Central Nervous System Focused Therapy in Frozen Shoulder

NCT05372497 | Completed

• 1 other identifier: MedipolUniversity2020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Frozen shoulder has been considered a self-limiting and benign disease with complete resolution of pain and ROM, but this can sometimes last for years. This prolonged pain and disability deprives patients of their routine life, occupational and recreational activities. Although appropriate treatment is needed so that they can quickly return to their lives, definitive treatment strategies have not been established and many different management strategies are used. The aim of this study is to investigate whether pain education and sensory education applied together with conventional physiotherapy are more effective than conventional physiotherapy alone.In this study, 21 people diagnosed with frozen shoulder who were referred by the doctor of Esenler Medipol Hospital, Department of Physical Therapy and Rehabilitation will be included in the study. Outcome measures: Pain Beliefs Scale, Pain Catastrophizing Scale, PainDetect Questionnaire, Tampa Kinesiophobia Scale, Shoulder Pain and Disability Index, Visual Analog Scale, Electrogoniometer, Two-point discrimination test, Numeric Rating Sleep Scale and Right/ Left Judgement Task. This study was designed as a prospective randomized controlled trial. 21 people were included in the study. Participants were randomly divided into two groups: Conventional physiotherapy group (CP group) (n=11), Conventional physiotherapy plus central nervous system focused treatment group (CP+CNS group) (n=10). Conventional physiotherapy was applied to both groups for 45-60 minutes, 5 days a week for 4 weeks. The CP group treatment session will take place as follows: Scapular mobilization, passive stretches, stick exercises, pendulum exercises and shoulder flexion, extension, internal rotation, external rotation, horizontal abduction/ adduction strengthening exercises. The CP+CNS group received central nervous system focused therapy that included chronic pain education, localization training, graphesthesia, graded motor imagery and mirror therapy in addition to conventional physiotherapy. The IG group protocol includes:

1. 1.week: Initial Evaluation, Conventional physiotherapy (CP), Chronic Pain Education, Localization Training Level 1, Right / Left Discrimination Training
2. 2.week: CP, Motor Imagery, Localization Training Level 2
3. 3.week: CP, Grafestesis Training, Isometric Exercise
4. 4.week: CP, Mirror Therapy, Functional Exercises, Final Evaluation

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (6)

• The Pain Catastrophizing Scale

  The PCS is used to evaluate the patient's feelings, thoughts, and emotions related to pain and catastrophizing. it is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater catastrophizing. The scores for each item are added to determine the subscales, and the total score is calculated by the summation of all items. The PCS scores range from 0 to 52 points

  Change from The Pain Catastrophizing Scale at 4 weeks

• Visual Analog Scale (VAS)

  It is used to assess pain. Although pain has been defined in many different ways, the most widely accepted is the International Association for the Study of Pain (IASP); It is a definition of "sensory, emotional, unpleasant feeling related to the past experiences of the person, whether due to an organic cause originating from any part of the body or not" (20). Visual Analogue Scale (VAS) is a reliable and valid pain measurement method in the evaluation of the severity of chronic pain (21). There is a numeric horizontal line between zero and ten. Zero means "no pain" and ten means "unbearable pain". Below the horizontal scale are facial expressions.

  Change from Visual Analog Scale (VAS) at 4 weeks

• Electrogoniometer

  Normal joint movements measurement is evaluated with active or passive movements. The most used instrument for the objective evaluation of these movements is the electrogoniometer. All joints are placed according to the anatomical position before measurement and this position is considered as the zero initial position. The electrogoniometer should not touch the body during measurement and should be placed lateral to the joint. In this study, shoulder joint electrogoniometer measurements will be made. Shoulder flexion, abduction, internal rotation, external rotation will be measured at the beginning and at the end of the 4th week, with an electrogoniometer, normal range of motion will be measured.

  Change from electrogoniometer at 4 weeks

• Two Point Discrimination Test

  The two-point discrimination test is the evaluation of the ability to perceive stimuli applied from two different points at the same time. A commercially available mechanical caliper will be used to measure two-point separation on the non-dominant and dominant shoulders. These areas within the shoulder will correspond to the C5, C6 and C7 dermatomes. Participants will be instructed to report to the tester if they repeatedly feel two points or if the pressure is greater than a light touch.Care should be taken that the warning given while performing the test does not cause pain. Evaluation will be made with the aid of an esthesiometer. The esthesiometer is used to measure the person's 2-point sensory threshold on the skin. The ruler opens until you feel the 2 points and the value is recorded.

