Adhesive Capsulitis of ShoulderNCT03705975
Manual Treatment and Proprioceptive Neuromusculer Fasilitation Techniques for Patients With Adhesive Capsulitis
A study testing Manual treatment in people with Adhesive Capsulitis of Shoulder, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- Manual treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 20 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adhesive capsulitis due to idiopathic or acquired reasons
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial, Manual Treatment and Classical Physiotherapy for One Group, PNF and Classical Physiotherapy for Other Group
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.
Read the 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.
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- Manual treatment
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual treatmentOther
Scapula mobilization, glenohumeral joint mobilization
| Study group | Role | What they receive |
|---|---|---|
| edit arms | Active comparator | 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. Receives: Other: Manual treatment |
| edit arm/intervention cross | Active comparator | 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. Receives: Other: Manual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion change
Flexion, abduction, internal and external rotation range of motion will assessed with universal goniometer.
Measured: change from baseline range of motion assessment at 8 weeks
Secondary outcomes (10)
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.
Measured: Change from baseline subjective pain assessment at 8 weeks
Scapular dyskinesis
Scapular dyskinesis will be assessed with Lateral Scapular Slide Test. To measure we used tape measure.
Measured: Change from baseline scapular dyskinesis assessment at 8 weeks
Muscle strenght
Shoulder complex muscle strenght will be assssed by muscle dynamometer.
Measured: Change from baseline muscle strenght assessment at 8 weeks
General arm function
Shoulder function will be assessed using Disabilities of the Arm, Shoulder and Hand Questionnare (DASH),
Measured: Change from baseline shoulder function assessment at 8 weeks
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.
Measured: Change from baseline health quality assessment at 8 weeks
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.
Measured: Change from baseline health quality assessment at 8 weeks
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.
Measured: Change from baseline general health level assessment at 8 weeks
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.
Measured: Change from baseline general health level assessment at 8 weeks
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.
Measured: Change from baseline general health level assessment at 8 weeks
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.
Measured: Change from baseline general health level assessment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Nov 2018
- Primary completion18 Apr 2019 (estimated)
- Study completion20 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Canli, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705975
- Sponsor's protocol ID
- Filiz Can
- Status last verified
- Jun 2018
- First submitted
- 19 Sep 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial, Manual Treatment and Classical Physiotherapy for One Group, PNF and Classical Physiotherapy for Other Group
- ClinicalTrials.gov ID
- NCT03705975
- Acronym / sponsor ID
- Filiz Can
- Conditions
- Adhesive Capsulitis of Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 18 Apr 2019 (estimated)
- Study completion
- 20 Apr 2019 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| edit arms | Active comparator | Other: Manual treatmentclassical 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. |
| edit arm/intervention cross | Active comparator | Other: Manual treatmentclassical 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adhesive capsulitis due to idiopathic or acquired reasons
Key exclusion criteria (7 listed)
- Cervical disk hernia
- Neuromusculer disease
- Shoulder impingement syndrome
- Rotator cuff tear
- Corticosteroid enjeksion in shoulder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual treatmentScapula mobilization, glenohumeral joint mobilization | Other | edit arm/intervention cross, edit arms |
Primary outcome
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.
10 secondary outcomes
Subjective pain assessment: VAS
Time frame: Change from baseline subjective pain assessment at 8 weeks
Scapular dyskinesis
Time frame: Change from baseline scapular dyskinesis assessment at 8 weeks
Muscle strenght
Time frame: Change from baseline muscle strenght assessment at 8 weeks
General arm function
Time frame: Change from baseline shoulder function assessment at 8 weeks
Health quality depent on health
Time frame: Change from baseline health quality assessment at 8 weeks
Health quality is not related to health
Time frame: Change from baseline health quality assessment at 8 weeks
general health level
Time frame: Change from baseline general health level assessment at 8 weeks
Self rated upper extremity disablity and symptoms.
Time frame: Change from baseline general health level assessment at 8 weeks
Self-assessment of symptoms and function of the shoulder
Time frame: Change from baseline general health level assessment at 8 weeks
To assess functional disability of the shoulder
Time frame: Change from baseline general health level assessment at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual treatment in people with Adhesive Capsulitis of Shoulder, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion change (time frame: change from baseline range of motion assessment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.