- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Menofya
-
Shibīn al Kawm, Menofya, Egypt, 32521
- 12
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control group, standardized physiotherapy group receiving (Stretch, strength, Postural correction)
The control group recieve conventional program without additional shockwave
|
Stretch + isometrics + postural correction
Other Names:
|
|
Experimental: Intervention group received Extracorporeal shockwave therapy + Standardized physiotherapy as control
Group B
|
Stretch + isometrics + postural correction
Other Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
|
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.
|
4 weeks
|
|
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 weeks
|
|
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.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neck Pain
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Rehabilitation
- Ultrasonic Therapy
- Diathermy
- Hyperthermia, Induced
- Exercise
- Extracorporeal Shockwave Therapy
Other Study ID Numbers
- Shockwave in neck pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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