Impact of TECAR Therapy on Pain and Function in Adhesive Capsulitis:

NCT06784128 | Completed

• 2 other identifiers: E2-23-3840ANKARA BILKENT CITY HOSPITAL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Transfer Energy Capacitive and Resistive (TECAR) therapy is a heat therapy method that increases blood circulation at the microscopic level by generating heat in the upper and lower layers of your tissues, reduces inflammation and supports tissue regeneration. In this study, we aimed to evaluate whether this treatment reduces pain and improves functioning in patients with frozen shoulder disease.

Conditions

Adhesive Capsulitis

Keywords

Adhesive Capsulitis; Pain Management; TECAR Therapy; VAS

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) for pain

  The Visual Analog Scale (VAS) was employed to evaluate pain intensity in patients. This scale features a 10 cm horizontal line, where one end represents "no pain" (0) and the other represents "worst imaginable pain" (10). Patients were instructed to place a mark on the line that best reflected their current pain level. The distance from the "no pain" end to the patient's mark was measured in centimeters and recorded as the VAS score, providing a numeric representation of their pain intensity

  VAS for pain was applied to the patients before the procedure and at the 4th week and the 12th week after the procedure.

Secondary Outcomes (1)

• Shoulder Pain and Disability Index (SPADI)

  SPADI) was applied to the patients before the procedure and at the 4th week and 12th week after the procedure.

Other Outcomes (1)

• Supraspinatus tendon thickness and bicipital peritendinous effusion

  Supraspinatus tendon thickness and bicipital peritendinous effusion were measured using ultrasonography before the study , four weeks after treatment , and 12 weeks later.

Study Arms (2)

TENS combined with therapeutic exercise and hot pack (Control Group)

ACTIVE COMPARATOR

TENS was employed as a non-invasive pain management technique in this study, utilizing the Intellect Advanced device manufactured by Chattanooga Group. Electrodes were strategically placed over the affected shoulder, ensuring coverage of the most painful areas as well as relevant nerve pathways to maximize the analgesic effect. A symmetric biphasic waveform was selected, with a frequency of 100 Hz and a pulse duration of 100 microseconds. The intensity of the stimulation was adjusted according to the patient's tolerance, typically aiming for a strong, yet comfortable tingling sensation.

Other: Therapeutic Exercise Program; Other: Hot Pack; Device: TENS

TECAR combined with TENS and therapeutic exercise and hot pack (TECAR Group)

EXPERIMENTAL

In the experimental group, in addition to conventional TENS and hotpack, TECAR therapy was also applied three times per week for a total of six sessions. TECAR therapy was administered using the BTL-6000 TR-Therapy PRO device by an experienced physiotherapist.The device emitted energy at a frequency of approximately 500 kHz and used three types of electrodes: active, neutral, and static application electrodes. The active electrodes were of two types, capacitive and resistive, and were applied directly during treatment. The neutral electrode functioned as a reference and was positioned beneath the patient's body, close to the treatment site. Each patient was seated in a comfortable position with the affected shoulder exposed, ensuring adequate support and stability throughout the treatment session. Each session lasted approximately 15 minutes.

Other: Therapeutic Exercise Program; Other: Hot Pack; Device: TECAR Therapy; Device: TENS

Interventions

Therapeutic Exercise Program OTHER

All patients were administered a therapeutic exercise program that included passive, active-assisted, and active range of motion exercises, stretching, strengthening, and mobilization exercises based on their level of movement restriction and pain intensity for 5 sessions per week for 2 weeks under the supervision of an experienced physiotherapist.

TECAR combined with TENS and therapeutic exercise and hot pack (TECAR Group); TENS combined with therapeutic exercise and hot pack (Control Group)

Hot Pack OTHER

As part of the treatment protocol, a hot pack was applied to the affected shoulder area for 30 minutes prior to any other therapeutic interventions. This initial application of heat was intended to promote muscle relaxation, increase local blood circulation, and reduce joint stiffness, effectively preparing the shoulder for the subsequent treatments, including therapeutic exercise, TENS and TECAR therapy. The hot pack was maintained at a temperature between 40-45°C, which is considered optimal for achieving therapeutic heat without causing discomfort or skin irritation.

TECAR combined with TENS and therapeutic exercise and hot pack (TECAR Group); TENS combined with therapeutic exercise and hot pack (Control Group)

TECAR Therapy DEVICE

TECAR therapy was administered using the BTL-6000 TR-Therapy PRO device which emitted energy at a frequency of approximately 500 kHz and used three types of electrodes: active, neutral, and static application electrodes. Each patient was seated in a comfortable position with the affected shoulder exposed, ensuring adequate support and stability throughout the treatment session. The affected shoulder was prepared with a conductive gel to enhance energy transfer. During the session, the capacitive electrode was initially applied, targeting the superficial muscles and tendons around the shoulder joint using circular or linear movements for 5 min. Following this, the resistive electrode was employed to target deeper structures, focusing on the joint capsule and rotator cuff muscles for 10 min. The output power was adjusted based on the patient's tolerance, ensuring a comfortable warm sensation without causing discomfort or burning feeling or pain.

