Transcutaneous Pulse Radiofrequency Treatment for Subacromial Impingement Syndrome

NCT04289610 | Completed

• 1 other identifier: Gazi University PMR
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder pain is the most common musculoskeletal problem after low back and neck pain. Subacromial impingement syndrome is one of the most common diseases that causes shoulder pain. Many methods are used to reduce pain and accelerate functional rehabilitation in patients with shoulder pain. Transcutaneous pulse radiofrequency therapy (TCPRF) is a needle-free, painless, and outpatient physical therapy modality that can be used to treat shoulder impingement syndrome. Acromio-humeral distance and supraspinatus tendon thickness measurements with ultrasound are reliable and effective methods to diagnose subacromial impingement syndrome. Although there are previous studies investigating the effectiveness of TCPRF treatment in patients with shoulder pain, there are no studies evaluating the effectiveness of treatment with ultrasound examination. In this study, the investigators aimed to show the effect of TCPRF treatment on pain, range of motion, functional status and ultrasound findings in subacromial impingement syndrome.

Conditions

Shoulder Impingement Syndrome

Keywords

Shoulder Pain; Transcutaneous radiofrequency treatment; Ultrasound

Outcome Measures

Primary Outcomes (3)

• The effect of transcutaneous pulsed radiofrequency (TCPRF) treatment on shoulder pain in subacromial impingement syndrome.

  Shoulder pain will be assessed by visual analog scale (VAS). A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Two extreme definitions of pain (0: no pain, 10: The most powerfull pain one can exprience) are written on both ends of a 100 mm line and the patient is asked to indicate where his condition is appropriate by drawing a line or by marking or pointing on this line.

  Change from baseline VAS at 1st week, 4th week and 12th week.

• The effect of transcutaneous pulsed radiofrequency (TCPRF) treatment on shoulder range of motion in subacromial impingement syndrome.

  Shoulder range of motion will be assessed by goniometer. A goniometer is an instrument that measures range of motion joint angles (degree) of the body . A goniometer will be used to evaluate shoulder joints.

  Change from baseline shoulder range of motion at 1st week, 4th week and 12th week.

• The effect of transcutaneous pulsed radiofrequency (TCPRF) treatment on shoulder disability in subacromial impingement syndrome.

  Shoulder disability will be assessed by shoulder pain and disability index (SPADI). SPADI is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The patient is asked to score how much difficulty he had during physical activities in the past week (zero means no difficulty, ten means unable to do the activity without help). Total score changes between 0 to 130. Zero defines no difficulty and 130 defines maximum disability.

  Change from baseline shoulder disability at 1st week, 4th week and 12th week.

Secondary Outcomes (3)

• Measurement of Acromiohumoral Distance

  Change from baseline acromiohumoral distance at 1st week, 4th week and 12th week.

• Assessment of Quality of life (QOL)

  Change from baseline Assessment of Quality of life (QOL) at 1st week, 4th week and 12th week.

• Measurement of Supraspinatus Tendon Thickness

  Change from baseline supraspinatus tendon thickness at 1st week, 4th week and 12th week.

Study Arms (2)

Control Group

SHAM COMPARATOR

In this group a pair of TCPRF electrodes will be applied to the painful shoulder at six standardized sites for 2 minutes each (approximately a total of 15 minutes). The device is not going to be activated in the control group. The device will be set at 0 V. TCPRF treatment is going to be applied for one session.

Device: Transcutaneous pulse radiofrequency therapy

Study Group

ACTIVE COMPARATOR

A pair of TCPRF electrodes will be applied to the painful shoulder at six standardized sites for 2 minutes each (approximately a total of 15 minutes). It will be activated in the study group. In the study group device will be set at 80 V, every pulse will continue for 10 milliseconds and 5 pulses per second. TCPRF treatment is going to be applied for one session in both groups.

Device: Transcutaneous pulse radiofrequency therapy

Interventions

Transcutaneous pulse radiofrequency therapy DEVICE

Transcutaneous pulse radiofrequency therapy (TCPRF) is a painless and outpatient physiotherapy modality

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Having (chronic) shoulder pain for more than 3 months
• No treatment for shoulder pain (physical therapy, joint area injection, radiofrequency treatment) in the past 3 months

You may not qualify if:

• Systemic rheumatic diseases
• Malignancy, acute infections Adhesive capsulitis
• Bicipital tendinitis
• Supraspinatus tendon full-thickness rupture
• Those who have undergone surgery for shoulders and neck
• Pace maker
• Pregnant women Those with cervical radiculopathy
• Those who do not agree to participate in the study

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Medical School, Physical Medicine and Rehabilitation Department

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (4)

• Taverner M, Loughnan T. Transcutaneous pulsed radiofrequency treatment for patients with shoulder pain booked for surgery: a double-blind, randomized controlled trial. Pain Pract. 2014 Feb;14(2):101-8. doi: 10.1111/papr.12059. Epub 2013 Apr 8.

  PMID: 23560519 RESULT

• Kul A, Ugur M. Comparison of the Efficacy of Conventional Physical Therapy Modalities and Kinesio Taping Treatments in Shoulder Impingement Syndrome. Eurasian J Med. 2019 Jun;51(2):139-144. doi: 10.5152/eurasianjmed.2018.17421. Epub 2018 Nov 30.

  PMID: 31258353 RESULT

• Taverner MG, Ward TL, Loughnan TE. Transcutaneous pulsed radiofrequency treatment in patients with painful knee awaiting total knee joint replacement. Clin J Pain. 2010 Jun;26(5):429-32. doi: 10.1097/AJP.0b013e3181d92a87.

  PMID: 20473051 RESULT

• McCreesh KM, Anjum S, Crotty JM, Lewis JS. Ultrasound measures of supraspinatus tendon thickness and acromiohumeral distance in rotator cuff tendinopathy are reliable. J Clin Ultrasound. 2016 Mar-Apr;44(3):159-66. doi: 10.1002/jcu.22318. Epub 2015 Dec 15.

  PMID: 26666736 RESULT

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, principal investigator

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 28, 2020
• Study Start: March 3, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)