Influence of Extracorporeal Shockwave Therapy in Patients of Mechanical Neck Pain

NCT ID: NCT07266272

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-03-27

Brief Summary

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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).

Detailed Description

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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:

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

Conditions

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Neck Pain Musculoskeletal Neck Pain Extracorporeal Shock Wave Therapy Mechanical Neck Pain Cervical Pain, Posterior Pain Threshold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Statistician and outcome assessor who is also an investigator.

Study Groups

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Control group, standardized physiotherapy group receiving (Stretch, strength, Postural correction)

The control group recieve conventional program without additional shockwave

Group Type OTHER

Exercise

Intervention Type OTHER

Stretch + isometrics + postural correction

Intervention group received Extracorporeal shockwave therapy + Standardized physiotherapy as control

Group B

Group Type EXPERIMENTAL

Extracorporeal Shockwave therapy

Intervention Type 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

Exercise

Intervention Type OTHER

Stretch + isometrics + postural correction

Interventions

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Extracorporeal Shockwave therapy

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

Intervention Type DEVICE

Exercise

Stretch + isometrics + postural correction

Intervention Type OTHER

Other Intervention Names

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ESWT Strength _ Activation_ stretch_ postural correction

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Faramawy Shible El.deeb

Assistant lecturer of physical therapy for orthopedics and sport injuries

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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12

Shibīn al Kawm, Menofya, Egypt

Site Status

Countries

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Egypt

References

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Akamatsu FE, Ayres BR, Saleh SO, Hojaij F, Andrade M, Hsing WT, Jacomo AL. Trigger points: an anatomical substratum. Biomed Res Int. 2015;2015:623287. doi: 10.1155/2015/623287. Epub 2015 Feb 24.

Reference Type RESULT
PMID: 25811029 (View on PubMed)

Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14.

Reference Type RESULT
PMID: 24828475 (View on PubMed)

Abadiyan F, Hadadnezhad M, Khosrokiani Z, Letafatkar A, Akhshik H. Adding a smartphone app to global postural re-education to improve neck pain, posture, quality of life, and endurance in people with nonspecific neck pain: a randomized controlled trial. Trials. 2021 Apr 12;22(1):274. doi: 10.1186/s13063-021-05214-8.

Reference Type RESULT
PMID: 33845880 (View on PubMed)

Romeo P, Lavanga V, Pagani D, Sansone V. Extracorporeal shock wave therapy in musculoskeletal disorders: a review. Med Princ Pract. 2014;23(1):7-13. doi: 10.1159/000355472. Epub 2013 Nov 5.

Reference Type RESULT
PMID: 24217134 (View on PubMed)

Rahbar M, Samandarian M, Salekzamani Y, Khamnian Z, Dolatkhah N. Effectiveness of extracorporeal shock wave therapy versus standard care in the treatment of neck and upper back myofascial pain: a single blinded randomised clinical trial. Clin Rehabil. 2021 Jan;35(1):102-113. doi: 10.1177/0269215520947074. Epub 2020 Jul 30.

Reference Type RESULT
PMID: 32731757 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Shockwave in patients of neck pain protocol

View Document

Other Identifiers

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Shockwave in neck pain

Identifier Type: -

Identifier Source: org_study_id

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