Neck PainrPWTNCT04758065
Effectiveness of Radial Pressure Waves Therapy in the Treatment of Non-Specific Neck Pain (rPWT)
A study testing Radial pressure waves Therapy and Therapeutic Exercise and Manual Therapy in people with Neck Pain, run by Universidad Pontificia Comillas at 2 sites in Spain.
Trial summary
The present study aims to know the effectiveness of radial pressure wave therapy in the treatment of people with nonspecific neck pain. The study hypothesis is that including radial pressure wave therapy in a protocol based on manual therapy and therapeutic exercise is more effective than the protocol alone for the… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Radial pressure waves Therapy and Therapeutic Exercise and Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Mar 2021to 30 Aug 2025
- 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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-Specific Neck Pain (NSNP)
- Age between 18 and 59 years,
Who cannot join
- Previous spine surgery.
- Neurological pathology.
- Rheumatoid arthritis.
- Fibromyalgia.
- Vertebral fractures or fissures.
- Radiculopathies.
Show all 13Show fewer
- Neurogenic pain.
- History of cervical trauma.
- Congenital spinal anomalies.
- Wear a cardiac pacemaker.
- Currently receiving physiotherapy treatment in the same body area where the study is carried out.
- Currently being treated with anticoagulants or antiaggregants.
- Have an infectious or neoplastic nucleus close to the body area under study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
San Juan de Dios School of Nursing and Phisiotherapy, Comillas Pontifical University
Ciempozuelos, Madrid, 28350
CIMEG Madrid
Madrid, 28010
About this study
Official title: Effectiveness of the Application of Radial Pressure Waves Together With a Manual Therapy Protocol and Therapeutic Exercise in the Treatment of Non-Specific Neck Pain: a Randomized Clinical Trial
The present study aims to know the effectiveness of radial pressure wave therapy in the treatment of people with nonspecific neck pain. The study hypothesis is that including radial pressure wave therapy in a protocol based on manual therapy and therapeutic exercise is more effective than the protocol alone for the treatment of nonspecific neck pain.
Participants will be randomly assigned into 2 groups, one will be applied only the manual therapy and exercise protocol and the other the same protocol, plus shock wave therapy. Data related to the pathology will be collected and compared between the two groups to determine which treatment is more effective.
Read the detailed description
Nonspecific neck pain is one of the main reasons for outpatient physiotherapy consultation and, due to its multifactorial origin, there are numerous approaches without a consensus on the effectiveness of the different treatments. The most recent systematic reviews show significant evidence about the efficacy of the combination of Manual Therapy (MT) and exercise on pain, muscle elasticity, posture, and functionality in patients suffering from neck pain.
During muscle evaluation, it is common to find painful pressure points that are not spontaneously. These asymptomatic areas, painful when pressed, appear as areas with loss of elasticity, when evaluated with quantitative elastography (shear wave), which influences their contractile capacity and their ability to develop strength, together with the inhibition caused by the pain. The accumulation of cytotoxic and nociceptive substances, derived from the excess activity, could be the cause of the shortening of muscle fibers, so an increase in vascularity could help improve their drainage and normalize their elasticity and functionality.
Radial shock waves have been shown to be effective in angiogenesis, increasing vascularity and oxygen saturation of treated areas, so it could be a useful tool to help solve this problem.
This study aims to determine the effectiveness of radial shock waves to locate and treat the areas of loss of elasticity, found during muscle evaluation, combined with a MT and exercise protocol, compared to the manual therapy and exercise protocol itself. To do this, participants will be randomly assigned into 2 groups, one will be applied only the manual therapy and exercise protocol and the other the same protocol, plus shock wave therapy. The data collected will be compared between the two groups. An intention-to-treat statistical analysis will be performed.
Objective:
To determine the influence of the application of radial pressure waves together with the usual Physiotherapy treatment on the elasticity of muscle tissue, pain, the amplitude and harmony of cervical movements, strength, and quality of life in people with nonspecific neck pain
Methods:
The research will begin at the end of February 2021 and will be carried out in the biomechanics and movement analysis laboratory of the San Juan de Dios School of Nursing and Physiotherapy, Comillas Pontifical University, and at the Cimeg Madrid facilities.
A preliminary pilot study will be carried out with 10 volunteers with nonspecific neck pain, in order to calculate the sample size appropriate to the proposed objectives.
Participants will be randomly assigned using sealed envelopes to one of the two groups.
