NCT07823933

Brief Summary

Shoulder pain is one of the most common symptoms of musculoskeletal injuries; one-quarter of the general population and two-thirds of adults experience this problem at some point in their lives.Rotator cuff tendinopathy also presents as a significant socio-economic issue, affecting patients' functionality, sleep, quality of life, and work performance. TECAR therapy (Targeted Radiofrequency Therapy) is a relatively new physical therapy method. This technique aims to induce hyperthermia in deep tissues by transferring high-frequency electromagnetic energy via capacitive-resistive electric transfer (CRET). This study aims to directly compare TECAR-a relatively new treatment modality-with exercise, which is crucial in shoulder rehabilitation, by evaluating the effects of both treatments on pain reduction, shoulder function, and quality of life in patients with rotator cuff tendinopathy.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Sep 2026Nov 2026

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 18, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 11, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

Rotator cuff tendinopathyTECAR therapyPhysical TherapyTR-terapi- targeted Radiofrequency Therapy

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    Visual Analog Scale (VAS): Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 ("no pain") to 10 ("worst pain imaginable"). Participants will mark the point on the scale that best represents their perceived pain intensity at the time of assessment. Higher scores indicate greater pain intensity.

    Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program

Secondary Outcomes (4)

  • Shoulder joint range of motion measurements

    Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program

  • Western Ontario Rotator Cuff Index

    Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program

  • Shoulder Pain and Disabilty Index

    Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program

  • Nottingham Health Profile (NHP)

    Baseline (T0)Week 2 (T1): At the end of the first group treatmentPost-treatment (T2): Immediately after completion of the treatment program

Study Arms (2)

Physical Therapy Group

ACTIVE COMPARATOR

A total of 10 treatment sessions-consisting of 5 sessions per week-will be administered, comprising a shoulder exercise program that includes range-of-motion exercises, stretching exercises (targeting the posterior joint capsule and pectoral muscles), rotator cuff strengthening exercises, and scapular mobilization exercises.

Device: tecar therapyOther: physical therapy

TECAR Group

ACTIVE COMPARATOR

In addition to exercise, TECAR therapy will be administered for a total of 10 sessions-at a frequency of 448 kHz and a duration of 25 minutes per session (10 minutes in capacitive mode and 15 minutes in resistive mode)-with a frequency of 5 sessions per week.

Device: tecar therapyOther: physical therapy

Interventions

A shoulder exercise program-comprising range-of-motion exercises, stretching exercises (including the posterior joint capsule and pectoral muscles), rotator cuff strengthening exercises, and scapular mobilization exercises-will be administered over a total of 10 sessions, at a frequency of 5 sessions per week. In addition to the exercises, TECAR therapy will be administered over a total of 10 sessions (5 sessions per week), consisting of a total duration of 25 minutes (10 minutes in capacitive mode and 15 minutes in resistive mode at a frequency of 448 kHz).

Physical Therapy GroupTECAR Group

A total of 10 treatment sessions-consisting of 5 sessions per week-will be administered, comprising a shoulder exercise program that includes range-of-motion exercises, stretching exercises (targeting the posterior joint capsule and pectoral muscles), rotator cuff strengthening exercises, and scapular mobilization exercises.

Physical Therapy GroupTECAR Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals experiencing pain in the shoulder and/or lateral deltoid region, with pain exacerbation during overhead activities.
  • Individuals exhibiting tenderness upon palpation at the rotator cuff tendon insertion site on the proximal humerus and/or restricted range of motion during active shoulder flexion, abduction, and internal and external rotation upon physical examination.
  • Individuals diagnosed with rotator cuff tendinosis or a partial-thickness tendon tear via imaging methods (ultrasound, magnetic resonance imaging).

You may not qualify if:

  • Full-thickness rotator cuff tear
  • Previous shoulder surgery
  • Presence of other conditions capable of causing shoulder pain and loss of function (other joint pathologies, cervical radiculopathy, etc.)
  • Systemic diseases such as diabetes, rheumatoid arthritis, hepatitis, or coagulopathy
  • Pregnancy
  • Infection
  • Pacemaker
  • Peripheral circulatory disorder
  • Known concomitant malignancy or end-stage organ failure
  • Intra-articular/subacromial steroid injection within the last 6 weeks or NSAID treatment within the last week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Ayşe U BAYKUT

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

kerem Çekinel

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start

September 18, 2026

Primary Completion (Estimated)

October 18, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

I haven't been able to decide yet.

Locations