Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

Efficacy of Extracorporeal Shock Wave Therapy (ESWT) on Cervical Myofascial 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.

Study Overview

• Status: Completed
• Conditions: Pain; Cervical Pain
• Intervention / Treatment: Device: extra-corporeal shock wave therapy; Drug: topical none steroidal anti-inflammatory drug

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Faculty of physical therapy, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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: 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.; Other Names: shock wave therapy
EXPERIMENTAL: control group; received only topical NSAID.	Drug: topical none steroidal anti-inflammatory drug; participants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks.; Other Names: topical NSAID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Qassim University
• Collaborators: Cairo University
• Investigators: Study Director: MAGED A BASHA, Dr, Assistant Professor, Qassim University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 3, 2018
• Primary Completion (ACTUAL): November 20, 2019
• Study Completion (ACTUAL): December 3, 2019

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (ACTUAL): February 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Anti-Inflammatory Agents
• Other Study ID Numbers: 1857PT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, and figure)
• IPD Sharing Time Frame: Immediately following publication.
• IPD Sharing Access Criteria: IPD will be available upon reasonable request by email from the main author after revising the requester qualification relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes