Jaén 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 1 inclusion and 1 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 23 Mar 2021. 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?
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?
Neck pain intensity (time frame: baseline). 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 23 Mar 2021.