Group 1 will perform a conventional treatment protocol of physical therapy based on manual therapy and therapeutic exercise, for 4 weeks. Participants will go to the facilities, once a week, to get 1 session of manual therapy treatment, based on the Maitland Concept, on the cervical and thoracic spine. Besides this, they will perform 3 sessions a week of home-based cervical therapeutic exercise.
Group 2 will perform the same treatment protocol as Group 1, and in addition, will get a radial pressure waves session in the pressure sore spots, found in the muscle evaluation.
Muscle Elasticity, Pain Pressure Threshold, Cervical Pain, Active Range of Motion, the harmony of movement, Shoulder lift strength, Quality of life, Disability, and Kinesiophobia will be measured before and after treatment (at 4 weeks), at one month, and at three months after the start of the study. while demographic variables (Number of sore spots, Age, Sex, Dominance, Height, Weight, Body Mass Index (BMI), Educational level, Work Activity, and Sports Activity) will only be measured at the baseline.
.
- Conditions
- Neck Pain
- Being tested
- Radial pressure waves Therapy, Therapeutic Exercise and Manual Therapy
- Keywords
- Neck pain, Pain, Radial pressure waves, Elastography, Shear Wave, Physiotherapy, Exercise, Intervention
- Medical subject headings
- Neck Pain, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial pressure waves TherapyOther
Combination of the usual physiotherapy treatment with the application of radial pressure waves compared with a control group in which only the usual treatment, in people with non-specific neck pain, will be applied.
During the first month, the participants will perform 3 weekly sessions of home-based cervical therapeutic exercise and will come to the facilities, once a week, to get a manual therapy session based on the Maitland Concept (15 minutes of posteroanterior mobilizations in the restricted and/or painful vertebrae of the cervical and thoracic spine). Besides this participants of the experimental group will receive a radial pressure waves treatment sessión.
Experimental Group: Home-based cervical therapeutic exercise, manual therapy, and radial pressure waves.
Therapeutic Exercise and Manual TherapyOther
Combination of the usual physiotherapy treatment with the application of radial pressure waves compared with a control group in which only the usual treatment, in people with non-specific neck pain, will be applied.
During the first month, the participants will perform 3 weekly sessions of home-based cervical therapeutic exercise and will come to the facilities, once a week, to get a manual therapy session based on the Maitland Concept (15 minutes of posteroanterior mobilizations in the restricted and/or painful vertebrae of the cervical and thoracic spine). Besides this participants of the experimental group will receive a radial pressure waves treatment sessión.
Control Group: Home-based cervical therapeutic exercise and manual therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1-Goup: Control group | Active comparator | Home-based cervical therapeutic exercise and manual therapy. Receives: Other: Therapeutic Exercise and Manual Therapy |
| 2-Group: Radial pressure waves Group | Experimental | Home-based cervical therapeutic exercise, manual therapy, and radial pressure waves. Receives: Other: Radial pressure waves Therapy; Other: Therapeutic Exercise and Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Elasticity
Using Shear Wave Elastography
Measured: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Secondary outcomes (18)
Change in Pain Pressure Threshold
Using algometer
Measured: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Cervical Pain assessed by Visual Analog Scale for acute pain (Spanish version)
Using Visual Analog Scale (VAS) for acute pain The VAS measures pain intensity with maximum reproducibility among observers. It consists of a horizontal line of 10 centimeters, at the ends of which are the extreme expressions of a symptom. In the left is the absence or less intensity and in the right the greater intensity. The patient is asked to mark on the line the point that indicates the intensity and it is measured with a millimeter ruler.
Reliability (ICC = 0.96-0.98)
Measured: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Active Range of Motion
Using the inertial sensor EBI 5.0 (ON) Biomedic. that provides information on the amplitude, speed, and acceleration of movements It is measured in degrees
Measured: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Jerk of cervical movements
Using the inertial sensor EBI 5.0 (ON) Biomedic, that provides information on the amplitude, speed, and acceleration of movements.
Jerk is a magnitude that measures the changes in acceleration during a movement, that is, the derivative of velocity with respect to time. For an angular movement, it is measured in (degrees/second^3)
Measured: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Shoulder lift strength
Using Linear Encoder Chronojump The changes in the force that participants perform when lifting the shoulder will be measured, with the linear encoder in Newtons (N). Linear encoders are dynamometric devices that directly and continuously record the distance traveled and the movement time of a known external load, which therefore allows, through calculations, to obtain variables such as power and mechanical work, force or speed.
