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Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

Primary Purpose

Pain, Cervical Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
extra-corporeal shock wave therapy
topical none steroidal anti-inflammatory drug
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ESWT Group

control group

Arm Description

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).

received only topical NSAID.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 11, 2020
Last Updated
February 12, 2020
Sponsor
Qassim University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04270968
Brief Title
Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery
Official Title
Efficacy of Extracorporeal Shock Wave Therapy (ESWT) on Cervical Myofascial Pain Following Neck Dissection Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 3, 2018 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
December 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
Cairo University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Cervical Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESWT Group
Arm Type
Experimental
Arm Description
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).
Arm Title
control group
Arm Type
Experimental
Arm Description
received only topical NSAID.
Intervention Type
Device
Intervention Name(s)
extra-corporeal shock wave therapy
Other Intervention Name(s)
shock wave therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
topical none steroidal anti-inflammatory drug
Other Intervention Name(s)
topical NSAID
Intervention Description
participants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
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.
Time Frame
before treatment
Title
Visual analogue scale
Description
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.
Time Frame
2 weeks of treatment
Title
Visual analogue scale
Description
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.
Time Frame
after 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Cervical range of motion assessment
Description
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.
Time Frame
before treatment
Title
Cervical range of motion assessment
Description
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.
Time Frame
2 weeks of treatment
Title
Cervical range of motion assessment
Description
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.
Time Frame
after 4 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MAGED A BASHA, Dr
Organizational Affiliation
Assistant Professor, Qassim University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Cairo
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
23093823
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.
Results Reference
result
PubMed Identifier
10484856
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. doi: 10.1016/s0885-3924(99)00054-8.
Results Reference
result
PubMed Identifier
22836591
Citation
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.
Results Reference
result

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Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

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