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CompletedNCT04270968Updated Feb 17, 2020

Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

An interventional study of extra-corporeal shock wave therapy and topical none steroidal anti-inflammatory drug in Pain and Cervical Pain, sponsored by Qassim University. Completed at 1 site in Egypt. Open to participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Qassim University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2019, 6 years 10 months ago, and no results have been posted to the registry.
  • Registered 1 year 3 months after the study started (first participant enrolled Nov 2018, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
35 Years to 60 Years
Sex
All
01

Study summary

Myofascial pain syndrome (MPS) is a musculoskeletal disorder which is characterized by pain, muscle spasms and muscle tenderness, as well as a limited range of motion, weakness, and rarely, autonomous dysfunction.

Read the detailed description

The occurrences of morbidity of the neck after cancer therapy were considerable and consisted of neck pain, loss of sensation, and decreased range of motion. Extracorporeal shock wave therapy (ESWT) is one of the treatment options used for patients with myofascial pain syndrome through elimination of ischemia and modulation of vasoneuroactive substance (two major causes of trigger pathophysiology) and mechanical transduction as a cellular response to external stimulation. the aim of this study was to investigate efficacy of extracorporeal shock wave therapy (ESWT) on cervical myofascial pain following neck dissection surgery.

02

Conditions studied

  • Pain
  • Cervical Pain

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03

In context

Neck Pain

1,231 studies on the registry are indexed under Neck Pain; 254 are open to participants now.

This study's enrollment of 46 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Qassim University is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Previous unilateral modified radical neck dissection.
  2. Patients with myofascial pain of upper trapezius for at least 3 months.
  3. Patients with palpable intramuscular taut band.
  4. Restriction in cervical ROM of lateral flexion and rotation.
  5. Provocation of the clinical symptoms by compression of the active trigger point

Exclusion criteria

Exclusion Criteria:

  1. Patient who received medication or other therapies for MPS within the previous 2 months.
  2. Patients with pacemaker, pregnancy
  3. Open wound at the treatment area.
  4. Cervical myelopathy or radiculopathy, cervical spine fracture or spondylolisthesis.
  5. Rheumatoid arthritis.
  6. Coagulopathy.
  7. Epilepsy or any psychological disorder.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    ESWT Group

    received ESWT once a week for 4 weeks (0.25 ml/mm2, 1000 shocks) plus topical none steroidal anti-inflammatory drug (NSAID; 3 times /day for 4 weeks).

    Device: extra-corporeal shock wave therapy

  • Experimental
    control group

    received only topical NSAID.

    Drug: topical none steroidal anti-inflammatory drug

Interventions

  • Deviceextra-corporeal shock wave therapy

    Extracorporeal Shock Wave Therapy (ESWT) has been introduced efficiently for more than twenty years as a treatment modality in orthopedic and musculoskeletal disorders. ESWT has mechanical and cellular impacts on tissues regeneration and pain management through cavitation bubbles, acoustic micro streaming, and hyper-vascularity that can directly affect tissue calcifications, and modulate cell activity.

    Also known as: shock wave therapy

  • Drugtopical none steroidal anti-inflammatory drug

    participants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks.

    Also known as: topical NSAID

06

What researchers measure

Primary outcomes

  1. Visual analogue scale

    VAS was utilized for assessing and quantifying pain exhibited by the patients through a 0-10 cm scale. Each subject was informed to mark the line according to the pain intensity experienced at that particular time where '0' means no pain and '10' means worst conceivable pain.

    Time frame: before treatment

  2. Visual analogue scale

    VAS was utilized for assessing and quantifying pain exhibited by the patients through a 0-10 cm scale. Each subject was informed to mark the line according to the pain intensity experienced at that particular time where '0' means no pain and '10' means worst conceivable pain.

    Time frame: 2 weeks of treatment

  3. Visual analogue scale

    VAS was utilized for assessing and quantifying pain exhibited by the patients through a 0-10 cm scale. Each subject was informed to mark the line according to the pain intensity experienced at that particular time where '0' means no pain and '10' means worst conceivable pain.

    Time frame: after 4 weeks of treatment

Secondary outcomes

  1. Cervical range of motion assessment

    Cervical range of motion device (CROM; Performance Attainment Associates) was used for assessment of neck lateral flexion and rotation of both sides. The CROM instrument contains a plastic frame put on the head above the nose and ears, attached at the head back by a Velcro strap to allow precise measure, re-measure and rotational motion in an upright place to avoid individual errors. Two independent inclinometers are connected to the frame and point the head position in relation to the gravity line. Another inclinometer indicates the head position in rotation in relation to a reference position.

    Time frame: before treatment

  2. Cervical range of motion assessment

    Cervical range of motion device (CROM; Performance Attainment Associates) was used for assessment of neck lateral flexion and rotation of both sides. The CROM instrument contains a plastic frame put on the head above the nose and ears, attached at the head back by a Velcro strap to allow precise measure, re-measure and rotational motion in an upright place to avoid individual errors. Two independent inclinometers are connected to the frame and point the head position in relation to the gravity line. Another inclinometer indicates the head position in rotation in relation to a reference position.

    Time frame: 2 weeks of treatment

  3. Cervical range of motion assessment

    Cervical range of motion device (CROM; Performance Attainment Associates) was used for assessment of neck lateral flexion and rotation of both sides. The CROM instrument contains a plastic frame put on the head above the nose and ears, attached at the head back by a Velcro strap to allow precise measure, re-measure and rotational motion in an upright place to avoid individual errors. Two independent inclinometers are connected to the frame and point the head position in relation to the gravity line. Another inclinometer indicates the head position in rotation in relation to a reference position.

    Time frame: after 4 weeks of treatment

07

Study locations

1 site
  • Faculty of Physical Therapy, Cairo University
    Cairo, 11432, Egypt
08

References and documents

Publications

  • Guru K, Manoor UK, Supe SS. A comprehensive review of head and neck cancer rehabilitation: physical therapy perspectives. Indian J Palliat Care. 2012 May;18(2):87-97. doi: 10.4103/0973-1075.100820. PubMed 23093823 ↗
  • Sist T, Miner M, Lema M. Characteristics of postradical neck pain syndrome: a report of 25 cases. J Pain Symptom Manage. 1999 Aug;18(2):95-102. doi: 10.1016/s0885-3924(99)00054-8. PubMed 10484856 ↗
  • Bron C, Dommerholt JD. Etiology of myofascial trigger points. Curr Pain Headache Rep. 2012 Oct;16(5):439-44. doi: 10.1007/s11916-012-0289-4. PubMed 22836591 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 11, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figure)

Supporting information: Study protocol, Sap, Icf, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04270968
Lead sponsor
Qassim University
Collaborators
Cairo University
Responsible party
Maged Basha (Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah., Qassim University) — Principal investigator
First posted
Feb 17, 2020
Start date
Nov 3, 2018
Primary completion
Nov 20, 2019
Completion
Dec 3, 2019
Last update
Feb 17, 2020

Study contacts

MAGED A BASHA, Dr
study director · Assistant Professor, Qassim University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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