Pulsed Radiofrequency to the Suprascapular Nerve

Ankara City Hospital

Status: Completed

Conditions: Shoulder Pain; Pain, Chronic

Treatments: Procedure: Pulse Radiofrequency to the suprascapular nerve

Study type: Interventional

Funder types: Other

Identifiers

NCT06527014

AnkaraCHBilkent1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Pulse Radiofrequency-Group 1

Active Comparator group

Description:

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.

Treatment:

Procedure: Pulse Radiofrequency to the suprascapular nerve

Conventional Physical Therapy-Group 2

No Intervention group

Description:

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.