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

NCT04758065 | Active Not Recruiting

• 1 other identifier: RPW-20/766-EC_X
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain

Keywords

Neck pain; Pain; Radial pressure waves; Elastography; Shear Wave; Physiotherapy; Exercise; Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Muscle Elasticity

  Using Shear Wave Elastography

  Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement

Secondary Outcomes (18)

• Change in Pain Pressure Threshold

  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)

  Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement

• Change in Active Range of Motion

  Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement

• Change in Jerk of cervical movements

  Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement

• Change in Shoulder lift strength

  Baseline, 4 weeks (after treatment), 1 month and 3 months after intervention commencement

Study Arms (2)

1-Goup: Control group

ACTIVE COMPARATOR

Home-based cervical therapeutic exercise and manual therapy.

Other: Therapeutic Exercise and Manual Therapy

2-Group: Radial pressure waves Group

EXPERIMENTAL

Home-based cervical therapeutic exercise, manual therapy, and radial pressure waves.

Other: Radial pressure waves Therapy; Other: Therapeutic Exercise and Manual Therapy

Interventions

Radial pressure waves Therapy OTHER

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.

2-Group: Radial pressure waves Group

Therapeutic Exercise and Manual Therapy OTHER

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.

1-Goup: Control group; 2-Group: Radial pressure waves Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pontificia Comillas: lead

Study Sites (2)

San Juan de Dios School of Nursing and Phisiotherapy, Comillas Pontifical University

Ciempozuelos, Madrid, 28350, Spain

Location

CIMEG Madrid

Madrid, 28010, Spain

Location

Related Publications (9)

• 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.

  PMID: 24787337 BACKGROUND

• Hong 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.

  PMID: 9685106 BACKGROUND

• Madson 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.

  PMID: 21109054 RESULT

• Hidalgo 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.

  PMID: 28826164 RESULT

• Ciubotariu 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.

  PMID: 17372728 RESULT

• Wang 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.

  PMID: 17307892 RESULT

• Kraemer 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.

  PMID: 27662701 RESULT

• Ballyns 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.

  PMID: 22837285 RESULT

• Kozinc 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.

  PMID: 32520959 RESULT

Related Links

• Tampa Scale for Kinesiophobia TSK-11
• NECK DISABILITY INDEX (NDI) Spanish Version

MeSH Terms

Conditions

Neck Pain; Pain; Motor Activity

Interventions

Exercise Therapy; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Complementary Therapies

Study Officials

• Carlos López Moreno, MSc

  San Juan de Dios School of Nursing and Phisiotherapy, Comillas Pontifical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of investigators at study inclusion to randomization sequence, using sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: It is a randomized controlled clinical trial with parallel groups.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 17, 2021
• Study Start: March 1, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 30, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting January 2022
• Access Criteria: Open Access

Locations

ES (2)