  Change from two point discrimination test at 4 weeks

• Pain Beliefs Scale

  It was developed by Edwards et al. in 1992. They mention that the most important purpose of developing the scale is to understand the psychological and organic attributions of chronic pain patients to the origin of pain, which have not been investigated until that time. In the original form of this scale, there are a total of 20 items covering beliefs about the sources of pain and the treatment method. Two subtests were created: Organic Beliefs subtest consisting of 8 items and Psychological Beliefs subtest consisting of 4 items. Scores range from 1 to 6 for each item. The total score for each subtest is calculated by adding the scores obtained from the items in that subtest and dividing by the number of items belonging to that subtest.

  Change from pain beliefs scale at 4 weeks

• Right/left Judgement Task

  For laterality assessment, SSDG was assessed with the Neuro Orthopedic Institute (NOI) Recognise Shoulder™ online program using an iPad. In order to gain familiarity, individuals were asked to mark whether 15 photos from the rapid test category belonged to the right or left shoulder. In the actual assessment, they were asked to answer 30 shoulder photos from the rapid test category as right and left as soon as possible. Mean response times (RT) in milliseconds (ms) and percentage of correct responses were reported separately for both the affected and unaffected shoulder region as the two main outcome measures. Responses below 500 ms and above 15000 ms were considered invalid.

  Change from right/left judgement task at 4 weeks

Secondary Outcomes (5)

• Tampa Kinesiophobia Scale (TKS)

  Change from tampa kinesiophobia scale (TKS) at 4 weeks

• Shoulder Pain and Disability Index (SPADI)

  Change from shoulder pain and disability index (SPADI) at 4 weeks

• Pain Detect (PD-Q)

  Change from shoulder pain detect (PD-Q)at 4 weeks

• Graded Chronic Pain Scale-Revised

  Change from graded chronic pain scale-revised at 4 weeks

• Sleep Scale

  Change from sleep scale at 4 weeks

Study Arms (2)

Conventional physiotherapy plus central nervous system focused treatment group (CP+CNS group)

EXPERIMENTAL

For the patients participating in the study, a protocol focused on the central nervous system and aimed at reducing hypersensitivity was applied with pain, graded sensory discrimination and graded motor imagery (GMI) training in addition to conventional physiotherapy. Graded sensory dicrimination training includes localization training level 1, localization training level 2 and graphesthesia training. GMI training includes right/left discrimination training, visual imagery, isometric and functional exercises, and mirror therapy. The treatment was applied in 20 sessions, for 45-60 minutes, 5 days a week.

Other: Intervention group (IG)

Conventional Physiotherapy Group (CP Group)

ACTIVE COMPARATOR

In the conventional physiotherapy group of the study, in addition to physiotherapy modalities for 20 sessions, 5 days a week, for 45-60 minutes each session, 5 days a week, electrotherapy, scapular mobilization, passive stretching, stick exercises, finger ladder exercises, pendulum exercises and shoulder flexion, extension, abduction, internal rotation, external rotation strengthening exercises were applied.

Other: Control group (CG)

Interventions

Intervention group (IG) OTHER

Participants randomized to this treatment will receive a central nervous system-focused intervention consisting of a 20-session treatment program delivered in 30-45-minute sessions scheduled 5 days a week over a 4-week period and standard physical therapy will be continued. * Chronic pain training will be given according to the needs of the person and 5-10 minutes will be allocated every day for the first week and chronic pain education will be divided into modules. * Right / Left Discrimination Training * Localization Training Level 1- Level 2 Training * Visual imagination Training * Visual Imagery Training * Mirror Therapy * Isometric and functional exercises

Conventional physiotherapy plus central nervous system focused treatment group (CP+CNS group)

Control group (CG) OTHER

The control group will receive only conventional physiotherapy. Conventional physiotherapy will be 5 days a week. The conventional physiotherapy treatment session will take place as follows. * Electrotherapy * Scapular mobilization * Passive stretches * Stick Exercises * Pendulum Exercises * Shoulder flexion, extension, internal rotation, external rotation, horizontal abduction/ adduction strengthening exercises Conventional physiotherapy intervention is planned for 45-60 minutes a day, five days a week for both groups.

Conventional Physiotherapy Group (CP Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with frozen shoulder with chronic pain lasting more than 3 months
• Being between the ages of 18-65
• Absence of fracture, dislocation or arthritis in the shoulder area evaluated by routine x-ray examination
• Patients who were not prescribed any medical treatment other than analgesics in the last 3 months were included.

You may not qualify if:

• Wide scar around the shoulder
• History of bilateral concurrent frozen shoulder
• If there has been surgical intervention on the affected shoulder
• Rotator cuff calcification
• Cervical radiculopathy
• History of physical therapy program for the same shoulder in the last 6 months

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Esenler Hospital

Istanbul, Istanbul, 34230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ayşe GÜRLÜK, MSc

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 12, 2022
• Study Start: May 11, 2022
• Primary Completion: July 15, 2022
• Study Completion: November 2, 2022
• Last Updated: December 9, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)