- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03161782
The Efficacy of Different Types of Stretching on Range of Motion, Pain and Function in Elbow Limitation
February 22, 2018 updated by: Tansu Birinci, Istanbul University
The Efficacy of Proprioceptive Neuromuscular Facilitation Stretching and Static Stretching on Range of Motion, Pain and Function in Elbow Limitation
The aim of the study is to compare the efficacy of Proprioceptive Neuromuscular Facilitation (PNF) stretching and static stretching on range of motion (ROM), pain and function in elbow limitation.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
To compare the efficacy of PNF stretching and static stretching on ROM, pain and function in elbow limitation, forty voluntary patients with elbow limitation, aged between 18-55 years will be randomly divided into two groups: PNF Stretching group and Static Stretching group.
PNF stretching will be combined with exercise and cold application in PNF Stretching group, static stretching will be combined with exercise and cold application in Static Stretching group, will be applied for 12 sessions.
The patients will be assessed before and after six-week treatment.
The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS).
ROM will be assesed with universal goniometer.
The functional status will be evaluated by Disabilities Arm, Shoulder and Hand (DASH).
Kinesiophobia and quality of life will be assessed with Tampa Scale for Kinesiophobia and Short Form-12, respectively.
The Global Rating of Change will be used to evaluate patient satisfaction.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Istanbul, Turkey
- Istanbul University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Subjectswill be included with
- Aged between 18 and 65 years
- Elbow fracture in the six months before the study
- Elbow limitation in flexion or extension
- Being volunteer to participate
- Fractures should be managed with conservatively or surgically
Exclusion Criteria:
- Malunion or Nonunion Fracture
- Occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
- Non-healing wound or infection
- Previously received physiotherapy for elbow limitation
- Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
- Could not adjust to treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PNF Stretching group
Each subject in PNF Stretching group will receive a treatment protocol consisting of PNF stretching, cold therapy and exercise.
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For hold-relax stretching, each subject in PNF Stretching group will be comfortably positioned in a supine lying position, and patient will move the joint to the end of the passive or pain-free ROM.
The therapist will ask for an isometric contraction of the restricting muscle or pattern (antagonists) with emphasis on rotation.
The patients will be asked to perform submaximal isometric contractions of the target muscle for 10 seconds.
After the contraction, the patients will be instructed to relax for 5 seconds.
The joint will be repositioned actively to the new limit of range, and then therapist will passively control the new ROM.
The procedure will be repeated 10 times with 10 seconds of rest between two successive trials.
Patients will be treated 2 times per week for 6 weeks.
Shoulder, elbow and wrist AROM exercises.
Elbow flexion and extansion self-stretching exercises Elbow and wrist strengthening exercises Proprioception exercises for elbow.
Grip strengthening exercises.
Cold therapy will be applied over the elbow for 15 minutes in the form of cold pack after stretching and exercise protocol.
|
|
Experimental: Static Stretching group
Each subject in Static Stretching group will receive a treatment protocol consisting of static stretching, cold therapy and exercise.
|
Shoulder, elbow and wrist AROM exercises.
Elbow flexion and extansion self-stretching exercises Elbow and wrist strengthening exercises Proprioception exercises for elbow.
Grip strengthening exercises.
Cold therapy will be applied over the elbow for 15 minutes in the form of cold pack after stretching and exercise protocol.
For static stretching, each subject in Static Stretching group will be comfortably positioned in a supine lying position, and the stretching of target muscle will be maintained for 20 seconds followed by 10 seconds of rest.
The procedure will be repeated 10 times with 10 seconds of rest between two successive trials.
Patients will be treated 2 times per week for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Status
Time Frame: After the six-week intervention
|
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
|
After the six-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active Range of Motion (AROM) Assessment
Time Frame: Baseline
|
The elbow's and forearm's AROM, including flexion, extansion, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer.
The process will be repeated three times in each direction, with the the average value recorded.
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Baseline
|
|
Active Range of Motion (AROM) Assessment
Time Frame: After the six-week intervention
|
The elbow's and forearm's AROM, including flexion, extansion, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer.
The process will be repeated three times in each direction, with the the average value recorded.
|
After the six-week intervention
|
|
Active Range of Motion (AROM) Assessment
Time Frame: 1-month follow up
|
The elbow's and forearm's AROM, including flexion, extansion, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer.
The process will be repeated three times in each direction, with the the average value recorded.
|
1-month follow up
|
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Functional Status
Time Frame: Baseline
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The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
|
Baseline
|
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Functional Status
Time Frame: 1-month follow up
|
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
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1-month follow up
|
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Pain Intensity
Time Frame: Baseline
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Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
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Baseline
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Pain Intensity
Time Frame: After the six-week intervention
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Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
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After the six-week intervention
|
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Pain Intensity
Time Frame: 1-month follow up
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Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
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1-month follow up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life
Time Frame: Baseline
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Quality of life of the patients will be assessed by Short Form-12.
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Baseline
|
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Quality of Life
Time Frame: After the six-week intervention
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Quality of life of the patients will be assessed by Short Form-12.
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After the six-week intervention
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Quality of Life
Time Frame: 1-month follow up
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Quality of life of the patients will be assessed by Short Form-12.
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1-month follow up
|
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Fear of movement (kinesiophobia)
Time Frame: Baseline
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Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale.
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Baseline
|
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Fear of movement (kinesiophobia)
Time Frame: After the six-week intervention
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Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale.
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After the six-week intervention
|
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Fear of movement (kinesiophobia)
Time Frame: 1-month follow up
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Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale.
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1-month follow up
|
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Patient Satisfaction
Time Frame: After the six-week intervention
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Patient Satisfaction will be assessed with Global Rating of Change Scale.
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After the six-week intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tansu Birinci, MSc, Istanbul University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
May 15, 2017
Study Completion (Actual)
July 25, 2017
Study Registration Dates
First Submitted
May 18, 2017
First Submitted That Met QC Criteria
May 18, 2017
First Posted (Actual)
May 22, 2017
Study Record Updates
Last Update Posted (Actual)
February 23, 2018
Last Update Submitted That Met QC Criteria
February 22, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 910801
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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