Effectiveness of Radial Pressure Waves Therapy in the Treatment of Non-Specific Neck Pain (rPWT) (rPWT)

  • STATUS
    Recruiting
  • End date
    Apr 15, 2023
  • participants needed
    60
  • sponsor
    Universidad Pontificia Comillas
Updated on 30 May 2022
shock
manual therapy
mobilisation

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.

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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Details
Condition Neck Pain
Treatment Radial pressure waves Therapy, Therapeutic Exercise and Manual Therapy
Clinical Study IdentifierNCT04758065
SponsorUniversidad Pontificia Comillas
Last Modified on30 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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