Pulsed Radiofrequency One or Three Nerves for Chronic Shoulder Pain. A Prospective, Randomized, Double-blind Study

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    142
  • sponsor
    Saint Petersburg State University, Russia
Updated on 7 October 2022

Summary

Pulsed radiofrequency (PRF) neuromodulation / or ablation is an interventional pain management method. Clinical use of PRF for shoulder pain management generally focuses on the suprascapular nerve, what is considered a safe and superior to placebo and physiotherapy. We study the use of the PRF neuromodulation the suprascapular, axillary, and articular branches of the lateral pectoral nerve, as well as the effectiveness of this combined technique compared to the PRF of the suprascapular nerve alone

Description

Background: It's believed that PRf of the suprascapular nerve is a safe and reliable treatment for shoulder pain. But PRF of the suprascapular nerve may be less effective than intra-articular steroid injections (Eyigor et al., 2010). There is also evidence that even test, diagnostic suprascapular nerve blockade in some patients may not give a satisfactory analgesic effect (Sinha et al., 2020). Probably, the unsatisfactory results of PRF suprascapular nerve as a search for a solution force the use of standard thermal RF ablation. (Bone et al., 2013) It is possible to expect a greater clinical effect from the combination of PRF of the three main articular nerves of the suprascapular, axillary and lateral pectoral nerves than from PRF of the suprascapular nerve alone. Nevertheless, having the task of obtaining the maximum effect from PRF, it seems important to maintain a balance between inevitable intervention and excessive intervention, considering that any intervention is associated with the risk of complications.

Methods: The study is planned to include 142 adult patients who are planned to have PRF of the suprascapular nerve due to the presence of chronic shoulder pain.The study is planned as a prospective randomized double-blind controlled trial. According to inclusion / exclusion criteria, written informed consent signing, patients will be randomized in a 1: 1 ratio into two groups: PRF of the suprascapular nerve (n=71) and PRF of the suprascapular, axillary and lateral pectoral nerves (n=71). Patients will be evaluated by a physician 4 weeks and 16 weeks after discharge to receive information on treatment results.

Sample size assessment: To identify differences of 5 points on the SPADI scale at a 5% significance level with 80% power, assuming an expected mean SPADI of 25.5 points and SD - 10.1 according to the study by Korkmaz et al 2010, 64 people will be required for each group. The number 128 was increased to 142 in the sample in order to compensate for observation losses.

Details
Condition Chronic Shoulder Pain
Treatment Pulsed radiofrequency neuromodulation of the suprascapular nerve only, Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves
Clinical Study IdentifierNCT04954391
SponsorSaint Petersburg State University, Russia
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Chronic pain (existing for more than three months at the time of examination) in the shoulder associated with the following pathology
rotator cuff injury
adhesive capsulitis
arthrosis of the shoulder joint
arthrosis of the acromioclavicular joint
subacromial impingement syndrome
a history of arthroscopic surgery
Signed informed consent to participate in the study
Lack of indications for shoulder surgery
Age> 18 years old 5 The positive effect of the test blockade of the suprascapular, axillary and lateral thoracic nerves with a local anesthetic (reduction of the pain level from the baseline according to NRS by at least 50%)

Exclusion Criteria

Rotator cuff calcific tendinopathy
infectious arthritis
Instability of the shoulder joint
cervical radiculopathy
contraindications to local anesthetics
coagulopathy and anticoagulant therapy
pregnancy
oncology
the impossibility of subjective assessment of the level of pain and function of the joint
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