Clinical trial NCT04758065: Effectiveness of Radial Pressure Waves Therapy in the Treatment of Non-Specific Neck Pain (rPWT)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain
Pain
Radial pressure waves
Elastography
Shear Wave
Physiotherapy
Exercise
Intervention
Lead sponsor: Universidad Pontificia Comillas
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized controlled clinical trial with parallel groups.
Primary purpose: TREATMENT

Brief 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 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.

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Eligibility criteria: Inclusion Criteria:

* Non-Specific Neck Pain (NSNP)
* Age between 18 and 59 years,

Exclusion Criteria:

* Previous spine surgery.
* Neurological pathology.
* Rheumatoid arthritis.
* Fibromyalgia.
* Vertebral fractures or fissures.
* Radiculopathies.
* 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.

Primary outcomes:
measure: Change in Muscle Elasticity
timeFrame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
Secondary outcomes:
measure: Change in Pain Pressure Threshold
timeFrame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
measure: Change in Cervical Pain assessed by Visual Analog Scale for acute pain (Spanish version)
timeFrame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
measure: Change in Active Range of Motion
timeFrame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
measure: Change in Jerk of cervical movements
timeFrame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
measure: Change in Shoulder lift strength
timeFrame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
measure: Change in the Quality of life assessed by the SF-12 questionnaire (Spanish version)
timeFrame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
measure: Change in Disability assessed by the Neck disability index (NDI) questionnaire (Spanish version)
timeFrame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
measure: Change in Kinesiophobia assessed by the Tampa Scale for Kinesiophobia-11 (TSK-11) questionnaire (Spanish version)
timeFrame: Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement
measure: Number of sore spots
timeFrame: Baseline
measure: Age in years
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Dominance
timeFrame: Baseline
measure: Height in centimeters
timeFrame: Baseline
measure: Weight in kilograms
timeFrame: Baseline
measure: Educational level
timeFrame: Baseline
measure: Work Activity
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Sports Activity, assessed by Rapid Assessment of Physical Activity-1 (RAPA-1) test
timeFrame: Baseline
Other outcomes:
Locations:
city: Ciempozuelos
country: Spain
facility: San Juan de Dios School of Nursing and Phisiotherapy, Comillas Pontifical University
state: Madrid
city: Madrid
country: Spain
facility: CIMEG Madrid
Study officials:
affiliation: San Juan de Dios School of Nursing and Phisiotherapy, Comillas Pontifical University
name: Carlos López Moreno, MSc
role: PRINCIPAL_INVESTIGATOR
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