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The Effect of PNF and Shoulder Stabilization Exercises on Pain, QoL and Functionality in Patient With AC

Primary Purpose

Adhesive Capsulitis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Proprioceptive Neuromuscular Facilitation (PNF)
Shoulder Stabilization Exercises
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring adhesive Capsulitis, pain, Proprioceptive Neuromuscular Facilitation, Shoulder Stabilization Exercises

Eligibility Criteria

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

Inclusion Criteria: Patients aged 20- 65 years diagnosed with unilateral Stage II adhesive capsulitis by magnetic resonance imaging Shoulder pain persisting for at least 3 months VAS pain score equal to or greater than 5/10 Patients who agreed to participate in the study Exclusion Criteria: - Receiving physical therapy or manual therapy on the same shoulder within 1 year Having mental and cognitive problems, Patients who have undergone surgical procedure/injection/manipulation to the shoulder joint for any reason Neurological disorders that affect shoulder function during daily activities Pain or discomfort in the cervical spine, elbow, wrist, or hand Other pathological conditions concerning the shoulder (rotator cuff tear, tendinitis, etc.)

Sites / Locations

  • Uskudar University Health ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

PNF Group

Stabilization Group

Arm Description

After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, additional PNF exercises were performed once a day, 5 times a week by the same Physiotherapist in the cases in the PNF group. It will be applied for a total of 3 weeks (Total of 15 sessions). PNF contract-relax to subscapularis and internal rotators (7 Sec of contraction and 15 Sec of relaxation in external rotation, 5 repetitions) Followed by facilitation of D2 Flexion patterns for 5 repetitions. PNF all scapular patterns with Rhythmic initiation and repeated contractions Technique .

After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, stabilization exercises were performed by the same Physiotherapist once a day, 5 times a week, for a total of 5 times a week. It will be applied for 3 weeks (Total of 15 sessions). scapular stabilization exercises stabilization exercise for the shoulder joints. In all the exercises, the subjects maintained the position for 10 seconds, and they took a rest for 3 seconds. Ten repetitions was considered one set, and the subjects conducted three sets. A break of 3 minutes was given between each set.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) Evaluation
The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to draw a line on this line to indicate where his condition is appropriate.

Secondary Outcome Measures

Manual Muscle Testing
During the testing of muscle strength without using any device ("manual muscle testing"), the evaluation system (Medical Research Council (MRC)) scale, which is widely used all over the world, is used. It is the evaluation of motion in the context of gravity.
SF-36 (Short Form 36) Quality of Life Scale
The scale, which is among the most common generic scales developed by Rand Corporation in 1992, consists of 36 items. Physical function (10 items), social function (2 items), role limitations due to physical functions (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain It consists of 8 parameters including (2 items) and general health perception (5 items).
DASH (Arm, Shoulder and Hand Problems Questionnaire)
The DASH questionnaire consists of 3 parts. The first part consists of 30 questions. 21 questions evaluate the degree of difficulty of the patient in daily activities, 5 questions evaluate the symptomatic features of pain, and 4 questions evaluate social function, self-confidence and sleep.
Joint Range of Motion
A Goniometer is the most common tool for measuring range of motion of the joints of the body. It uses a stationary arm, fulcrum, and movement arm to measure joint angles from the axis of the joint. Making a ROM measurement by using a goniometer requires training for reliable results. See the goniometry collection of pages for instructions on how to correctly (reliably and accurately) place the goniometer when measuring range of motion.