TECAR combined with TENS and therapeutic exercise and hot pack (TECAR Group)

TENS DEVICE

TENS was employed as a non-invasive pain management technique in this study, utilizing the Intellect Advanced device manufactured by Chattanooga Group. Electrodes were strategically placed over the affected shoulder, ensuring coverage of the most painful areas as well as relevant nerve pathways to maximize the analgesic effect. A symmetric biphasic waveform was selected, with a frequency of 100 Hz and a pulse duration of 100 microseconds. The intensity of the stimulation was adjusted according to the patient's tolerance, typically aiming for a strong, yet comfortable tingling sensation.

TECAR combined with TENS and therapeutic exercise and hot pack (TECAR Group); TENS combined with therapeutic exercise and hot pack (Control Group)

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were than 18 years of age
• Patients with unilateral shoulder pain of at least 3 on a 10-point Visual Analog Scale (VAS);
• Patients who experienced a more than 50% loss of passive ROM (abduction or external rotation) in the glenohumeral joint relative to the unaffected side
• Patients who had been experiencing the related symptoms for ≥ 3 months.

You may not qualify if:

• Patients who had previous shoulder surgery
• Patients who had shoulder injection within the last 3 months
• Patients with inflammatory rheumatic disease,
• Patients with cervical radiculopathy
• Pregnant patients
• Pateints with thyroid disease
• Patients with malignancy,
• Patients who had history of cardiac pacemakers,
• Patients with epilepsy
• Patients who had neurological disease with or without cognitive impairment

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Çankaya, Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (8)

• Fields BKK, Skalski MR, Patel DB, White EA, Tomasian A, Gross JS, Matcuk GR Jr. Adhesive capsulitis: review of imaging findings, pathophysiology, clinical presentation, and treatment options. Skeletal Radiol. 2019 Aug;48(8):1171-1184. doi: 10.1007/s00256-018-3139-6. Epub 2019 Jan 3.

  PMID: 30607455 BACKGROUND

• Coccetta CA, Sale P, Ferrara PE, Specchia A, Maccauro G, Ferriero G, Ronconi G. Effects of capacitive and resistive electric transfer therapy in patients with knee osteoarthritis: a randomized controlled trial. Int J Rehabil Res. 2019 Jun;42(2):106-111. doi: 10.1097/MRR.0000000000000324.

  PMID: 30362981 BACKGROUND

• Paolucci T, Pezzi L, Centra MA, Porreca A, Barbato C, Bellomo RG, Saggini R. Effects of capacitive and resistive electric transfer therapy in patients with painful shoulder impingement syndrome: a comparative study. J Int Med Res. 2020 Feb;48(2):300060519883090. doi: 10.1177/0300060519883090. Epub 2019 Nov 4.

  PMID: 31680597 BACKGROUND

• Barassi G, Mariani C, Supplizi M, Prosperi L, Di Simone E, Marinucci C, Pellegrino R, Guglielmi V, Younes A, Di Iorio A. Capacitive and Resistive Electric Transfer Therapy: A Comparison of Operating Methods in Non-specific Chronic Low Back Pain. Adv Exp Med Biol. 2022;1375:39-46. doi: 10.1007/5584_2021_692.

  PMID: 35147930 BACKGROUND

• Hawamdeh M. The effectiveness of capacitive resistive diathermy (Tecartherapy®) in acute and chronic musculoskeletal lesions and pathologies. Eur J Sci Res. 2014;118(3):336-40

  BACKGROUND

• Jain TK, Sharma NK. The effectiveness of physiotherapeutic interventions in treatment of frozen shoulder/adhesive capsulitis: a systematic review. J Back Musculoskelet Rehabil. 2014;27(3):247-73. doi: 10.3233/BMR-130443.

  PMID: 24284277 BACKGROUND

• Le HV, Lee SJ, Nazarian A, Rodriguez EK. Adhesive capsulitis of the shoulder: review of pathophysiology and current clinical treatments. Shoulder Elbow. 2017 Apr;9(2):75-84. doi: 10.1177/1758573216676786. Epub 2016 Nov 7.

  PMID: 28405218 BACKGROUND

• Vita F, Pederiva D, Tedeschi R, Spinnato P, Origlio F, Faldini C, Miceli M, Stella SM, Galletti S, Cavallo M, Pilla F, Donati D. Adhesive capsulitis: the importance of early diagnosis and treatment. J Ultrasound. 2024 Sep;27(3):579-587. doi: 10.1007/s40477-024-00891-y. Epub 2024 Jun 6.

  PMID: 38844748 BACKGROUND

Related Links

• Hawamdeh M. The effectiveness of capacitive resistive diathermy (Tecartherapy®) in acute and chronic musculoskeletal lesions and pathologies. Eur J Sci Res. 2014;118(3):336-40

MeSH Terms

Conditions

Bursitis; Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Öznur Uzun, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Deputy Chief of Physical Medicine and Rehabilitation Hospital, Principal Investigator

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 20, 2025
• Study Start: December 1, 2023
• Primary Completion: June 15, 2024
• Study Completion: July 20, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD will become available starting 6 months after publication.
• Access Criteria: The doctors who are specialized in Physical Medicine and Rehabilitation will be able to access upon contact with the principal investigators via email.

Locations

TU (1)