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

NCT ID: NCT06784128

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-07-20

Brief Summary

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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.

Detailed Description

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Adhesive capsulitis (AC), commonly known as "frozen shoulder," is a prevalent and painful condition resulting from the contracture of the glenohumeral capsule, which significantly impacts individuals' quality of life. While AC is self-limiting in many cases, some patients may experience long-term functional limitations if not treated promptly. One promising intervention is transfer energy capacitive and resistive (TECAR) therapy, which has gained attention for its potential to enhance tissue regeneration, reduce inflammation, and improve pain management by generating heat in superficial and deep tissues. This study aimed to evaluate the effects of TECAR therapy on pain and functional outcomes in patients with adhesive capsulitis (AC).

This prospective, randomized controlled clinical trial included 60 patients \[TECAR group: 30, (50.37 ± 13.90 years); control group: 30, (55.27 ± 10.44 years)\]. Both groups completed a 2-week tailored therapeutic exercise program, with 30-minute hot pack application and Transcutaneous Electrical Nerve Stimulation. The TECAR group also received three TECAR therapy sessions per week, for a total of six sessions. Pain was measured using the Visual Analog Scale (VAS), functional status with the Shoulder Pain and Disability Index (SPADI), and supraspinatus tendon thickness and bicipital effusion were assessed via ultrasonography. Evaluations were conducted at baseline, 1 and 3 months post-treatment.

Conditions

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Adhesive Capsulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

Therapeutic Exercise Program

Intervention Type 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.

Hot Pack

Intervention Type 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.

TENS

Intervention Type 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)

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.

Group Type EXPERIMENTAL

Therapeutic Exercise Program

Intervention Type 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.

Hot Pack

Intervention Type 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 Therapy

Intervention Type 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.

TENS

Intervention Type 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.

Interventions

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Therapeutic Exercise Program

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.

Intervention Type OTHER

Hot Pack

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.

Intervention Type OTHER

TECAR Therapy

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.

Intervention Type DEVICE

TENS

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Oznur Uzun

MD, Deputy Chief of Physical Medicine and Rehabilitation Hospital, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Öznur Uzun, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Çankaya, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30607455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30362981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31680597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35147930 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 24284277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28405218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38844748 (View on PubMed)

Related Links

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https://www.semanticscholar.org/paper/The-effectiveness-of-Capacitive-Resistive-Diathermy-Hawamdeh/b5d02c41a382e1d9043d3d4f6ed9f2f5e9797737

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

Other Identifiers

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ANKARA BILKENT CITY HOSPITAL

Identifier Type: OTHER

Identifier Source: secondary_id

E2-23-3840

Identifier Type: -

Identifier Source: org_study_id

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