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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Istanbul, Turkey
        • Istanbul University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PNF Stretching group
Each subject in PNF Stretching group will receive a treatment protocol consisting of PNF stretching, cold therapy and exercise.
Other: PNF stretching
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.
Other: 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.
Other: Cold Therapy
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.
Other: 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.
Other: Cold Therapy
Cold therapy will be applied over the elbow for 15 minutes in the form of cold pack after stretching and exercise protocol.
Other: Static Stretching
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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
Functional Status
Time Frame: Baseline
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
Baseline
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).
1-month follow up
Pain Intensity
Time Frame: Baseline
Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
Baseline
Pain Intensity
Time Frame: After the six-week intervention
Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
After the six-week intervention
Pain Intensity
Time Frame: 1-month follow up
Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
1-month follow up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Baseline
Quality of life of the patients will be assessed by Short Form-12.
Baseline
Quality of Life
Time Frame: After the six-week intervention
Quality of life of the patients will be assessed by Short Form-12.
After the six-week intervention
Quality of Life
Time Frame: 1-month follow up
Quality of life of the patients will be assessed by Short Form-12.
1-month follow up
Fear of movement (kinesiophobia)
Time Frame: Baseline
Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale.
Baseline
Fear of movement (kinesiophobia)
Time Frame: After the six-week intervention
Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale.
After the six-week intervention
Fear of movement (kinesiophobia)
Time Frame: 1-month follow up
Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale.
1-month follow up
Patient Satisfaction
Time Frame: After the six-week intervention
Patient Satisfaction will be assessed with Global Rating of Change Scale.
After the six-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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