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NCT Number: NCT07131839

Central Sensitization Presence on the Results of Shoulder Adhesive Capsulitis

Patients with adhesive capulitis longlasting more than 3 months were participated in the study. they were divided into two groups whether they have central sensitizaiton or not. Conventional physical therapy responses were measured and compared between two groups.

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Key information

Conditions

Adhesive Capsulitis of the Shoulder Bursitis Chronic Pain Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

About this study

Adhesive capsulitis is a well known musculoskeletal syndrome that effects daily living activities and patiemts suffer from chronic shoulder pain. Central sensitization has been defined in patients with chronic pain due to amplified neuronal connections and signals in the central nervous system. Previously, it was shown that refractory long lasting musculoskeletal disorders may show challenging treatment process and decreased outcome due to central sensitization. However to the best of our knowledge there was not any study that evaluates the treatment response of presence of central sensitization in adhesive capsulitis patients. Total of 32 adhesive capsulitis patients were particapted in the study. Sixteen patients with adhesive capsulitis with (Group 1) and without central sensitization (Group 2) were received conventional physical therapy and exercise. Treatment response were evaluated with Visual Analog Scale (VAS), Shoulder pain and disability index (SPADI) Tampa Kinesiophobia Scale (TKS) and Pain Catastrophizing Scale (PCS). Additionally shoulder range of motion was measured at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1)patients with adhesive capsulitis between 18-80 years old 2) symptoms ongoing more than 3 months 3) willing to participated in the study

Exclusion criteria

  • patients with cervical radiculopathy 2) Patients with predisposing factors to adhesive capsulitis, such as diabetes mellitus, thyroid disease, coronary artery disease, lung pathologies or tuberculosis 3) any defined central sensitization syndrome such as fibromiyalgia before 4) presence of rheumatologic diseases 5) pregnancy 6) patients underwent bypass surgery or who have cardiac pacemaker 7) patients with septic arthritis or sepsis 8) malignancy 9) patients that underwent surgery through the shoulder region or had injection through the shoulder joint in the last 3 months.

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Treatment and study plan

Primary outcomes

  1. Visual Analog Scale

    Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

    A 10 cm VAS, with known validity and reliability, was used as a self-reported measure for the severity of joint pain.

  2. Shoulder Pain Disability Index (SPADI)

    Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

    This questionnaire was developed to assess shoulder joint pain and disability. The SPADI has two sections; first section contains 5 questions to evaluate pain, whereas second item contains 8 questions to evaluate disability. Scores vary 0-130 and higher scores indicates high disability rates and pain

  3. Measurement of Shoulder range of motion

    Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

    The same physician performed the measurement for the joint ranges in each plane of the joint with a goniometer. The goniometer's pivot point was positioned on the lateral projection of the shoulder joint while subjects in supine position. The fixed arm aligned parallel to the axillary lateral midline , while the movable arm tracked the humerus' lateral midline movement towards the axilla. The joint was passively forced to the end of the direction of range and measured twice and the average was taken

Secondary outcomes

  1. Tampa Kinesiophobia Scale (TKS)

    Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

    It was used to measure pain and the resulting fear and avoidance of moving the painful body part. TKS contains 17 questions assess parameters of injury/re-injury and fear or avoidance in work-related activities. Scores vary 17-68 and higher scores indicates higher kinseiophobia levels

  2. Pain Catastrophizing Scale (PCS)

    Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2).

    PCS was created to evaluate the perception of catastrophizing caused by pain. It provide an objective assessment of the cognitive status related to pain. It consists of a self-administered 13-question and Likert scale (0, means never; 4, means always) is used in scoring. Total score is between 0-52 and with higher scores, perception of catastrophizing increases

  3. Beck Depression Inventory (BDI)

    Time frame: at baseline (T0), after treatment (T1) and at 2nd week after completion of conventional rehabilitation program (T2)

    Beck Depression Inventory (BDI) is used to evaluate the characteristics of depression and anxiety. BDI consists of 21 questions, higher scores imply increased depression symptom severity

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Effects of Central Sensitization Presence on the Results of Shoulder Adhesive Capsulitis Treatment With Physical Therapy Agents and Exercise

Acronym: FrozenShoulder

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2025
Registry last updated
Aug 20, 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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