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Manual Treatment and Proprioceptive Neuromusculer Fasilitation Techniques for Patients With Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual treatment
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder

Eligibility Criteria

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

Inclusion Criteria:

  • adhesive capsulitis due to idiopathic or acquired reasons

Exclusion Criteria:

  • Cervical disk hernia
  • Neuromusculer disease
  • Shoulder impingement syndrome
  • Rotator cuff tear
  • Corticosteroid enjeksion in shoulder
  • Tumour
  • Physical therapy or manual treatment is implemented same shoulder last 6 months

Sites / Locations

  • Kübra

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

edit arms

edit arm/intervention cross

Arm Description

classical physiotherapy and manual treatment. Classical physiotherapy consisting of hotpack and ultrason. Hotpack duration is 20 minutes and ultrason duration is 5 minutes in one session. Manual treatment is consist of scapular mobilization, glenohumeral joint inferior and posterior mobilization. Treatment modality is implemented by physical therapist three times a week for 8 weeks.

classical physiotherapy and proprioceptive neuromusculer fasilitation. Classical physiotherapy consist of hotpack and ultrason. Hotpack duration is 20 minutes and ultrason duration is 5 minutes in one session. Scapular PNF and upper extremity PNF (flexion-abduction-external rotation) pattern. Treatment programme was implemented by physical therapist three times a week for 8 weeks.

Outcomes

Primary Outcome Measures

Range of motion change
Flexion, abduction, internal and external rotation range of motion will assessed with universal goniometer.

Secondary Outcome Measures

Subjective pain assessment: VAS
Rest, activity and night pain will be assessed by Visuel Analog Scale (VAS). It is self reported pain scale.We will question the intensty of shoulder region pain at rest, night and activity by VAS. The pain intensity was scored on a 100-mm visual analog scale (VAS) where 0 cm indicated "no pain" and 10 cm indicated "worst imaginable pain.
Scapular dyskinesis
Scapular dyskinesis will be assessed with Lateral Scapular Slide Test. To measure we used tape measure.
Muscle strenght
Shoulder complex muscle strenght will be assssed by muscle dynamometer.
General arm function
Shoulder function will be assessed using Disabilities of the Arm, Shoulder and Hand Questionnare (DASH),
Health quality depent on health
Health quality depent on health will be assessed using the "Quality of Life (SF-36)" questionnare. Assesses 8 dimensions of health with 36 items such as physical function, social function, role constraints, mental health, vitality (energy), pain and general perception of health. Each subsection of the quality of life questionnaire is scored between 0 and 100 points. Higher score indicates better outcome.
Health quality is not related to health
Health quality is not related to health will be assessed using the " World Health Organization Quality of Life Assessment (EUROHIS-QOL)". It contains 8 questions. Two of the questions include general health and general quality of life questions, while the remaining 6 questions consist of questions about physical, spiritual, environmental and social dimensions.These questions how long the patient has experienced some things in the last two weeks, what they can do, whether it is good or satisfying, what they think about the quality of life, health and other aspects of life. The total score is calculated by summing the items. The total score is between 8 and 40 points. Higher score indicate worse outcome.
general health level
general healt level will be assessed using "Health Assessment Questionnaire". Health Assessment Questionnare two to three questions in each of eight areas of activities of daily living (ADL): dressing and grooming, arising. eating, walking, hygiene, reach, grip, and activities. The total score ranges between 0-24. The highest score indicate more disability level.
Self rated upper extremity disablity and symptoms.
Self rated upper extremity disablity and symptoms will be assessed using the "Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)" survey. 30 items (total score): 6 items about symptoms (3 about pain, 1 for tingling/numb-ness, 1 for weakness, 1 for stiffness) and 24 about function (21 about physical function, 3 about social/role function). The patients point out the appropriate response between 1-5 points according to the Likert system for each question (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: no disability). A score of 0-100 points is obtained from each section according to the results of the DASH survey ( 0=no disability, 100=most severe disability). 0 score indicate best and 100 score indicate worst outcome. Higher values represent worse outcome.
Self-assessment of symptoms and function of the shoulder
Self-assessment of symptoms and function of the shoulder will be assessed using the Shoulder Pain and Disability Index (SPADI).The SPADI total score is the unweightedmean of the pain and function subscores.Originally, 0 score indicate best and 100 score indicate worst.
To assess functional disability of the shoulder
Functional disability of the shoulder will be assessed using the Simple Shoulder Test.Total score of 12 items: 2 about function related to pain, 7 about function/strength,and 3 about range of motion.0 score indicate worst and 100 score indicate best function.

