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Completed

NCT Number: NCT04270968

Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

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.

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Key information

Conditions

Pain Cervical Pain Neck Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Cairo, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

extra-corporeal shock wave therapy

Device

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.

Other names: shock wave therapy

topical none steroidal anti-inflammatory drug

Drug

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

Other names: topical NSAID

Primary outcomes

  1. Visual analogue scale

    Time frame: before treatment

    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.

  2. Visual analogue scale

    Time frame: 2 weeks of treatment

    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.

  3. Visual analogue scale

    Time frame: after 4 weeks of treatment

    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.

Secondary outcomes

  1. Cervical range of motion assessment

    Time frame: before treatment

    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.

  2. Cervical range of motion assessment

    Time frame: 2 weeks of treatment

    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.

  3. Cervical range of motion assessment

    Time frame: after 4 weeks of treatment

    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.

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Collaborators

  • Cairo University

Registry information

Official study title

Efficacy of Extracorporeal Shock Wave Therapy (ESWT) on Cervical Myofascial Pain Following Neck Dissection Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2020
Registry last updated
Feb 17, 2020

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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