- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705975
Manual Treatment and Proprioceptive Neuromusculer Fasilitation Techniques for Patients With Adhesive Capsulitis
Randomized Controlled Trial, Manual Treatment and Classical Physiotherapy for One Group, PNF and Classical Physiotherapy for Other Group
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Sıhhıye
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Ankara, Sıhhıye, Turkey
- Kübra
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: edit arms
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.
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Scapula mobilization, glenohumeral joint mobilization
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Active Comparator: edit arm/intervention cross
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.
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Scapula mobilization, glenohumeral joint mobilization
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion change
Time Frame: change from baseline range of motion assessment at 8 weeks
|
Flexion, abduction, internal and external rotation range of motion will assessed with universal goniometer.
|
change from baseline range of motion assessment at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective pain assessment: VAS
Time Frame: Change from baseline subjective pain assessment at 8 weeks
|
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.
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Change from baseline subjective pain assessment at 8 weeks
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Scapular dyskinesis
Time Frame: Change from baseline scapular dyskinesis assessment at 8 weeks
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Scapular dyskinesis will be assessed with Lateral Scapular Slide Test.
To measure we used tape measure.
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Change from baseline scapular dyskinesis assessment at 8 weeks
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Muscle strenght
Time Frame: Change from baseline muscle strenght assessment at 8 weeks
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Shoulder complex muscle strenght will be assssed by muscle dynamometer.
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Change from baseline muscle strenght assessment at 8 weeks
|
General arm function
Time Frame: Change from baseline shoulder function assessment at 8 weeks
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Shoulder function will be assessed using Disabilities of the Arm, Shoulder and Hand Questionnare (DASH),
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Change from baseline shoulder function assessment at 8 weeks
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Health quality depent on health
Time Frame: Change from baseline health quality assessment at 8 weeks
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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.
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Change from baseline health quality assessment at 8 weeks
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Health quality is not related to health
Time Frame: Change from baseline health quality assessment at 8 weeks
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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.
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Change from baseline health quality assessment at 8 weeks
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general health level
Time Frame: Change from baseline general health level assessment at 8 weeks
|
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.
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Change from baseline general health level assessment at 8 weeks
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Self rated upper extremity disablity and symptoms.
Time Frame: Change from baseline general health level assessment at 8 weeks
|
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.
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Change from baseline general health level assessment at 8 weeks
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Self-assessment of symptoms and function of the shoulder
Time Frame: Change from baseline general health level assessment at 8 weeks
|
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.
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Change from baseline general health level assessment at 8 weeks
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To assess functional disability of the shoulder
Time Frame: Change from baseline general health level assessment at 8 weeks
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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.
|
Change from baseline general health level assessment at 8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Filiz Can
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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