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Efficacy of Combined Treatment With Pain and Sensory Education in Frozen Shoulder Patients

Primary Purpose

Frozen Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
intervention group
control group
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul Medipol University Esenler HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

intervention group

control group

Arm Description

Outcomes

Primary Outcome Measures

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
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.
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.
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.
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.

Secondary Outcome Measures

Tampa Kinesiophobia Scale (TKS)
The Tampa Kinesiophobia Scale (TKS) was originally developed by Miller, Kopri, and Todd in 1991 but was not published. Vlaeyen et al. republished the original 17-question scale in 1995 with permission from the researchers who developed it. The validity and reliability study of the Turkish version was conducted by Yılmaz et al. in 2011. TKS is a 17-item scale developed to measure fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. A 4-point Likert scoring (1=I totally disagree, 4=I totally agree) is used in the scale. After reversing the 4th, 8th, 12th and 16th items, the total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Shoulder Pain and Disability Index (SPADI)
The functional status of the patients was evaluated using the "Shoulder Pain and Disability Index". Shoulder pain and disability index is a questionnaire developed to measure shoulder pain-related pain and disability, consisting of two parts, pain and disability, and containing a total of 13 questions. There are 5 questions in the subgroup of the questionnaire that evaluates pain, and the patient is asked to express the severity of his pain during different activities in the last week by scoring between zero (no pain) and 10 (the most severe pain). In the subgroup in which disability is evaluated, there are 8 questions and the patient is asked to rate how much difficulty he has had during the different activities he has done in the last week, between zero (no difficulty) and 10 (receiving help). A total score of zero indicates maximum well-being, and 130 points indicate maximum ill health.
Pain Detect (PD-Q)
The PD-Q is a simple questionnaire that allows the detection of neuropathic pain components in patients with chronic pain. PD-Q consists of four main parts. In the first part, it evaluates the intensity of current pain, the average and maximum pain intensity over the past 4 weeks. In the second part, patients are asked to mark one of the four graphs that best describe their pain course patterns. The third section includes a sensory map representing the homunculus, a bidirectional item about the presence of radiating pain, and questions that attempt to mark the area of pain with an arrow pointing in the direction of the radiating pain. In the last part, there are seven Likert-type items asking the intensity of the sensation marked on the homunculus. This last section provides scores between 0 and 35 points. The final score is obtained by adding the total scores of the last three sections from -1 to 38. PD-Q uses two cut-off values.
Graded Chronic Pain Scale-Revised
Persons with chronic pain are placed at grades 1, 2, or 3. Among persons with chronic pain, those who report that pain limits their life activities or work on most days or every day in the past 3 months (item 2) are placed at grade 3 (high-impact chronic pain). Among the remaining persons with chronic pain, those with a PEG total score of 12 or greater are placed at grade 2 (bothersome chronic pain). Those with chronic pain that is not high impact and whose PEG score is less than 12 are placed at grade 1 (mild chronic pain).
Sleep Scale
A scale of zero to ten points will be used to assess sleep quality. The person will be asked to score between 0-10 points for sleep quality, considering how many hours they sleep, how easily they fall asleep, how often they wake up at night (except to go to the bathroom), how often they wake up early in the morning without having to, and how refreshing their sleep is. 0 means "terrible", 1-2-3 means "poor", 4-5-6 means "balanced", 7-8-9 means "good", 10 means "great".

