Pulsed Radiofrequency to the Suprascapular Nerve

Not Applicable

Completed

• Conditions: Pain, Chronic; Shoulder Pain
• Interventions: Procedure: Pulse Radiofrequency to the suprascapular nerve

• Registration Number: NCT06527014
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

This study carried out in 27 chronic shoulder pain patients aged between 18-75 years in Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital. Total of 25 patients, who had \> 3 months shoulder pain and pain more than \> 4 according to the numerical rating scale (NRS), completed the study. Twenty-seven patients randomized into two groups, 21 patients underwent pRF of Suprascapular nerve (SSN) in Group 1; 16 patients received 10 sessions conventional physical therapy (CPT) program. One patient did not come to follow-ups after SSN pRF procedure, other patient did not complete the 10 session CPT program.

Approval for the study was granted by the 2nd Ethics Committee of Ankara Bilkent City Hospital (Protocol number: E2-23-3799). The study was conducted in line with the Helsinki Declaration. All patients signed informed consent prior to participation.

Inclusion criteria were 1) shoulder pain lasts more than 3 months 2) Shoulder pain more than 4 according to NRS 3) no passive range of motion limitation 4) unilateral chronic shoulder pain 5) INR\> 1.2 in blood samples.

Exclusion criteria were 1) Adhesive capsulitis that cause passive range of motion in shoulder joint 2) History of intra-articular joint injection or physical therapy at the last 6 months 3) History of fracture, trauma or surgery 4) Accompanying rheumatologic disease or other inflammatory arthritis involved shoulder joint 5) Local infection, sepsis, malignancy or pregnancy 6) Uncontrolled diabetes or other co-morbidities that worsens general condition 7) History of allergy to the materials used in treatment 8) Mental disorders that lead incooperation.

After the informed consent patients divided into 2 groups with closed envelope method by the staff who is not participated in the study. Group 1 underwent SSN pRF and Group 2 received 10 sessions of CPT program including hotpack, therapeatic ultrasound as a deep heater and transcutaneous electrical nerve stimulation (TENS). All patients were thought shoulder exercises such as pendulum exercises and isometric exercises around shoulder muscles to be performed individually until the 1st month follow-up.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-27
• Last Update Submitted: 2024-07-27
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulse Radiofrequency-Group 1	Pulse Radiofrequency to the suprascapular nerve	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.

Primary Outcome Measures

Name	Time	Method
Numarical Rating Scale	partcipants were evaluated at baseline and 1st month follow-up	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.
QuickDASH	partcipants were evaluated at baseline and 1st month follow-up	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.

Trial Locations

Locations (1)

Ankara Bİlkent City Hospital; 🇹🇷 Ankara, Turkey