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NCT Number: NCT07158255

Effects of Exercise on Adhesive Capsulitis

Our study aims to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan Kalyoncu University

Gaziantep, (505) 090-5846, Turkey (Türkiye)

About this study

Adhesive capsulitis (AC) is a common shoulder condition characterized by a gradual increase in spontaneous pain and a limitation in glenohumeral joint range of motion. Its pathophysiology, a pathological process of capsular fibrosis following synovial inflammation, is relatively well understood, but its cause remains unknown. The literature on the treatment of frozen shoulder, whose etiology remains unknown, provides evidence of the effectiveness of conservative treatment approaches such as physiotherapy, analgesics, and steroid injections. Early treatment success is achieved through pain reduction and increased function rather than achieving full range of motion. Pain with movement is minimal in primary frozen shoulder in Stage 1, while night pain accompanied by activity pain is also observed in Stages 2 and 3. Secondary frozen shoulder presents with similar pain, primarily caused by inflammation in the shoulder joint capsule. Increasing range of motion without pain suppression is quite difficult in patients with frozen shoulder. Although heat or electrotherapy methods are accepted to have theoretically positive effects on pain in treatment, it is difficult to determine the effect of a single method on the natural course of the disease. For this reason, therapeutic methods are generally applied in addition to manual therapy and therapeutic exercises. Thermal tools and stretching exercises are frequently used in physiotherapy to maintain and regain flexibility. Ultrasonography, which is among the clinical diagnostic methods performed in patients with adhesive capsulitis, has shown increased thickness, especially in the coracohumeral ligament, followed by fibrous changes in the supraspinatus tendon and long head of the biceps. The effectiveness of exercise training combined with electrotherapy on many factors has been frequently investigated in the literature. However, a review of the literature did not find any studies on the effects of exercise training given in adhesive capsulitis on shoulder architecture. The fact that ultrasonographic examination, an indispensable part of the diagnosis and treatment process, provides objective data on the effects of exercise will increase the quality of the study. In this context, our study; The aim of this study is to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with adhesive capsulitis by a physician,
  • Between the ages of 35-60,
  • Not diagnosed with cervical disc herniation that could cause other shoulder pathologies,
  • Not participating in an upper extremity-related physiotherapy program within the last 6 months,
  • Volunteering individuals to participate in the study

Exclusion criteria

  • Individuals who have undergone shoulder surgery consistent with any pathology,
  • Individuals with a neurological history,
  • Individuals diagnosed with diabetes mellitus (DM)

Treatment and study plan

electrotherapy treatment

Other

Patients in the electrotherapy group will receive 15 sessions of TENS, hotpack, and ultrasound, 45 minutes each, 5 days a week, for 3 weeks. The treatment program is planned for 20 minutes of TENS, 15 minutes of hotpack, and 10 minutes of ultrasound.

Exercise training

Other

In addition to electrotherapy, the patients in the study group will receive 15 sessions (45 minutes, 5 days a week, for 3 weeks) of exercise training consistent with the literature. Exercise training includes programs to increase joint range of motion and mobility at the pain threshold and to restore functionality. Following electrotherapy, upper extremity normal range of motion exercises, anterior and posterior capsule stretching exercises, pendulum exercises, wand exercises, isometric training in 3 planes, and isotonic strengthening exercises will be applied. Five exercises will be selected each day, performed under the supervision of a physiotherapist. A 2-minute rest period will be provided after each exercise, followed by a transition to the next exercise. Care will be taken to perform the exercises within the pain threshold and to ensure that the pain does not exceed a VAS score of 2.

Primary outcomes

  1. Ultrasonographic Measurement

    Time frame: through of the study, average 3 weeks

    Thickness and density measurements of the coracohumeral ligament, supraspinatus tendon, infraspinatus tendon, long head of biceps and deltoid fascia, which constitute the shoulder architecture of the patients and are among the structures most affected by adhesive capsulitis, will be evaluated with an Ultrasound (Measured by 7.5-10 Mhz mobile ultrasound (ALEXUS A10HRL) device.

  2. The pain

    Time frame: through of the study, average 3 weeks

    Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

  3. Range of Motion

    Time frame: through of the study, average 3 weeks

    A Universal Goniometer will be used to assess normal range of motion. Measurements will be made regarding shoulder flexion, extension, abduction, adduction, internal and external rotation ranges of motion in three planes of the upper extremity shoulder joint, and the results will be recorded in degrees.

  4. Upper extremity functionality

    Time frame: through of the study, average 3 weeks

    The Questionnaire for Arm, Shoulder, and Hand Disabilities (Q-DASH) will be used to assess individuals' upper extremity functions. This questionnaire is a self-administered measurement tool with validated validity and reliability in Turkish. The validity and reliability of the Turkish version of the DASH questionnaire (DASH-T) was conducted in Turkey by Düger et al. in 2006. The questionnaire, consisting of 30 questions, assesses the individual's ability to perform functional activities (21 items), pain (5 items), and psychosocial aspects of the disease (4 items). The total score ranges from 0 to 100, with a higher score indicating better outcomes.

Secondary outcomes

  1. Kinesiophobia

    Time frame: through of the study, average 3 weeks

    The Tampa Kinesiophobia Scale will be used to assess the fear of movement and movement avoidance in individuals diagnosed with adhesive capsulitis. The survey, whose validity and reliability study was conducted by Yılmaz et al. in 2011, consists of 17 descriptive questions. Each question uses a 4-point Likert-type scoring system (1=Strongly disagree, 2=Agree, 3=Disagree, 4=Strongly agree). Based on the responses, the individual receives a total score between 17 and 68. A high score on the scale indicates a high degree of kinesiophobia.

  2. The quality of Life

    Time frame: through of the study, average 3 weeks

    The European General Quality of Life Scale (EQ-5D) will be used to assess patients' quality of life. The EQ-5D general quality of life scale was developed in 1987 by the EuroQol group, the Western European Society for the Study of Quality of Life, and consists of two sections. The first section describes the current health profile in five subdimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses for each section have five options: "no problem," "mild problem," "moderate problem," "severe problem," and "extreme problem." The second section consists of a visual analog scale (VAS). In this section, individuals rate their current health status on a scale resembling a thermometer. Quality of life scores ranging from 0 to 100 are obtained from the visual analog scale. As the scale score increases, the perception of health increases in a positive direction.

Study contacts

Contact information is provided by the study sponsor or research team.

Tuğba GÖNEN, Asisst. Prof. Dr.

CONTACT

[email protected]

505 090 58 46

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

Effect of Exercise Training on Pain, Range of Motion, Functionality and Shoulder Architecture in Patients With Adhesive Capsulitis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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