Postoperative PainNCT03161782
The Efficacy of Different Types of Stretching on Range of Motion, Pain and Function in Elbow Limitation
A study testing PNF stretching, Static Stretching and Exercise in people with Postoperative Pain and Elbow Fracture, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Elbow Fracture, Stiffness of Elbow, Not Elsewhere Classified
- What is being tested?
- PNF stretching, Static Stretching and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 25 Jul 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- PNF stretching, Static Stretching, Exercise, Cold Therapy
- Keywords
- pain, exercise, proprioceptive neuromuscular facilitation stretching, static stretching
- Medical subject headings
- Pain, Postoperative, Elbow Fractures, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF stretchingOther
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.
Static StretchingOther
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.
ExerciseOther
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 TherapyOther
Cold therapy will be applied over the elbow for 15 minutes in the form of cold pack after stretching and exercise protocol.
| Study group | Role | What they receive |
|---|---|---|
| PNF Stretching group | Experimental | Each subject in PNF Stretching group will receive a treatment protocol consisting of PNF stretching, cold therapy and exercise. Receives: Other: PNF stretching; Other: Exercise; Other: Cold Therapy |
| Static Stretching group | Experimental | Each subject in Static Stretching group will receive a treatment protocol consisting of static stretching, cold therapy and exercise. Receives: Other: Static Stretching; Other: Exercise; Other: Cold Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Status
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
Measured: After the six-week intervention
Secondary outcomes (8)
Active Range of Motion (AROM) Assessment
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.
Measured: Baseline
Active Range of Motion (AROM) Assessment
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.
Measured: After the six-week intervention
Active Range of Motion (AROM) Assessment
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.
Measured: 1-month follow up
Functional Status
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
Measured: Baseline
Functional Status
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
Measured: 1-month follow up
Pain Intensity
Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
Measured: Baseline
Pain Intensity
Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
Measured: After the six-week intervention
Pain Intensity
Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
Measured: 1-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Jan 2017
- Primary completion15 May 2017
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tansu Birinci, Istanbul University
- Investigators
- Tansu Birinci, MSc, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161782
- Sponsor's protocol ID
- 910801
- Status last verified
- Feb 2018
- First submitted
- 18 May 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Proprioceptive Neuromuscular Facilitation Stretching and Static Stretching on Range of Motion, Pain and Function in Elbow Limitation
- ClinicalTrials.gov ID
- NCT03161782
- Acronym / sponsor ID
- 910801
- Keywords
- pain, exercise, proprioceptive neuromuscular facilitation stretching, static stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 22 May 2017 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNF Stretching group | Experimental | Other: PNF stretching, Other: Exercise, Other: Cold TherapyEach subject in PNF Stretching group will receive a treatment protocol consisting of PNF stretching, cold therapy and exercise. |
| Static Stretching group | Experimental | Other: Static Stretching, Other: Exercise, Other: Cold TherapyEach subject in Static Stretching group will receive a treatment protocol consisting of static stretching, cold therapy and exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| PNF stretchingFor 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. | Other | PNF Stretching group |
| Static StretchingFor 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. | Other | Static Stretching group |
| ExerciseShoulder, elbow and wrist AROM exercises. Elbow flexion and extansion self-stretching exercises Elbow and wrist strengthening exercises Proprioception exercises for elbow. Grip strengthening exercises. | Other | PNF Stretching group, Static Stretching group |
| Cold TherapyCold therapy will be applied over the elbow for 15 minutes in the form of cold pack after stretching and exercise protocol. | Other | PNF Stretching group, Static Stretching group |
Primary outcome
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).
8 secondary outcomes
Active Range of Motion (AROM) Assessment
Time frame: Baseline
Active Range of Motion (AROM) Assessment
Time frame: After the six-week intervention
Active Range of Motion (AROM) Assessment
Time frame: 1-month follow up
Functional Status
Time frame: Baseline
Functional Status
Time frame: 1-month follow up
Pain Intensity
Time frame: Baseline
Pain Intensity
Time frame: After the six-week intervention
Pain Intensity
Time frame: 1-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Tansu Birinci, MSc principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF stretching, Static Stretching and Exercise in people with Postoperative Pain and Elbow Fracture, run by Istanbul 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Status (time frame: After the six-week intervention). 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 23 Feb 2018.