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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03705975
Other study ID # Filiz Can
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date April 20, 2019

Study information

Verified date June 2018
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date April 20, 2019
Est. primary completion date April 18, 2019
Accepts healthy volunteers No
Gender All
Age group 35 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Manual treatment
Scapula mobilization, glenohumeral joint mobilization

Locations

Country Name City State
Turkey Kübra Ankara Sihhiye

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of motion change 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 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. Change from baseline subjective pain assessment at 8 weeks
Secondary Scapular dyskinesis Scapular dyskinesis will be assessed with Lateral Scapular Slide Test. To measure we used tape measure. Change from baseline scapular dyskinesis assessment at 8 weeks
Secondary Muscle strenght Shoulder complex muscle strenght will be assssed by muscle dynamometer. Change from baseline muscle strenght assessment at 8 weeks
Secondary General arm function Shoulder function will be assessed using Disabilities of the Arm, Shoulder and Hand Questionnare (DASH), Change from baseline shoulder function assessment at 8 weeks
Secondary 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. Change from baseline health quality assessment at 8 weeks
Secondary 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. Change from baseline health quality assessment at 8 weeks
Secondary 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. Change from baseline general health level assessment at 8 weeks
Secondary 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. Change from baseline general health level assessment at 8 weeks
Secondary 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. Change from baseline general health level assessment at 8 weeks
Secondary 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. Change from baseline general health level assessment at 8 weeks
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