Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270968
• Other study ID #: 1857PT
• Status: Completed
• Phase: N/A
• Start date: November 3, 2018
• Est. completion date: December 3, 2019

Study information

• Verified date: February 2020
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 3, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Cervical Pain
• Neck Pain
• Pain

Intervention

Device:
• extra-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.

Drug:
• topical none steroidal anti-inflammatory drug
participants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Cairo University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Qassim University	Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before treatment
Primary	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.	2 weeks of treatment
Primary	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.	after 4 weeks of treatment
Secondary	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.	before treatment
Secondary	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.	2 weeks of treatment
Secondary	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.	after 4 weeks of treatment