Reliability: Pearson's correlation of all variables compared with the Biopac system (reference value) (≥0.94)
Measured: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in the Quality of life assessed by the SF-12 questionnaire (Spanish version)
Using SF-12 questionnaire. The SF-12 questionnaire (Spanish version) is a validated instrument to measure the Health-Related Quality of Life (HRQoL) of people. It consists of 12 items that collect measures on the functional and emotional state of the individual. When completing the questionnaire, the participant will obtain a value about their health between 1 and 5, where 1 is very good and 5 is bad.
Reliability in all dimensions (Cronbach α ≥0.70)
Measured: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Disability assessed by the Neck disability index (NDI) questionnaire (Spanish version)
Using Neck disability index (NDI) questionnaire. The Cervical Disability Index (NDI) is a 10-item questionnaire that measures disability related to neck pain reported by the patient. It offers 6 possible answers that represent 6 progressive levels of functional capacity and is scored from 0 to 5. The total score is expressed in percentage terms with respect to the maximum possible. The NDI is the most widely used questionnaire for neck pain. The NDI has been shown to be valid when compared to other measures of pain and disability.
Reliability in all dimensions (Cronbach α = 0.944), intraclass correlation (0.98)
Measured: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Kinesiophobia assessed by the Tampa Scale for Kinesiophobia-11 (TSK-11) questionnaire (Spanish version)
Using Tampa Scale for Kinesiophobia-11 (TSK-11) questionnaire (Spanish version).
The Tampa Scale for Kinesiophobia (TSK) is one of the most widely used measures to assess pain-related fear in patients with pain.
TSK is composed of 11 items, with a score range between 1 and 4, as follows: (1) Totally disagree, (2) Disagree, (3) Agree, (4) Totally agree. The total score of the scale range from 11- 44, where 11 means no kinesiophobia, 44 means severe kinesiophobia, and score ± 23 indicates there is kinesiophobia.
Fiabilidad en todas las dimensiones (Cronbach α= 0.79), test-retest (ICC=0.81)
Measured: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Number of sore spots
The variable "number of painful sore spots" in the assessed muscles, will be recorded in order to establish correlations with the dependent variables.
Measured: Baseline
Age in years
The variable "age" of the participants will be recorded in order to establish correlations with the dependent variables.
Measured: Baseline
Gender
The variable "gender" of the participants will be recorded in order to establish correlations with the dependent variables.
Male/Female
Measured: Baseline
Dominance
The variable "dominance" of the participants will be recorded in order to establish correlations with the dependent variables.
Right/Left
Measured: Baseline
Height in centimeters
The variable "Height" of the participants will be recorded, in centimeters, in order to establish correlations with the dependent variables.
Measured: Baseline
Weight in kilograms
The variable "Weight" of the participants will be recorded, in kilograms, in order to establish correlations with the dependent variables.
Measured: Baseline
Educational level
The variable "Educational level" of the participants will be recorded, using a shelf-completed registration document, in order to establish correlations with the dependent variables.
Measured: Baseline
Work Activity
The variable "Work Activity" of the participants will be recorded, using a shelf-completed registration document, in order to establish correlations with the dependent variables.
Measured: Baseline
Body Mass Index (BMI)
The variable "BMI" of the participants will be recorded, using a BMI calculator that combines the weight and height of the participants, in order to establish correlations with the dependent variables.
Measured: Baseline
Sports Activity, assessed by Rapid Assessment of Physical Activity-1 (RAPA-1) test
The variable "Sports Activity" of the participants will be recorded, using the RAPA-1 test, in order to establish correlations with the dependent variables.
RAPA-1 test is composed of 7 items related to the level of physical activity of the participants, with a score range between 1 and 7, as follows: (1) Sedentary (2-3) Not very active, (4-5) Moderately active, (6-7) active.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Mar 2021
- Primary completionAug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
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
- Model description
- It is a randomized controlled clinical trial with parallel groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pontificia Comillas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos López Moreno, Universidad Pontificia Comillas
- Investigators
- Carlos López Moreno, MSc, Principal investigator, San Juan de Dios School of Nursing and Phisiotherapy, Comillas Pontifical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758065
- Sponsor's protocol ID
- RPW-20/766-EC_X
- Acronym
- rPWT
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dissemination in biomedical research journals
Publications
Gerwin RD. Diagnosis of myofascial pain syndrome. Phys Med Rehabil Clin N Am. 2014 May;25(2):341-55. doi: 10.1016/j.pmr.2014.01.011. Epub 2014 Mar 18.
