Neck Pain MusculoskeletalNCT07266272
Influence of Extracorporeal Shockwave Therapy in Patients of Mechanical Neck Pain
A study testing Extracorporeal Shockwave therapy and Exercise in people with Neck Pain Musculoskeletal and Neck Pain, run by Benha University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Neck Pain Musculoskeletal, Neck Pain, Extracorporeal Shock Wave Therapy
- What is being tested?
- Extracorporeal Shockwave therapy and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Neck Pain Musculoskeletal, Neck Pain, Extracorporeal Shock Wave Therapy, Mechanical Neck Pain, Cervical Pain, Posterior, Pain Threshold
- Being tested
- Extracorporeal Shockwave therapy, Exercise
- Keywords
- Neck pain, Cervical joint position sense, Cervical range of motion, Pressure pain threshold, Extracorporeal shock wave therapy, Chronic mechanical neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave therapyDevice
Also called ESWT
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
ExerciseOther
Also called Strength _ Activation_ stretch_ postural correction
Stretch + isometrics + postural correction
| Study group | Role | What they receive |
|---|---|---|
| Control group, standardized physiotherapy group receiving (Stretch, strength, Postural correction) | Other | The control group recieve conventional program without additional shockwave Receives: Other: Exercise |
| Intervention group received Extracorporeal shockwave therapy + Standardized physiotherapy as control | Experimental | Group B Receives: Device: Extracorporeal Shockwave therapy; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold (PPT)
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.
Measured: 4 weeks
Secondary outcomes (4)
Active cervical range of motion
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.
Measured: 4 weeks
Joint position sense
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.
Measured: 4 weeks
Neck Pain
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.
Measured: 4 weeks
Neck disability index (NDI)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Jul 2023
- Primary completion25 Feb 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neck Pain MusculoskeletalStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Faramawy Shible El.deeb, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266272
- Sponsor's protocol ID
- Shockwave in neck pain
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25811029Abbott 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.
PubMed 24828475Abadiyan 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.
PubMed 33845880Romeo 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.
PubMed 24217134Rahbar 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.
PubMed 32731757
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Extracorporeal Shockwave Therapy in Patients of Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT07266272
- Acronym / sponsor ID
- Shockwave in neck pain
- Conditions
- Neck Pain Musculoskeletal, Neck Pain, Extracorporeal Shock Wave Therapy, Mechanical Neck Pain, Cervical Pain, Posterior, Pain Threshold
- Keywords
- Neck pain, Cervical joint position sense, Cervical range of motion, Pressure pain threshold, Extracorporeal shock wave therapy, Chronic mechanical neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group, standardized physiotherapy group receiving (Stretch, strength, Postural correction) | Other | Other: ExerciseThe control group recieve conventional program without additional shockwave |
| Intervention group received Extracorporeal shockwave therapy + Standardized physiotherapy as control | Experimental | Device: Extracorporeal Shockwave therapy, Other: ExerciseGroup B |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shockwave therapyAlso: ESWTRadial, 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 | Device | Intervention group received Extracorporeal shockwave therapy + Standardized physiotherapy as control |
| ExerciseAlso: Strength _ Activation_ stretch_ postural correctionStretch + isometrics + postural correction | Other | Control group, standardized physiotherapy group receiving (Stretch, strength, Postural correction), Intervention group received Extracorporeal shockwave therapy + Standardized physiotherapy as control |
Primary outcome
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 secondary outcomes
Active cervical range of motion
Time frame: 4 weeks
Joint position sense
Time frame: 4 weeks
Neck Pain
Time frame: 4 weeks
Neck disability index (NDI)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Results publication: PubMed 25811029Akamatsu 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.
- Results publication: PubMed 24828475Abbott 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.
- Results publication: PubMed 33845880Abadiyan 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.
- Results publication: PubMed 24217134Romeo 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.
- Results publication: PubMed 32731757Rahbar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave therapy and Exercise in people with Neck Pain Musculoskeletal and Neck Pain, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (PPT) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07266272, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.