Full Information

First Posted
September 19, 2018
Last Updated
April 14, 2019
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03705975
Brief Title
Manual Treatment and Proprioceptive Neuromusculer Fasilitation Techniques for Patients With Adhesive Capsulitis
Official Title
Randomized Controlled Trial, Manual Treatment and Classical Physiotherapy for One Group, PNF and Classical Physiotherapy for Other Group
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
April 18, 2019 (Anticipated)
Study Completion Date
April 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe 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
This study aim was to compare the effectiveness of manual treatment and proprioceptive neuromuscular fasilitation (PNF) techniques in patients with adhesive capsulitis. One group will receive classical physical therapy including hotpack,ultrason and in additon manual treatment application. Other group receive classical physical therapy including hotpack, ultrason and in addition PNF techniques. Two group will be made wand exercise at home three times a day 10 times at one session.
Detailed Description
There is no consensus physical therapy treatment protocol in adhesive capsulitis. It is because it etiology and pathophysiology is unknown. Also it has different clinical stage. PNF techniques often used by physical therapist in adhesive capsulitis aim increasing range of motion, improving muscle strenght and decreasing pain. PNF techniques improves neuromusculer control of central nervous system via stimulating muscle spindles, golgi tendon organs and other receptors in connective tissue. However, there is limited evidence effectivenes of PNF techniques in adhesive capsulitis. Other technique often used by physical therapist in adhesive capsulitis is manual treatment. Manual treatment decreases pain and improves function. It re-arrange glenohumeral joint arthrocinematic. It diminishes capsule fibrosis. There is no reasearh aimed comparing the PNF and manual treatment. Our aim was to compare the effectiveness of manual treatment and PNF techiques in patients with adhesive capsulitis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
edit arms
Arm Type
Active Comparator
Arm Description
classical physiotherapy and manual treatment. Classical physiotherapy consisting of hotpack and ultrason. Hotpack duration is 20 minutes and ultrason duration is 5 minutes in one session. Manual treatment is consist of scapular mobilization, glenohumeral joint inferior and posterior mobilization. Treatment modality is implemented by physical therapist three times a week for 8 weeks.
Arm Title
edit arm/intervention cross
Arm Type
Active Comparator
Arm Description
classical physiotherapy and proprioceptive neuromusculer fasilitation. Classical physiotherapy consist of hotpack and ultrason. Hotpack duration is 20 minutes and ultrason duration is 5 minutes in one session. Scapular PNF and upper extremity PNF (flexion-abduction-external rotation) pattern. Treatment programme was implemented by physical therapist three times a week for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Manual treatment
Intervention Description
Scapula mobilization, glenohumeral joint mobilization
Primary Outcome Measure Information:
Title
Range of motion change
Description
Flexion, abduction, internal and external rotation range of motion will assessed with universal goniometer.
Time Frame
change from baseline range of motion assessment at 8 weeks
Secondary Outcome Measure Information:
Title
Subjective pain assessment: VAS
Description
Rest, activity and night pain will be assessed by Visuel Analog Scale (VAS). It is self reported pain scale.We will question the intensty of shoulder region pain at rest, night and activity by VAS. The pain intensity was scored on a 100-mm visual analog scale (VAS) where 0 cm indicated "no pain" and 10 cm indicated "worst imaginable pain.
Time Frame
Change from baseline subjective pain assessment at 8 weeks
Title
Scapular dyskinesis
Description
Scapular dyskinesis will be assessed with Lateral Scapular Slide Test. To measure we used tape measure.
Time Frame
Change from baseline scapular dyskinesis assessment at 8 weeks
Title
Muscle strenght
Description
Shoulder complex muscle strenght will be assssed by muscle dynamometer.
Time Frame
Change from baseline muscle strenght assessment at 8 weeks
Title
General arm function
Description