PubMed 24787337Hong CZ, Simons DG. Pathophysiologic and electrophysiologic mechanisms of myofascial trigger points. Arch Phys Med Rehabil. 1998 Jul;79(7):863-72. doi: 10.1016/s0003-9993(98)90371-9.
PubMed 9685106Madson TJ, Cieslak KR, Gay RE. Joint mobilization vs massage for chronic mechanical neck pain: a pilot study to assess recruitment strategies and estimate outcome measure variability. J Manipulative Physiol Ther. 2010 Nov-Dec;33(9):644-51. doi: 10.1016/j.jmpt.2010.08.008. Epub 2010 Oct 18.
PubMed 21109054Hidalgo 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 28826164Ciubotariu A, Arendt-Nielsen L, Graven-Nielsen T. Localized muscle pain causes prolonged recovery after fatiguing isometric contractions. Exp Brain Res. 2007 Jul;181(1):147-58. doi: 10.1007/s00221-007-0913-4. Epub 2007 Mar 20.
PubMed 17372728Wang CJ, Ko JY, Chan YS, Weng LH, Hsu SL. Extracorporeal shockwave for chronic patellar tendinopathy. Am J Sports Med. 2007 Jun;35(6):972-8. doi: 10.1177/0363546506298109. Epub 2007 Feb 16.
PubMed 17307892Kraemer R, Sorg H, Forstmeier V, Knobloch K, Liodaki E, Stang FH, Mailaender P, Kisch T. Immediate Dose-Response Effect of High-Energy Versus Low-Energy Extracorporeal Shock Wave Therapy on Cutaneous Microcirculation. Ultrasound Med Biol. 2016 Dec;42(12):2975-2982. doi: 10.1016/j.ultrasmedbio.2016.08.010. Epub 2016 Sep 20.
PubMed 27662701Ballyns JJ, Turo D, Otto P, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. Office-based elastographic technique for quantifying mechanical properties of skeletal muscle. J Ultrasound Med. 2012 Aug;31(8):1209-19. doi: 10.7863/jum.2012.31.8.1209.
PubMed 22837285Kozinc Z, Sarabon N. Shear-wave elastography for assessment of trapezius muscle stiffness: Reliability and association with low-level muscle activity. PLoS One. 2020 Jun 10;15(6):e0234359. doi: 10.1371/journal.pone.0234359. eCollection 2020.
PubMed 32520959
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Application of Radial Pressure Waves Together With a Manual Therapy Protocol and Therapeutic Exercise in the Treatment of Non-Specific Neck Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04758065
- Acronym / sponsor ID
- rPWT / RPW-20/766-EC_X
- Conditions
- Neck Pain
- Keywords
- Neck pain, Pain, Radial pressure waves, Elastography, Shear Wave, Physiotherapy, Exercise, Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Pontificia ComillasUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 17 Feb 2021 (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 present study aims to know the effectiveness of radial pressure wave therapy in the treatment of people with nonspecific neck pain. The study hypothesis is that including radial pressure wave therapy in a protocol based on manual therapy and therapeutic exercise is more effective than the protocol alone for the treatment of nonspecific neck pain.
Participants will be randomly assigned into 2 groups, one will be applied only the manual therapy and exercise protocol and the other the same protocol, plus shock wave therapy. Data related to the pathology will be collected and compared between the two groups to determine which treatment is more effective.
Detailed description
Nonspecific neck pain is one of the main reasons for outpatient physiotherapy consultation and, due to its multifactorial origin, there are numerous approaches without a consensus on the effectiveness of the different treatments. The most recent systematic reviews show significant evidence about the efficacy of the combination of Manual Therapy (MT) and exercise on pain, muscle elasticity, posture, and functionality in patients suffering from neck pain.
During muscle evaluation, it is common to find painful pressure points that are not spontaneously. These asymptomatic areas, painful when pressed, appear as areas with loss of elasticity, when evaluated with quantitative elastography (shear wave), which influences their contractile capacity and their ability to develop strength, together with the inhibition caused by the pain. The accumulation of cytotoxic and nociceptive substances, derived from the excess activity, could be the cause of the shortening of muscle fibers, so an increase in vascularity could help improve their drainage and normalize their elasticity and functionality.
