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Adhesive CapsulitisTECARNCT06784128

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

A study testing Therapeutic Exercise Program, Hot Pack and TECAR Therapy in people with Adhesive Capsulitis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 67 years
Conditions the study is for
Adhesive Capsulitis
What is being tested?
Therapeutic Exercise Program, Hot Pack and TECAR Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2023to 20 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 67 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • Patients with malignancy,
  • Patients who had history of cardiac pacemakers,
  • Patients with epilepsy
  • Patients who had neurological disease with or without cognitive impairment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

    Çankaya, Ankara, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Impact of TECAR Therapy on Pain and Function in Adhesive Capsulitis: A Randomized Controlled Trial

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.

Read the detailed description

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.

Being tested
Therapeutic Exercise Program, Hot Pack, TECAR Therapy, TENS
Keywords
Adhesive Capsulitis, Pain Management, TECAR Therapy, VAS
Medical subject headings
Bursitis, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic Exercise ProgramOther

    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 PackOther

    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 TherapyDevice

    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.

  • TENSDevice

    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.

Study groups in NCT06784128
Study groupRoleWhat they receive
TENS combined with therapeutic exercise and hot pack (Control Group)Active comparatorTENS 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.
Receives: Other: Therapeutic Exercise Program; Other: Hot Pack; Device: TENS
TECAR combined with TENS and therapeutic exercise and hot pack (TECAR Group)ExperimentalIn 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.
Receives: Other: Therapeutic Exercise Program; Other: Hot Pack; Device: TECAR Therapy; Device: TENS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)
  1. Shoulder Pain and Disability Index (SPADI)

    The Shoulder Pain and Disability Index (SPADI) was used to evaluate both pain and functional limitations related to shoulder disorders. SPADI is a patient-reported outcome measure consisting of 13 items, divided into two subscales: pain (5 items) and disability (8 items). Each item is rated on a numerical rating scale (0:no pain or difficulty to 10:worst pain imaginable or extreme difficulty). The scores for each subscale are averaged to create a total score, expressed as a percentage, with higher scores reflecting greater pain and disability. SPADI is widely recognized and validated for assessing shoulder-related pain and functional impairment in both clinical practice and research

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start1 Dec 2023
  3. Primary completion15 Jun 2024
  4. Study completion20 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784128
Sponsor's protocol ID
E2-23-3840
Other IDs
ANKARA BILKENT CITY HOSPITAL
Acronym
TECAR
Status last verified
Jan 2025
First submitted
15 Jan 2025
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We can share our Study Protocol, Statistical Analysis plan and patients' informed Consent Forms.

Publications

  • 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.

    PubMed 30607455
  • 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.

    PubMed 30362981
  • 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.

    PubMed 31680597
  • 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.

    PubMed 35147930
  • 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

  • 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.

    PubMed 24284277
  • 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.

    PubMed 28405218
  • 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.

    PubMed 38844748

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Exercise Program, Hot Pack and TECAR Therapy in people with Adhesive Capsulitis, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) for pain (time frame: VAS for pain was applied to the patients before the procedure and at the 4th week and the 12th week after the procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06784128, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.

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