Pulsed Radiofrequency to the Suprascapular Nerve

NCT06527014 | Completed

• 1 other identifier: AnkaraCHBilkent1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Regardless of the etiology, chronic shoulder pain is a distressing condition that affects daily life and is among the first common reasons for musculoskeletal system problems when admitting to clinics. Pulsed radiofrequency (pRF) treatment to the suprascapular nerve (SSN) is a promising interventional procedure, that is thought to be effective in case of chronic shoulder pain. However, conventional physical therapy program is preferred more often and found more applicable. The aim of current study is to compare the effectiveness of two treatment procedures.

Conditions

Pain, Chronic; Shoulder Pain

Keywords

Pain; Injections; Nerve Block; Shoulder pain; Function

Outcome Measures

Primary Outcomes (2)

• Numarical Rating Scale

  Numerical rating scale (NRS): It is a rating scale for self reported pain. 0 , means there is no pain and 10, represents the most pain experienced in life time.

  partcipants were evaluated at baseline and 1st month follow-up

• QuickDASH

  It is self-reported questionnaire related to pain and disfunction. Abilities and symptoms are asked about last week. All questions are rated 0-5. Higher scores are related more disability for upper extremity.

  partcipants were evaluated at baseline and 1st month follow-up

Study Arms (2)

Pulse Radiofrequency-Group 1

ACTIVE COMPARATOR

Procedures were performed with patient seated leaving their affected shoulder exposed. First, the spina scapula was identified and scapular notch and transverse scapular ligament identified. The needle was inserted out plane. A standard radiofrequency device (NeuroTherm NT1100, Neurotherm Inc.,USA) was used with 22-gauge 10-cm, 5 mm RF cannulas (Abbott Medical , USA) for SN blocks.The cannula was placed through the transverse scapular ligament area and sensory fibre stimulation was started between 0.3 and 1 V. The patient was asked for feedback on symptoms such as numbness, paresthesia and/or pain. If the patient did not report any sensory symptoms within the specified sensory stimulation range, the cannula was repositioned. Motor stimulation was applied up to 2 V and it was checked whether there was any muscle contraction or not. If any contraction was figured out as a result of motor stimulation.Eventually, the SN was ablated at 42°C for 4 minutes in pRF mode.

Procedure: Pulse Radiofrequency to the suprascapular nerve

Conventional Physical Therapy-Group 2

NO INTERVENTION

Patients in the Group 2 received physical therapy modalities including hot packs, transcutaneous electrical nerve stimulation (TENS) and deep heater ultrasound to the shoulder. The hot packs were preserved at 71°C, then application of hot packs were done at a temperature of 40-43°C with TENS (4 cannulated electrodes) adjusted at 60-100 Hz for 20 minutes. Therapeutic deep heater ultrasound was applied to warm up subcutaneous tissues for 10 minutes at 1.5 watts/cm2. Until follow-up process was over, no medications other than paracetamol were allowed.

Interventions

Pulse Radiofrequency to the suprascapular nerve PROCEDURE

Pulse radiofrequency ablation to the Suprascapular nerve

Pulse Radiofrequency-Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Shoulder pain lasts more than 3 months
• Shoulder pain more than 4 according to NRS
• No passive range of motion limitation
• Unilateral chronic shoulder pain
• INR\> 1.2 in blood samples.

You may not qualify if:

• Adhesive capsulitis that cause passive range of motion in shoulder joint
• History of intra-articular joint injection or physical therapy at the last 6 months
• History of fracture, trauma or surgery
• Accompanying rheumatologic disease or other inflammatory arthritis involved shoulder joint
• Local infection, sepsis, malignancy or pregnancy
• Uncontrolled diabetes or other co-morbidities that worsens general condition
• History of allergy to the materials used in treatment
• Mental disorders that lead incooperation.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bİlkent City Hospital

Ankara, 00650, Turkey (Türkiye)

Location

Related Publications (4)

• Akbari N, Ozen S, Senlikci HB, Haberal M, Cetin N. Ultrasound-guided versus blind subacromial corticosteroid and local anesthetic injection in the treatment of subacromial impingement syndrome: A randomized study of efficacy. Jt Dis Relat Surg. 2020;31(1):115-22. doi: 10.5606/ehc.2020.71056.

  PMID: 32160504 RESULT

• Crookes T, Wall C, Byrnes J, Johnson T, Gill D. Chronic shoulder pain. Aust J Gen Pract. 2023 Nov;52(11):753-758. doi: 10.31128/AJGP-04-23-6790.

  PMID: 37935145 RESULT

• Esparza-Minana JM, Mazzinari G. Adaptation of an Ultrasound-Guided Technique for Pulsed Radiofrequency on Axillary and Suprascapular Nerves in the Treatment of Shoulder Pain. Pain Med. 2019 Aug 1;20(8):1547-1550. doi: 10.1093/pm/pny311.

  PMID: 30690499 RESULT

• Bergamaschi ECQA, Sakata RK, Giraldes ALA, Ferraro LHC. Comparative Randomized Study Between Pulsed Radiofrequency and Suprascapular Nerve Block for the Treatment of Chronic Shoulder Pain. Clin J Pain. 2024 Mar 1;40(3):182-186. doi: 10.1097/AJP.0000000000001184.

  PMID: 38050367 RESULT

MeSH Terms

Conditions

Chronic Pain; Shoulder Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Emre Adıgüzel, Prof

  Ankara City Hospital Bilkent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 30, 2024
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)