Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

Not Applicable

Completed

• Conditions: Cervical Pain; Pain
• Interventions: Device: extra-corporeal shock wave therapy; Drug: topical none steroidal anti-inflammatory drug

• Registration Number: NCT04270968
• Lead Sponsor: Qassim University

Brief 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.

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.

Study Timeline

• Study Start: 2018-11-03
• Primary Completion: 2019-11-20
• Study Completion: 2019-12-03
• Status Verified: 2020-02
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-12
• Last Update Submitted: 2020-02-12
• Study First Posted: 2020-02-17
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESWT Group	extra-corporeal shock wave therapy	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).
control group	topical none steroidal anti-inflammatory drug	received only topical NSAID.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Physical Therapy, Cairo University; 🇪🇬 Cairo, Egypt