Clinical trial NCT06527014: Pulsed Radiofrequency to the Suprascapular Nerve
Official title: Comparison of the Effectiveness of Pulsed Radiofrequency (pRF) to the Suprascapular Nerve Versus Conventional Physical Therapy Program in Chronic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Shoulder Pain
Keywords: Pain
Injections
Nerve Block
Shoulder pain
Function
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Numarical Rating Scale
timeFrame: partcipants were evaluated at baseline and 1st month follow-up
measure: QuickDASH
timeFrame: partcipants were evaluated at baseline and 1st month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bİlkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Emre Adıgüzel, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.