Full Information

First Posted
March 10, 2023
Last Updated
October 18, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT05797311
Brief Title
The Effect of PNF and Shoulder Stabilization Exercises on Pain, QoL and Functionality in Patient With AC
Official Title
The Effect of Proprioceptive Neuromuscular Facilitation and Shoulder Stabilization Exercises on Pain, Quality of Life and Functionality in Adhesive Capsulitis Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adhesive capsulitis (AC), also known as frozen shoulder, is an insidious, painful condition of the shoulder lasting more than 3 months. This inflammatory condition causing fibrosis of the glenohumeral joint capsule is accompanied by gradual progressive stiffness and marked limitation of range of motion (typically external rotation). Patients experiencing this condition often suffer from poor quality of life due to the limitation of both the active and passive range of shoulder mobility. The prevalence of frozen shoulder is between 2-5% and is more common in women. Along with the increase in comorbidities and changes in lifestyle, the incidence of FS is increasing. However, the natural history and pathogenesis of adhesive capsulitis have not been widely studied and are still unknown. Adhesive capsulitis presents clinically as shoulder pain with progressive restricted movement, both active and passive, with normal radiographic scans of the glenohumeral joint. Classically, it progresses prognostically with 3 overlapping stages: pain (stage 1, lasting 2-9 months), stiffness (stage 2, lasting 4-12 months), and healing (stage 3, lasting 5-24 months). However, this is an estimated time frame and many patients may still experience symptoms after 6 years. Treatment modalities include conservative (ie, steroid injection, physiotherapy) and operative (ie, distension arthrography, manipulation under anesthesia, and arthroscopic release). Various physical therapy treatments commonly used in the treatment of adhesive capsulitis include ice pack, hot pack, transcutaneous electrical nerve stimulation and active and passive ROM exercises, joint mobilization techniques, proprioceptive neuromuscular facilitation (PNF), supervised home exercise programs, and Kinesio taping.
Detailed Description
There are studies on the application of PNF techniques in proprioceptive neuromuscular facilitation (PNF), sports injuries, orthopedics, cardiorespiratory and neurological conditions developed by Knott and Kabat. Recently, the application of these techniques in orthopedic conditions has been developing. However, studies have been conducted to find out the effect of PNF therapy on Adhesive Capsulitis, but there is conflicting evidence between them. Although some studies have suggested PNF, determining which technique is better in the treatment of AC remains controversial and needs to be answered. Therefore, in our study, it was aimed to compare the effects and advantages of proprioceptive neuromuscular exercises and shoulder stabilization exercises applied in the treatment of patients with Adhesive capsulitis and to evaluate the acute effects of these exercises on shoulder movements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
adhesive Capsulitis, pain, Proprioceptive Neuromuscular Facilitation, Shoulder Stabilization Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PNF Group
Arm Type
Experimental
Arm Description
After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, additional PNF exercises were performed once a day, 5 times a week by the same Physiotherapist in the cases in the PNF group. It will be applied for a total of 3 weeks (Total of 15 sessions). PNF contract-relax to subscapularis and internal rotators (7 Sec of contraction and 15 Sec of relaxation in external rotation, 5 repetitions) Followed by facilitation of D2 Flexion patterns for 5 repetitions. PNF all scapular patterns with Rhythmic initiation and repeated contractions Technique .
Arm Title
Stabilization Group
Arm Type
Other
Arm Description
After classical physiotherapy consisting of 40 minutes of hot pack, TENS, US and Exercise (a set of stretching exercises including Wand and Codman pendulum exercises) was applied by an experienced Physiotherapist, stabilization exercises were performed by the same Physiotherapist once a day, 5 times a week, for a total of 5 times a week. It will be applied for 3 weeks (Total of 15 sessions). scapular stabilization exercises stabilization exercise for the shoulder joints. In all the exercises, the subjects maintained the position for 10 seconds, and they took a rest for 3 seconds. Ten repetitions was considered one set, and the subjects conducted three sets. A break of 3 minutes was given between each set.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation (PNF)
Intervention Description
Proprioceptive Neuromuscular Facilitation (PNF) techniques are a therapeutic exercise approach developed based on functional activities in daily life. At the stage of regaining movement and function, it creates models similar to functional activities.
Intervention Type
Other
Intervention Name(s)
Shoulder Stabilization Exercises
Intervention Description
Scapular stabilization exercise and stabilization exercise for the shoulder joints
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Evaluation
Description
The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to draw a line on this line to indicate where his condition is appropriate.
Time Frame
Change from baseline to week 3
Secondary Outcome Measure Information:
Title
Manual Muscle Testing
Description
