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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03161782
Other study ID # 910801
Secondary ID
Status Completed
Phase N/A
First received May 18, 2017
Last updated February 22, 2018
Start date January 1, 2017
Est. completion date July 25, 2017

Study information

Verified date February 2018
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 25, 2017
Est. primary completion date May 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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
Cold therapy will be applied over the elbow for 15 minutes in the form of cold pack after stretching and exercise protocol.

Locations

Country Name City State
Turkey Istanbul University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Quality of Life Quality of life of the patients will be assessed by Short Form-12. Baseline
Other Quality of Life Quality of life of the patients will be assessed by Short Form-12. After the six-week intervention
Other Quality of Life Quality of life of the patients will be assessed by Short Form-12. 1-month follow up
Other Fear of movement (kinesiophobia) Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale. Baseline
Other Fear of movement (kinesiophobia) Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale. After the six-week intervention
Other Fear of movement (kinesiophobia) Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale. 1-month follow up
Other Patient Satisfaction Patient Satisfaction will be assessed with Global Rating of Change Scale. After the six-week intervention
Primary Functional Status 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 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. Baseline
Secondary 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. After the six-week intervention
Secondary 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. 1-month follow up
Secondary Functional Status The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). Baseline
Secondary Functional Status The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). 1-month follow up
Secondary Pain Intensity Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale. Baseline
Secondary Pain Intensity Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale. After the six-week intervention
Secondary Pain Intensity Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale. 1-month follow up
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