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Completed

NCT Number: NCT05797311

The Effect of PNF and Shoulder Stabilization Exercises on Pain, QoL and Functionality in Patient With AC

Adhesive capsulitis (AC), also known as frozen shoulder, is an insidious, painful condition of the shoulder lasting more than 3 months. This inflammatory condition causing fibrosis of the glenohumeral joint capsule is accompanied by gradual progressive stiffness and marked limitation of range of motion (typically external rotation). Patients experiencing this condition often suffer from poor quality of life due to the limitation of both the active and passive range of shoulder mobility. The prevalence of frozen shoulder is between 2-5% and is more common in women. Along with the increase in comorbidities and changes in lifestyle, the incidence of FS is increasing. However, the natural history and pathogenesis of adhesive capsulitis have not been widely studied and are still unknown. Adhesive capsulitis presents clinically as shoulder pain with progressive restricted movement, both active and passive, with normal radiographic scans of the glenohumeral joint. Classically, it progresses prognostically with 3 overlapping stages: pain (stage 1, lasting 2-9 months), stiffness (stage 2, lasting 4-12 months), and healing (stage 3, lasting 5-24 months). However, this is an estimated time frame and many patients may still experience symptoms after 6 years. Treatment modalities include conservative (ie, steroid injection, physiotherapy) and operative (ie, distension arthrography, manipulation under anesthesia, and arthroscopic release).

Various physical therapy treatments commonly used in the treatment of adhesive capsulitis include ice pack, hot pack, transcutaneous electrical nerve stimulation and active and passive ROM exercises, joint mobilization techniques, proprioceptive neuromuscular facilitation (PNF), supervised home exercise programs, and Kinesio taping.

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uskudar University Health Science

Istanbul, Turkey (Türkiye)

About this study

There are studies on the application of PNF techniques in proprioceptive neuromuscular facilitation (PNF), sports injuries, orthopedics, cardiorespiratory and neurological conditions developed by Knott and Kabat. Recently, the application of these techniques in orthopedic conditions has been developing. However, studies have been conducted to find out the effect of PNF therapy on Adhesive Capsulitis, but there is conflicting evidence between them. Although some studies have suggested PNF, determining which technique is better in the treatment of AC remains controversial and needs to be answered. Therefore, in our study, it was aimed to compare the effects and advantages of proprioceptive neuromuscular exercises and shoulder stabilization exercises applied in the treatment of patients with Adhesive capsulitis and to evaluate the acute effects of these exercises on shoulder movements.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 20- 65 years diagnosed with unilateral Stage II adhesive capsulitis by magnetic resonance imaging
  • Shoulder pain persisting for at least 3 months
  • VAS pain score equal to or greater than 5/10
  • Patients who agreed to participate in the study

Exclusion criteria

  • - Receiving physical therapy or manual therapy on the same shoulder within 1 year
  • Having mental and cognitive problems,
  • Patients who have undergone surgical procedure/injection/manipulation to the shoulder joint for any reason
  • Neurological disorders that affect shoulder function during daily activities
  • Pain or discomfort in the cervical spine, elbow, wrist, or hand
  • Other pathological conditions concerning the shoulder (rotator cuff tear, tendinitis, etc.)

Treatment and study plan

Proprioceptive neuromuscular facilitation (PNF)

Other

Proprioceptive Neuromuscular Facilitation (PNF) techniques are a therapeutic exercise approach developed based on functional activities in daily life. At the stage of regaining movement and function, it creates models similar to functional activities.

Shoulder stabilization exercises

Other

Scapular stabilization exercise and stabilization exercise for the shoulder joints

Primary outcomes

  1. Visual Analog Scale (VAS) Evaluation

    Time frame: Change from baseline to week 3

    The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to draw a line on this line to indicate where his condition is appropriate.

Secondary outcomes

  1. Manual Muscle Testing

    Time frame: Change from baseline to week 3

    During the testing of muscle strength without using any device ("manual muscle testing"), the evaluation system (Medical Research Council (MRC)) scale, which is widely used all over the world, is used. It is the evaluation of motion in the context of gravity.

  2. Joint Range of Motion

    Time frame: Change from baseline to week 3

    A Goniometer is the most common tool for measuring range of motion of the joints of the body. It uses a stationary arm, fulcrum, and movement arm to measure joint angles from the axis of the joint. Making a ROM measurement by using a goniometer requires training for reliable results. See the goniometry collection of pages for instructions on how to correctly (reliably and accurately) place the goniometer when measuring range of motion.

  3. DASH (Arm, Shoulder and Hand Problems Questionnaire)

    Time frame: Change from baseline to week 3

    The DASH questionnaire consists of 3 parts. The first part consists of 30 questions. 21 questions evaluate the degree of difficulty of the patient in daily activities, 5 questions evaluate the symptomatic features of pain, and 4 questions evaluate social function, self-confidence and sleep.

  4. Short Form 12 (SF-12)

    Time frame: Change from baseline to week 3

    SF-12, a measure of Health-Related Quality of Life, can be used in age, disease and treatment groups. It is a shortened version of the SF-36 and contains 12 questions, each with two to five answer options. The patient is told to choose the option that best suits him/her. The SF-12 covers eight dimensions: general health, physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. A physical and mental health score, each ranging from 0 to 100, can be calculated using scoring algorithms. Scores are calibrated to a mean score of 50, or the norm, with lower scores representing worse and higher scores representing better Health-Related Quality of Life.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

The Effect of Proprioceptive Neuromuscular Facilitation and Shoulder Stabilization Exercises on Pain, Quality of Life and Functionality in Adhesive Capsulitis Treatment

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 4, 2023
Registry last updated
Feb 20, 2024

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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