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Completed

NCT Number: NCT07266272

Influence of Extracorporeal Shockwave Therapy in Patients of Mechanical Neck Pain

Purpose:

The study aimed to determine whether adding extracorporeal shockwave therapy (ESWT) to a standardized physiotherapy program provides additional benefits for patients with chronic mechanical neck pain. Specifically, it examined effects on pain intensity, pressure pain threshold (PPT), neck disability index (NDI), cervical active range of motion (AROM), and joint position sense (JPS).

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

12

Shibīn al Kawm, Menofya, 32521, Egypt

About this study

Study Summary Summary of the Study: Influence of Extracorporeal Shockwave Therapy in Patients with Mechanical Neck Pain

Purpose:

The study aimed to determine whether adding extracorporeal shockwave therapy (ESWT) to a standardized physiotherapy program provides additional benefits for patients with chronic mechanical neck pain. Specifically, it examined effects on pain intensity, pressure pain threshold (PPT), neck disability index (NDI), cervical active range of motion (AROM), and joint position sense (JPS).

Key Details:

  • Study Design: Double-blinded, pretest-posttest controlled clinical trial.
  • Participants: 52 patients aged 18-29 with chronic mechanical neck pain for over 3 months.
  • Groups:
  • Group A: Standardized physiotherapy only (stretching, isometric exercises, posture training).
  • Group B: ESWT + standardized physiotherapy.
  • Duration: 4 weeks, 2 sessions/week (1 ESWT + 1 physiotherapy in Group B).
  • Assessments: NPRS for pain, pressure algometer for PPT, Arabic NDI, goniometer for AROM & JPS.
  • Results:
  • Adding ESWT significantly improved PPT, left cervical rotation AROM, cervical extension JPS, and right cervical rotation JPS.
  • No significant differences between groups in other measures.
  • Conclusion: ESWT combined with physiotherapy may enhance pain threshold, AROM in rotation, and proprioception compared to physiotherapy alone.

Sources of Strength in the Study:

  • Double-blind design reduces bias.
  • Randomized allocation with adequate sample size determined by power analysis.
  • Use of validated measurement tools (NPRS, NDI Arabic version, Wagner algometer, standard goniometer).
  • Clearly defined inclusion/exclusion criteria ensuring sample homogeneity.
  • Use of standardized physiotherapy protocol enhances reproducibility.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients (both males and females) with chronic non-specific neck pain for more than three months.
  • The patient's age is between 18 and 29 years old.
  • The patient has at least one taut band at the upper fibers of the trapezius as described in assessment procedures.
  • patient's numeric pain rating scale (NPRS) was 3 to 8 out of 10

Exclusion criteria

  • Were treated for neck or shoulder pain during the last three months.
  • Had a neck or shoulder operation during the last two years.
  • Had any structural pathology of the cervical spine, such as disk prolapse, spinal stenosis, or cervical spondylosis.
  • Had a traumatic history, instability, and spasmodic torticollis.
  • Had cardiovascular, respiratory, or allergic disease or neck osteoarthritis.
  • Had homeostatic disorders.
  • Fibromyalgia, shoulder diseases (tendonitis, bursitis, capsulitis).
  • Inflammatory rheumatic diseases.
  • Severe psychiatric illness and other diseases that restrict physical loading, and pregnancy (Salo et al., 2010).
  • Patients with vertebrobasilar insufficiency and vertigo.

Treatment and study plan

Extracorporeal shockwave therapy

Device

Radial, pneumatic extracorporeal shockwave therapy: The ESWT was applied using the following treatment parameters: 2,000 pulses, intensity of 1 to 1.2 bars, and 10 Hz frequency

Other names: ESWT

Exercise

Other

Stretch + isometrics + postural correction

Other names: Strength _ Activation_ stretch_ postural correction

Primary outcomes

  1. Pressure pain threshold (PPT)

    Time frame: 4 weeks

    The minimum amount of pressure applied to body tissue that a person perceives as pain, rather than just pressure, is measured by an algometer. Another definition is the point at which a sensation changes from pressure to pain. measured by an algometer. A higher score is better, and a lower score is worse.

Secondary outcomes

  1. Active cervical range of motion

    Time frame: 4 weeks

    Active cervical range of motion in 6 directions: flexion, extension, sidebending in both directions, and rotation in both directions. The higher score is better, and the lower score is worse.

  2. Joint position sense

    Time frame: 4 weeks

    Joint position sense is measured by joint position error via the head repositioning test. The head repositioning test is the ability of the individual to detect the predetermined position again using the neck's sense of position and movement in 6 directions. The lower score is better, and the higher score is worse. The lowest score is zero.

  3. Neck Pain

    Time frame: 4 weeks

    Pain is an unpleasant sensation measured by numeric pain rating score (NPRS) The highest score is 10, and the lowest score is zero. Ten is maximum pain, and zero is no pain. The higher score is worse, and the lower score is better.

  4. Neck disability index (NDI)

    Time frame: 4 weeks

    The index displays the level of neck disability (questionnaire). The higher score is worse, and the lower score is better. Percentage score: The highest score is 100%, and the lowest score is 0%. Raw score: the lowest score is 0, and the highest score is 50.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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