Full Information

First Posted
April 27, 2022
Last Updated
May 10, 2022
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05372497
Brief Title
Efficacy of Combined Treatment With Pain and Sensory Education in Frozen Shoulder Patients
Official Title
Efficacy of Combined Treatment With Pain and Sensory Education in Frozen Shoulder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2022 (Anticipated)
Primary Completion Date
June 10, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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. H0: Conventional physiotherapy applied together with pain training and sensory training is not different from conventional physiotherapy applied alone. H1: Conventional physiotherapy applied together with pain education and sensory education is different from conventional physiotherapy applied alone. This study will be carried out in Esenler Medipol Hospital located in Esenler district of Istanbul province. Twenty people diagnosed with frozen shoulder referred by the doctor of Esenler Medipol Hospital Physical Therapy and Rehabilitation Department will be included in the study. The study will take place between July 2021 and December 2021. Rating scales include: Pain beliefs scale Pain catastrophizing scale Pain Detect pain questionnaire Tampa Kinesiophobia Scale (TKS) Shoulder pain and disability index (SPADI) Visual Analog Scale Electrogoniometry to measure normal joint motion Two-point discrimination test will be used for sensory evaluation. This study was designed as a prospective, randomized, controlled study, and the 20 subjects included in the study, regardless of gender, will be randomly divided into two groups: the conventional physiotherapy group (n=10), the conventional physiotherapy group with pain education, and the sensory education group. (n=10) The patients will be divided into two as control group and intervention group. The control group will receive only conventional physiotherapy. The intervention group, on the other hand, will receive conventional physiotherapy with pain training prepared in the form of a 20-minute presentation in the first week the patient starts the sessions, and 15-minute sensory training 3 days a week in the remaining weeks. Conventional physiotherapy will be 5 days a week. The conventional physiotherapy treatment session will take place as follows. 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. The intervention group will receive conventional physiotherapy treatment along with pain education and sensory education. Intervention group protocol includes: First week: Initial Evaluation (1 day) Chronic Pain Education Presentation (4 days) Localization Therapy - level 1 (4 days): the first phase of localization training (tactile discrimination training) is performed by placing a mirror between the upper extremities in order to provide visual feedback to the patient. With the blunt tip of the probe, the 9-hole grid and their localization on the shoulder are introduced. After the familiarization period, the patient continues to train with the blunt tip of the probe (2 seconds) using a random number sequence. Right / Left Discrimination Training (4 days) Standard Physical Therapy (5 days) Second week: Standard Physical Therapy Visual Imagery (5 days) Localization Training level 2 (5 days) Third week: Standard Physical Therapy Grafestesis Training (5 days) Isometric exercise (5 days) Fourth week: Standard Physical Therapy Mirror Therapy Functional Exercises Final Evaluation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Title
control group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
intervention group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
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. 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.
Primary Outcome Measure Information:
Title
The Pain Catastrophizing Scale
Description
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
Time Frame
Change from The Pain Catastrophizing Scale at 4 weeks
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
Change from Visual Analog Scale (VAS) at 4 weeks
Title
Electrogoniometer
Description
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.
Time Frame
Change from electrogoniometer at 4 weeks
Title
Two Point Discrimination Test
Description
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.
Time Frame
Change from two point discrimination test at 4 weeks
Title
Pain Beliefs Scale
Description
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.
Time Frame
Change from pain beliefs scale at 4 weeks
Secondary Outcome Measure Information:
Title
Tampa Kinesiophobia Scale (TKS)
Description
The Tampa Kinesiophobia Scale (TKS) was originally developed by Miller, Kopri, and Todd in 1991 but was not published. Vlaeyen et al. republished the original 17-question scale in 1995 with permission from the researchers who developed it. The validity and reliability study of the Turkish version was conducted by Yılmaz et al. in 2011. TKS is a 17-item scale developed to measure fear of movement/re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. A 4-point Likert scoring (1=I totally disagree, 4=I totally agree) is used in the scale. After reversing the 4th, 8th, 12th and 16th items, the total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Time Frame
Change from tampa kinesiophobia scale (TKS) at 4 weeks
Title
Shoulder Pain and Disability Index (SPADI)
Description
The functional status of the patients was evaluated using the "Shoulder Pain and Disability Index". Shoulder pain and disability index is a questionnaire developed to measure shoulder pain-related pain and disability, consisting of two parts, pain and disability, and containing a total of 13 questions. There are 5 questions in the subgroup of the questionnaire that evaluates pain, and the patient is asked to express the severity of his pain during different activities in the last week by scoring between zero (no pain) and 10 (the most severe pain). In the subgroup in which disability is evaluated, there are 8 questions and the patient is asked to rate how much difficulty he has had during the different activities he has done in the last week, between zero (no difficulty) and 10 (receiving help). A total score of zero indicates maximum well-being, and 130 points indicate maximum ill health.
Time Frame
Change from shoulder pain and disability index (SPADI) at 4 weeks
Title
Pain Detect (PD-Q)
Description
The PD-Q is a simple questionnaire that allows the detection of neuropathic pain components in patients with chronic pain. PD-Q consists of four main parts. In the first part, it evaluates the intensity of current pain, the average and maximum pain intensity over the past 4 weeks. In the second part, patients are asked to mark one of the four graphs that best describe their pain course patterns. The third section includes a sensory map representing the homunculus, a bidirectional item about the presence of radiating pain, and questions that attempt to mark the area of pain with an arrow pointing in the direction of the radiating pain. In the last part, there are seven Likert-type items asking the intensity of the sensation marked on the homunculus. This last section provides scores between 0 and 35 points. The final score is obtained by adding the total scores of the last three sections from -1 to 38. PD-Q uses two cut-off values.
Time Frame
Change from shoulder pain detect (PD-Q)at 4 weeks
Title
Graded Chronic Pain Scale-Revised
Description
Persons with chronic pain are placed at grades 1, 2, or 3. Among persons with chronic pain, those who report that pain limits their life activities or work on most days or every day in the past 3 months (item 2) are placed at grade 3 (high-impact chronic pain). Among the remaining persons with chronic pain, those with a PEG total score of 12 or greater are placed at grade 2 (bothersome chronic pain). Those with chronic pain that is not high impact and whose PEG score is less than 12 are placed at grade 1 (mild chronic pain).
Time Frame
Change from graded chronic pain scale-revised at 4 weeks
Title
Sleep Scale
Description
A scale of zero to ten points will be used to assess sleep quality. The person will be asked to score between 0-10 points for sleep quality, considering how many hours they sleep, how easily they fall asleep, how often they wake up at night (except to go to the bathroom), how often they wake up early in the morning without having to, and how refreshing their sleep is. 0 means "terrible", 1-2-3 means "poor", 4-5-6 means "balanced", 7-8-9 means "good", 10 means "great".
Time Frame
Change from sleep scale at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşe GÜRLÜK
Phone
+905387626212
Email
aysegurluk@gmail.com
Facility Information:
Facility Name
Istanbul Medipol University Esenler Hospital
City
Istanbul
ZIP/Postal Code
34230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayşe GÜRLÜK
Phone
+905387626212
Email
aysegurluk@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Combined Treatment With Pain and Sensory Education in Frozen Shoulder Patients

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