Shock Wave Therapy On Cervical Pain Following Neck Dissection Surgery

NCT04270968 | Completed FDA Device

• 1 other identifier: 1857PT
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Cervical Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Cervical range of motion assessment

  before treatment

• Cervical range of motion assessment

  2 weeks of treatment

• Cervical range of motion assessment

  after 4 weeks of treatment

Study Arms (2)

ESWT Group

EXPERIMENTAL

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

control group

EXPERIMENTAL

received only topical NSAID.

Drug: topical none steroidal anti-inflammatory drug

Interventions

extra-corporeal shock wave therapy DEVICE

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.

Also known as: shock wave therapy

ESWT Group

topical none steroidal anti-inflammatory drug DRUG

participants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks.

Also known as: topical NSAID

control group

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qassim University: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, 11432, Egypt

Location

Related Publications (3)

• 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.

  PMID: 23093823 RESULT

• 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.

  PMID: 10484856 RESULT

• 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.

  PMID: 22836591 RESULT

MeSH Terms

Conditions

Pain; Neck Pain

Interventions

Extracorporeal Shockwave Therapy; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• MAGED A BASHA, Dr

  Assistant Professor, Qassim University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: November 3, 2018
• Primary Completion: November 20, 2019
• Study Completion: December 3, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Immediately following publication.
• 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.

Locations

EG (1)