During the testing of muscle strength without using any device ("manual muscle testing"), the evaluation system (Medical Research Council (MRC)) scale, which is widely used all over the world, is used. It is the evaluation of motion in the context of gravity.
Time Frame
Change from baseline to week 3
Title
SF-36 (Short Form 36) Quality of Life Scale
Description
The scale, which is among the most common generic scales developed by Rand Corporation in 1992, consists of 36 items. Physical function (10 items), social function (2 items), role limitations due to physical functions (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain It consists of 8 parameters including (2 items) and general health perception (5 items).
Time Frame
Change from baseline to week 3
Title
DASH (Arm, Shoulder and Hand Problems Questionnaire)
Description
The DASH questionnaire consists of 3 parts. The first part consists of 30 questions. 21 questions evaluate the degree of difficulty of the patient in daily activities, 5 questions evaluate the symptomatic features of pain, and 4 questions evaluate social function, self-confidence and sleep.
Time Frame
Change from baseline to week 3
Title
Joint Range of Motion
Description
A Goniometer is the most common tool for measuring range of motion of the joints of the body. It uses a stationary arm, fulcrum, and movement arm to measure joint angles from the axis of the joint. Making a ROM measurement by using a goniometer requires training for reliable results. See the goniometry collection of pages for instructions on how to correctly (reliably and accurately) place the goniometer when measuring range of motion.
Time Frame
Change from baseline to week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 20- 65 years diagnosed with unilateral Stage II adhesive capsulitis by magnetic resonance imaging Shoulder pain persisting for at least 3 months VAS pain score equal to or greater than 5/10 Patients who agreed to participate in the study Exclusion Criteria: - Receiving physical therapy or manual therapy on the same shoulder within 1 year Having mental and cognitive problems, Patients who have undergone surgical procedure/injection/manipulation to the shoulder joint for any reason Neurological disorders that affect shoulder function during daily activities Pain or discomfort in the cervical spine, elbow, wrist, or hand Other pathological conditions concerning the shoulder (rotator cuff tear, tendinitis, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
osman coban, PhD
Phone
00905337242919
Email
oscoban@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
safiye gul abat
Email
abat-safiye96@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
safiye gul abat, PT
Organizational Affiliation
Uskudar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uskudar University Health Science
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
osman coban, Asst. Phd
Phone
00905337242919
Email
oscoban@hotmail.com
First Name & Middle Initial & Last Name & Degree
safiye gul abat, PT
Email
gul-safiye96@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31475043
Citation
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Results Reference
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Citation
Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.
Results Reference
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PubMed Identifier
33326025
Citation
Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.
Results Reference
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PubMed Identifier
30828190
Citation
Barbosa F, Swamy G, Salem H, Creswell T, Espag M, Tambe A, Clark D. Chronic adhesive capsulitis (Frozen shoulder): Comparative outcomes of treatment in patients with diabetes and obesity. J Clin Orthop Trauma. 2019 Mar-Apr;10(2):265-268. doi: 10.1016/j.jcot.2018.02.015. Epub 2018 Feb 25.
Results Reference
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PubMed Identifier
26984658
Citation
Kraal T, Visser C, Sierevelt I, Beimers L. How to treat a frozen shoulder? A survey among shoulder specialists in the Netherlands and Belgium. Acta Orthop Belg. 2016 Mar;82(1):78-84.
Results Reference
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PubMed Identifier
20110457
Citation
Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.
Results Reference
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PubMed Identifier
31789299
Citation
Tedla JS, Sangadala DR. Proprioceptive neuromuscular facilitation techniques in adhesive capsulitis: a systematic review and meta-analysis. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):482-491.
Results Reference
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PubMed Identifier
27190456
Citation
Balci NC, Yuruk ZO, Zeybek A, Gulsen M, Tekindal MA. Acute effect of scapular proprioceptive neuromuscular facilitation (PNF) techniques and classic exercises in adhesive capsulitis: a randomized controlled trial. J Phys Ther Sci. 2016 Apr;28(4):1219-27. doi: 10.1589/jpts.28.1219. Epub 2016 Apr 28.
Results Reference
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PubMed Identifier
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Citation
Park SI, Choi YK, Lee JH, Kim YM. Effects of shoulder stabilization exercise on pain and functional recovery of shoulder impingement syndrome patients. J Phys Ther Sci. 2013 Nov;25(11):1359-62. doi: 10.1589/jpts.25.1359. Epub 2013 Dec 11.
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Citation
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The Effect of PNF and Shoulder Stabilization Exercises on Pain, QoL and Functionality in Patient With AC

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