Superficial Cervical Plexus Block for Neck and Shoulder Pain

NCT03210181 | Completed

• 1 other identifier: 1072013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Myofascial pain is an important cause of neck pain or neck and shoulder pain. Neck shoulder pain is a common socioeconomic problem that negatively affects the quality of life. Different treatment strategies with limited effectiveness or application have been implemented. However, medication remains a widely used approach. The levator scapulae is one of the muscles involved in myofascial pain leading to levator scapulae syndrome. The muscle limits the rotation of the neck. It is innervated by branches of the third and fourth cervical nerves through the cervical plexus. Hence, performing superficial cervical plexus block may have some potential effect in reducing myofascial pain.

Conditions

Neck Pain; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Analgesic consumption

  Patients will record the type and amount of analgesics they consume daily

  2 weeks

Secondary Outcomes (1)

• Pain

  2 weeks

Study Arms (2)

Block

EXPERIMENTAL

Patients will receive superficial cervical plexus block

Other: Superficial cervical plexus block

Placebo

PLACEBO COMPARATOR

Patients will receive normal saline

Other: Placebo

Interventions

Superficial cervical plexus block OTHER

A nerve stimulator is used to guide the superficial cervical block. The nerve stimulator needle is first passed over the skin after aseptic preparation from the distal to proximal part of the posterior border of the sternocleidomastoid. Upon contraction of the levator scapulae, a mark is placed and the skin is infiltrated with 1 ml lidocaine 1%. A 22-G, 2.5 cm nerve stimulator needle is subsequently advanced through the skin by 0.5-1 cm depending on patient's weight while passing 5-8.5 mA current at 1 Hz. Then, the stimulating current is reduced to 0.5-0.6 mA while maintaining muscle contraction. At this point, 3-5 ml of the anesthetic mixture is injected.

Block

Placebo OTHER

Patients will receive an equivalent volume of normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years,
• have neck shoulder pain non-radiating to the arm,
• tenderness in levator scapulae
• refractory to oral analgesics, antiinflammatory medication and physical therapy
• have negative radiographs and bone scans of the shoulders and cervical spine.

You may not qualify if:

• organic disease of the brain or spinal cord,
• radiculopathy,
• malignancy,
• hypothyroidism,
• complete blood count (CBC) with high creatine phosphokinase (CPK)
• myopathy,
• autoimmune diseases that are associated with sub clinical myopathy,
• fibromyalgia,
• coagulopathy
• have allergy to bupivacaine,
• taking glucocorticoid and statins

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Conditions

Neck Pain; Shoulder Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of Anesthesia and Pain Management Department

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 6, 2017
• Study Start: July 4, 2017
• Primary Completion: January 26, 2018
• Study Completion: January 26, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

LE (1)