Radial shock waves have been shown to be effective in angiogenesis, increasing vascularity and oxygen saturation of treated areas, so it could be a useful tool to help solve this problem.
This study aims to determine the effectiveness of radial shock waves to locate and treat the areas of loss of elasticity, found during muscle evaluation, combined with a MT and exercise protocol, compared to the manual therapy and exercise protocol itself. To do this, participants will be randomly assigned into 2 groups, one will be applied only the manual therapy and exercise protocol and the other the same protocol, plus shock wave therapy. The data collected will be compared between the two groups. An intention-to-treat statistical analysis will be performed.
Objective:
To determine the influence of the application of radial pressure waves together with the usual Physiotherapy treatment on the elasticity of muscle tissue, pain, the amplitude and harmony of cervical movements, strength, and quality of life in people with nonspecific neck pain
Methods:
The research will begin at the end of February 2021 and will be carried out in the biomechanics and movement analysis laboratory of the San Juan de Dios School of Nursing and Physiotherapy, Comillas Pontifical University, and at the Cimeg Madrid facilities.
A preliminary pilot study will be carried out with 10 volunteers with nonspecific neck pain, in order to calculate the sample size appropriate to the proposed objectives.
Participants will be randomly assigned using sealed envelopes to one of the two groups.
Group 1 will perform a conventional treatment protocol of physical therapy based on manual therapy and therapeutic exercise, for 4 weeks. Participants will go to the facilities, once a week, to get 1 session of manual therapy treatment, based on the Maitland Concept, on the cervical and thoracic spine. Besides this, they will perform 3 sessions a week of home-based cervical therapeutic exercise.
Group 2 will perform the same treatment protocol as Group 1, and in addition, will get a radial pressure waves session in the pressure sore spots, found in the muscle evaluation.
Muscle Elasticity, Pain Pressure Threshold, Cervical Pain, Active Range of Motion, the harmony of movement, Shoulder lift strength, Quality of life, Disability, and Kinesiophobia will be measured before and after treatment (at 4 weeks), at one month, and at three months after the start of the study. while demographic variables (Number of sore spots, Age, Sex, Dominance, Height, Weight, Body Mass Index (BMI), Educational level, Work Activity, and Sports Activity) will only be measured at the baseline.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a randomized controlled clinical trial with parallel groups.
| Arm | Type | Receives |
|---|---|---|
| 1-Goup: Control group | Active comparator | Other: Therapeutic Exercise and Manual TherapyHome-based cervical therapeutic exercise and manual therapy. |
| 2-Group: Radial pressure waves Group | Experimental | Other: Radial pressure waves Therapy, Other: Therapeutic Exercise and Manual TherapyHome-based cervical therapeutic exercise, manual therapy, and radial pressure waves. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-Specific Neck Pain (NSNP)
- Age between 18 and 59 years,
Key exclusion criteria (13 listed)
- Previous spine surgery.
- Neurological pathology.
- Rheumatoid arthritis.
- Fibromyalgia.
- Vertebral fractures or fissures.
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 pressure waves TherapyCombination of the usual physiotherapy treatment with the application of radial pressure waves compared with a control group in which only the usual treatment, in people with non-specific neck pain, will be applied. During the first month, the participants will perform 3 weekly sessions of home-based cervical therapeutic exercise and will come to the facilities, once a week, to get a manual therapy session based on the Maitland Concept (15 minutes of posteroanterior mobilizations in the restricted and/or painful vertebrae of the cervical and thoracic spine). Besides this participants of the experimental group will receive a radial pressure waves treatment sessión. Experimental Group: Home-based cervical therapeutic exercise, manual therapy, and radial pressure waves. | Other | 2-Group: Radial pressure waves Group |
| Therapeutic Exercise and Manual TherapyCombination of the usual physiotherapy treatment with the application of radial pressure waves compared with a control group in which only the usual treatment, in people with non-specific neck pain, will be applied. During the first month, the participants will perform 3 weekly sessions of home-based cervical therapeutic exercise and will come to the facilities, once a week, to get a manual therapy session based on the Maitland Concept (15 minutes of posteroanterior mobilizations in the restricted and/or painful vertebrae of the cervical and thoracic spine). Besides this participants of the experimental group will receive a radial pressure waves treatment sessión. Control Group: Home-based cervical therapeutic exercise and manual therapy. | Other | 1-Goup: Control group, 2-Group: Radial pressure waves Group |
Primary outcome
Change in Muscle Elasticity
Time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Using Shear Wave Elastography
18 secondary outcomes
Change in Pain Pressure Threshold
Time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Cervical Pain assessed by Visual Analog Scale for acute pain (Spanish version)
Time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Active Range of Motion
Time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Jerk of cervical movements
Time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Shoulder lift strength
Time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in the Quality of life assessed by the SF-12 questionnaire (Spanish version)
Time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Disability assessed by the Neck disability index (NDI) questionnaire (Spanish version)
Time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Change in Kinesiophobia assessed by the Tampa Scale for Kinesiophobia-11 (TSK-11) questionnaire (Spanish version)
Time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Number of sore spots
Time frame: Baseline
Age in years
Time frame: Baseline
Gender
Time frame: Baseline
Dominance
Time frame: Baseline
Height in centimeters
Time frame: Baseline
Weight in kilograms
Time frame: Baseline
Educational level
Time frame: Baseline
Work Activity
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Sports Activity, assessed by Rapid Assessment of Physical Activity-1 (RAPA-1) test
Time frame: Baseline
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 2 Apr 2025.