Shoulder function will be assessed using Disabilities of the Arm, Shoulder and Hand Questionnare (DASH),
Time Frame
Change from baseline shoulder function assessment at 8 weeks
Title
Health quality depent on health
Description
Health quality depent on health will be assessed using the "Quality of Life (SF-36)" questionnare. Assesses 8 dimensions of health with 36 items such as physical function, social function, role constraints, mental health, vitality (energy), pain and general perception of health. Each subsection of the quality of life questionnaire is scored between 0 and 100 points. Higher score indicates better outcome.
Time Frame
Change from baseline health quality assessment at 8 weeks
Title
Health quality is not related to health
Description
Health quality is not related to health will be assessed using the " World Health Organization Quality of Life Assessment (EUROHIS-QOL)". It contains 8 questions. Two of the questions include general health and general quality of life questions, while the remaining 6 questions consist of questions about physical, spiritual, environmental and social dimensions.These questions how long the patient has experienced some things in the last two weeks, what they can do, whether it is good or satisfying, what they think about the quality of life, health and other aspects of life. The total score is calculated by summing the items. The total score is between 8 and 40 points. Higher score indicate worse outcome.
Time Frame
Change from baseline health quality assessment at 8 weeks
Title
general health level
Description
general healt level will be assessed using "Health Assessment Questionnaire". Health Assessment Questionnare two to three questions in each of eight areas of activities of daily living (ADL): dressing and grooming, arising. eating, walking, hygiene, reach, grip, and activities. The total score ranges between 0-24. The highest score indicate more disability level.
Time Frame
Change from baseline general health level assessment at 8 weeks
Title
Self rated upper extremity disablity and symptoms.
Description
Self rated upper extremity disablity and symptoms will be assessed using the "Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)" survey. 30 items (total score): 6 items about symptoms (3 about pain, 1 for tingling/numb-ness, 1 for weakness, 1 for stiffness) and 24 about function (21 about physical function, 3 about social/role function). The patients point out the appropriate response between 1-5 points according to the Likert system for each question (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: no disability). A score of 0-100 points is obtained from each section according to the results of the DASH survey ( 0=no disability, 100=most severe disability). 0 score indicate best and 100 score indicate worst outcome. Higher values represent worse outcome.
Time Frame
Change from baseline general health level assessment at 8 weeks
Title
Self-assessment of symptoms and function of the shoulder
Description
Self-assessment of symptoms and function of the shoulder will be assessed using the Shoulder Pain and Disability Index (SPADI).The SPADI total score is the unweightedmean of the pain and function subscores.Originally, 0 score indicate best and 100 score indicate worst.
Time Frame
Change from baseline general health level assessment at 8 weeks
Title
To assess functional disability of the shoulder
Description
Functional disability of the shoulder will be assessed using the Simple Shoulder Test.Total score of 12 items: 2 about function related to pain, 7 about function/strength,and 3 about range of motion.0 score indicate worst and 100 score indicate best function.
Time Frame
Change from baseline general health level assessment at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adhesive capsulitis due to idiopathic or acquired reasons Exclusion Criteria: Cervical disk hernia Neuromusculer disease Shoulder impingement syndrome Rotator cuff tear Corticosteroid enjeksion in shoulder Tumour Physical therapy or manual treatment is implemented same shoulder last 6 months
Facility Information:
Facility Name
Kübra
City
Ankara
State/Province
Sıhhıye
Country
Turkey

12. IPD Sharing Statement

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Manual Treatment and Proprioceptive Neuromusculer Fasilitation Techniques for Patients With Adhesive Capsulitis

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