Neck PainNCT03210181
Superficial Cervical Plexus Block for Neck and Shoulder Pain
A study testing Superficial cervical plexus block in people with Neck Pain and Shoulder Pain, run by Makassed General Hospital at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain, Shoulder Pain
- What is being tested?
- Superficial cervical plexus block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 4 Jul 2017to 26 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- organic disease of the brain or spinal cord,
- radiculopathy,
- malignancy,
- hypothyroidism,
- complete blood count (CBC) with high creatine phosphokinase (CPK)
- myopathy,
Show all 11Show fewer
- autoimmune diseases that are associated with sub clinical myopathy,
- fibromyalgia,
- coagulopathy
- have allergy to bupivacaine,
- taking glucocorticoid and statins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Superficial Cervical Plexus Block for Neck and Shoulder Pain Due to Levator Scapulae Syndrome: a Randomized, Double Blind Clinical Trial
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.
Read the detailed description
Patients are randomly divided into two equal groups using the computer-based sealed envelope technique. Group I (Block) will receive superficial cervical plexus block and group II (Placebo) will receive placebo. The physician, patient and data collector are all blind to the patients' assigned group.
Demographic data including gender, age, BMI and American Society of Anesthesiologists (ASA) physical status will be noted at the initial visit. Moreover, patients' medical history, pain history, characteristics and type of pain, as well as previous treatment are collected for each patient. In addition, side effects, pain scores and analgesic consumption will be recorded after performing the block.
Patients will receive 14 daily charts to record daily pain scores, symptoms and the use of analgesics. Patients will be told to take their medications as usual. They will be contacted via phone calls to ensure that they are recording information in the charts.
Pain is assessed using the visual analogue scale (VAS). Patients with score <4 are given 500 mg paracetamol with a maximum of 6 tables per day, or ketoprofen 100 mg tablet to a maximum of 3 tables per 24 hours. Patients with a score>4 are given tramadol hydrochloride 100 mg tablet to a maximum of 3 tablets per day.
Superficial cervical plexus block technique 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. Each 10 ml of the anesthetic mixture contains: 3ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1:200,000, 3 ml bupivacaine 0.5% and 1 ml clonidine 150µg/ml. Group II will receive an equivalent volume of normal saline.
- Conditions
- Neck Pain, Shoulder Pain
- Being tested
- Superficial cervical plexus block, Placebo
- Medical subject headings
- Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial cervical plexus blockOther
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.
PlaceboOther
Patients will receive an equivalent volume of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Block | Experimental | Patients will receive superficial cervical plexus block Receives: Other: Superficial cervical plexus block |
| Placebo | Placebo comparator | Patients will receive normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
Patients will record the type and amount of analgesics they consume daily
Measured: 2 weeks
Secondary outcomes (1)
Pain
Patients will record their pain using the Visual Analogue Scale (VAS)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start4 Jul 2017
- Primary completion26 Jan 2018
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoher Naja, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210181
- Sponsor's protocol ID
- 1072013
- Status last verified
- Feb 2018
- First submitted
- 4 Jul 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superficial Cervical Plexus Block for Neck and Shoulder Pain Due to Levator Scapulae Syndrome: a Randomized, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03210181
- Acronym / sponsor ID
- 1072013
- Conditions
- Neck Pain, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients are randomly divided into two equal groups using the computer-based sealed envelope technique. Group I (Block) will receive superficial cervical plexus block and group II (Placebo) will receive placebo. The physician, patient and data collector are all blind to the patients' assigned group.
Demographic data including gender, age, BMI and American Society of Anesthesiologists (ASA) physical status will be noted at the initial visit. Moreover, patients' medical history, pain history, characteristics and type of pain, as well as previous treatment are collected for each patient. In addition, side effects, pain scores and analgesic consumption will be recorded after performing the block.
Patients will receive 14 daily charts to record daily pain scores, symptoms and the use of analgesics. Patients will be told to take their medications as usual. They will be contacted via phone calls to ensure that they are recording information in the charts.
Pain is assessed using the visual analogue scale (VAS). Patients with score <4 are given 500 mg paracetamol with a maximum of 6 tables per day, or ketoprofen 100 mg tablet to a maximum of 3 tables per 24 hours. Patients with a score>4 are given tramadol hydrochloride 100 mg tablet to a maximum of 3 tablets per day.
Superficial cervical plexus block technique 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. Each 10 ml of the anesthetic mixture contains: 3ml lidocaine 2%, 3 ml lidocaine 2% with epinephrine 1:200,000, 3 ml bupivacaine 0.5% and 1 ml clonidine 150µg/ml. Group II will receive an equivalent volume of normal saline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block | Experimental | Other: Superficial cervical plexus blockPatients will receive superficial cervical plexus block |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- organic disease of the brain or spinal cord,
- radiculopathy,
- malignancy,
- hypothyroidism,
- complete blood count (CBC) with high creatine phosphokinase (CPK)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial cervical plexus blockA 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. | Other | Block |
| PlaceboPatients will receive an equivalent volume of normal saline | Other | Placebo |
Primary outcome
Analgesic consumption
Time frame: 2 weeks
Patients will record the type and amount of analgesics they consume daily
1 secondary outcome
Pain
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial cervical plexus block in people with Neck Pain and Shoulder Pain, run by Makassed General Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic consumption (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.