- Background: PubMed 24787337Gerwin RD. Diagnosis of myofascial pain syndrome. Phys Med Rehabil Clin N Am. 2014 May;25(2):341-55. doi: 10.1016/j.pmr.2014.01.011. Epub 2014 Mar 18.
- Background: PubMed 9685106Hong CZ, Simons DG. Pathophysiologic and electrophysiologic mechanisms of myofascial trigger points. Arch Phys Med Rehabil. 1998 Jul;79(7):863-72. doi: 10.1016/s0003-9993(98)90371-9.
- Results publication: PubMed 21109054Madson TJ, Cieslak KR, Gay RE. Joint mobilization vs massage for chronic mechanical neck pain: a pilot study to assess recruitment strategies and estimate outcome measure variability. J Manipulative Physiol Ther. 2010 Nov-Dec;33(9):644-51. doi: 10.1016/j.jmpt.2010.08.008. Epub 2010 Oct 18.
- Results publication: 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.
- Results publication: PubMed 17372728Ciubotariu A, Arendt-Nielsen L, Graven-Nielsen T. Localized muscle pain causes prolonged recovery after fatiguing isometric contractions. Exp Brain Res. 2007 Jul;181(1):147-58. doi: 10.1007/s00221-007-0913-4. Epub 2007 Mar 20.
- Results publication: PubMed 17307892Wang CJ, Ko JY, Chan YS, Weng LH, Hsu SL. Extracorporeal shockwave for chronic patellar tendinopathy. Am J Sports Med. 2007 Jun;35(6):972-8. doi: 10.1177/0363546506298109. Epub 2007 Feb 16.
- Results publication: PubMed 27662701Kraemer R, Sorg H, Forstmeier V, Knobloch K, Liodaki E, Stang FH, Mailaender P, Kisch T. Immediate Dose-Response Effect of High-Energy Versus Low-Energy Extracorporeal Shock Wave Therapy on Cutaneous Microcirculation. Ultrasound Med Biol. 2016 Dec;42(12):2975-2982. doi: 10.1016/j.ultrasmedbio.2016.08.010. Epub 2016 Sep 20.
- Results publication: PubMed 22837285Ballyns JJ, Turo D, Otto P, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. Office-based elastographic technique for quantifying mechanical properties of skeletal muscle. J Ultrasound Med. 2012 Aug;31(8):1209-19. doi: 10.7863/jum.2012.31.8.1209.
- Results publication: PubMed 32520959Kozinc Z, Sarabon N. Shear-wave elastography for assessment of trapezius muscle stiffness: Reliability and association with low-level muscle activity. PLoS One. 2020 Jun 10;15(6):e0234359. doi: 10.1371/journal.pone.0234359. eCollection 2020.
- Tampa Scale for Kinesiophobia TSK-11Link provided by the sponsor.
- NECK DISABILITY INDEX (NDI) Spanish VersionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Dissemination in biomedical research journals
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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.
Carlos López Moreno, MSc principal investigator
San Juan de Dios School of Nursing and Phisiotherapy, Comillas Pontifical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial pressure waves Therapy and Therapeutic Exercise and Manual Therapy in people with Neck Pain, run by Universidad Pontificia Comillas at 2 sites 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 2 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Change in Muscle Elasticity (time frame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement). 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 NCT04758065, 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 2 Apr 2025.