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Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

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StatusCompleted
Sponsors
Qassim University
Collaborators
Cairo University

Keywords

Abstract

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.

Dates

Last Verified: 01/31/2020
First Submitted: 02/10/2020
Estimated Enrollment Submitted: 02/11/2020
First Posted: 02/16/2020
Last Update Submitted: 02/11/2020
Last Update Posted: 02/16/2020
Actual Study Start Date: 11/02/2018
Estimated Primary Completion Date: 11/19/2019
Estimated Study Completion Date: 12/02/2019

Condition or disease

Pain
Cervical Pain

Intervention/treatment

Device: ESWT Group

Drug: control group

Phase

-

Arm Groups

ArmIntervention/treatment
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: ESWT Group
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.
Experimental: control group
received only topical NSAID.
Drug: control group
participants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks.

Eligibility Criteria

Ages Eligible for Study 35 Years To 35 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Criteria

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.

Outcome

Primary Outcome Measures

1. Visual analogue scale [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 [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 [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 Outcome Measures

1. Cervical range of motion assessment [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 [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 [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.

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