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Completed

NCT Number: NCT06527014

Pulsed Radiofrequency to the Suprascapular Nerve

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bİlkent City Hospital

Ankara, 00650, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulse Radiofrequency to the suprascapular nerve

Procedure

Pulse radiofrequency ablation to the Suprascapular nerve

Primary outcomes

  1. Numarical Rating Scale

    Time frame: 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.

  2. QuickDASH

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of the Effectiveness of Pulsed Radiofrequency (pRF) to the Suprascapular Nerve Versus Conventional Physical Therapy Program in Chronic Shoulder Pain

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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